Abstract:
Calf supporting device includes a U-shaped or O-shaped support and, within the support, and attached to its inner surface, sealed bags at least partly filled with cushioning material to suspend a user&#39;s heel. The device also includes a foot pad at the end from which a user&#39;s foot protrudes for placement against, and support of the sole of a user&#39;s protruding foot.

Description:
This invention relates to an article of manufacture, namely, a calf, ankle and foot orthotic support device for men, women and children that allows the heel to float or be suspended, provides compression to the leg, and provides support for the foot. These articles are lower extremity management systems, and are sometimes called ankle/foot orthotics (AFO). As used herein, the terms “orthotic device” and “orthotic support device” mean an apparatus used to support, align, prevent, or correct deformities. This device includes a rigid, U-shaped or O-shaped support member, or a flexible support member that, in use, assumes an O-shape or a U-shape. These support members have a plurality of bags mounted inside the support member. These bags are at least partially filled with cushioning material such as particulates or natural fiber. 
     In a first embodiment, this device comprises a rigid, preferably thin-walled, U-shaped shell. Within this shell is a U-shaped block of sufficient thickness, rigidity, and flexibility to support the ankle, foot and heel of a user. Preferably, the U-shaped block is attached to the inner surface of the shell. 
     The shell is preferably made of a plastic such as a polycarbonate, ABS, or another plastic material. The shell is preferably about five to about twenty inches in length, about ten to about twenty-five inches in width, and about one-sixteenth of an inch to about five-sixteenths of an inch in thickness. In preferred embodiments, the shell is about three to about six inches longer than the U-shaped block at one end of the block. 
     The U-shaped block is preferably made of a foamed plastic such as cross-linked polyethylene, and may have a thickness ranging from about two to about four inches, at its thickest dimension, to about one-half inch to about two inches at its thinnest dimension. The inner profile of the block is U-shaped. Its outer profile is also U-shaped, terminating at the upper edges of the block in inwardly tapering or straight surfaces. The degree of taper from the legs of the U-shaped block is in the range of about twenty-five percent to about seventy-five percent. 
     Within this U-shaped block, and attached to its inner surface, are one or more scaled bags, preferably sealed fabric bags, at least partially filled with cushioning material. Preferably, these bags extend over substantially the entire length of the U-shaped block. The bags are wide enough to form a U-shaped or O-shaped supporting surface for the calf and ankle. The bags are preferably made of a material such as Spandex or another sturdy elasticized fabric. 
     A second embodiment includes a U-shaped outer member preferably made of a foamed plastic, or a plurality of foamed plastic layers joined to one another. This outer U-shaped support member can vary in thickness from about one inch or more at one end to about 0.5 inch at the other end, and is preferably thicker at the bottom of the U-shaped member than at the top of the side walls forming the U-shape. 
     Within this outer foamed U-shaped member is a thinner, more rigid plastic sheeting layer, preferably having a uniform thickness from end-to-end, and from the bottom of the U-shape to the top. Preferably, this thickness is in the range of about one-sixteenth of an inch to about thirteen-sixteenths of an inch. 
     Atop this rigid plastic sheeting is another foamed member whose dimensions are similar to those of the outer foamed member(s). Like the outer foamed members, this member can include a plurality of pieces of foam laminated or otherwise joined together. 
     Attached to the inner surface of the first and the second embodiments are one or more sealed bags at least partly filled with a cushioning material such as particulate solids, feathers or fibers such as wool. Preferably, the sealed bags are generally tubular, are approximately the same length as the support member, and have a cross-sectional area in the range of about four to about twenty-five square inches. Where a plurality of bags are used, one or more bags may be attached to one another, and/or one or more may be unattached to others. 
     In some embodiments, there are at least three such bags, with one such bag at the bottom of the U-shaped member, and another along each inner side of the U-shaped member. Another bag, whether unattached to the others or attached to one of the side bags, is positioned to extend over the top of a user&#39;s calf when the user&#39;s calf is placed into the U-shaped member. In other embodiments, there may be five, six or more bags, with two or more bags attached to one another, and others unattached to any other bag. 
     Preferably, the cushioning materials are loose inside the bags, and comprise particulates such as styrofoam or other plastic beads, seeds or natural materials such as feathers or fibers. Where the cushioning material is styrofoam beads or seeds, these particulates preferably have a diameter of less than about one-eighth of an inch, preferably less than about three thirty-seconds of an inch. Their volume is smaller than the inner volume of the sealed bag to permit both movement of the cushioning material, and support for an ankle, foot, calf and/or heel resting on the outer surface of the bags, without substantial abrasion. Preferably, the volume is also sufficient to avoid ulceration, and/or ischemia in the ankle, foot or heel of a user. The cushioning material preferably occupies at least about thirty percent and up to about ninety-five percent of the inner volume of each sealed bag. 
     In other embodiments, the U-shaped support member is flexible and/or bendable. In such embodiments, the U-shaped member may include a plurality of tubular air bags joined edge-to-edge to form a structure similar to an air mattress. Attached to one surface of the air mattress are one or more support bags filled at least in part with the cushioning material. The bags may, but need not all be the same length. Some of the bags may be longer than others to provide better support to the ankle and foot. Other bags for use atop the calf of a user may be shorter. 
     In all embodiments, the devices include one or more straps, e.g. Velcro straps or webbing, to hold the support device to the foot and ankle of a user. In some embodiments, these straps pass over one or more sealed bags containing cushioning material placed atop a user&#39;s calf/lower leg resting within the support device, such that the straps hold the topmost bag firmly against the top of the user&#39;s calf/lower leg. 
     The straps may be attached to an inner or the outer surface of the device to removably or detachably secure the orthotic device to the lower leg of a user. With these straps, the device can be bound firmly to the calf of a user to provide compression. 
     In preferred embodiments, the support device also includes a foot pad that engages and supports the sole of a user&#39;s foot. Since a user&#39;s foot extends beyond the end of the support device, the foot is susceptible to foot drop, foot contracture, or both. The foot pad minimizes these undesirable results. 
     The foot pad itself is a foot-sized bag at least partially filled with cushioning material such as particulate solids, feathers or fibers such as wool. Preferably, at least about thirty-five percent of the volume of the bag is filled with such cushioning material. More preferably, at least about fifty percent of the volume of the bag is filled with such cushioning material. The foot pad also includes a stiffener on the side of the bag opposite the side that contacts the foot of a user. The stiffener can be made of firm duck, thermoplastics such as polyethylene, ABS, polypropylene or polycarbonate, or other rigid materials, and may be molded in a desired shape, e.g. the shape of the bottom of a user&#39;s foot. The foot pad may have a sleeve or pocket to permit insertion and removal of one or more stiffeners of differing sizes and shapes. The pocket or sleeve preferably includes, at its opening, a closure e.g. a Velcro closure to hold the stiffener in place in the sleeve or pocket. For example, an insertable stiffener may be shaped to conform to the base of a user&#39;s foot, and/or the stiffener may function like the sole of a shoe, thus permitting a user to be ambulatory. 
     The foot pad is attached to, and preferably separable from a supporting strap by fasteners such as Velcro and can be positioned along the strap to maximize a user&#39;s comfort. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention can better be understood by reference to the drawings, in which: 
     FIG. 1 shows an end elevation view of a first embodiment of the support device; 
     FIG. 2 shows a side elevation view of the embodiment of FIG. 1; 
     FIG. 3 shows an end elevation view of a second embodiment of the heel support device; 
     FIG. 4 shows a side elevation view in cross-section, taken on line  3 — 3  of FIG. 3, of the embodiment shown in FIG. 3; 
     FIG. 5 shows an end elevation view of a third embodiment of the heel support device; 
     FIG. 6 shows a first embodiment of a foot pad including an internal stiffener that attaches, removably, to a strap for securing the foot pad over the sole of a user&#39;s foot; 
     FIG. 7 shows a second embodiment of such a foot pad, including a sleeve for insertion and removal of internal stiffeners of differing sizes and shapes; 
     FIG. 8 shows a bottom plan view of the second foot pad embodiment shown in FIG. 7; 
     FIG. 9 shows a cross-sectional view of the foot pad embodiment of FIG. 8, taken on line A—A on FIG. 8; and 
     FIG. 10 shows a cross-sectional view of the foot pad embodiment of FIG. 8, taken on line B—B of FIG.  8 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In FIGS. 1 and 2, orthotic device  10  includes outer, rigid, U-shaped shell  1 . Shell  1  is made of ABS, and is about fifteen inches long, twenty inches wide, and about one-sixteenth of an inch in thickness. Attached to the inner wall surface  7  of shell  1  is block  2  made of cross-linked polyethylene foam. Block  2  is U-shaped, and is secured to the inner surface  7  of shell  1  by glue or otherwise. Block  2  has two inwardly tapering end surfaces  8  and  9  formed at approximately a forty-five degree angle to the plane of each leg of block  2 . Attached to the inner surface  10  of block  2  is sealed bag  3  made of Spandex and partially filled with styrofoam beads  4 . Sealed bag  3  is about one inch wide, about twelve inches long, and has a wall thickness of about one-thirty-seconds of an inch. 
     Inside bag  3 , and filling about sixty percent of its inner volume, are styrofoam beads  4 . Beads  4  are loose within bag  3 . As FIG. 1 shows, foot  5  of a user can be placed within the U-shaped region  13  formed by the inner surface  14  of bag  3 , with the heel of foot  5  projecting beyond the end of bag  3  onto extension  6  (see FIG.  2 ). Extension  6  is an integral part of shell  1 , and is of a sufficient length to receive the user&#39;s heel. 
     Orthotic device  10  can be secured to foot  5  by Velcro or webbing straps  11  and  12 . There may be more than one pair of such straps. In preferred embodiments, there are at least three such pairs of straps, spaced along the length of shell  1 . 
     FIGS. 3 and 4 show a second embodiment  100  of the support device. This embodiment includes an outer, firm, soft, U-shaped shell  101 , made of foamed cross-linked polyethylene. At proximal end  102 , the thickness of shell  101  is about one inch. Shell  101  tapers at its distal end to a thickness of about one-quarter of an inch. Shell  101  also tapers to a thickness of about one-quarter of an inch at the upper ends of arms  103  and  104  of the U-shaped member. Shell  101  is about fifteen inches long, and eight inches wide. 
     Attached to inner wall surface  105  of shell  101  is rigid, plastic, U-shaped member  106 , attached to surface  105  by glue or otherwise. Member  106  has a thickness in the range of about one-sixteenth to three-sixteenths of an inch, and provides rigidity to the device. 
     Attached to this rigid sheeting, or sandwiched between the sheeting  106  and shell  101 , are a plurality of straps that extend over the top surface  107  of device  100  to hold the device to the calf/lower leg of a user. 
     Attached to the inner surface  109  of U-shaped member  106  is U-shaped foam member  108 . The dimensions of this U-shaped member are approximately the same as those of U-shaped member  101 . Member  108  can be made of the same material as shell  107 , or of a different foam material. Member  108  may include slots to allow straps to pass through, and to secure the device atop a user&#39;s calf/lower leg. 
     Attached to the inner surface of member  108  are bags  110 ,  111 ,  112 , and  113 . Bags  112  and  113  are connected to one another along their length at junction  114 . Bags  112 ,  111 , and  110  are attached to the inner surface  115  of member  108  by glue or other means  116 ,  117 , and  118 . These bags are about twelve to about fifteen inches in length, about three to about five inches in diameter, and have a volume in the range of about seventy to about two hundred seventy cubic inches. Inside these sealed bags are particulates such as light styrofoam beads or natural matter such as feathers or seeds, occupying about thirty percent or more of the internal volume of each bag. The bags may all be of the same length, or may differ in length, depending on the support structure desired. The bags may also be joined to one another along their length, or may be unattached to one another. 
     In FIG. 3, bag  113  projects above the plane formed by the upper edges of device  100 , and is positioned to lie atop the lower leg of a user positioned in space  119  formed by the inner surfaces  110 ,  111 , and  112 . 
     FIG. 5 shows a third embodiment  200  of a support device. U-shaped support is formed by gas-filled bags  201 ,  202 ,  203 ,  204 ,  205 ,  206 , and  207 . Some of these bags may be of substantially uniform cross-section from end-to-end. Others may taper from a first cross-section to a second, smaller cross-section along their length, with the larger cross-section at the end that supports, and elevates the calf, ankle and heel of a user. The support member may also taper in profile from the heel end to the opposite end, to minimize contact between a user&#39;s foot surfaces and the gas filled bags  201 ,  202 ,  203 ,  204 ,  205 ,  206  and  207 . 
     Bags  201 - 207  are joined to one another along their length at contiguous surfaces  208 ,  209 ,  210 ,  211 ,  212 , and  213 . On inner surface  214  of device  200  are a plurality of fabric or plastic bags  215 ,  216 ,  217 ,  218 ,  219 ,  220 , and  221 , each filled to thirty percent of the bag&#39;s volume or more with cushioning particulates or natural matter. In structure, form, and content, these bags are similar to bags  110 ,  111 ,  112 , and  113  in FIGS. 3 and 4. These bags may be unattached to one another, or may be joined to one another along contiguous surfaces  222 ,  223 ,  224 ,  225 ,  226 , and  227 . 
     Attached to ends  206 / 207  are straps  228  and  229 . These straps are of sufficient length to overlap one another, and are attached to one another by Velcro, or another suitable connector, to hold device  200  under a user&#39;s foot and ankle. There may be additional bags unconnected to the device for placement over a user&#39;s calf/lower leg, and beneath straps  228  and  229 , to provide additional cushioning under a user&#39;s foot. The bags  215 - 221  may be of the same length, size and shape, or can differ from one another in length, size and shape, depending on the desired support structure. 
     FIG. 6 shows a first foot pad embodiment  300  including a top, foot-contacting, fabric piece  301 , a bottom fabric piece  308 , and, between fabric pieces  301  and  308 , internal, rigid stiffener  307 , here made of a thermoplastic such as ABS. The first and second pieces  301  and  308  of foot pad  300  are held together, with stiffener  307  between them, by seams  304  and  305 . Within the space formed between stiffener  307  and fabric piece  301  is cushioning material, here beads  303 . These beads fill more than seventy-five percent of this space. Attached to the bottom surface  309  of fabric piece  308  is Velcro pad  306 . Velcro pad  306  permits attachment of footpad  300  to strap  230  shown in FIG.  5 . (CAM: Please add a strap  230  to FIG.  5 ). 
     FIG. 7 shows a second foot pad embodiment  400 . Foot pad  400  includes first fabric piece  401 , second fabric piece  402 , and third fabric piece  403 . Fabric pieces  402  and  403  form a sleeve or pocket  404  in which a stiffener  405  of desired shape and size can be inserted. Within space  406  formed between fabric pieces  401  and  402  are cushioning material  407 , here beads, which fill more than fifty percent of the volume in this space. Attached to the bottom surface  408  of foot pad  400  is Velcro pad  409 . Velcro pad  409  permits attachment of foot pad  400  at a desired location along strap  230 , shown in FIG.  5 . 
     FIG. 8 shows a bottom plan view of foot pad  400 . Seam  410  forms three sides of a pocket  412  with an entrance or opening to the pocket at  411 . Velcro pad  413 , near the entrance to sleeve  412 , along with a complementary facing Velcro pad (see FIG.  9 ), provides a closure to hold a stiffener within sleeve  404 . 
     FIGS. 9 and 10 show cross-sectional views of the foot pad  400  taken on lines A—A and B—B, respectively, in FIG.  8 . FIG. 9 shows opposing Velcro pads  413  and  414  at the entrance  411  to sleeve  404  that hold a stiffener in sleeve  404  when attached to one another.