Patent Document

CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/614,782 filed Mar. 23, 2012 and U.S. Provisional Patent Application No. 61/495,082, filed Jun. 9, 2011, the entireties of which applications are hereby incorporated by reference into this application. 
    
    
     BACKGROUND OF THE INVENTION 
     Conventional supports provide a polyester filled or foam boot for support of a lower leg. Other conventional supports include an ankle foot orthotic (AFO) or foot wrap. Another conventional support includes an air chamber in a boot configuration. The air chamber supports a leg and heel above a surface of a bed patient when lying in a supine or side lying position, such as in a hospital bed. The conventional supports have the disadvantage that pressure is applied to the heel or leg for maintaining the heel above the surface of the bed. In addition, the leg can be raised too high such that joints can lock, nerves can be potentially entrapped and the circulation to the leg can be compromised. In addition, the intralumenal pressure of conventional supports minimizes its ability to contour to the object applying the force. 
     It is desirable to provide a low pressure fluidized lower leg protection system for supporting the leg and heel when a patient is recumbent while maintaining neutral leg alignment without lifting the leg and heel from the resting surface. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a fluidized lower leg protection and support system and method. It is optimal to barely elevate the heel from the surface of the bed. This helps to minimize leg rotation and locking of the knee. The system can include an inner positioner. The inner positioner includes a bladder preferably filled with a fluidized particulate material to provide three-dimensional contouring to the lower leg and heel. The inner positioner has low pressure and is not sufficient alone to support the leg. The inner positioner has little or no flow characteristics unless an outside force is applied other than gravity. The inner positioner can displace and contour three-dimensionally as though it was fluid to the sides and top of the leg while not having flow characteristics that would result in migration of the medium under the force of gravity. The inner positioner can provide three-dimensional contouring to the Achilles tendon. The inner positioner can include a temperature regulating material for keeping the leg in an optimal range of skin temperature to keep the leg comfortable longer. The inner positioner can be shaped as a pad to mold to the underside portion of the lower leg and heel. Alternatively, the inner positioner can include various shapes to support the lower leg and heel. In one embodiment, the inner positioner also includes a portion which extends over a top portion of the leg (shin). 
     The system can also include an outer support which is received over the inner positioner. The outer support can be in the shape of an open boot. The outer support can include an ultra low pressure plenum. The ultra low pressure plenum is filled at a predetermined low pressure for distributing pressure along the length of the outer support, but not providing significant elevation of the lower leg and heel by itself. The ultra low pressure plenum will not support the lower leg and heel unless the ultra low outer support is closed around the lower leg and heel. In this embodiment, the inner positioner is partially filled with the fluidized particulate material so it cannot support a leg on its own. For example, the inner positioner can be filled up to ⅔ of its capacity. The inner support provides three-dimensional contouring to the supported lower leg and heel. The outer portion of the inner positioner contours to the inner portion of the ultra low pressure plenum for providing more gas displacement of the outer support than if the inner positioner was not present. 
     In one embodiment the system is strapless. In an alternate embodiment, the system includes a strap for attachment of the outer support to the leg. The strap can be sufficiently wide and cushioned to protect the skin. In one embodiment, the strap is air bearing. In one embodiment, a rear end of the outer support includes a gate, which can be opened to allow access to the foot and heel from the rear of the boot. When the outer support is fully opened, the outer support is in a flat position to provide a treatment area without lifting of the leg. 
     The inner positioner or outer support can include a fluidized thermal regulating medium. In one embodiment, a phase change material can be used for adjusting the temperature of the system. 
     The system of the present invention can be a one size fits all and adapts to the size and shape of a patient&#39;s leg. The system maintains neutral alignment and helps prevent foot drop. The system gently but securely wraps the leg, helping to maintain constant heel position. The system promotes proper dorsiflexion without causing undue pressure on the lower limb. 
     The combination of the inner positioner including a fluidized medium along with the outer support including a ultra low pressure plenum creates sufficient support of the lower leg while responding to normal patient movement. The combination of the inner positioner and the outer support provides three-dimensional contouring to the lower leg and heel for micro adjustment while the outer support or boot is closed for minimizing friction and shear. This is not possible in conventional devices having the disadvantage that the inner chamber is not free to communicate with the leg without negatively affecting the functionality of the outer chamber. 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 and provide comfort to the skin. The natural contour of the leg can be maintained while eliminating harmful pressure to the heel, ankle, Achilles and foot. The system of the present invention can respond to the twisting of the leg without causing movement of the outer support. The system of the present invention can minimize shear forces that would be associated with a non-fluidized medium. 
     The invention will be more fully described by reference to the following drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic diagram of an inner support of a fluidized lower leg protection and support system. 
         FIG. 2  is a schematic diagram of an embodiment of the fluidized lower leg protection and support system including an outer support. 
         FIG. 3  is a schematic diagram of an alternate embodiment of the fluidized lower leg protection and support system including an outer support. 
         FIG. 4  is a schematic diagram of the outer support for the system shown in  FIG. 3 . 
         FIG. 5  is a schematic diagram of an alternate embodiment of the fluidized lower leg protection and support system including an outer support. 
         FIG. 6  is a schematic diagram of the outer support for the system shown in  FIG. 5 . 
         FIG. 7  is a schematic diagram of the system of  FIG. 5  in a closed position. 
         FIG. 8  is a schematic diagram of the other side of the diagram shown in  FIG. 7 . 
         FIG. 9  is an end view of the diagram shown in  FIG. 7 . 
         FIG. 10A  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including an outer support. 
         FIG. 10B  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including an outer support. 
         FIG. 11  is a schematic diagram of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 10  from an opposite side. 
         FIG. 12A  is a schematic diagram of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 10  from a rear side. 
         FIG. 12B  is a schematic diagram of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 10  from a rear side. 
         FIG. 13  is a schematic diagram of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 10  from a rear side in an open position. 
         FIG. 14  is a schematic plan view of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 10 . 
         FIG. 15  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including an outer support and support strap. 
         FIG. 16  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including an outer support, support strap and anide strap. 
         FIG. 17  is a schematic diagram of the embodiment of a fluidized lower leg protection and support system shown in  FIG. 16  from an opposite side. 
         FIG. 18  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including an opening between side portions of the outer support. 
         FIG. 19  is a schematic diagram of an alternate embodiment of a fluidized lower leg protection and support system including a plenum providing low air loss. 
         FIG. 21A  is a schematic diagram of an alternate embodiment of a fluidized leg protection and support system including a cover. 
         FIG. 21B  is a schematic diagram of a rear view of the fluidized leg protection and support system shown in  FIG. 21A . 
         FIG. 20  is a schematic diagram of plan view of an outer support used in the fluidized leg protection and support system. 
     
    
    
     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. 
     Fluidized lower leg protection and support system  10  includes inner positioner  14 , as shown in  FIG. 1 . Inner positioner  14  is formed of bladder  13  including fluidized material  15  therein. Fluidized material  15  can be a particulate material including interstitial spaces between the particles. A lubricant can be present in the interstitial spaces. For example, the lubricant can be a particulate material having a lower coefficient of friction, such as a powder. The volume of the particulate material can be controlled for controlling the interstitial air within the fluidized medium. 
     Bladder  13  is filled with fluidized material  15  which can retain its shape after sculpting. The flowability or lubricity of fluidized material  15  can be increased by adding a lubricant or by the removal of gas from the interstitial spaces or both. The preferred medium of fluidized material  15  is a particulate material that has been modified in such a way that it acts like a fluid Fluidized material  15  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 bladder  13  to increase in height and maintain support of a body part. Fluidized material  15  is made of a viscosity that will allow it to contour but not collapse under the weight of the body part. 
     At sea level, the normal interstitial air pressure would exceed about 760 millibars of mercury. This increases or decreases marginally as altitude varies. Depending on the nature of the particulate fluidized material  15 , the pressure can be lowered below about 500 millibars, preferably, lowered below about 350 millibars to about 5 millibars, while still maintaining the necessary flow characteristics of the product. The amount the pressure is lowered is dependent on the interstitial spaces needed to provide desired flow characteristics of the product. 
     Fluidized material  15  can include beads, such as polyethylene or polystyrene (PS) beads, expanded polyethylene (PE), crosslinked expanded polyethylene (PE), polypropylene (PP) pellets, closed cell foams, microspheres, encapsulated phase changing materials (PCM). The beads can be hard shelled or flexible. In one embodiment, the beads are flexible and gas can be evacuated from the beads. In one embodiment, hard beads can be mixed with flexible beads in which gas can be evacuated from the flexible beads. In an alternative embodiment, fluidized material  15  can a porous foam substance including pockets of interstitial gas. In one embodiment, fluidized material  15  can be a polyurethane foam. The polyurethane foam can be open or closed cell and cut into small shapes such as spheres or blocks. For example, a sphere of polyurethane foam can have a size of 2 inches in diameter. For example, a block of polyurethane foam can be a 1×1×1 inch block. 
     Suitable examples of fluidized material  15  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 about 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, fluidized material  15  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, 6,197,099 and 8,171,585, each of which is hereby incorporated by reference into this application. Bladder  13  provides micro-contouring because fluidized material  15  can respond three dimensionally. 
     For example, bladder  13  can be formed of a flexible plastic, such as urethane. Upon removal of residual gas from fluidized material  15  bladder  13  flows concurrent with the flow of fluidized material  15  such that bladder  13  moves with movement of fluidized material  15 . Bladder  13  can have a size and shape to support lower leg  16  and heel  17  of a user. Bladder  13  can include portion  18  which extends over top portion  19  of lower leg  16 . Optionally, gas can communicate throughout the whole bladder  13  for allowing maximum contouring and functional displacement of both the gas and the fluidized chamber thereby providing maximum contouring to a desired body part. 
       FIG. 2  is a schematic diagram of an embodiment of fluidized lower leg protection and support system  20  including outer support  22 . Outer support  22  is configured in a shape to conform to a shape of lower leg  16  and optionally heel  17 . Outer support  22  can include ultra low pressure plenum  24  within outer support  22 . Air pressure within ultra low pressure plenum  24  is reduced sufficiently to provide reduced pressure for conforming outer support  22  to the shape of lower leg  16  and optionally heel  17  for distributing pressure along the length of outer support  22 . Lower pressure plenum  24  does not provide support of lower leg  16  and heel  17 . For example, the pressure in ultra low pressure plenum  24  can be below 20 mm of water. It will be appreciated that all equivalents such as mm Hg and PSI can be used for measuring the pressure within ultra low pressure plenum  24 . 
     The pressure within ultra low pressure plenum  24  can be below about 20 mm of water if no inner positioner is used or if an area of less than about 30% of outer support  22  is covered by inner positioner  14 . The pressure within ultra low pressure plenum  24  can be below about 10 mm of water if an area of between about 30% to about 60% of outer support  22  is covered by inner positioner  14 . The pressure within ultra low pressure plenum  24  can be below about 5 mm of water if an area of greater than about 60% of outer support  22  is covered by inner positioner  14 . 
     Outer support  22  can be received over inner positioner  14 . Inner positioner  14  can be shaped as a pad to mold to the underside portion of lower leg  16  and heel  17 . Inner positioner  14  is formed of bladder  13  including fluidized material  15  therein which can retain its shape after sculpting, as described above. 
     Strap  26  can be attached to outer support  22 . Strap  26  can include a hook and loop material for attaching outer support to lower leg  16 . Strap  26  can have a width in the range of one to five inches which is comfortable to the user. Strap  26  can include a cushioning material. In one embodiment, strap  26  is air bearing. 
     Inner positioner  14  or outer support  22  can include thermo-regulating medium  27 . Thermo-regulating medium  27  can be a phase change material for adjusting the temperature to adapt support system  10  to temperature changes of a body part of a user. Thermo-regulating material  27  can be associated with fluidized material  15  or cover (not shown) placed over inner positioner  14 . An example material for thermo-regulating material  27  is manufactured by Outlast Technologies as fibers, fabrics, and foams comprising micro-encapsulated phase changing materials referred to as Thermocules, which store and release heat as further described in U.S. Pat. Nos. 7,790,283, 7,666,502 and 7,579,078, hereby incorporated by reference into this application. 
       FIG. 3-FIG .  9  illustrate alternate embodiments of an embodiment of fluidized lower leg protection and support system  30  including outer support  32 . Outer support  32  includes a plurality of continuous ultra low pressure plenums  34 . A gas can be added at a predetermined pressure through valve  35  for inflating side ultra low pressure plenums  34 . 
     Straps  36  and  38  extend from side  39  of outer support  32  for closing outer support  32  around lower leg  16 , as shown in  FIGS. 7 and 8 . Straps  36  and  38  can be air bearing. Strap  36  can provide closure near ankle  40 . Strap  38  can provide closure around calf  42 . Preferably, strap  38  has a wider diameter, for example, in the range of about 3 inches to about 5 inches for providing closure around calf  42 . Inner positioner  14  formed of bladder  13 , including fluidized material  15  is received within outer support  32 , as shown in  FIGS. 4 and 6 . Bottom end of outer support  32  can include opening  37 , as shown in  FIG. 9 . During use, inner diameter  50  of bladder  13  contours to lower leg  16  and heel  17  and outer diameter  52  of bladder  13  contours to outer support  32 . 
       FIGS. 10-14  illustrate an alternate embodiment of a fluidized lower leg protection and support system  50 . Outer support  52  can include a plurality of rows of parallel ultra low pressure plenums  53 . For example, ultra low pressure plenums  53  can be positioned within outer support  52  along the length L 1  of outer support  52 . Flap  54  can extend over front of lower leg  16 . Flap  54  can include air chambers  55 , which protect lower leg  16  from strap  56 . Flap  54  can also provide anti-rotation of fluidized lower leg protection and support system  50 . Strap  56  can be adjustable for closing flap  54  for different sizes of legs. Strap  54  can include a coupling portion  57  at one end thereof for attaching to attachment section  58 . Coupling portion  57  can be formed of a hook and loop material. Attachment section  58  can be formed of a hook and loop material. Attachment section  58  can be positioned along length L 1  of outer support  52 . Outer support  52  can be received under U-shaped base  59 , as shown in  FIG. 12 . U-shaped base  59  provides anti-rotation of outer support  52 . 
     Rear end  60  of outer support  52  can include overlapping flap members  62  and  63  for forming a gate to allow access to foot  19  including heel  17 , as shown in  FIGS. 12 and 13 . Flap members  62  and  63  can include respective coupling portions  64  and  65  for attaching flap members  62  and  63  to one another. For example, coupling portions  64  and  65  can be formed of a hook and loop material. Flap members  62  and  63  can be opened to allow access to foot  19 , as shown in  FIG. 14 . 
       FIG. 15  illustrates an alternate embodiment of a fluidized lower leg protection support system  70 , including support strap  72 . Support strap  72  can extend around rear end  60  for providing support, for example, in supporting a patient with foot drop. Support strap  72  can include coupling portion  77  at one end thereof. Coupling portion  77  can be formed of a hook and loop material. Coupling portion  77  can attach to attachment section  58 . 
       FIGS. 16 and 17  illustrate an alternate embodiment of a fluidized lower leg protection support system  80 . Support strap  82  can include coupling portion  87  at one end thereof. Coupling portion  87  can be formed of a hook and loop material. Coupling portion  87  can attach to attachment section  88 . Attachment section  88  can be positioned circumferentially around top portion  89 . Coupling portion  87  can be coupled at various locations on attachment section  88 . Ankle strap  92  can attach to attachment section  94 . Ankle strap  92  can include coupling portion  93  at one end thereof. Coupling portion  93  can be formed of a hook and loop material. Attachment section  94  can be formed of a hook and loop material. Ankle strap  92  can be positioned above ankle  95 . Attachment section  94  can be positioned adjacent or below ankle  95 . 
       FIG. 18  illustrates an alternate embodiment of a fluidized lower leg protection and support system  100  which includes opening  102  between side portions  103  and  104  for allowing air to contact lower leg  16  and allowing cooling of lower leg  16  while providing support. Straps  105  and  106  can attach to respective attachment sections  107  and  108 . Straps  105  and  106  can include coupling portion  109  at one end thereof. Coupling portion  109  can be formed of a hook and loop material. Attachment section  107  and  108  can be formed of a hook and loop material. 
     Inner positioner  14  described above can be used with each of the fluidized lower leg protection support systems  50 ,  70 ,  80  and  100 . In one embodiment, inner positioner  14  is positioned horizontally at ankle  19  and wraps around the Achilles to protect the ankle. 
       FIG. 19  illustrates an alternate embodiment of fluidized lower leg support system  1000 . Outer support  1001  of system  1000  has a three layer construction. Top layer  1020 , intermediate layer  1030  and bottom layer  1040  are sealed to one another along outside edge  1050 . For example, top layer  1020 , intermediate layer  1030  and bottom layer  1040  can be formed of urethane. 
     Plenum  1100  formed between top layer  1020  and intermediate layer  1030  can include dynamic air. Air  1150  is pumped into plenum  1100  through valve  1110  by pump  1120 . Air  1150  is pumped beneath top layer  1020 . Top layer  1020  is perforated with apertures  1180 . Plenum  1100  provides a dynamic amount of air to system  1000  for adjusting the amount of air in plenum  1140  and providing low air loss. 
     Plenum  1140  formed between bottom layer  1040  and intermediate layer  1030  can include a fixed amount of static air. In one embodiment, plenum  1140  is filled with an ultra low pressure of a pressure of about 20 mm of water to about 5 mm of water or in some cases even lower pressures can be used. Valve  1160  can be used to adjust the pressure in plenum  1140 . 
       FIGS. 20-21  illustrate an alternate embodiment of fluidized lower leg support system  2000 . Outer support  2052  can include a plurality of rows of parallel ultra low pressure plenums  2053 . For example, ultra low pressure plenums  2053  can be positioned within outer support  2052  along the length L 1  of outer support  2052 . 
     Cover  2100  can be attached over outer support  2052  after lower leg  16  is received in outer support  2052  as shown in  FIG. 21A . Rear end  2060  of cover  2100  can include overlapping flap members  2062  and  2063 . Flap members  2062  and  2063  can include respective coupling portions  2064  and  2065  for attaching flap members  2062  and  2063  to one another. For example, coupling portions  2064  and  2065  can be formed of a hook and loop material. Strap  2056  can be adjustable for closing cover  2100  for different sizes of legs. Strap  2056  can include a coupling portion  2057  at one end thereof for attaching to attachment section  2058 . Coupling portion  2057  can be formed of a hook and loop material. Attachment section  2058  can be formed of a hook and loop material. Attachment section  2058  can be positioned along length L 1  of cover  2100 . 
     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.

Technology Category: 1