Abstract:
An orthosis walking boot includes a posterior plastic shell with an open foot supporting portion extending outward from an integral open vertical leg extension to support a user&#39;s foot and leg and an anterior plastic shell with a horizontal foot covering portion for overlapping and covering the open foot supporting portion of the posterior shell and an integral open vertical leg extension for positioning within the posterior open vertical leg extension of the posterior shell. A two layer foam posterior liner extends upward within the posterior shell open vertical leg extension to receive the user&#39;s leg and adjustable fastening units secure the anterior shell to the posterior shell. An alternative orthosis walking boot with integrally attached foam liners on the posterior plastic shell and the anterior plastic shell is provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application No. 62/211,517 filed on Aug. 28, 2015; the entire contents all of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    Charcot Syndrome, also known as Charcot Arthropathy, is a condition where patients lose sensations in the feet or ankles and may experience dislocations of bones and joints or fractures without injury or trauma, according to the American Orthopaedic Foot and Ankle Society. Patients with Charcot Syndrome experience increased warmth, swelling and redness in the feet and ankles. Fractures and dislocations that occur due to the condition can produce deformities of the feet or ankles which may affect the stability and flexibility of bones and joints. 
         [0004]    Charcot foot is a serious condition that can lead to disfigurement, disability and amputation, according to the American College of Foot and Ankle Surgeons. As the condition advances, the joints crumble, and the foot adopts an abnormal appearance. Patients with diabetes, patients with long-term neuropathy, and neuropathic patients with tight Achilles tendons fall at risk of developing the condition and ought to take extra precaution and seek immediate treatment as soon as symptoms appear. Charcot can be a micro fracturing and dissolving of the bone commonly in the mid foot region. 
         [0005]    2. Description of Related Art 
         [0006]    Orthotics in the form of walking casts have attempted to protect the patient&#39;s foot while enabling the patient to still be mobile. The boot orthosis attempts to protect the patient&#39;s foot by encompassing it in plastic shells while accommodating any edema and reducing weight on the ankle/foot by trying to transfer it to the patient&#39;s leg and calf area by securing an anterior shell on the exterior of a posterior shell. Problems have occurred in trying to adjust the fit on the patient because of the potential of edema reduction as a result of a successful treatment and application of medication. 
       SUMMARY OF THE INVENTION 
       [0007]    The orthosis walking boot utilizes a separate anterior shell with sufficient flexibility to overlap and cover a lower foot supporting portion of a stiffer posterior shell. A flexible split hinge on the anterior shell facilitates expansion and contraction movements of an anterior foot covering and the hinge divides the anterior foot covering from an anterior front vertical leg extension covering that extends upward and has an integral foam leg covering liner for contacting the user. The back of the posterior shell is configured to conform to a back calf or lower leg of the patient and has a rear oblong opening to provide a degree of flexibility and size adjustment with a heat gun of the posterior shell. The anterior front leg covering is configured to slide within the upward extension of the more rigid posterior shell, since the exterior of the anterior shell has a relatively rigid smooth plastic outer surface that will interface with and slide across an interior smooth plastic surface of the upward extension of the posterior shell. 
         [0008]    The upward extension of the posterior shell surrounds an approximately U-shaped cross sectional foam liner that extends upward from a fixation at the heel of a foot portion of the posterior shell without a further fixation to the inner surface of the upward extension of the posterior shell. The foam posterior liner has a denser exterior layer for providing a support structure and a less dense interior foam layer for contacting the user. Accordingly, the foam posterior liner will bear directly against an outer side of the foam leg covering liner that is adhered to an interior surface of the anterior shell when inserted in the posterior shell. 
         [0009]    An alternative arrangement of the upward extension of the posterior shell can have a U-shaped foam liner integrally attached to an interior of the upward extension of the posterior shell with the exterior of the anterior shell being directly against the foam liner of the upward extension of the posterior shell. 
         [0010]    Appropriate flexible fastening straps are positioned with braces above the adjacent oblong opening and below the oblong opening and can be affixed to the patient&#39;s lower leg by bearing against the foam leg liner to reduce a portion of the patient&#39;s weight that would be bearing on the foot and thereby transform the weight bearing surfaces to the lower portion of the calf of the leg of the patient and an upper portion of the calf, to reduce the direct weight that must be borne by the bottom of the foot. 
         [0011]    As a patient responds to a medical treatment of the Charcot Syndrome and the edema is reduced, the relatively flexible anterior shell can be appropriately adjusted in position and sized by the fastening to accommodate any reduction in the edema swelling while still maintaining a comfortable fit relative to the posterior shell to provide protection for the patient&#39;s foot and ankle. 
         [0012]    Appropriate support braces are attached to the posterior shell to permit adjustment of the location of the anterior shell with the fastening straps to assure protection while permitting adjustment during treatment of the patient. Straps with a combination of hook and nap material such as provided with Velcro® products and their competitors can be secured through the support braces and to the front of the anterior shell. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The objects and features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description, taken in connection with the accompanying drawings. 
           [0014]      FIG. 1  is a perspective view of an assembled orthosis walking boot having the anterior shell fastened to the posterior shell with straps providing compression and positioning on the patient when tightened through braces; 
           [0015]      FIG. 2  is a cross sectional view of the orthosis walking boot attached to a patient suffering from Charcot disease with edema in the ankle/foot area; 
           [0016]      FIG. 3  is an exploded view of the orthosis walking boot disclosing the interior of the posterior shell and the exterior of the anterior shell; 
           [0017]      FIG. 4  is a side view of an assembled relationship of the anterior shell and the posterior shell without the straps; 
           [0018]      FIG. 5  is a rear view disclosing the relationship of the anterior hard shell and the posterior hard shell along with the foam and an oval opening through the back of the posterior hard shell; 
           [0019]      FIG. 6  discloses a relationship of fastening nap and hook sections of the individual straps; 
           [0020]      FIG. 7  discloses a comparison between an open and closed configuration for the orthosis walking boot; 
           [0021]      FIG. 8  is a schematic top view of a relationship between the flexible anterior shell and the more rigid posterior shell; 
           [0022]      FIG. 9  is an exploded view of another embodiment of the orthosis walking boot with an interior of both the posterior shell and the anterior shell having integrally attached foam liners; and 
           [0023]      FIG. 10  is a schematic top view of a relationship between the flexible anterior shell and the more rigid posterior shell with respective integrally attached foam liners. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0024]    Referring to  FIG. 1 , an orthosis walking boot  2  includes an anterior shell component  4  and a posterior shell component  14 . The anterior shell  4  can be formed from a polypropylene plastic while the posterior shell  14  can also be formed from a thicker polypropylene plastic. The anterior shell  4  has an approximately L configuration with a lower anterior foot covering  6  and an upper front leg covering  10 . A split hinge  8  extends across an upper surface of the anterior shell  4  to divide the front leg covering  10  from the anterior foot covering  6 . As can be seen in  FIGS. 1 and 3 , a V opening  9  to the perimeter is provided on either side of the hinge  8  to facilitate adjustments and insertion of the front leg covering  10  into the posterior shell  14 . 
         [0025]    The V side openings  9  are configured to permit a first portion of the first leg covering  10  to be inserted directly against an internal surface of the posterior shell  14  while the anterior foot covering  6  is also configured to extend over and enclose a foot opening  7 , as shown in  FIG. 2 , that illustrates a user or patient&#39;s foot. 
         [0026]    With reference to  FIG. 3 , a foam posterior liner  20  can be a copolymer of ethylene-vinyl acetate (EVA) and provides a bottom covering on the interior of the posterior shell  14 . An additional foam insert  21  can be provided immediately above the foam posterior lining  20  to contact the bottom of the patient&#39;s foot and can be reconfigured to address any foot issues such as swelling or ulcer sores. As can be seen in  FIG. 3  and  FIG. 8 , a first foam embodiment of an EVA foam posterior lining  20  extends upward within the upward extension of the posterior shell  18  in a relatively loose manner that is not bound or affixed to the upward extension  18 . The foam posterior lining  20  can extend upward above a top edge of the posterior shell  14  as seen in  FIG. 1 . Additionally, as seen in  FIG. 3 , a trim line of the foam posterior liner  20  extends forward beyond the front edges of the upward extension of the posterior shell  18  to facilitate an entrance of the front leg covering  10 . The foam posterior liner  20  has an outer layer of  22  pound density of EVA to provide support while the inner layer of EVA has a  5  pound density to contact the patient with a soft foam. 
         [0027]    This arrangement of the foam posterior liner  20  facilitates an introduction of the respective sides of the anterior front leg covering  10  so that the outer plastic shell of the anterior shell  4  can bear directly against an interior surface of an upward extension of the posterior shell  18  to assure that the foam lining  20  can be positioned within an affixed anterior foam liner  12  on the anterior leg covering shell  10 . An example of an applicable foam for the liner  12  can be a Volara® polyethylene foam that can be purchased, for example, with an adhesive glue for affixing to both an interior curved surface of the front vertical leg covering  10  and the anterior foot covering portion  6 . Volara® which can be purchased as a polyolefin-based polyethylene foam from Sekisui Voltec LLC having a closed cell configuration with virtually microscopic cells to provide an extremely soft texture with a consistent thickness/texture/density and a relatively high tensile strength, low water absorption and vapor transmission. 
         [0028]    A second embodiment of an orthosis walking boot  2  where a foam posterior liner  23  can be laminated on the interior of the upward extension  18  of the posterior shell  14  can be seen in  FIGS. 9 and 10 . Thus, depending on the circumstances of the patient, the orthotist can select either the free standing foam liner  20  arrangement shown in  FIGS. 1, 3 and 8  or the laminated foam posterior liner  23  shown in  FIGS. 9 and 10 . 
         [0029]    A plurality of rectangular segments  24  of one of a hook and nap material such as Velcro® can be adhered to a front surface of the anterior shell  4 , as seen in  FIG. 3 . As disclosed, hook material is disclosed in our drawings but nap material could be utilized. The segments  24  have an adhesive on a rear surface for a firm securement to the anterior shell  4 . A set of four braces  26  have a size sufficient to receive and pass the straps  22  to set the desired positions of the posterior shell  14  and the anterior shell  4 . As seen in  FIG. 2 , anterior foot covering  6  can be affixed to the posterior shell  14 . A set of four braces  26  are attached on the respective left and right hand side of the posterior shell  14 , as seen in  FIGS. 3 and 4 . Each of the braces  26  can support a roller  25  of a size and dimension to receive and permit smooth movement of the flexible straps  22  for tightening the anterior shell  4  so that the anterior foot covering  6  can be independently positioned and tightened to meet the demands of the patient&#39;s foot. Likewise, the braces  26  that extend outward from an upward extension of the posterior shell  18  can receive a strap  22  and permit a subjective tightening in an effort to transfer weight to a patient&#39;s lower leg and reduce the weight on the bottom of the foot of a patient. The segments  24  can be either of a nap or hook configuration to facilitate locking the straps  22  to the front of the anterior shell  4 . As shown for example in  FIG. 3 , the segments  24  of a rectangular configuration are a hook material. 
         [0030]    The braces  26  are not only dimensioned to freely permit the straps  22  to pass through as far as width and thickness of the straps  22 , but further have a roller  25  in the form of a free rolling cylinder to further facilitate tightening the straps  22  by using the leverage of the straps  22  extending through the braces  26 . 
         [0031]    The bottom of the posterior shell  14  has a sole  28 , of rubber or similar material, that is permanently fastened to the bottom of the posterior shell  14 . The outer edges of the vertically upwardly extending posterior shell  18  has concave edges  30  that extend somewhat outward for facilitating an insertion of the anterior front leg covering  10 , see the top view of  FIG. 8 . As can be seen in  FIG. 3  and  FIG. 8 , this indent extends for substantially the length of the edges  30  of the upward extension  18  of the posterior shell  144  and is configured to accommodate the outer edges of the anterior front leg covering  10 . 
         [0032]    The foam posterior liner  20  includes a thin relatively more dense outer surface  32  that can support the foam interior liner  20  that will contact the patient&#39;s leg. This arrangement permits the relatively dense surface  32 , shown in  FIG. 8 , to maintain an open configuration and further facilitates the insertion of the anterior front vertical leg covering  10  into the upward extension  18  of the posterior shell  14 . 
         [0033]    Also assisting the nesting of the anterior front leg covering  10  into the upward extension  18  of the posterior shell  14  is the manner in which the foam posterior liner  20  extends beyond and forward of a trimline of the posterior extension  18  of the posterior shell  14  as seen in  FIG. 3 . This arrangement facilitates an internal mounting of the front leg covering  10  into the posterior upward extension  18 . Additionally, because of the split hinge  8  and its peripheral openings  9 , our orthosis walking boot  2  provides some freedom in adjusting a height of the anterior foot covering  6  separate from the securement of the front leg covering  10  within the posterior shell  14 . As shown in  FIG. 1 , the upper strap  22  adjacent the upper opening enables the patient&#39;s upper calf to be comfortably surrounded with foam linings  20  and  12  while the straps  22  permit a sufficient tightening to transfer a portion of the patient&#39;s weight, that is usually supported by the foot, from the user&#39;s calf down to the sole  28  of the orthosis walking boot  2 . 
         [0034]    Likewise, the lower strap  22  on the front leg covering  10  also permits some weight of the patient to be transferred again to the sole  28  as opposed to exerting a force through the inflamed foot, as shown in  FIG. 2 , that is now protected within the posterior foot opening  7 . 
         [0035]    Referring to  FIG. 5 , a back perspective of the orthosis walking boot  2  is disclosed with the oblong opening  34  extending through the upward extension  18  of the posterior shell  14  with a rear surface of the semi-rigid base  32  shown. 
         [0036]    As can be determined, the oblong opening  34  not only lightens the boot, it still provides sufficient strength while contributing some flexibility to the upper portion or upward extension  18  of the posterior shell  14  to accommodate the tightening of the straps  22 . It also permits the orthotist to localize an application of heat for any size adjustments on the posterior upper portion of the shell  14  and the lower portion below the oblong opening  34 , since there is less plastic to receive heat from the heat gun. 
         [0037]    The straps  22  shown in  FIG. 6  are arranged with combinations of hook portions  36  and nap portions  38  to facilitate looping the strap  22  to affix it to one of the braces  26  and threading the strap  22  through the opposite side brace  26  so that the rollers  25  facilitate pulling a strap  22  back across and tightening it with the nap  36  at the end of the strap  22  by fastening to the hooks on the other side of the same strap. The rectangular hook segments  24  provide another direct anchor point on the anterior shell  4  for the respective straps  22 . 
         [0038]    Referring to  FIG. 7 , a view of the anterior shell  4  is shown schematically in an open position for an insertion into the posterior shell  14 . The closed position of  FIG. 7  shows a relationship of the anterior and posterior shells in a closed condition as an illustration. 
         [0039]    In  FIG. 2 , a patient with a swollen edema is shown mounted with an orthosis walking boot  2  with the anterior foot covering  6  appropriately mounted over posterior side wall perimeter  40  of the sole to provide space for the swollen foot and further encapturing the posterior foot opening  7  to provide protection for the patient. 
         [0040]    The orthosis walking boot  2  can serve the patient not only at the initial treatment of the Charcot Syndrome but also as the foot is being successfully treated so that the edema is being reduced and the same orthosis walking boot  2  can then be adjusted to accommodate the comfort of the patient with an appropriate sizing between the anterior shell  4  and the posterior shell  14  as described above. 
         [0041]    While the above features of the present invention teach apparatus, process and an improved orthosis walking boot, it can be readily appreciated that it would be possible to deviate from the above embodiments of the present invention and, as will be readily understood by those skilled in the art, the invention is capable of many modifications and improvements within the scope and spirit thereof. Accordingly, it will be understood that the invention is not to be limited by the specific embodiments but only by the spirit and scope of the appended claims.