Sealed positioner that maintains internal air pressure in different environments

Abstract

A sealed positioner for positioning a subject or a body part of a subject includes a filter that maintains the internal air pressure, and thus a particular "feel," of the positioner as the positioner is moved from one environment to another. The sealed positioner can maintain its internal air pressure and "feel" regardless of the environment in which it is used (e.g., altitude, atmospheric pressure, etc.). Methods by which the internal air pressure and feel of the sealed positioner are maintained as the sealed positioner is moved from one environment to another are also disclosed.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 402,033, entitled "SEALED POSITIONERS THAT MAINTAIN INTERNAL AIR PRESSURE IN DIFFERENT ENVIRONMENTS," filed August 29, 2022 (the "'033 Provisional Application"). The entire disclosure of the '033 Provisional Application is hereby incorporated herein.

[0002] The present disclosure relates generally to seal positioners for positioning a subject or a body part of a subject, and more particularly to seal positioners with configurations that allow the seal positioner to maintain its internal air pressure and, therefore, a particular "feel" as it moves from one environment to another. More particularly, the present disclosure relates to seal positioners with configurations that allow the seal positioner to maintain its internal air pressure and "feel" regardless of the environment in which it is used (e.g., altitude, atmospheric pressure, etc.). The present disclosure also relates to methods by which the internal air pressure and feel of the seal positioner are maintained as it moves from one environment to another. [Background technology]

[0003] Positioners are often used in medical settings to maintain the position of a subject or a subject's body parts. For example, medical positioners have been used in neonatal intensive care units (NICUs) to position newborns, including premature babies. Medical positioners have also been used to help stabilize body parts undergoing medical procedures or recovering from surgery.

[0004] Because medical positioners are typically used on a subject or a body part of a subject, the sensation, or "feel," that the medical positioner provides on the subject's body is usually important. In the example of a NICU, experience has shown that medical positioners that provide the feel of a prenatal environment (i.e., within the mother's womb) allow premature infants to experience normal development, which is not possible with medical positioners that do not provide the feel of a prenatal environment.

[0005] In embodiments in which the deformable element of the medical positioner is sealed, the ability of the medical positioner to provide a particular sensation or “feel” to the subject may depend on the atmospheric pressure at which the medical positioner is used. This is particularly true for medical positioners that contain air. Such medical positioners may have internal air pressure that allows the sealing cover of the medical positioner to be relatively loose at low altitudes (e.g., at sea level), but when the medical positioner is exposed to a low-pressure environment (e.g., at higher altitudes, during airplane travel, etc.), that internal air pressure may increase and undesirably expand the sealing cover. Summary of the Invention [Means for solving the problem]

[0006] The positioner of the present disclosure, which may include a cushioning material, is sealed. A sealed positioner, or sealed positioner, may include a deformable material, a container for the deformable material, and a sealing cover having at least one filter. The deformable material and the container may together define a shapeable core of the positioner. Optionally, the positioner may include an intermediate material between the container and the sealing cover. The relative configuration of the sealing cover, filter, and shapeable core, as well as the sealing cover, shapeable core, and optional intermediate material, may together provide a particular feel to the sealing positioner.

[0007] Deformable materials can include moldable compositions, cushioning filler materials that can retain their shape when placed under load, etc. Particles or portions of the deformable material may themselves be resilient, but the deformable material as a whole may be substantially devoid of resilience or may lack resilience altogether.

[0008] The container can hold a deformable material. In embodiments where the deformable material comprises a cushioning filler material, the container may comprise a bag (e.g., a breathable bag, etc.). In embodiments where the deformable material comprises a moldable composition (e.g., lubricated particulates, particulates in a fluid, etc.), the container may comprise a sealed bladder.

[0009] An optional intermediate material is disposed on the exterior of the container. The intermediate material may include a cushioning material, a quantity of cushioning filler material (i.e., a compressible filler material that allows air to flow) that can maintain its shape when placed under load (e.g., compressible beads, polyfiber, foam rubber, spacer fabric, etc.), etc. The intermediate material may be disposed between the shape-changeable core and the inner surface of the sealing cover. In some embodiments, the intermediate material may fill only a portion of the interior of the sealing cover, for example, only one side of the shape-changeable core (e.g., the base), or multiple sides of the shape-changeable core, but not all of the sides. Alternatively, the intermediate material may be disposed around the entire periphery of the shape-changeable core.

[0010] Alternatively, the intermediate material can include a gas or mixture of gases (such as, for example, air) inside the hermetic cover between at least a portion of the shape-changeable core and the inner surface of the hermetic cover.

[0011] The sealing cover may include an outer surface and an inner surface. The inner surface of the sealing cover may define an interior of the sealing cover. The interior of the sealing cover may have at least one characteristic (e.g., volume, air pressure, etc.) that may constitute a predetermined characteristic of the interior. The interior of the sealing cover contains and retains the container and optional buffering or filler material. The sealing cover may be impermeable to fluids and air and may provide a barrier that prevents the passage of microorganisms. The sealing cover may include a hermetically sealed cover.

[0012] The filter of the sealing cover can maintain the sealing property of the sealing cover and allow air to flow in and out of the interior of the sealing cover without affecting at least one characteristic of the interior of the sealing cover and without compromising the integrity of the sealing cover. The at least one characteristic maintained in the interior of the sealing cover as air flows into and / or out of the filter can include the volume of the interior of the sealing cover, the air pressure in the interior of the sealing cover, the maximum particle size in the interior of the sealing cover, etc. The filter allows air to enter and exit the interior of the sealing cover, but can be impermeable to liquids and prevent microorganisms from entering and exiting the interior of the sealing cover.

[0013] The filter may enable the sealed positioner to be used in a variety of different environments at multiple different altitudes and / or pressures (e.g., atmospheric pressure, etc.) while maintaining at least one characteristic of the sealed positioner, such as the feel of the sealed positioner. For example, the filter may enable the sealed positioner to maintain or substantially (e.g., within about 10%) its intended volume at multiple different altitudes. As another example, the filter may enable the sealed positioner to maintain or substantially (e.g., within about 10%) its intended pressure at multiple different altitudes.

[0014] Other aspects of the disclosure, as well as features and advantages of various aspects of the disclosure, will become apparent to those skilled in the art by consideration of the following description, the accompanying drawings, and the appended claims. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a perspective view of an embodiment of a sealing positioner including a shape-changeable core and a filtered cover. FIG. [Figure 2] FIG. 2 is a cutaway perspective view of the embodiment of the seal positioner shown in FIG. 1, showing the internal elements of the seal positioner. [Figure 3] FIG. 2 is a cross-sectional view of the embodiment of the seal positioner shown in FIG. 1. [Figure 4] FIG. 10 is a cutaway perspective view of another embodiment of a sealing positioner including a shape-changeable core, an intermediate material, and a filtered cover, wherein the intermediate material is positioned between only a portion of the shape-changeable core (e.g., a base) and the cover. [Figure 5] FIG. 5 is a cross-sectional view of the embodiment of the seal positioner shown in FIG. 4. [Figure 6] 10 is a cutaway perspective view of yet another embodiment of a sealing positioner including a shape-changeable core, an intermediate material, and a filtered cover, the intermediate material surrounding the shape-changeable core. FIG. [Figure 7] FIG. 7 is a cross-sectional view of the embodiment of the seal positioner shown in FIG. 6. [Figure 8] 10 is a cutaway perspective view of yet another embodiment of a sealing positioner including a shape-shiftable core and a filtered cover, where the shape-shiftable core housing also includes a filter. FIG. [Figure 9] FIG. 9 is a cross-sectional view of the embodiment of the seal positioner shown in FIG. 8. DETAILED DESCRIPTION OF THE INVENTION

[0016] 1-3, an embodiment of a seal positioner 10 is shown. The seal positioner 10 includes a shape-changeable core 20 and a seal cover 50 with a filter 60. The shape-changeable core 20 includes a deformable material 30 and a container 40 for the deformable material 30.

[0017] The shape-changeable core 20 may be deformable. In some embodiments, the shape-changeable core 20 may also be compressible. In some embodiments, the deformable material 30 of the shape-changeable core 20 may comprise a material that flows, or a "flowable material." The container 40 of the shape-changeable core 20 may comprise a flexible container (e.g., a bag, a bladder, etc.).

[0018] The deformable material 30 can include a dry, flowable material. The dry, flowable material can include particles 32 that can freely flow relative to one another. A volume of the dry, flowable material, or a collection of particles 32, can retain its shape when placed under a load. As an example, the particles 32 of the dry, flowable material can include compressible beads. The compressible beads can be compressed from a round (e.g., spherical, spheroidal, etc.) shape to a flatter shape. The compressible beads can also be porous. In some embodiments, the compressible beads can include expanded beads. More specifically, the expanded beads can include expanded polyethylene beads. In a specific example, the expanded beads can include polyethylene beads available from JSP International Group, Ltd. (Wayne, Pennsylvania), such as white polyethylene beads sold as ARPAK® 4313 polyethylene beads, having a density of 14.4 g / L to 18.0 g / L. Other materials that can be foamed or expanded and then compressed can also be used as compressible beads.

[0019] The compressible beads can have an uncompressed state and a compressed state. When uncompressed, the compressible beads can flow freely throughout the container 40. When compressed, the compressible beads can be pressed flat against each other. The coefficient of friction of the surface of the compressed compressible beads prevents the beads from flowing past each other, allowing the compressible beads to define a semi-rigid layer. Thus, the compressible beads can define a conformable layer that can transition between a flowable state and a semi-rigid state.

[0020] As an alternative to compressible beads, the deformable material 30 can include other compressible media that can be used that function as described above. For example, fibers (e.g., polyfiber, microfiber, etc.) that flow when uncompressed but provide a more rigid structure when compressed can be used. In some embodiments, materials that allow for temperature regulation (e.g., phase change materials, etc.) can be used instead of or in addition to the compressible media.

[0021] In embodiments in which the deformable material 30 comprises a dry, flowable material, air may flow through the container 40 of the shape-changeable core 20. By way of example, the container 40 may comprise a fabric bag or the like.

[0022] As another example, the deformable material 30 of the shape-changeable core 20 may include a fluidizing medium, such as particulates (e.g., hollow particulates) dispersed throughout a lubricant (e.g., liquid silicone). The container 40 for such a fluidizing medium may include a sealed polyurethane bladder or the like. Alternatively, a shape-changeable core 20 having a deformable material 30 that includes a fluidizing medium may be compressible, since the fluidizing medium can flow from one location to another within the container 40. The fluidizing medium of such a shape-changeable core 20 may be substantially incompressible.

[0023] The sealing cover 50 may be formed from a flexible material. The flexibility of the material allows the sealing cover 50 to conform to the shape of the subject's body part, the shape of the subject, and / or the surface on which the sealing positioner 10 rests while being used to support the body part or subject. The material of the sealing cover 50 may be impermeable (e.g., to fluids, including air and liquids). The sealing cover 50 may be defined and / or sealed by any of a variety of suitable processes, which may, of course, depend on the material from which the sealing cover 50 is defined. Some non-limiting examples of processes for defining and / or sealing the sealing cover 50 include heat sealing, radio frequency (RF) welding, ultrasonic sewing, and conventional sewing to secure edges of material together to define and / or seal the sealing cover 50.

[0024] The hermetic cover 50 includes an outer surface 52 and an inner surface 54. The inner surface 54 defines an interior 56 of the hermetic cover 50.

[0025] The outer surface 52 of the sealing cover 50 can have a texture that imparts certain properties to the outer surface 52. For example, a portion of the outer surface 52 can prevent the sealing cover 50 from slipping when placed on another surface (e.g., can include a non-slip material, etc.). As another example, at least a portion of the outer surface 52 of the sealing cover 50 can have a texture that is comfortable when placed on a body part of a subject. As yet another example, at least a portion of the outer surface 52 of the sealing cover 50 can provide a particular benefit (e.g., allowing air to flow between the sealing cover 50 and the subject, increasing oxygen levels in the subject's skin, stimulating blood flow in the subject's skin, etc.).

[0026] The filter 60 may have a configuration that allows it to maintain at least one characteristic of the interior 56 of the sealing cover 50, such as a predetermined or predefined volume, pressure, and / or maximum particle size. Without limitation, the filter 60 may allow air to pass through while restricting the size of particles that can pass through. In some embodiments, the filter 60 may be an antibacterial filter that can exclude bacteria and even viruses from the interior of the sealing cover 50. An example of such a filter 60 is the PNEUMAPURE® filter available from Pneuma Pure Limited and disclosed in U.S. Patent Nos. 8,561,233 ("the '233 patent") and 8,950,028 ("the '028 patent"), the disclosures of which are incorporated herein in their entireties. Such a filter 60 may be assembled and secured to the sealing cover 50 in the manner and orientation described in the '233 and '028 patents. Such a filter 60 can maintain a predetermined volume, air pressure, and / or maximum particle size within the interior 56 of the sealing cover 50 while preventing microorganisms (e.g., bacteria, fungi, mold, and even some viruses) from entering the interior 56 of the sealing cover 50.

[0027] In some embodiments, the hermetic cover 50 may be disposed in direct and substantial contact with the outer surface 22 of the shapeable core 20. In other embodiments, a gas or mixture of gases (e.g., air, etc.) may be located between the shapeable core 20 and the inner surface 54 of the shapeable cover 50. The gas may occupy a predetermined or pre-defined volume of the space between the shapeable core 20 and the inner surface of the shapeable cover 50. The gas may exert a predetermined or pre-defined pressure (e.g., air pressure, etc.) on the interior 56 of the hermetic cover 50.

[0028] 4 and 5, another embodiment of a sealing positioner 10' is shown. The sealing positioner 10' includes the shape-shiftable core 20 and the sealing cover 50 with the filter 60, as previously described herein with respect to FIGS. 1-3. In addition, the sealing positioner 10' includes an intermediate material 70' between a portion of the shape-shiftable core 20 and the inner surface 54 of the sealing cover 50. More specifically, the intermediate material 70' can be located between the base 28 of the shape-shiftable core 20 and the base 58 of the sealing cover 50.

[0029] The intermediate material 70' can include a dry, flowable material. The dry, flowable material can include particles 72' that can freely flow relative to one another. A volume of the dry, flowable material, or a collection of particles 72', can retain a shape when placed under a load. As an example, the particles 72' of the dry, flowable material can include compressible beads, as previously described herein. Alternative, non-limiting examples of the intermediate material 70' include polyfiber, foam rubber, spacer fabric, and the like.

[0030] 6 and 7 illustrate another embodiment of a sealing positioner 10″. The sealing positioner 10″ includes a shape-shiftable core 20 and a sealing cover 50 with a filter 60, as described herein above with respect to FIGS. 1-3, and an intermediate material 70′, as described herein above with respect to FIGS. 4 and 5. The intermediate material 70′ can surround or substantially surround the shape-shiftable core 20. More specifically, the intermediate material 70′ can be located or positionable between all surfaces of the shape-shiftable core 20 and the inner surface 54 of the sealing cover 50.

[0031] 8 and 9, another embodiment of the seal positioner 10''' is shown. The seal positioner 10''' includes a shape-shiftable core 20''' and a seal cover 50 with a filter 60. The shape-shiftable core 20''' may be configured substantially as previously described herein with reference to FIGS. 1-3, with the addition of a filter 60''' to the container 40''' of the shape-shiftable core 20'''. The filter 60''' may have a configuration similar to that previously described herein with reference to FIGS. 1-3.

[0032] In embodiments in which the deformable material 30 of the shape-changeable core 20''' comprises a fluid (e.g., a liquid, a gel, etc.) with, for example, particulates dispersed throughout a liquid medium, the filter 60''' may include an oleophobic coating on the filter membrane (e.g., instead of a hydrophobic coating, etc.) and be oriented in a direction opposite to that described by the '233 and '028 patents, with the filter membrane or its optional backing facing the interior 46''' of the container 40''' and the deformable material 30''' therein. Such an arrangement may allow the filter 60''' to add or subtract volume, pressure, etc. of the surrounding air within the deformable material 30'''.

[0033] The sealing positioner 10'''' may be free of an intermediate material 70' (Figures 4 and 5) or gas between the shape-changeable core 20''' and the sealing cover 50, or may include a gas as shown in and described with reference to Figures 1-3, or may include an intermediate material 70' as shown in and described with reference to Figures 4 and 5 or Figures 6 and 7.

[0034] 1-3 , more specifically, in embodiments in which the deformable material 30 of the shape-changeable core 20 comprises compressible beads and the container 40 of the shape-changeable core 20 is breathable, the compressible beads may be compressed under the weight of an object, such as a body part of a subject or a subject, when the body part of the subject (e.g., head, back, torso, buttocks, legs, feet, etc.) rests on the shape-changeable core 20. The container 40 and the deformable material 30 therein may conform to the shape of the object and / or the surface supporting the shape-changeable core 20. In embodiments in which the deformable material 30 comprises beads and the container 40 is breathable, air may escape from the interstitial spaces between the compressible beads and from the container 40 upon compression. As friction between the compressed beads increases, the compressible beads may define a semi-rigid layer that conforms to the shape of the object and / or the shape of the surface supporting the compressible layer and / or the shape of the element of which the compressible layer is a part. The volume of compressible beads within container 40 may be large enough to allow the compressible beads to remain between the object and the surface on which shape-changeable core 20 rests.

[0035] When the compressive force is removed (e.g., by lifting the body part, subject, etc.), the compressible beads can expand when the compressive force is removed, drawing air into the container 40 and the gaps between the compressible beads. As the compressible beads return to their initial shape, surface contact, and therefore friction, between adjacent compressible beads is reduced. Thus, the beads can again flow relative to one another.

[0036] A method for transporting the seal positioner 10 (or any other embodiment of the seal positioner) includes providing the seal positioner 10, moving the seal positioner 10 from a first environment to a second environment, and maintaining a predetermined pressure within the seal positioner 10. Additionally, such a method can include maintaining at least one characteristic of the seal of the seal cover 50 of the seal positioner 10 and the interior 56 of the seal cover 50 while moving the seal positioner 10 from the first environment to the second environment.

[0037] Providing the sealing positioner 10 may include providing the sealing positioner 10 including a shape-changeable core 20 within a sealing cover 50. An interior 56 of the sealing cover 50 (e.g., a portion of the interior between the shape-changeable core 20 and an inner surface 54 of the sealing cover 50, the entire interior 56, etc.) may have a predetermined pressure and / or a predetermined volume.

[0038] Moving the sealed positioner 10 from a first environment to a second environment can include moving the sealed positioner 10 from a first environment having a first pressure (e.g., a first atmospheric pressure at a first altitude) to a second environment having a second pressure (e.g., a second atmospheric pressure at a second altitude within an aircraft (e.g., a medical transport helicopter, airplane, etc.)). The first pressure and the second pressure can be different from each other.

[0039] Maintaining the predetermined pressure may include maintaining the predetermined pressure in the interior 56 of the sealing cover 50 regardless of the environment, altitude, and / or pressure in which the seal positioner is located. For example, the predetermined pressure may be the same while the seal positioner 10 is located in a first environment, while the seal positioner is being moved from the first environment to a second environment, and while the seal positioner is located in the second environment. The predetermined pressure may be maintained by flowing gas through the filter 60 of the sealing cover 50. While the seal positioner 10 is being moved from the first environment to the second environment with the first pressure greater than the second pressure, gas may flow from the interior 56 of the sealing cover to a location outside the sealing cover 50. Alternatively, while the seal positioner 10 is being moved from the first environment to the second environment with the first pressure less than the second pressure, gas may flow from a location outside the sealing cover 50 into the interior of the sealing cover 50. In any event, by maintaining a predetermined pressure within the interior 56 of the sealing positioner 10, the sealing positioner 10 can provide the subject with the same sensation or feel regardless of the environment in which the sealing positioner 10 is used.

[0040] While the foregoing disclosure provides many specific examples, these should not be construed as limiting the scope of any of the following claims, but merely as providing illustrations of some embodiments of the elements and features of the disclosed subject matter. Other embodiments of the disclosed subject matter and their elements and features may be devised that do not depart from the spirit or scope of any of the claims. Features of different embodiments may be used in combination. Accordingly, the scope of each claim is limited only by its plain language and its legal equivalents.

Claims

1. In sealed positioners, a sealing cover defining an exterior of the sealing positioner and including an interior having a substantially constant air pressure; a filter within the sealing cover that allows air to flow into and out of the interior of the sealing cover while sealing the sealing cover and maintaining the substantially constant air pressure within the interior of the sealing cover; a deformable core within the interior of the hermetic cover; A sealed positioner comprising:

2. The sealing positioner of claim 1 , wherein the filter comprises an antibacterial filter.

3. The seal positioner of claim 1 or 2, wherein the seal cover is defined from an impermeable material.

4. The seal positioner of claim 1 or 2, wherein the shapeable core comprises a moldable material.

5. The seal positioner of claim 4 , wherein the moldable material comprises compressible beads.

6. The seal positioner of claim 5 , wherein the compressible beads comprise expanded polyethylene beads.

7. The seal positioner of claim 4 , wherein the moldable material comprises particles dispersed throughout a fluid medium.

8. The sealed positioner of claim 7 , wherein the particles comprise hollow microparticles and the fluid medium comprises liquid silicone.

9. In sealed positioners, A shape-changeable core; a sealing cover including an inner surface defining an interior of the sealing cover, the interior carrying the shape-changeable core and having a predetermined pressure and maximum particle size between the shape-changeable core and the inner surface of the sealing cover; a filter within the sealing cover that allows air to flow into and out of the interior of the sealing cover while maintaining the sealing of the sealing cover, the predetermined pressure, and the maximum particle size; and A sealed positioner comprising:

10. The sealing positioner of claim 9 , wherein the filter excludes bacteria from the interior of the sealing cover.

11. The seal positioner of claim 10 , wherein the filter further excludes viruses from the interior of the seal cover.

12. The seal positioner of claim 9 or 10, wherein the seal cover is defined from an impermeable material.

13. 11. The seal positioner of claim 9 or 10, wherein the shapeable core comprises a moldable material.

14. The seal positioner of claim 13 , wherein the moldable material comprises compressible beads.

15. The seal positioner of claim 13 , wherein the moldable material comprises particles dispersed throughout a fluid medium.

16. 1. A method for transporting a sealed positioner, comprising: providing a seal positioner including a deformable core within a seal cover, the seal positioner having a predetermined pressure between the deformable core and an inner surface of the seal cover; moving the sealed positioner from a first environment to a second environment, the first environment having a first pressure and the second environment having a second pressure, the first pressure and the second pressure being different from one another; maintaining the predetermined pressure between the shape-changeable core and the inner surface of the hermetic cover by flowing gas through a filter in the hermetic cover while the hermetic positioner is located in the first environment, while the hermetic positioner is moved from the first environment to the second environment, and while the hermetic positioner is located in the second environment; maintaining a seal of the seal cover and at least one characteristic of the interior of the seal cover while moving the seal positioner from the first environment to the second environment; A method comprising:

17. 17. The method of claim 16, wherein flowing gas through the filter comprises flowing gas from the interior of the hermetic cover to a location outside the hermetic cover while moving the hermetic positioner from the first environment to the second environment with the first pressure exceeding the second pressure.

18. 18. The method of claim 16 or 17, wherein flowing gas through the filter comprises flowing gas from a location outside the hermetic cover to the interior of the hermetic cover while moving the hermetic positioner from the first environment to the second environment with the first pressure below the second pressure.

19. 18. The method of claim 16 or 17, wherein moving the seal positioner from the first environment to the second environment comprises moving the seal positioner from a first altitude to a second altitude.

20. 18. The method of claim 16 or 17, wherein maintaining the predetermined pressure includes maintaining the feel of the seal positioner in the first environment and the second environment.

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