Abstract:
An orthotic insert for use in various types of foot gear consisting of a first blank and a second blank fused together. The first blank is a flexible pad generally contoured to the bottom of a person&#39;s foot and the second blank is more rigid and contoured to the calcaneal and arch regions of a specific individual&#39;s foot. In combination the first and second blank form an orthotic insert which offers support to and is resiliently deformable in the heel area and flexible in the toe area thus emulating the requirement of the human gait cycle.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates generally to orthotic inserts for use in conjunction with various types of footwear. 
     The following patent application deals with developments concerning applicant&#39;s own U.S. Pat. No. 3,995,002 issued Nov. 30, 1976, U.S. Pat. No. 4,237,626 issued Dec. 9, 1980 and application Ser. No. 294,306 filed Aug. 19, 1981. 
     The first citation teaches the use of an orthotic casting system whereby a slipper mold is taken of the plantar surface of an individual&#39;s foot which, when the mold is cured, provides a negative template from which a positive cast can be fabricated. The final insert is then constructed using the positive cast to emulate the plantar surface of the individual&#39;s foot. 
     The second of applicant&#39;s patents cited teaches the use of a heel cup insert which is deformable and which can take an impression of the plantar surface of the heel and maintain that contour when cured so that the angulation of the calcaneal area can be adjusted to correct for rear foot varus or valgus. 
     The application cited provides a significant time saving in the ortho-casting process because it eliminates the necessity of making a negative mold from which the positive insert is constructed. Instead, the original mold itself becomes the insert. By eliminating a time consuming and labor intensive step custom fit orthosis can be created quickly and at a reduced cost. 
     The instant application represents a significant and novel improvement over the art disclosed in the above citations. Although a process may be somewhat the same as that described in applicant&#39;s U.S. Pat. No. 3,995,002, the materials employed in the instant application exhibit certain synergistic characteristics that further enhance desirable effects in a new, novel and unobvious manner. 
     The structure disclosed herein employs the orthocasting method in applicant&#39;s U.S. Pat. No. 3,995,002 to form a negative mold or slipper cast from which a positive cast of the plantar surface of an individual&#39;s foot is formed. Using this positive cast as a template, an orthotic insert is formed to underlie the area under the foot from the calcaneal area forward to the first metatarsal head, including the arch area, and from there laterally to the distal side of the foot or fifth metatarsal head. The insert itself is fabricated by applying to the positive cast a fiberglass and resin wafer selectively impregnated between layers having graphite fibers. The insert is then heat cured and cut to the limits of the cast. This is significant because of the unexpected benefits associated with the resulting structure due to the order and direction in which they are laminated together. The flexing characteristics of the insert, which are integral to its performance, can be beneficially controlled by adjusting the placement, amount, and direction of the graphite fibers impregnated between the layers of resin and fibre glass. The insert formed using the structure disclosed herein is extremely lightweight and relatively thin in comparison and is even more tuneable to the person&#39;s foot and activities because flex and rigidity can be adjusted over different areas of the insert to emphasize certain orthotic needs and compensate for certain orthotic abnormalities. If orthotic adjustment is painful to the patient because of excessive rigidity in a particular portion of that orthotic then it can be initiated gradually by introducing a further insert with a preferred zone of accentuated flexibility in the appropriate area, while maintaining a preferred rigidity throughout the remainder of the insert. This is accomplished by varying the configuration of the impregnated graphite and the thickness of the resinous core. 
     SUMMARY AND OBJECTS OF THE INVENTION 
     Accordingly, it is a primary object of the present invention to provide a novel orthotic insert device in which the flexibility of the insert can be beneficially controlled and altered in specific zones to conform to the podiatric requirements of each individual person. 
     It is a further object of the present invention to provide a novel orthotic insert device which can flex and dissipate stress differentially according to the activity for which it was designed. 
     It is a still further object of the present invention to provide a novel orthotic insert device which gives the podiatrist, the athlete, and the general consumer a whole new range of control to beneficially adjust and tune one&#39;s foot gear to one&#39;s requirements and activities. 
     It is another object of the present invention to provide a novel orthotic insert device which is extremely lightweight and lends itself well to mass production techniques. 
     It is still another object of the present invention to provide a novel orthotic insert device which is relatively rigid in the heel and arch areas for support and alignment and relatively flexible in the toe area and ball of the foot to allow for easy execution of the later phases of the gait cycle. 
     A further object contemplates providing a device of the character described above which can exhibit varied resistance to leading along its surface as a function of its composition. 
     These and other objects will be made manifest when considering the following detailed specification when taken in conjunction with the appended drawing figures. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING FIGURES 
     FIG. 1 is a top view of the first blank where the dotted line shows the positioning of the second blank beneath. 
     FIG. 2 is a top view of the second blank. 
     FIG. 3 is a perspective view of the layers comprising the second blank and the positive cast upon which they are contoured. 
     FIG. 4 is a series of top views of the graphite layers indicating the various directions in which the graphite fibers may be configured. 
     FIG. 5 is a perspective view of the finished insert with cutaway sections. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings in detail wherein like reference numerals represent like parts throughout the several figures, reference numeral 10 refers generally to a two-layered first blank which is generally configured in the outline of the bottom of an individual&#39;s foot, and 20 refers to the second blank. 
     As shown in FIG. 1, the first blank includes layer 1 of a cloth material such as nylon, Dacron, cotton or the like which is abrasion resistant and absorbs perspiration well. A second layer 2 is a thin flexible layer of rubber or neoprene or the like which is coextensive with and adhered to the first layer 1. The two layers together 1 and 2 form a first blank 10 which with second blank 20 forms an entire insert 30. 
     The blank 10 has the shape generally conforming to one&#39;s foot with a calcaneal or heel area 8, an area underlying the arch 3, an area underlying the ball of the foot 4 and a toe area 5. 
     FIG. 2 shows a second blank generally referred to by reference numeral 20, which is designed to underlie the first blank 10 from the calcaneal area 8 to the arch area 3 and terminate at the first and fifth metatarsal head 6 as shown by the dotted line in FIG. 1. 
     The first blank 10 and the second blank 20 become annealed or fused together after the second blank 20 has been custom formed to the individual&#39;s foot. 
     After the second blank 20 becomes contoured to the portion of the foot which it underlies, by a process to be described hereinafter, it is relatively rigid compared to the first blank 10 which must remain flexible. This is because during the human gait cycle the stress of the body weight is initially placed on the rear foot and then the weight is shifted forward through the sub-talar joint and mid-tarsal joint onto the metatarsal heads and finally through the toes. The first ray (first metatarsal) 6 is prime mechanism from which one propels himself forward. The first ray 6 must remain stable for this to occur efficiently. This stability is predicated upon a locked mid-tarsal joint and adequate muscular assistance. Thus, the insert may be relatively rigid beneath the calcaneal area 8, the arch area 3 and the first metatarsal head area 6, but must remain flexible in the ball of the foot area 4 and the toe area 5 so that the entire footgear can bend during the later part or toe roll segment of the gait cycle. 
     The rigidity of the insert beneath the first metatarsal head area 6 helps stabilize this area during propulsion thus preventing such abnormalities as Hallux valgus (bunion) and plantar callosities which may result from inadequate stabilization of the first ray during propulsion. Therefore, the shape and rigidity of the second blank 20 lends support and stabilization to the foot at the chief site of propulsion 6 and the flexibility of the first blank 10 allows the forefoot and the associated footgear to flex during the later stages of the gait cycle. 
     The second blank 20 can be formed and contoured around a positive cast obtained using the method and apparatus disclosed in applicant&#39;s U.S. Pat. No. 3,995,002. However, alternative layers of fiberglass, resin, and graphite, from which the second blank 20 is formed, are layed upon the positive cast thus contouring the shape of the second blank 20. As shown in FIG. 3, the second blank 20 is constructed from a plurality of layers. A first layer 11 is preferably a sheet constructed from a cloth such as fiberglass or nylon mesh and impregnated with resin. A second layer 12 can be a sheet of graphite with the woven graphite fibers running preferably diagonally from corner to corner. A next layer 13 is also a glass and resin sheet which may be the same as the first sheet 11 or may be a different thickness or contain a different percentage of resin. A next layer 14 can be a graphite sheet with the woven graphite fibers running orthogonally to the sides of that layer. A bottom layer 11 maybe a glass and resin sheet similar to the top layer 11. These various layers are applied to a positive cast 15 formed as in U.S. Pat. No. 3,995,002 so that the final lamination will replicate the contours of the positive cast 15. It should also be noted that the second blank 20 can be formed from as few as three layers such as layers 11, 12 and 13. Furthermore, once the second blank 20 is contoured, it forms a peripheral lip 9 around the heel area which cups the heel when load is brought to bear on the insert 30. Thus, the insert 30 beneficially deforms to grasp and support the calcaneal area. 
     The graphite layers 12 and 14 can be formed with the graphite fibers running in a variety of different directions, as shown in FIG. 4. Alternately, the graphite layers 12 and 14 can appear with the fibers interwoven into a grid as shown in FIG. 3. If the graphite layer is configured with the graphite fibers running horizontally (16 FIG. 4), then the blank 20 will tend to flex more readily about the axis parallel to the fibers, line C. Similarly, the fibers can be arranged in any direction to create a series of axes about which the insert will flex more readily, 17, 18 and 19 FIG. 4. Thus, the arrangement and configuration of the fibers relative to themselves and relative to the glass and resin layers determines the amount and direction of the flexibility of the completed insert 30. Furthermore, if preferred zones of rigidity or flexibility are desired, the configuration, and the number of the graphite layers can be varied to achieve the desired effects. For example, the insert 30 may require arch and heel posts 21 FIG. 5 in order to properly support the foot and provide a proper transition from the insert 30 to the footgear. The posts 21 also provide a means to limit motion in the subtalar joint and in so doing the post determines the position of the calcaneus to the ground (supporting surface). 
     After the second blank 20 has been formed to the specific contours of the individual&#39;s foot as described above, it is best cured at 350° for 45 minutes and then it is ready to be fixed to the bottom of the first blank 10 to create the final insert 30, as shown in FIG. 5. 
     Having thus described the preferred embodiment of the invention, it should be understood that numerous structural modifications and adaptations may be resorted to without departing from the spirit of the invention.