Abstract:
A method system of custom forming orthotic shoe inserts adapted for use in multiple shoe types. The method steps to fit, form and fabricate custom inserts directed to individual patient requirements using heat malleable synthetic resin material in combination with removably secured overlying foot engagement pad and selective secured remedial arch pad directing the so-formed orthotic support.

Description:
BACKGROUND OF THE INVENTION 
   1. Technical Field 
   This invention relates to customized molded orthotic devices specifically designed for corrective therapeutic treatment of foot, knee, hip, pelvic and spinal dysfunctional ailments promoting proper biomechanical function in the foot, knee, hip, pelvis and spine. 
   2. Description of Prior Art 
   Prior art customized molded orthotic devices have been developed in conjunction with the use of orthotic labs to be used with shoes to provide a custom contoured low profile fixture to fit the planar surface of the foot. Initially, such devices were formed from metal and leather with later material advances currently using heat formed synthetic or molded synthetic resin material to custom fit for each patient. This system could only be produced by orthotic labs where all the shaping and construction of the custom molded orthotic plate took place. Such hard plastic fixtures use a custom mold taken from the patient&#39;s foot in combination with constructive contouring to supplement the needed therapeutic treatment and correction of such devices. Such custom orthotics are typically designed for use in the primary shoe of the patient and thus limits their use. Most practitioners make only impressions of a patient&#39;s foot, which then are shipped to an orthotic lab. Orthotic labs receive the impression and create casts of the foot with plaster which takes much time and energy to build and form. Other models are pre-molded and are fitted according to the size of foot. Pre-molded orthotics cannot give customized foot support which is mandatory for optimal biomechanical joint function. 
   A variety of prior art devices have been developed for such orthotics, see for example U.S. Pat. No. 5,015,427, Patent Publications 2002/018360A1 and 2004/0194348AN and PCT Patent Publications PCT/AU91/00185 and PCT/AU03/0034. 
   In U.S. Pat. No. 5,015,427 a process is disclosed for making an orthotic footwear insert made of a resilient shock absorbing layer to be positioned in the heel receiving area of the shoe. 
   U.S. Patent Publication 2002/0183 60A1 discloses the use of a heating mat to manufacture a custom orthotic device by heating up a sheet of flexible heat deformable material then applying it to the shaped part of a patient&#39;s body. 
   U.S. Patent Publication 2004/0194348AN illustrates a heat malleable orthotic shoe insert in which a cuffed heel portion is combined with a deformable mid-foot portion having a medial longitudinal arch and a deformable upper bearing surface. This insert requires that a heated mid-foot portion be engaged and pushed down upon by the patient&#39;s foot to form the impression therein. 
   PCT patent application publication AU91/00185 defines an orthotic device for the foot which is preshaped by use of a template cast to fit the patient&#39;s foot. 
   PCT patent application publication AU03/0034 outlines an orthotic insert is formed by combining two portions of material of different densities placed in a mold under heat and pressure. Once formed and cooled, the compound insert is then reheated and placed in the shoe of the patient who then pushes down thereagainst conforming the insert to the patient&#39;s foot. 
   SUMMARY OF THE INVENTION 
   A method and process of forming custom molded foot orthotics using a multiple step process that includes precise location of critical structural features of a patient&#39;s foot and the fabrication of the foot orthotic. This orthotic system is fabricated “in house” from start to finish and can be accomplished at the practitioner&#39;s office without the need of an orthotic lab. This is a direct molding procedure eliminating the use of plasters and all the various steps used in indirect molding of orthotics. A heat deformable material is pressed upward superiorly with the practitioner&#39;s hands and fingers against the medial and lateral longitudinal arches of the foot independent of a patient&#39;s weight deforming by transferring to provide a truly custom and efficient support portion of the medial and lateral portions of the weight bearing foot orthotics. The hindfoot is pressed superiorly on both sides to form a custom fit around the heel. This new customized orthotic procedure save time and cost and bypasses all the various steps of typical molding techniques. In 20-30 minutes this direct mold orthotic can be built from start to finish. 

   
     DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a top plan view of the contoured molded left orthotic hard shell portion of the invention; 
       FIG. 2  is a side elevational view thereof; 
       FIG. 3  is a front elevational view on lines  3 - 3  of  FIG. 1 ; 
       FIG. 4  is a top plan view of the custom soft top that is placed over the contoured molded orthotic shell shown in  FIG. 1 ; 
       FIG. 5  is a side elevational view thereof; 
       FIG. 6  is a top plan view of the completed customized moldable orthotic shell with a custom soft top and a transverse arch assembly; 
       FIG. 7  is a graphic left lateral side elevational view representation of a patient&#39;s foot being marked for the lateral longitudinal arch and fifth metatarsal-phalangeal joint; 
       FIG. 8  is a graphic partial bottom plan view of a patient&#39;s left foot being marked for the distal portion of the metatarsal bones; 
       FIG. 9  is a graphic partial top plan view of a patient&#39;s left foot marked for the first and fifth metatarsal-phalangeal joint; 
       FIG. 10  is a top plan view and a side elevational view of an orthotic synthetic resin orthopedic reinforcement plate material (orthotic blank) before forming; 
       FIG. 11  is a graphic medial side elevational representation of a patient&#39;s left foot marked for the medial longitudinal arch and the first metatarsal-phalangeal joint; 
       FIG. 12  is an exploded partial sectional side elevational view illustrating portions of an orthotic blank to be positioned on a non-stick tray to be heated; 
       FIG. 13  is an exploded side elevational view of positioning of the heated orthotic blank on a flexible foam placemat prior to deformation; 
       FIG. 14  is a graphic side elevational view of the patient&#39;s left foot positioned on the orthotic blank and support assembly set for deformation; 
       FIG. 15  is a graphic side elevational left view of the patient&#39;s left foot representing the applied upward force by the practitioner deforming the orthotic blank against the patient&#39;s left medial longitudinal arch; 
       FIG. 16  is a graphic side elevational view illustrating the foot bringing the heel up from the surface with applied downward pressure by a health professional “practitioner” (not shown) on the metatarsal-phalangeal joints to complete the deformation of the orthotic blank; 
       FIG. 17  is a left medial side elevational graphic representation that illustrates the repositioned alignment of the patient&#39;s foot on a cooled formed orthotic plate for final tracing of the foot&#39;s perimeter thereon; and 
       FIG. 18  is a top plan view of the formed orthotic plate with the patient&#39;s foot outlined thereon for final trimming and preparation. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Referring now to  FIGS. 1-3  and  6  of the drawings, a molded foot orthotic  10  of the invention can be seen having a contoured support shell portion  11  and a soft top foot engagement portion  12 . The contoured support shell  11  is molded from a synthetic material orthotic blank  13 , best seen in  FIG. 10  of the drawings which is malleable when heated retaining its configured shape once cooled. The orthotic blank  13  has an arcuate end  13 A and an oppositely disposed straight end  13 B. 
   To prepare a custom foot orthotics  10  of the invention, a patient&#39;s foot  14  is first examined by the practitioner to determine the position of specific physical attributes associated therewith and accordingly mark same on the foot  14  as follows and illustrated in  FIGS. 7 ,  8 ,  9  and  11  of the drawings. 
   Referring to  FIGS. 7 and 11  of the drawings, the medial longitudinal arch at  15  “inside arch” is the highest central point of the medial longitudinal arch. The lateral longitudinal arch at  16  “outside arch” marking same for future reference is the highest centered point of the lateral longitudinal arch. 
   The practitioner then locates and marks the distal posterior portion of the metatarsal bones  17  in  FIG. 8  of the drawings on the bottom  18  of the foot  14 . The first metatarsal phalangeal joint at  19  shown in  FIGS. 9 and 11  of the drawings is then located and marked on the top  20  of the foot  14  as well as the fifth metatarsal-phalangeal head at  21  best seen in  FIG. 7  of the drawings. 
   To determine the correct size of the orthotic blank  13  to be used, the patient&#39;s foot  14  is placed thereon as seen in  FIG. 11  of the drawings so as to extend from the back of a heel portion  22  to the hereinbefore described first metatarsal-phalangeal joint at  19  as indicated by size line arrow indicator L. 
   Referring now to  FIG. 12  of the drawings, the pre-selected orthotic blank  13  is then prepared for heating in a convection oven (not shown) by placing on a silicone sheet  23  and then onto a non-stick transportation tray  24 . The orthotic blank  13  is then heated in the convection oven at 400 degrees Fahrenheit for a predetermined time to impart malleability which is typically four to five minutes in most applications. 
   For positioning and forming of the orthotic blank  13  a flexible slow recovery foam material mat  25  with a second sheet of silicone material  26  thereon is placed on the floor F indicated in broken lines for alignment with the patient&#39;s foot  14  from a sitting position in which the lower leg  27  shown in broken lines and the foot  14  is orientated on a vertical plane in 90 degrees angular relationship to the patient&#39;s upper leg portion (not shown) in the hereinbefore described sitting position. 
   The heated and now malleable orthotic blank  13  with its silicone sheet  23  is removed from the convection oven and immediately placed on the second silicone sheet  26  on the mat  25 . A heat protection pad  28  defining a barrier for the foot is formed of a bi-layer construction of slow recovery insulating foam material  28 A and a silicone sheet  28 B glued together and positioned for aligned engagement on top of the heated orthotic blank  13 . If the patient&#39;s Achilles tendon is perpendicular to the floor F and not bowing, the knees, not shown, should be directly above the foot. If the Achilles tendons are bowing inward, the practitioner slightly moves the knee laterally outward in relation to the foot. This will form a medial heel wedge in the molding process. If the Achilles tendon is bowing outward, the practitioner moves the knee medial. This will form a lateral heel wedge in the molding process. The degree of the spreading or approximating of the knee is directly proportional to the degree of inward/outward bowing of the Achilles tendon. The patient is instructed to raise their toes  29  upwardly for engagement thereon as seen in  FIG. 14  of the drawings. The raising of the toes maximizes the medial and lateral longitudinal arch but is not mandatory. If the practitioner desires a lesser longitudinal arches, the patient is instructed to keep the toes down (flat). Given that the orthotic material blank  13  will stay malleable for only fifteen to thirty seconds after removal from the oven, the practitioner must move quickly. After it is determined whether to maximize the arches or not the practitioner must place his hands at the bottom of the medial and lateral arches positions. The practitioner then applies upward superior pressure against the foam material mat  25  and the medial longitudinal arch position of the foot (represented by force arrow A in  FIG. 15  of the drawings) and the lateral longitudinal arch of the foot at  32  to form a corresponding “outside” lateral arch at  33  shown in broken lines in the orthotic blank  13  thus forming by manual manipulation a medial longitudinal arch  31  portion and the lateral longitudinal on the orthotic blank  13 . Superior upward pressure with the practitioner&#39;s hands is also applied to both the medial and lateral sides of the heel to form a customized heel cup for the patient. 
   To complete the forming process, the practitioner instructs the patient to quickly lift their heel  22  putting equal pressure (indicated by force arrow A 1 ) on the ball of the foot  34  while being stabilized by the practitioner&#39;s hands presented by force arrow A 2  in  FIG. 16  of the drawings. Alternately, the practitioner can instruct the patient to keep the foot neutral while downward pressure is placed on the superior distal metatarsal heads of the foot  14 . This downward pressure whether the heels are up or down helps flatten the mid and forefoot portion of the orthotic blank  13  to prevent rocking and tipping to one side. 
   The now newly formed custom orthotic plate  35  is removed and cooled typically by running water to set thermally as will be well known and understood by those skilled in the art. 
   To complete the fit/forming process of the invention, the patient&#39;s foot  14  is then repositioned on the cooled configured orthotic plate  35  under the guidance of the practitioner and comfortably positioned to maximize the medial and lateral longitudinal arches. The practitioner then proceeds to mark the configured orthotic plate  35  based first on the positioning of the first metatarsal phalangeal joint  19  in  FIG. 11  of the drawings and then the fifth metatarsal phalangeal joint  21  see  FIG. 7  of the drawings, these positions having been determined previously and generally illustrated in  FIGS. 7 ,  11 ,  19  and  21  of the drawings. An outline  38  of the so engaged foot  14  is then traced onto the configured orthotic plate  35  with a straight line at  39  applied to and extending transversely between the so marked  36  and  37  (the first  19  and fifth  21  metatarsal phalangeal joint) as seen in broken lines in  FIG. 18  of the drawings. The thus marked configured orthotic plate  35  is then trimmed and sanded by use of power tools and hand application resulting in the finished exterior shape indicated in trace broken lines  38  in  FIG. 18  of the drawings and solid lines generally in  FIGS. 1-3  of the drawings. 
   Referring back to  FIG. 8  of the drawings, the patient&#39;s foot  14  is now re-marked on the foot&#39;s bottom surface  18  outlining the first, third, and fifth distal tarsal heads indicated at  40  using a transfer dye marker. The configured orthotic plate  35  is then quickly applied and held against the bottom  18  of the patient&#39;s foot  14  to affect a marking transfer thereon. This step transfers the indicia marks indicating the relative position of the patient&#39;s transverse arch on the upper surface  33 A of the configured orthotic plate  35 . A transverse arch pad  41 , well known in the art, having a contoured raised upper surface is selected based on the approximate required size and position and it is adhesively attached to the configured orthotic plate  35  upper surface  33 A as illustrated in  FIGS. 1-3  of the drawings. It will be noted that transverse arch pad  41  comes in a variety of shapes and sizes and must be placed beyond the distal portion of the metatarsal heads as hereinbefore described. 
   The soft top foot engagement portion  12  of the invention is configured from a resilient cloth foam material sheet  42  shown in broken lines by tracing at  43  the patient&#39;s foot  14  or a shoe insert (not shown) if available. The configured orthotic plate  35  is then applied and its outlined traced at  45  over the shoe/foot outline and then cut to become a shaped soft top  44  as seen generally in  FIGS. 4 ,  5  and  6  of the drawings. 
   Hook  45 A and loop  45 B registerable engaged material commercially available and known under the Velcro® trademark is adhesively secured respectively to an underside surface  46  portion of the soft top  44  extending inwardly from a “heel end”  47  thereof. The corresponding loop portion  45 B is adhesively secured to the upper surface  33 A of the configured orthotic plate  35  for registerable alignment with the corresponding hook material  45 A when the overlying soft top  44  is positioned thereover and secured thereon thus completing the custom foot orthotic assembly  10  of the invention as seen in  FIG. 6  of the drawings. 
   It will be noted that the orthopedic orthotic blank  13  is available in different dimensional sizes, shapes and thicknesses to accommodate a variety of foot sizes required and specific rigidity dependent on the patient&#39;s weight. 
   An example of same would be a semi-rigid reinforcement plate material for a patient under 225 pounds and a rigid reinforcement plate blank material for those over 225 pounds. A flexible plate (not shown) would be indicated for children (not shown) or for tight fitting shoe applications 
   It will be seen that by combining the custom molded hard support shell portion  11  so configured as the configured orthotic plate  35  with the removably secured foot engagement portion  12  fabricated as the soft top  44  will provide for a true custom foot orthotic device that can be used in virtually all the shoes of the patient as hereinbefore described. 
   It will thus be seen that a new and novel “in house” custom foot orthotic forming system and apparatus has been illustrated and described and it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the spirit of the invention.