US20070083995A1

US20070083995A1 - Fluidized positioning and protection system

Info

Publication number: US20070083995A1
Application number: US11/546,868
Authority: US
Inventors: William Purdy; Robert Purdy
Original assignee: SUNDANCE ENTERPRISES
Current assignee: SUNDANCE ENTERPRISES
Priority date: 2005-10-12
Filing date: 2006-10-12
Publication date: 2007-04-19
Also published as: WO2007047379A3; WO2007047379A2

Abstract

The present invention provides a fluidized positioning system including an inner bladder formed of a medium that has no memory or substantially no memory. An outer bladder is placed adjacent to or coupled to the inner bladder. The outer bladder is partially filled with a composition. The composition can be beads, such as polystyrene beads, or beads made of a similar medium. A valve extending from the outer bladder permits the evacuation of all or some of the air from the outer bladder which causes the outer bladder to be reduced in size due to loss of air between the beads and adjusts the rigidity of the outer bladder to allow the outer bladder to form fit the inner bladder around whatever body extremity it is being used on.

Description

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Patent Application No. 60/725,800, filed Oct. 12, 2005 and U.S. Provisional Patent Application No. 60/844,227, filed Sep. 13, 2006, the entirety of both of which are hereby incorporated by reference into this application.

BACKGROUND OF THE APPLICATION

1. Field of the Invention
The present invention relates to a body part support and in particular, to a custom fitting limb or body part support.
2. Background of the Invention
Conventionally body positioning and cushioning in a hospital setting is performed with foam and gel materials. These materials, however, do not have the ability to react three dimensionally to forces being applied by bony prominences. Twisting and sliding are typical of what occurs during positional changes. By definition, materials that have memory cannot react to these two categories of movement. They are especially unable to respond when twisting and sliding occur simultaneously.
It is desirable to accommodate three-dimensional movements while providing positioning and preventing damage to skin.

SUMMARY OF THE INVENTION

Proper positioning is a key component of patient care in all settings from neonatal care to geriatric. Friction and shear are key factors in skin breakdown while trying to properly position patients. In patients whose health is compromised, friction and shear can be potentially more damaging to the skin integrity than interface pressure. It has been found that complex three dimensional movements of a patient can be matched by using a medium that has no memory or substantially no memory.
In one embodiment, the present invention provides a fluidized positioning system including an inner bladder formed of a medium that has no memory or substantially no memory. For example, the medium can be formed of a fluidized composition of a mixture of microspheres and lubricant.
The medium that has no memory or substantially no memory can be formed of a medium that is fluidized. A suitable medium for positioning provides the characteristics of a fluid except for flow capability. In one embodiment, the medium provides no flow or substantially no flow. The medium can provide three dimensional contouring.
In one embodiment, an outer bladder is placed adjacent to or coupled to the inner bladder. The outer bladder is partially filled with a composition. The composition can be beads, such as polystyrene beads, or beads made of a similar medium. A valve extending from the outer bladder permits the evacuation of all or some of the air from the outer bladder which causes the outer bladder to be reduced in size due to loss of air between the beads and adjusts the rigidity of the outer bladder to allow the outer bladder to form fit the inner bladder around whatever body extremity it is being used on. Accordingly, the viscosity of the medium within the outer bladder is changed due to air evacuation. For example, the system can be sized to fit around a limb, such as an arm or leg or a portion thereof, finger, toe, torso, occiput, face or neck.
In one embodiment, a plurality of compartments are formed in the inner bladder or a quilting arrangement of the inner bladder is used. In an alternate embodiment, a plurality of containers are used in the outer bladder. One or more stop cocks can be positioned within a manifold before an inlet port to each of the containers. Each stop cock can be regulated to allow a predetermined amount of vacuum from a valve to be applied to each container to deflate each container or to stop the vacuum from being applied to specific containers. Accordingly, individual containers can be controlled to provide a feeling of soft or firm or a variation thereof.
The fluidized positioning and protection system can be used, for example, in mattresses for spinal patients, neonates, infants and toddlers or any embodiment in which contouring and support are desired and for spinal alignment, head and neck alignment, prevention of nerve entrapment, casting or passive splinting of body parts, and extension of body parts, such as the neck. Other uses for fluidized positioning and protection system include sports equipment, such as helmets or pads, vehicular seats, car seats and seats for infants and toddlers.
In one embodiment, the fluidized positioning and protection system provides attenuation of forces. A plurality of layers can include one or more microcontouring layers of no memory or substantially no memory medium and one or more gross containing layers being partially filled with a composition of beads or a similar medium and a valve for permitting evacuation of all or some of the air from the medium and one or more layers of foam. The number of layers and arrangement determined the amount of attenuation.
The present invention can provide suitable positioning which has a positive effect on all the following body functions including, for example: circulation, neuro, orthopedic, digestive, respiration, and pulmonary.
The present invention provides a positioning system that is strong enough to support the patient but soft enough that it does not compress capillaries or nerves in the process.
The invention will be more fully described by reference to the following drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan schematic view of a fluidized positioning and protection system including a partial cross section of the outer bladder in accordance with the teachings of the present invention.
FIG. 2 is a top plan schematic view of the fluidized positioning and protection system formed in the shape of a face mask.
FIG. 3 is a top plan schematic view of the fluidized positioning and protection system formed as a heel and lower leg support.
FIG. 4 is a top plan schematic diagram of the fluidized positioning and protection system including a cross section of the inner bladder.
FIG. 5 is a schematic diagram of a side view of a compartment of the protection system shown in FIG. 4 after contouring.
FIG. 6 is a top plan schematic diagram of the fluidized positioning and protection system including a cross section of the inner bladder.
FIG. 7 is a schematic vertical cross sectional view of an embodiment of the fluidized positioning and protection system.
FIG. 8 is a schematic top plan view of an embodiment of the fluidized positioning and protection system providing attenuation of forces for supporting a head of a user.
FIG. 9 is a schematic side view of an embodiment of the fluidized positioning and protection system.
FIG. 10A is a schematic diagram of a side vertical cross sectional view of an embodiment of the fluidized positioning and protection system.
FIG. 10B is a top plan view of the fluidized positioning and protection system shown in FIG. 10A.
FIG. 10C is a top horizontal cross sectional view of the fluidized positioning and protection system.
FIG. 10D is a top horizontal cross sectional view of an embodiment of the fluidized positioning and protection system.
FIG. 10E is a side schematic view of the fluidized positioning and protection system shown in FIG. 10A during use.
FIG. 11A is a top plan view of an embodiment of the fluidized positioning and protection system.
FIG. 11B is a bottom plan view of the fluidized positioning and protection system shown in FIG. 11A.
FIG. 11C is a side elevational view of the fluidized positioning and protection system shown in FIG. 11A.
FIG. 12 is a perspective top view of an embodiment of the fluidized positioning and protection system.
FIG. 13 is a schematic diagram of a vertical cross section of an embodiment of the fluidized positioning and protection system.
FIG. 14 is a top schematic view of an embodiment of the fluidized positioning and protection system.
FIG. 15A is a schematic top plan view including a partial view of a cover of the fluidized positioning and protection system for use as an infant support.
FIG. 15B is a schematic diagram of an embodiment of a layer used in the system shown in FIG. 15A.
FIG. 15C is a schematic diagram of an embodiment of a layer used in the system shown in FIG. 15A.
FIG. 16A is a schematic diagram of an embodiment of the fluidized positioning and protection system during use by an infant or baby in a car seat.
FIG. 16B is a schematic diagram of use of prior art car seat by an infant or baby.
FIG. 17A is a side view of an embodiment of the fluidized positioning and protection system before use by an infant or baby.
FIG. 17B is an embodiment of the fluidized positioning and protection system during use in a seat.
FIG. 17C is an embodiment of the fluidized positioning and protection system during use in a seat.
FIG. 17D is an embodiment of the fluidized positioning and protection system during use in a seat.
FIG. 18A is a schematic diagram of a top view of the fluidized positioning and protection system including a tab during use as a pillow.
FIG. 18B is a schematic diagram of an underside view of the system shown in FIG. 18A.
FIG. 18C is a side view of the system shown in FIG. 18A in an uncompressed position of the tab.
FIG. 18D is a top view of the system shown in FIG. 18A in an uncompressed position of the tab.
FIG. 18E is a side view of the system shown in FIG. 18A during use in an uncompressed position of the tab.
FIG. 19A is a side view of an embodiment of the fluidized positioning and protection system in an uncompressed position of the tab.
FIG. 19B is a top plan view of an embodiment of the fluidized positioning and protection system during use in an uncompressed position of the tab.
FIG. 19C is a side view of an embodiment of the fluidized positioning and protection system in a compressed position of the tab.
FIG. 19D is a top plan view of an embodiment of the fluidized positioning and protection system during use in a compressed position of the tab.

DETAILED DESCRIPTION

Reference will now be made in greater detail to a preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts.
FIG. 1 is a top plan view of a fluidized positioning and protection system 10 in accordance with the teachings of the present invention. Inner bladder 11 is filled with composition 12 which can retain its shape after sculpting. For example, inner bladder 11 can be formed of a flexible plastic, such as urethane. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory. The no memory or substantially no memory feature enables inner bladder 11 to increase in height and maintain support of a body part. Inner bladder 11 provides micro-contouring because composition 12 can respond three dimensionally. Composition 12 is made of a viscosity that will allow it to contour but not collapse under the weight of the body part. Suitable examples of composition 12 can be formed of a mixture of microspheres and lubricant. The microspheres can include hollow or gas-filled structural bubbles (typically of glass or plastic) with an average diameter of less than 200 microns. The composition flows and stresses in response to a deforming pressure exerted on it and the composition ceases to flow and stresses when the deforming pressure is terminated. For example, composition 12 can be formed of a product referenced to as Floam™. A flowable compound comprising lubricated microspheres, including the compound itself, formulations for making the compound, methods for making the compound, products made from the compound and methods for making products from the compound as defined by U.S. Pat. Nos. 5,421,874, 5,549,743, 5,626,657, 6,020,055 and 6,197,099.
Outer bladder 14 is positioned adjacent to inner bladder 11. Outer bladder 14 can be coupled to inner bladder 11. For example, outer bladder 14 can be coupled to inner bladder 11 using a hook and loop material, sewing or adhesive. Alternatively, outer bladder 14 and inner bladder 11 have one or more portions which are integral to one another. Typically, outer bladder 14 has a larger size than inner bladder 11. For example, outer bladder 14 can be at least about 10% to about 80% larger than inner bladder 11, preferably about 20% to about 30% larger than inner bladder 11. Outer bladder 14 is partially filled with a composition, such as beads 17. Suitable beads include polystyrene beads, or beads made of a similar medium. Valve 18 extending from outer bladder 14 permits the evacuation of all or some of the air from outer bladder 14 which causes outer bladder 14 to be reduced in size due to loss of air between beads 17 and adjusts the rigidity of outer bladder 14 to allow outer bladder 14 to come in contact with inner bladder 11 and form fit around whatever body extremity it is being used on. In an alternate embodiment, breathable open cell foam 19 can be used in combination with beads 17 or as a stand alone material within outer bladder 14.
Fluidized positioning and protection system 10 can be formed to fit around any body extremity. For example, fluidized positioning and protection system 10 can be sized to fit around a limb, such as an arm or leg or a portion thereof, finger, toe, torso, occiput, face or neck.
During operation, outer bladder 14 is placed adjacent or underneath a body part and inner bladder 11 contacts the body part. Air is removed from outer bladder 14 with valve 18 to allow fluidized positioning and protection system 10 to fit around the body part and provide a predetermined degree of rigidity. After completion of use of fluidized positioning and protection system 10, valve 18 can be released thereby drawing air back into outer bladder 14 rendering fluidized positioning and protection system 10 flexible so that it can be reused to be custom-fitted to either another patient or another body part on the same patient. Accordingly, inner bladder 11 provides a micro-contour of the body part while outer bladder 14 provides support and gross contouring to prevent unwanted mobility of the body part.
The amount of air evacuated from the outer chamber determines the rigidity of outer bladder 14. Although, outer bladder 14 and inner bladder 11 are connected, the rigidity will not diminish the contouring capability of inner bladder 11. The rigidity of the outer bladder 14 functions to prevent contracture while the contouring zero memory or substantially zero memory medium of inner bladder 11 helps prevent soft tissue damage due to capillary occlusion.
The present invention provides customization by deflation. As the deflation in outer bladder 14 occurs using valve 18, there is a simultaneous migration of composition 12 having the zero memory or substantially no memory medium in inner bladder 11 to contour to whatever body part is being surrounded by the device. This feature is only achievable if the medium inside inner bladder 11 has no “memory” (i.e. a desire to return to its original shape) or substantially no memory. Any material with memory will stretch thus causing “surface tension” as it attempts to return to its original position.
While inner bladder 11 contours to the body, outside wall 20 of outer bladder 14 will take the shape of the bed or whatever device the patient is sitting in or laying upon. This feature serves as a stabilizing component of the device. Conventional devices with a rigid shell do not take the shape of the mattress and are therefore not as stable. They can slide or rotate causing potential injury.
The present invention provides adjustability which enables a “one size fits all” product. Conventionally this is accomplished through inflation.
In one embodiment, fluidized positioning and protection system 10 is formed as a face mask, as shown in FIG. 2. Outer bladder 14 has a curved shape relating to portions of the face, such as the forehead and the cheek bones. Inner bladder 11 is micro-contoured upon receiving a user's nose. Outer bladder 14 is partially filled with beads 17. Air is evacuated from outer bladder 14 to allow outer bladder 14 to fit around the portions of the face for providing support and proper head/neck spinal alignment.
In an alternate embodiment, fluidized positioning and protection system 10 is formed as a heel and lower leg support, as shown in FIG. 3. Heel protection portion 30 is formed of at one end of fluidized positioning and protection system 10. Heel protection portion 30 includes inner bladder 11 and outer bladder 14. Inner bladder 11 is formed of a no memory material or substantially no memory material. Outer bladder 14 is partially filled with a composition of beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 extending from outer bladder 14 permits the evacuation of all or some of the air from outer bladder 14 of heel protection portion 30 which causes outer bladder 30 to be reduced in size and adjusts the rigidity of outer bladder 14.
Leg protection portion 34 is formed of fluidized positioning and protection system 10. Leg protection portion 34 includes inner bladder 11 and outer bladder 14. Inner bladder 11 is formed of a no memory material or substantially no memory material. Outer bladder 14 is partially filled with a composition of beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 extending from outer bladder 14 of leg protection portion 34 permits the evacuation of all or some of the air from outer bladder 14 which causes outer bladder 14 to be reduced in size and adjusts the rigidity of outer bladder 14.
Heel protection portion 30 is coupled by coupler 32 to leg protection portion 34. For example, coupler 32 can be formed of metal or plastic. Alternatively, coupler 32 can be a bladder including a sufficient amount of composition 12 to provide three-dimensional molding. In one embodiment, outer bladder 14 of heel protection portion 30, outer bladder 14 of leg protection portion 34 and coupler 32 are integral to one another and air valve 18 is used to remove air from outer bladder 14 of heel protection portion 30, outer bladder 14 of leg protection portion 34 and coupler 32.
Heel protection portion 30 can be rotatable with respect to leg protection portion 34. For example, heel protection portion 30 can be rotated to place a received heel in an immobilized or suspended condition. Alternatively, heel protection portion 30 can be rotated to elevate the foot. Heel protection portion 30 can include vertical wall 36 for preventing foot drop. Leg protection portion 34 protects the Achilles tendon while maintaining support of the heel and lower extremity.
In general, the custom fitting protection can be used in such a way as to elevate the foot without “locking out the knee” due to three dimensional molding. The natural contour of the leg can be maintained while eliminating harmful pressure to the heel, ankle, Achilles and foot.
FIG. 4 illustrates an embodiment of fluidized positioning and protection system 50. Fluidized positioning and protection system 50 comprises inner bladder 51 and outer bladder 54. Outer bladder 54 is positioned adjacent or coupled to inner bladder 51. Inner bladder 51 comprises one or more compartments 52 a-52 n retained therein. One or more of compartments 52 a-52 n can be positioned within inner bladder 51 without attachment thereto or they can be attached using a sewn or welded seam. For example, compartments 52 a-52 n can comprise tubular structures closed at either end. Compartments 52 a-52 n are formed of a breathable and stretchable material to allow for air or fluid exchange with outer bladder 54. For example compartments 52 a-52 n can be formed of a nylon material. In one embodiment, a plurality of compartments 52 a-52 n can be used in which varying degrees of contours and support can be selected for each of compartments 52 a-52 n. Fill volume of compartments 52 a-52 n can be varied and the numbers and size of compartments 52 a-52 n can be selected to alter the feel and contouring ability of inner bladder 51.
One or more compartments 52 a-52 n are filled with composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory. Composition 12 can be formed of particles such as microspheres for providing a micro-contour to an object received on inner bladder 51. Composition 12 can be any material which provides a zero memory characteristic or a substantially zero memory characteristic. Inner bladder 51 can conform and contour completely three dimensionally.
Inner bladder 51 contours to outer bladder 54. Outer bladder 54 is formed of a material to provide gross contouring to inner bladder 51 or on a surface of which outer wall 55 of outer bladder 54 contacts. For example, outer bladder 54 can be partially filled with beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 extending from outer bladder 54 permits the evacuation of all or some of the air from outer bladder 54 which causes outer bladder 54 to be reduced in size and adjusts the rigidity of outer bladder 54 to allow outer bladder 54 to fit around whatever body extremity it is being used on. The depth of outer bladder 54 is sufficient so as not to have contouring of inner bladder 51 affected by the contouring of outer bladder 54. Outer bladder 54 can be formed of a material such as plastic that is washable and waterproof and flexible enough to allow for molding at different positions. Outer bladder 54 can be air tight. Inner bladder 51 and outer bladder 54 can be remolded if position changes are needed by releasing valve 18 and vacuum within outer bladder 54 to remove the rigidity of outer bladder 54 and thereafter deflating outer bladder 54 to form a vacuum after the position change has been made.
Outer bladder 54 can be evacuated by power system 56 connected to valve 18. Power system 56 can be powered either by AC or battery.
Inner bladder 51 can be formed of sufficient means and depth to provide an independent contour or buffer zone to outer bladder 54. FIG. 5 illustrates buffer zone 60 formed within compartment 52 after contouring. Buffer zone 60 is unaffected by contouring of upper surface 58 or lower surface 59 of inner bladder 51. Inner bladder 51 provides contouring only upon application of a stimulus.
In an alternate embodiment, outer bladder 54 can be evacuated manually by attaching pumping device 57 to valve 18, as shown in FIG. 6. Alternatively, in a hospital or clinical environment, an adjustable wall suction can be used as pumping device 57. Power system 56 and pumping device 57 can provide variable rigidity of outer bladder 54 depending on a selected amount of air evacuated from outer bladder 54. A low setting can allow a caregiver to mold fluidized positioning and protection system 50 in an intermediate position before rendering a final molded position.
Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 can be used for example in mattresses for spinal patients, neonates, infants and toddlers or any embodiment in which contouring and support are desired.
Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 can also be used for spinal alignment, head and neck alignment, prevention of nerve entrapment, casting or passive splinting of body parts, and extension of body parts, such as the neck. Other uses for fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 include sports equipment, such as helmets or pads, vehicular seats, car seats and seats for infants and toddlers.
Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 can provide effective positioning including but are not limited to the following: elevation of the heels without causing damage to another area of the leg. For example shear and friction could potentially cause skin breakdown around the achilles tendon. Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 provides a fluidized cradling effect to prevent the leg from rotating in or out causing potential problems in the hip.
Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 can also provide offloading of the occiput while maintaining neutral cervical alignment. Typically, all the weight of the head is supported by the occiput. Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 provides offloading which spreads the pressure across a larger surface area and responds to the three dimensional movement of the head.
A turning and repositioning of a patient in a hospital on a schedule can be maintained. Fluidized positioning and protection system 10 and/or fluidized positioning and protection system 50 can provide support of the body and maintain the position dictated by the medical protocol.
FIG. 7 illustrates fluidized positioning and protection system 70 providing an attenuation of forces from an object, such as a bony body extremity. Body extremity 71 contacts outer surface 72 of outer layer 73. Outer surface 72 comprises a thin membrane of a material such as waterproof flexible film urethane or PVC for providing micro-contouring. Outer layer 73 can comprise a bladder filled with a zero memory medium or substantially zero memory medium. For example, outer layer 73 can be filled with compartment 12. Outer layer 73 receives the first impact of body extremity 71 and provides minimal resistance to allow for acute angle penetration. Outer layer 73 provides marginal support for a body extremity 71 generating force.
Inner layer 75 is adjacent or coupled to outer layer 73. Surface 74 of inner layer 75 can be formed of a thin membrane of a material such as urethane. Surface 74 typically has less contouring than outer surface 72 since force of body extremity 71 has been partially dissipated in outer layer 73.
Inner layer 75 is formed of a material to provide gross contouring to surface 74. For example, inner layer 75 is a bladder partially filled with beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 extending from inner layer 75 permits the evacuation of all or some of the air from inner layer 75 which causes inner layer 75 to be reduced in size and adjusts the rigidity of inner layer 75.
Inner layer 76 is adjacent or coupled to inner layer 75. Inner layer 76 provides a small amount or no deformation resulting from attenuation of forces in inner layer 75. Inner layer 76 can be formed of, for example, a polyester foam material, urethane foam.
Support layer 77 is adjacent or coupled to inner layer 76. Support layer 77 provides deformity in response to surface 78 upon which system 70 rests. For example, support layer 77 conforms to protrusion 79 of surface 78. Support layer 77 is formed of a material to provide gross contouring. For example, support layer 77 is partially filled with beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 extending from support layer 77 permits the evacuation of all or some of the air from support layer 77 which causes support layer 77 to be reduced in size and adjusts the rigidity support layer 77. In alternate embodiments, various numbers of layers can be used. The number of layers selected determines the amount of attenuation.
FIG. 8 illustrates fluidized positioning and protection system 80 providing an attenuation of forces for supporting a head of a user. Outer layer 83 provides micro-contouring of head 81. Outer layer 83 provides marginal support for head 81. Outer layer 83 can comprise a bladder filled with zero memory medium or substantially zero memory medium. For example, outer layer 83 can be filled with composition 12.
Layer 85 is adjacent or coupled to outer layer 83. Layer 85 is formed of a material to provide gross contouring. For example, layer 85 is partially filled with beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 a extending from layer 85 permits the evacuation of all or some of the air from layer 85 which causes layer 85 to be reduced in size and adjusts the rigidity of layer 85.
Inner layer 87 is coupled or adjacent to layer 85. Inner layer 87 is formed of a material to provide gross contouring. For example, inner layer 87 is partially filled with beads 17, such as polystyrene beads, or beads made of a similar medium. Valve 18 b extending from inner layer 87 permits the evacuation of all or some of the air from inner layer 87 which causes inner layer 87 to be reduced in size and adjusts the rigidity of inner layer 87.
During operation, head 81 is positioned within outer layer 83 and sides 82 of outer layer 83. Outer layer 83 and sides 82 can be folded to the shape of the face such as the orbital, cheek or chin. Outer layer 83 and sides 82 provide micro-contouring to head 81 and provides anti-shear and capillary perfusion. Thereafter, valve 18 a is activated to deflate layer 85. Layer 85 provides gross contouring and rigidity for support of head 81. Thereafter, inner layer 87 can be adjusted to neutralize the spine height. Valve 18 b is activated to deflate inner layer 87. Inner layer 87 provides gross contouring and additional support of head 81. System 80 provides, for example, spreading of forces across the forehead, cushioning of the cheek, support of the jaw and support of the chin.
FIG. 9 illustrates a top plan view of an embodiment of fluidized positioning and protection system 90. Top layer 92 provides contouring to a body extremity. For example, top layer 92 can provide three-dimensional contouring. Top layer 92 has no vacuum for providing constant contouring. Top layer 92 is positioned adjacent to or coupled to bottom layer 94. Bottom layer 94 is partially filled with beads 17. Valve 18 extending from bottom layer 94 provides a vacuum for forming rigid and gross molding of bottom layer 94. Fluidized positioning and protection system 90 can be used as a seat, for example, as a wheel chair seat, baby seat, office seat, changing table, bassinet and developmental seat for infants or toddlers.
In one embodiment, system 90 can be used as a lap table to elevate or support a book placed on upper surface of system 90. During use, system 90 is gross molded to book to provide hands free support of the book on system 90. It will be appreciated that system 90 can be deflated to reduce the size of system 90 during travel or packing of system 90.
FIGS. 10A-10E illustrate an embodiment of fluidized positioning and protection system 100. A plurality of containers 102 reside within housing 101. Each of containers 102 are formed of a breathable, flexible and elastic material. Housing 101 is formed of a non-breathable membrane with no elasticity. For example, housing 101 can be formed of urethane. Containers 102 are filled with beads 17 and/or breathable open cell foam. In one embodiment, a plurality of containers 102 labeled A-R are positioned in a plurality of rows 1-6, as shown in FIG. 10C. In one embodiment, adjacent rows of containers are connected with hook and loop seam 106 for providing modular repair and stability. It is desirable that no seam is provided along the spine line.
Optionally, adjacent containers 102 can be connected to one another along seams 103 to provide a quilted arrangement. The fill weight of beads into containers 102 is selected to allow beads 17 to have room for natural expansion. For example, beads 17 can be filled to allow the undeflated unit to be about 2.5 inches deep.
Manifold 105 is coupled to an inlet port 107 for each row of containers 102. One or more stop cocks 108 are positioned within manifold 105 before each inlet port 107 to containers 102. Each stop cock 108 can be regulated to allow a predetermined amount of vacuum from valve 18 to be applied to each container 102 to deflate each container 102 or to stop vacuum from being applied to specific containers 102. In one embodiment, stop cock 106 positioned adjacent a front section (i.e., rows 5 and 6) is closed to stop vacuum from being applied to containers of rows 5 and 6 to allow for soft feel of system 100 at the lower leg and heel. Accordingly, individual containers 102 can be controlled to provide a feeling of soft or firm or a variation thereof.
Containers 102 can have a shape and size to be used as a mattress. For example, container 102 can have a width of about 35 inches and a length of about 20 inches. Inner chambers 109 can be formed within container 102. For example, two inner chambers 109 of a width of about 10 inches and a length of about 18 inches can be used within container 102. Base 110 can support housing 101, as shown in FIG. 10A. For example, base 110 can be formed of foam. Cover 112 encloses one or more housings 101 and base 110. Cover 112 can be attached with hook and loop material 113 to one or more housings 101.
System 100 can be used as a surface for stretchers, mattresses and as an operating room surface. System 100 can be used for spinal precautions during treatment of trauma to limit mobility of a patient.
In one embodiment, a neck brace can be used to support the head of a patient. The patient wearing the neck brace can be positioned on system 100 and a vacuum can be applied to one or more containers 102 for molding system 100 around the patient, as shown in FIG. 10D. In this embodiment, the position and alignment of the head is maintained and system 100 molds to the patient including the shoulders and curvature of the spine to provide distal support and proximal relief to the occipital pressure. In conventional systems, the neck brace or collar digs into the head rather than a mattress surface and all contact is on the occiput. In the present invention, the neck brace is externally supported not internally using the occiput. System 100 provides stabilization by providing natural spinal alignment, offloads occipital pressure without elevation or twisting of the head, allows the neck brace to stabilize without providing damaging pressure and reduces pressure minimizing the physiological turning triggers. System 100 provides ideal immobilization by maintaining neutral spinal curvature, maximizing surface area contact and normalizing interface pressure.
In one embodiment, system 100 can be used as a surface for a stretcher. System 100 can be attached to stretcher surface 115 with corner straps 116, as shown in FIGS. 11A-11B. Anti-slip surface 117 is formed or attached to bottom surface 118 of cover 112, as shown in FIGS. 11B and 11C.
FIG. 12 illustrates a schematic diagram of an embodiment of fluidized positioning and protection system 120, which can be used as a mattress. Base 130 extends around fluidized positioning and protection system 120. Head portion 121 includes foam buffer 122 having a depth D₁of about 15 inches and a length L₁of about 25 inches for an eighty inch mattress length or an 84 inch mattress length. Head portion 121 comprises a plurality of containers 123 filled with beads 17 and/or open cell foam 19. The fill weight of beads into containers 123 is selected to allow beads 17 to have room for natural expansion. For example, beads 17 can be filled to allow the undeflated unit to be about 50% vacuum.
Body portion 124 includes foam buffer 125 having a depth D₁of about 10 inches and a length L₁of about 35 inches for an 80 inch mattress length or about 39 inches for an 84 inch mattress length. Body portion 124 comprises a plurality of containers 123 filled with beads 17 and/or open cell foam 19. The fill weight of beads 17 into containers 123 is selected to allow beads 17 to have room for natural expansion. For example, beads 17 can be filled to allow the undeflated unit to be about 33% vacuum.
Foot portion 126 includes foam buffer 127 having a depth D₁of about 15 inches and a length L₁of about 24 inches for an 80 inch mattress or an 84 inch mattress foot portion 126 comprises a plurality of containers 123 filled with beads 17 and/or open cell foam 19. The fill weight of beads into containers 123 is selected to allow beads 17 to have room for natural expansion. For example, beads 17 can be filled to allow the undeflated unit to be about 50% vacuum.
FIG. 13 illustrates a schematic diagram of an embodiment of containers or bladders used for gross contouring. Bladder 200 comprises housing 201. Housing 201 is formed of a non-breathable material, such as urethane, providing a loose fit around containers 202. Containers 202 are filled with beads 17 and/or open cell foam 19. Beads 17 can be formed of a soft material and are disbursed within container 202. Container 202 is formed of a stretchable and breathable material, such as nylon. Air lock 204 allows for stopping flow of air to or from bladder 20. Air lock 204 is coupled to valve 18.
FIG. 14 illustrates an embodiment of fluidized positioning and protection system 300 including head stabilization and leg stabilization. Bladder 301 is positioned at foot portion 302. Bladder 301 is filled with composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory.
Bladder 304 is positioned at head portion 305. Bladder 304 is shaped to a head and neck of a user. Bladder 304 is filled with composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory.
Bladder 306 is positioned beneath or coupled to bladder 304. Bladder 306 is partially filled with beads 17 and/or open cell foam 19. Valve 18 extending from bladder 306 permits the evacuation of all or some of air from bladder 306 to adjust the rigidity of bladder 306 to contact bladder 304 and provide occipital offload without lift.
FIGS. 15A-15B illustrate an embodiment of fluidized positioning and protection system 400 which can be used for infant support. Fluidized positioning and protection system 400 can be used as a support layer between the infant and an infant car seat. Alternatively, fluidized positioning and protection system 400 can be used as a support layer in any type of seat, including an air plane seat, toddler car seat, stroller or changing table.
Inner layer 401 is positioned adjacent the infant. Inner layer 401 can be a bladder filled with composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory. Inner layer 401 can be formed of an elastic material. Inner layer 401 can be formed of a breathable material, such as nylon.
In one embodiment, inner layer 401 can be formed of a plurality of compartments 402 in a quilted arrangement as shown in FIG. 15B. Referring to FIG. 15A, cover 403 can be attached to inner layer 401. Each of compartments 402 is filled with composition 12. For example, cover 403 can be attached with hook and loop material 406 to inner layer 401. Cover 403 can be formed of a washable material.
Outer layer 408 is adjacent to or coupled to inner layer 401. Outer layer 408 can be a bladder partially filled with beads 17 and/or open cell foam 19. Valve 18 extending from outer layer 408 permits the evacuation of all or some of air from outer layer 408 to adjust the rigidity of outer layer 408 to contact inner layer 401.
Outer layer 408 can be formed of a plurality of chambers 409, as shown in FIG. 15C. Chambers 409 prevent migration of beads 17 within outer layer 408.
During use, fluidized protection system 400 can be placed on a seat, stroller, changing table or any other surface. An infant, baby or toddler can be positioned on fluidized positioning and protection system 400. Evacuation of all or some of the air within outer layer 408 provides support of the child. In addition, an object, such as a bottle, can be placed adjacent the child. Thereafter, evacuation of all or some of the air within outer bladder 408 provides support of the object adjacent to the child.
In one embodiment, fluidized positioning and protection system 400 can be used in a car seat. Evacuation of all or some of the air within outer layer 408 provides support of the infant within the car seat. Fluidized positioning and protection system 400 provides a desirable position in car seat 500, as shown in FIG. 16A in comparison to a conventional car seat as shown in FIG. 16B. Fluidized positioning and protection system 400 can be removed from car seat 500 and placed on a surface. Thereafter vacuum within inner bladder 400 can be released to readjust positioning and provide reduced support of the infant within fluidized positioning and protection system 400.
Proper positioning is critical in the development of the newborn especially when the baby is born prematurely. Fluidized positioning and protection system 400 is firm enough to maintain a position but inner layer 401 is soft enough to allow the small movements that are normal to the development of a child. The child can be nested in fluidized positioning and protection system 400 to simulate the uterine environment during their early developmental stages.
The skin of a newborn can be very fragile and is subject to tearing and other pressure related damage. The head of a newborn is still quite moldable and needs to be cradled in such a way that it does not become abnormally shaped as the baby develops. Fluidized positioning and protection system 400 prevents skin damage and provides support of the head of a newborn.
Fluidized positioning and protection system 400 allows the baby to have sufficient support in a car seat to maintain neutral postural alignment while the car is in motion. While the child will have the ability to move its head naturally within the realm of normal development, the head will not flop around or roll unnecessarily due to inner layer 401 being formed of breathable zero memory contouring layer which is supported by outer layer 408 which is more distal to the child. Fluidized positioning and protection system 400 functions much the same as an attenuation barrier. The closer it is to the baby contact the softer and more comfortable it will feel. As you get farther from the body the medium becomes stiffer with less contouring capability. If the air is not evacuated from outer layer 408 the immersion will be minimal as compartments 402 in inner layer 401 are sufficiently small so as to not allow immersion to the level at which it is unsafe for the baby.
Inner layer 401 and outer layer 408 achieve an attenuation effect. Flow within inner layer 401 and outer layer 408 is controlled by elasticity of inner layer 401.
Inner layer 401 and outer layer 408 are formed of a breathable material to allow outer layer 408 to release air to change the viscosity of the medium within inner layer 401 and allow inner layer 401 to breathe since it is next to the child and would present a suffocation hazard if it did not allow for the pass through of air.
FIGS. 17A-17B illustrate an alternate embodiment of fluidized positioning and protection system 600. Inner layer 601 is filled with capsules 602 of composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory. For example, capsules 602 can have a diameter of about 3 inches to about 5 inches. Outer layer 604 is positioned adjacent inner layer 601. Chamber 604 can be coupled or integral with inner layer 601. Outer layer 604 is filled with capsules 605 of composition 12 which can retain its shape after sculpting. Capsule 605 can have a larger diameter than capsule 602. For example, capsule 605 can have a diameter of about 8 inches to about 12 inches.
Valve 18 extending from outer layer 604 permits the evacuation of all or some of the air from outer layer 604 to adjust the rigidity of outer layer 604. In this embodiment, head elevation and body angle are adjustable. Inner layer 601 is formed of a soft, breathable and formable material. Inner layer 601 provides for movement and allows support. Evacuation of outer layer 604 provides support when necessary.
System 600 can be used to provide infant, baby or toddler or any child support in a car seat. System 600 can be formed to the shape of the infant, baby, toddler or any child. Alternatively, system 600 can be used for support of an infant, baby, toddler, child or adult in a sitting or reclined position, as shown in FIGS. 17C-17D.
FIGS. 18A-18E illustrate an alternate embodiment of fluidized positioning and protection system 700. Bladder 701 is filled with composition 12 which can retain its shape after sculpting. Composition 12 refers to a compound or composition which can be sculpted and retain its shape and has no memory or substantially no memory. Tab 702 extends from bladder 701. Tab 702 functions as a reservoir for composition 12. Positions 703-706 of bladder 701 are shown in FIGS. 18C-18D. During use, bladder 701 can be used as a pillow and tab 702 can be placed behind the back or scapula as shown in FIGS. 18A-18B. Downward pressure at position 703 displaces composition 12 to position 704 to support the spine, as shown in FIG. 18E. Support at position 704 off loads occiput at position 705. Minimal displacement at position 705 increases support at adjacent position 704 and position 706.
FIG. 19A-19B illustrates use of tab 702 to increase the volume around a designated portion of a patient. FIGS. 19A-19B illustrate tab 702 in a not compressed position. In FIGS. 19C-19D, tab 702 is compressed towards bladder 701 to increase height of bladder 701. One or more tabs 702 can be formed in system 700 depending on the volume increase desired for support. For example, support for a leg using system 700 can require additional volume than support of an arm.
It is to be understood that the above-described embodiments are illustrative of only a few of the many possible specific embodiments, which can represent applications of the principles of the invention. Numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention.

Claims

1. A system for providing positioning of a received body part comprising:

an inner bladder, said inner bladder being filled with a first composition which can retain its shape after sculpting;

an outer bladder positioned adjacent to said inner bladder, said outer bladder being filled with a second composition; and

a valve extending from said outer bladder, said valve permitting evacuation of air from said outer bladder wherein rigidity of said outer bladder is controlled by said valve to allow said system to form fit around a received body part.

2. The system of claim 1 wherein said first composition is a composition having no memory or substantially no memory.

3. The system of claim 1 wherein said first composition is a composition which flows in response to a deforming pressure and ceases to flow when there is no deforming pressure.

4. The system of claim 1 wherein said first composition provides three dimensional contouring.

5. The system of claim 1 wherein said first composition is formed of a mixture of microspheres and a lubricant.

6. The system of claim 1 wherein said inner bladder has sufficient depth to provide an independent contour to said outer bladder.

7. The system of claim 1 wherein said second composition comprises beads.

8. The system of claim 1 wherein said second composition comprises polystyrene beads.

9. The system of claim 1 wherein said second composition comprises open cell foam.

10. The system of claim 1 wherein said second composition comprises open cell foam and beads.

11. The system of claim 1 wherein said inner bladder comprises one or more compartments positioned within inner bladder, said one or more compartments being filled with said first composition for filling said inner bladder.

12. The system of claim 10 wherein said one or more compartments are formed of a breathable and stretchable material.

13. The system of claim 10 wherein said inner bladder comprises a plurality of compartments and each of said compartments having a predetermined contouring for altering the contouring ability of said inner bladder.

14. The system of claim 1 wherein said valve is connected to a pump for manually evacuating said air.

15. The system of claim 1 wherein said valve is connected to a pump for automatically evacuating said air.

16. A method for providing positioning of a received body part comprising:

providing an inner bladder, said inner bladder being filled with a first composition which can retain its shape after sculpting;

providing an outer bladder positioned adjacent to said inner bladder, said outer bladder being filled with a second composition;

positioning a body part on said inner bladder; and

evacuating air from said outer bladder, wherein rigidity of said outer bladder is controlled by said valve to allow said outer bladder to form fit around a received body part.

17. The method of claim 16 wherein said first composition is a composition having no memory or substantially no memory.

18. The method of claim 16 wherein said first composition is a composition which flows in response to a deforming pressure and ceases to flow when there is no deforming pressure.

19. The method of claim 16 wherein said first composition provides three dimensional contouring.

20. The method of claim 16 wherein said first composition is formed of a mixture of microspheres and a lubricant.

21. The method of claim 16 wherein said second composition comprises beads.

22. The method of claim 16 wherein said second composition comprises polystyrene beads.

23. The method of claim 16 wherein said second composition comprises open cell foam.

24. The method of claim 16 wherein said second composition comprise open cell foam and beads.

25. A system for providing positioning of a received leg and heel comprising:

a heel portion comprising a first inner bladder, said first inner bladder being filled with a first composition which can retain its shape after sculpting, a first outer bladder positioned adjacent to said first inner bladder, said first outer bladder being filled with a second composition, a first valve extending from said outer first bladder, said first valve permitting evacuation of air from said first outer bladder wherein rigidity of said first outer bladder is controlled by said first valve to allow said first outer bladder to form fit around a received heel;

a leg portion comprising a second inner bladder, said second inner bladder being filled with said first composition which can retain its shape after sculpting, a second outer bladder positioned adjacent to said second inner bladder, said second outer bladder being filled with said second composition, a second valve extending from said second outer bladder, said second valve permitting evacuation of air from said second outer bladder wherein rigidity of said second outer bladder is controlled by said second valve to allow said second outer bladder to form fit around a received leg portion and said heel portion being coupled to said leg portion.

26. The system of claim 25 wherein said heel portion is coupled to said leg portion using a coupler.

27. The system of claim 25 wherein said heel portion is coupled to said leg portion with a connection bladder, said connection bladder being filled with said first composition.

28. A system for providing positioning of a received face comprising:

a valve extending from said outer bladder, said valve permitting evacuation of air from said outer bladder wherein rigidity of said outer bladder is controlled by said valve to allow said outer bladder to form fit around a received face.

29. A mattress comprising:

a valve extending from said outer bladder, said valve permitting evacuation of air from said outer bladder wherein rigidity of said outer bladder is controlled by said valve.

30. A system for providing attenuation of forces from a received body part comprising:

an outer layer, said outer layer being filled with a first composition which can retain its shape after sculpting;

one or more inner layer positioned adjacent to said outer layer, said one or more inner layers being filled with a second composition; and

a valve extending from each of said one or more inner layers, each said valve permitting evacuation of air from one of said one or more said inner layers wherein rigidity of each of said one or more inner layers is controlled by a respective said valve.

31. The system of claim 30 wherein said system comprises two said inner layers and further comprising a support layer positioned between a first said inner layer and a second said inner layer, said support layer being formed of a foam material.

32. A system for providing attenuation of forces for supporting a head of a user comprising:

one or more inner layers positioned adjacent to said outer layer, said one or more inner layers being filled with a second composition, and a valve extending from each of said one or more inner layers, each said valve permitting evacuation of air from one of said one or more said inner layers wherein rigidity of each of said one or more inner layers is controlled by a respective said valve.

33. A seat for providing positioning of a received body part comprising:

34. A system for providing positioning of a received body part comprising:

a housing;

a plurality of rows of one or more containers positioned in said housing;

said one or more containers being filled with a composition; and

a valve extending from said housing, said valve permitting evacuation of air from said rows of one or more containers.

35. The system of claim 34 further comprising a manifold coupled to said valve, each of said rows of said one or more containers being coupled to an inlet port, each of said inlet ports being coupled to said manifold, a stop cock positioned within said manifold before each of said inlet ports, each stop cock being regulated to allow a predetermined amount of vacuum from said valve to be applied to each of said one or more containers.

36. The system of claim 34 wherein each of said containers is formed of a stretchable and breathable material.

37. The system of claim 34 wherein a plurality of said containers are connected to one another.

38. The system of claim 34 further comprising a base for supporting said plurality of rows of said one or more containers, said base being received in said housing.

39. The system of claim 35 wherein said composition comprises beads and/or open cell foam.

40. A mattress comprising:

a housing;

a plurality of rows of one or more containers positioned in said housing;

said one or more containers being filled with a composition; and

41. The system of claim 40 further comprising a manifold coupled to said valve, each of said rows of said one or more containers being coupled to an inlet port, each of said inlet ports being coupled to said manifold, a stop cock positioned within said manifold before each of said inlet ports, each stop cock being regulated to allow a predetermined amount of vacuum from said valve to be applied to each of said rows of one or more containers.

42. The system of claim 34 wherein each of said containers is formed of a stretchable and breathable material.

43. The system of claim 34 wherein a plurality of said containers are connected to one another.

44. The system of claim 40 further comprising a base for supporting said plurality of rows of said one or more containers, said base being received in said housing.

45. The system of claim 34 wherein said composition comprises beads and/or open cell foam.

46. A stretcher comprising:

a stretcher surface;

a plurality of rows of one or more containers positioned in a housing;

said one or more containers being filled with a composition; and

47. The system of claim 46 further comprising a manifold coupled to said valve, each of said rows of said one or more containers being coupled to an inlet port, each of said inlet ports being coupled to said manifold, a stop cock positioned within said manifold before each of said inlet ports, each stop cock being regulated to allow a predetermined amount of vacuum from said valve to be applied to each of said rows of one or more containers.

48. The system of claim 46 wherein each of said containers is formed of a stretchable and breathable material.

49. The system of claim 46 wherein a plurality of said containers are connected to one another.

50. The system of claim 46 further comprising a base for supporting said plurality of rows of said one or more containers, said base being received in said housing.

51. The system of claim 46 wherein said composition comprises beads and/or open cell foam.

52. The stretcher of claim 46 further comprising an anti-slip surface formed on a bottom surface of said housing.

53. The stretcher of claim 46 wherein said housing is attached to said stretcher surface with one or more straps.

54. A system for providing positioning of a received body part comprising:

a bladder;

a plurality of containers within said bladder, each of said containers being filled with a composition; and

a valve extending from said bladder, said valve permitting evacuation of air from said outer bladder wherein rigidity of said outer bladder is controlled by said valve.

55. The system of claim 54 wherein said containers are formed of a breathable and stretchable material.

56. The system of claim 54 wherein said bladder is formed of a non-breathable plastic material.

57. The system of claim 54 wherein said bladder is formed of urethane.

58. A mattress comprising:

a head portion comprising a first inner bladder, said first inner bladder being filled with a first composition which can retain its shape after sculpting, a first outer bladder positioned adjacent to said first inner bladder, said first outer bladder being filled with a second composition, a valve extending from said first outer bladder, said valve permitting evacuation of air from said first outer bladder wherein rigidity of said first outer bladder is controlled by said valve to allow said first outer bladder to form fit around a received head; and

a foot portion comprising a second inner bladder, said second inner bladder being filled with said first composition which can retain its shape after sculpting.

59. A system for providing support of an infant comprising:

a valve extending from said outer bladder, said valve permitting evacuation of air from said outer bladder wherein rigidity of said outer bladder is controlled by said valve part.

60. The system of claim 59 wherein said first composition is a composition having no memory or substantially no memory.

61. The system of claim 59 wherein said first composition is a composition which flows in response to a deforming pressure and ceases to flow when there is no deforming pressure.

62. The system of claim 59 wherein said first composition provides three dimensional contouring.

63. The system of claim 59 wherein said first composition is formed of a mixture of microspheres and a lubricant.

64. The system of claim 59 wherein said second composition comprises beads.

65. The system of claim 59 wherein said second composition comprises polystyrene beads.

66. The system of claim 59 wherein said second composition comprises open cell foam.

67. The system of claim 59 wherein said second composition comprises open cell foam and beads.

68. The system of claim 59 wherein said inner bladder comprises one or more compartments positioned within inner bladder, said one or more compartments being filled with said first composition for filling said inner bladder.

69. The system of claim 68 wherein said one or more compartments are formed of a breathable and stretchable material.

70. The system of claim 59 wherein a plurality of said containers are connected to one another.

71. The system of claim 59 wherein said outer bladder comprises a plurality of compartments, each of said compartments being filled with said second composition.

72. The system of claim 59 wherein said first composition comprises first capsules formed of a composition having memory or substantially no memory, said second composition comprises capsules formed of a composition having memory or substantially no memory, a diameter of said second capsules being larger than a diameter of said first capsules.

73. The system of claim 59 wherein a cover is placed over said inner bladder.

74. A method for providing support of an infant comprising:

positioning an infant or said inner bladder; and

evacuating air from said outer bladder to form a vacuum, wherein rigidity of said outer bladder is controlled by said valve to allow said system to form fit around a received infant.

75. The method of claim 74 further comprising the step of:

releasing at least a portion of the vacuum within said outer bladder.

76. The method of claim 74 further comprising the step of:

placing an object adjacent to said infant before said step of evacuating air from said outer bladder, wherein after air is evacuated from said outer bladder said positioned object remains adjacent said infant.

77. A system for providing positioning of a body part comprising

a bladder, said bladder being filled with a first composition which can retain its shape after sculpting; and

a tab protruding from said bladder wherein said tab is movable into said bladder for increasing height of said bladder.

78. The system of claim 77 wherein said first composition is a composition having no memory or substantially no memory.

79. The system of claim 77 wherein said first composition is a composition which flows in response to a deforming pressure and ceases to flow when there is no deforming pressure.

80. The system of claim 77 wherein said first composition provides three dimensional contouring.

81. The system of claim 77 wherein said first composition is formed of a mixture of microspheres and a lubricant.

82. The system of claim 77 wherein said first composition is formed of a mixture of microspheres and a lubricant.