Abstract:
An AFO for automatically lifting the toes about the phalanges joint to assist a person when they have a medical condition referred to as “drop foot” comprising, in combination, a support that transcends vertically between two points on the lower front leg, a primary tension member attached to the upper point with a snap swivel leads to where it is fastened to the toe of a shoe at an optimum location just above the big toenail and a secondary tension member placed over the primary member so that it aids in lifting the toes and keeping them lifted. A lower strap holding the support to the front of the leg in the vicinity of the ankle does so in a spiral manner, preventing a “choking” effect that would impede circulation. The entire device is lightweight, easy on/off, comfortable and doesn&#39;t need to go in a shoe.

Description:
FIELD OF THE INVENTION 
       [0001]    THIS INVENTION relates to a new and novel ankle foot orthosis (AFO), and more specifically to an improved AFO device that is fastened to and worn on the lower leg to provide an attachment point for a tension member that further attaches to the toe of a shoe, slipper, or foot covering, providing lift to the foot and, in particular, the toe portion of a foot. Contributing to this is another separate tension member that when fastened to this improved AFO device functions as a human tendon, and both of these in combination greatly assist a person walk in a more normal manner with a medical condition known as “drop foot”. 
       BACKGROUND OF THE INVENTION 
       [0002]    CONVENTIONAL ankle foot orthosis called AFOs, which stands for Ankle Foot Orthosis, are used to assist a person in walking when they have a medical condition commonly referred to as “drop foot”. The drop foot condition prevents normal walking movements because the front portion of the foot, including the toe(s), does not respond to nerve signals and is unable to be raised in a spontaneously normal manner causing the foot to “droop” down at the toe. Individuals suffering from the “drop foot” malady have lost, or are seriously restricted in, the ability to voluntarily flex and move one or more of the toes, achieve upward rotation of the entire foot, may drag the foot and have difficulty walking without tripping and falling. 
         [0003]    When walking with only one foot affected with “drop foot”, the good foot that has taken a step now supports the entire body weight; then as the other foot starts to advance by swinging forward, if the drooped front (toe) of that affected foot “stubbs”, drags on carpet, or hits any type of obstruction however slight as it advances, the “dropped foot” will stop! At that instant the forward momentum of walking could cause an immediate, and sometimes disastrous, fall. 
         [0004]    The “drop foot” condition may exist in either the right, or left foot, and sometimes both feet are affected. If both feet are affected walking is very difficult and the person may walk by shuffling, or dragging the feet and may also require the use of other assisting devices, such as canes or walkers. 
         [0005]    AFO devices have been on the market for years and most of them will provide support for all, or portions of, the foot. They are constructed of various combinations of materials, such as plastic, metal, or fabrics, so that they only support the foot at a roughly ninety-degree angle to the leg to keep it from drooping down. Many of them have portions that go inside of a shoe, fit and clamp around the lower leg, and some require special shoes. Most are expensive and nearly all are extremely uncomfortable to wear, especially if they must be tightly clamped around the large calf muscle of the leg, which causes extreme pain. On ones requiring insertion into a shoe, they must be cushioned in some manner by foam, layers of padding, or stockings and when all of this is put together it has to fit inside of the shoe. In addition, the rigid nature of most AFO device construction prevents ankle flex and rotation. None of the un-powered devices have the ability to raise the toes. 
         [0006]    Since the foot is still held in a flat-out straight position at a ninety-degree angle, or less, to the heel, the use of these devices still requires a peculiar type of gait when walking. Even though the foot no longer “droops”, being held up by the AFO device, the toes are still in a flat plane with the foot. The entire foot must be raised up in order to swing forward without catching the toe and tripping and the risk of tripping and falling is still present. This also forces the person to use an unnatural circular lift, thrust forward and set down motion with the foot when walking and each step taken causes a “slapping” sound that causes embarrassment to the patient. 
         [0007]    Most of these devices require much time to put on. Other devices built into special shoes share many of the same restrictive requirements, could require them to be individually fitted and are much more expensive. Still further devices rely on straps that fit around the leg, but these straps tend to slip down the leg, lose their effectiveness, and if excessively tight, start to put pressure on leg muscles, restrict circulation and become uncomfortable to wear for long periods of time. 
         [0008]    In addition to the foregoing problems created with the use of conventional AFO devices, a serious problem exists by patients needing such a device not wearing them due to the time it takes to put them on, the discomforts they cause, or that they can only tolerate them for a short time. By not wearing a needed AFO the patient is highly exposed to the dangers of tripping and falling at any time. 
       SUMMARY OF THE INVENTION 
       [0009]    WHAT IS NEEDED is an AFO device for patients with “drop foot” that will not only have the means to support the foot, but also provide means to automatically raise the toes so that a normal walking gait may be achieved without tripping. 
         [0010]    The present invention presents a new and novel ankle foot orthosis (AFO) to provide such assistance. The embodiment consists of the combination of an assembled apparatus fastened to the lower leg of the patient with a tensioning device connected to a conventional shoe and having a secondary tensioning device connected in such a manner to act as an artificial tendon to provide automatic toe lift, as well as: 
         [0011]    An apparatus comfortable to wear for long periods of time; a means for it to be lightweight and inexpensive; means for it to be easily and quickly put on and taken off; means for two points of attachment to the lower leg for stability; the means to automatically provide additional upward force to lift up the toes to allow ground and obstacle clearance as the foot swings forward with each step for a nearly normal walking gait without tripping and falling; the means to prevent the front of the shoe (toes) from catching on an object and causing tripping; the means to attach the device to any type of foot covering at the correct location of over the base of the big toenail to provide necessary lift for the toes; the means for it to be adaptable for wear with any type of foot coverings such as shoes and slippers; the means to provide a method to prevent the toe lifting segment from putting pressure on the sides of the toes when the device is to be worn with soft foot coverings; a means to outfit multiple foot coverings with inexpensive, permanent toe lifting attachments, allowing instant and interchangeable use of different foot coverings; and the means whereby use of the apparatus by patients requiring an AFO device to be used on both feet will benefit from all the above and may not require the use of other assisting devices, all of which are a part of this invention. 
       DESCRIPTION OF PRIOR ART 
       [0012]    U.S. Pat. No. 7,077,818 discloses an ankle-foot orthosis having a structural frame formed from at least one layer of fabric impregnated with a hardened structural resin. The frame includes at least one anterior support member that extends downwardly from an upper leg engaging portion to define an anterior ankle portion which extends to a medial portion connected to a foot plate. 
         [0013]    U.S. Pat. No. 6,926,687 discloses an ankle-foot orthosis for relief of a patient from orthopedic dysfunctions comprising, in combination, a shoe and a brace assembly. The brace assembly comprises a leg member and a pair of opposed upright members. The leg member is constructed and arranged such that portions of the inner surface of the leg member complementarily conform to portions of the rear and sides of a patient&#39;s lower leg. Each upright member of the pair of upright members is connected to the leg member and extends downwardly from the leg member to a distal end. The support brace further comprises means for resiliently connecting a portion of the support brace to the upper portion of the shoe. In use, at least a portion of the distal ends of the upright members is inserted into a portion of the heel portion of the shoe between sides of the shoe and the patient&#39;s foot. 
         [0014]    U.S. Pat. No. 5,961,477 discloses a foot and ankle orthosis adapted for use by a patient in both resting and walking modes. The orthosis includes a generally L-shaped support member which has a leg portion positioned behind the patient&#39;s lower leg, a heel portion positioned behind the patient&#39;s heel and Achilles&#39; tendon area, and a foot portion positioned substantially entirely against the sole of the patient&#39;s foot, when in normal operative use position. The foot portion has an upper surface and a lower surface and the heel portion connects the leg portion and the foot portion. A walking sole plate is releasably connectable to the generally L-shaped support member, to thereby permit optional use by the patient of the walking sole plate in combination with the generally L-shaped support member for facilitating ambulation by the patient. A manually operable locking mechanism is attached to the lower surface of the foot portion of the generally L-shaped support member, to thereby permit rapid, selectively; releasable connection of the walking sole plate to the generally L-shaped support member. 
         [0015]    Other U.S. patents of possible interest relative to the present invention are U.S. Pat. Nos. 3,976,059, 4,446,856, 4,559,934, 4,651,723, 4,693,239, 4,834,078, 4,938,777, 5,088,479, 5,219,324, 5,603,692, 5,897,515, 6,299,587, 6,319,218, 6,827,696, 6,860,864, 6,908,445, 6,929,614, 6,945,947, 6,997,891, and 7,018,352. 
       REFERENCE 
       [0016]    Reference is hereby made to U.S.P.T.O. Disclosure Document 603834 dated Jul. 24, 2006 entitled “Lewis Lift AFO Device”, Herbert H. Lewis, inventor. 
     
     
       DESCRIPTION OF THE DRAWINGS 
         [0017]    A preferred embodiment of the invention is illustrated in the accompanying drawings in which: 
           [0018]      FIG. 1  is a side view of the dropped foot condition requiring the present invention; and 
           [0019]      FIG. 2  is a side view of an explanation for need of the present invention; and 
           [0020]      FIG. 3  is a side view of a typical existing AFO; and 
           [0021]      FIG. 4  is a side view of the present invention of a type used for fitting purposes; and 
           [0022]      FIG. 5  illustrates a shoe attachment to a tension member of the present invention; and 
           [0023]      FIG. 6  is a partial sectional view at “D-D” from  FIG. 5  showing the attachment point; and 
           [0024]      FIG. 7  is a side view of the present invention; and 
           [0025]      FIG. 8  is a sectional view at “C-C” from  FIG. 7 ; and 
           [0026]      FIG. 9  is a partial side view of the spiral wrap and secondary tension member; and 
           [0027]      FIG. 10  is a sectional view at “A-A” from  FIG. 4  of the present invention; and 
           [0028]      FIG. 11  is a sectional view at “B-B” from  FIG. 7  of the present invention; and 
           [0029]      FIG. 12  is a side view showing the secondary position of the lower leg strap; and 
           [0030]      FIG. 13  is a graphic of the assisted walking gait, all in accordance with the invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0031]    Referring more particularly to the drawings, the Numeral  1  in  FIG. 1  designates an overall Side View of a shoe  20  (no other foot covering  21  shown) encasing a drop foot  22  reposing at a downward angle  23  due to a medical condition known as “drop Foot”. This is where the toes  24  of the drop foot  22  would hang below  25  a straight reference line  26  to show how the drop foot  22  in a shoe  20  would unavoidably droop down due to the problems associated with “drop foot”. 
         [0032]    Referring now to  FIG. 2 : The walking swing  27  would normally flex  28  a normal foot  29  about the ankle  42  and would have the shoe toe  30  bent slightly upward  31  to clear the straight reference line  26 , but a drop foot  22  having toes  24  that droop at a downward angle  23  would stub  32  the shoe toe  30  and stop the forward movement  33  of the walking swing  27 , resulting in an immediate fall  34 . 
         [0033]    Referring now to  FIG. 3 : This is a side view of a prior art plastic AFO  35  that has a foot cup  36  that holds the drop foot  22  at roughly a ninety-degree angle  37 . It is held in place by a strap  38  fastened to the plastic AFO  35  at a point  39 . The placement of this device binds the calf muscle  40  at many points of contact  41  and causes much pain. The drop foot  22  is rigidly encased in the plastic AFO  35  and the ankle  42  cannot flex  43 . All of this is enclosed in stockings (not shown) and thrust inside of a shoe (not shown). The inconvenience of this design causes pain and problems not found in the present invention. 
         [0034]    Now,  FIG. 4  is a side view illustrating the present AFO invention  44  that is fastened to the front part  45  of a human leg  46  and consists of a support bar  47  with an upper attachment point  48  and a secondary attachment point  49 . This support bar  47  may be of a two-piece design  51  as shown here but, this is intended for fitting purposes only. Made of various materials shaped for structural rigidity (See  FIG. 8 ), and using adjustment holes  52  to change the length  53 , a conventional machine screw  54  and wing-nut  55  holds the two-piece design  51  in place while measurements are taken. The upper attachment point  48  includes an upper strap  56  made of a conventional soft lined strapping material fitted above the calf muscle  40  and just below the knee  58  and fastened to the leg  46  with Velcro™ press together connectors  57 . The upper strap  56  is connected to the support bar  47  at the upper attachment point  48  by conventional means such as a rivet  59  along with a ring assembly  60  and washers  61 . The front part  45  of the leg  46  is separated and cushioned from the support bar  47  by a soft foam pad  62 . A similar soft foam pad  63  at the secondary attachment point  49  cushions the front part  45  of the leg  46  at the ankle  42  and, along with a lower strap  65  made from a conventional soft lined strapping material secured to the leg  46  with Velcro™ press together connectors  57 , forms a vital support point  64  for the support bar  47 . This arrangement allows the support bar  47  to be held away  66  from the front  45  of the leg  46  by the soft foam pad  62  and  63  leaving an empty space  67  that prevents contact. Measurement of the length  53  of the two-piece design  51  on the present AFO invention  44 , when fitted to a patient, allows customization of the device as shown in  FIG. 7 . Most components shown here also apply to  FIG. 7  with some modification. 
         [0035]    A further part of the AFO invention  44  shown here is a fitting version of a tension member assembly  68  that will support  69  a drop foot  22 , as well as raise  70  the toes  24  above a straight reference line  26 . The top end  71  of the fitting chord  72  is permanently fastened  73  to a snap  74  with a tie wrap  75 . The snap  74  attaches to the ring  76  of the ring assembly  60 . The lower end  77  of the fitting chord  72  is passed through  78  eyelets  79  of a fitting shoe  80  thence back up  81  with enough tension  82  applied to the fitting chord  72  to support  69  a drop foot  22  and replicate a shoe toe  30  or other foot covering  21  bent slightly upward  31 . The lower end  77  of the fitting chord  72  is then temporally secured  84  with a knot  85 , all for purposes of customizing the present invention by fitting to a patient. 
         [0036]    Now,  FIG. 5  is an illustration showing a typical shoe  20  that could be any type of foot covering  21  with a tension member assembly  68  attached to the shoe toe  30  at the optimum location  86  directly above the base  87  of the big toenail  88  of the toes  24  on a drop foot  22 . A hole  89  in each side  90  of the foot covering  21  allows the tension member  91  of the tension member assembly  68  to be passed through  78  the holes  89  and back up  81  to a wire wrap  75  that, when tightened, secures the two-lines  92  of the tension member  91  together. Excess materials  93  are trimmed off. To keep the two lines  92  of the tension member  91  from exerting side pressure  94  on the toes  24  when a soft foot covering  21  is used, a spreader bar  83  is used. To complete the tension member assembly  68  the tension member  91  is permanently fastened  73  to a snap  74  with a tie wrap  75 . With all components put together and adjusted as shown in  FIG. 5  and  FIG. 6 , the assembled combination of parts become the primary tension member and shoe assembly  101 . 
         [0037]    Accordingly,  FIG. 6  is a partial sectional view “D-D” from  FIG. 5  through a shoe toe  30  for showing the optimum location  86  of attachment points  95  for the tension member assembly  68  on any foot covering  21 . This would be as close as possible to the location of the base  87  of the big toenail  88  on the affected drop foot  22  within the confines of the shoe  20 . These attachment points  95  would provide a natural pivotal point  96  allowing the shoe toe  30  and toes  24  to be lifted upward  31  in relation to the straight reference line  26  by the amount of tension  82  applied to the tension member  91 . The tension member  91  is passed through  78  holes  89  punched in the foot covering  21  just below  97  the outside surface  98 . A spreader bar  83  placed on the tension member assembly  68  and pulled down to the outside surface  98  prevents the two lines  92  (not shown) of the tension member assembly  68  from putting undue pressure on the toes. The important attribute to raise the toes  70  is achieved by placing the attachment points  95  over the big toenail  88  and using the natural pivotal point  96  of the drop foot  22  at the phalanges joint  99  where the rows of toes start will become more significant as the description continues. 
         [0038]      FIG. 7  is a side view of the present AFO invention  44  in its entirety, consisting of a primary tension member and shoe assembly  101  with a secondary tension member assembly  102 , fastened in combination to a support bar assembly  100  on a human leg  46 . 
         [0039]    The support bar assembly  100  containing the upper attachment point  48  is easily fastened to the front part  45  of the leg  46  with an upper strap  56  and Velcro™ press together connectors  57  above the calf muscle  40  and just below the knee  58 . Similarly, a support point  64  is established at the secondary attachment point  49  with a lower strap  65  attached to the human leg  46  in a spiral  103  configuration just above the ankle  42 , refer to Section “B-B”. 
         [0040]    A drop foot  22  is placed into a shoe  20  of the primary tension member and shoe assembly  101  and quickly connected to the support bar assembly  100  with a snap  74 . 
         [0041]    The secondary tension member assembly  102  is fastened to the support bar assembly  100  over the primary tension member and shoe assembly  101  with Velcro™ press together connectors and the orthosis has been easily made ready to support the dropped foot and raise toes  70  by providing necessary upward  31  lift. 
         [0042]    Then,  FIG. 8  is a cross section “C-C” showing how the support bar assembly  100  may be made structurally strong using various shaped support bar  47  configurations without limitation. Foam rubber padding  104  is secured by using glue  105  as required and open space  67  is not a necessity. 
         [0043]      FIG. 9  shows the secondary connection of the support bar assembly  100  to the human leg  46  and how the lower strap  65  that is fastened to the support bar  47  at the secondary attachment point  49  wraps around  106  the human leg  46  in spiral  107  configurations forming an angle  108  to keep from constricting the leg. Velcro™ fasteners (not shown) attached to the lower strap end and the support bar at point  109  secure the device at some distance  110  above the straight reference line  26 . Then, the end  111  of the secondary tension member assembly  102  is first attached  112  to the lower strap  65 , then placed over  113  the tension member  91  and the other end  114  secondly attached  115  to the opposite side of the lower strap  65  with Velcro™ fasteners  57  to draw back  116  the tension member  91  adding/decreasing  117  tension as the ankle  42  is allowed to flex  28 . The in/out  118  movement of the secondary tension member assembly  102  is imparted by elastic strips  119  and with a wear strip  120  added to increase service life. The secondary tension member assembly  102  thus acts as an artificial tendon to provide upward  31  lift. 
         [0044]    Now,  FIG. 10  is a Cross Section “A-A” of the support bar assembly  100  attached to the front part  45  of a human leg  46  with the upper strap  56  wrapped around and secured with Velcro™ press together connectors  57 .  FIG. 11  is a Cross Section “B-B” of the support bar assembly  100  attached to the front part  45  of a human leg  46  with the lower strap  65  wrapped around and secured with Velcro™ press together connectors  57 . The end  111  of the secondary tension member assembly  102  comprised of elastic strips  119  and a wear strip  120  is first attached  112  to the lower strap  65  then placed over  113  the tension member  91  and the other end  114  attached  115  with Velcro™ fasteners  57 . 
         [0045]      FIG. 12  is a side view of the support bar assembly  100  that has been extended  121  from the preferred location  122  so that the lower strap  65  along with the soft foam pad  63  will rest at ankle  42  level where a normal foot  29  widens  123  to provide natural stop points  124  just above the shoe  20  for a patient requiring a lower placement of the present AFO invention. 
         [0046]      FIG. 13  illustrates the natural walking gait  125  achieved with use of the present AFO invention  44 . From a reference line  26 , the drop foot encased in a shoe, or other foot covering, is being supported with the toes raised up  70  to provide ground clearance  126 , and with the ability of the ankle  42  to flex  28 , a normal walking swing  27  may be used, all with the combined use of a support bar assembly  100 , a primary tension member assembly  101  to provide the necessary upward  31  lift, and a secondary tension member assembly  102  to act as an artificial tendon providing varying in/out  118  tensioning to further provide upward lift  31  of the shoe toe  30 . 
         [0047]    Other objects, features and advantages of the present invention will become apparent upon considering the specifications and when taken in conjunction with the accompanying drawings. While a preferred embodiment of this invention has been specifically shown and described, this was for the purposes of illustration only, and not for the purposes of any limitation, the scope of the invention being in accordance with the following claims.