Abstract:
A system and method for comfortably restraining a child&#39;s feet undergoing the Ponseti method for treatment of club feet, using a foot and ankle abduction orthosis, where the improvement includes a shoe with an integral sole and attachment mechanism, as well as having a soft pliable area around the feet and ankle support.

Description:
BACKGROUND OF INVENTION 
   For years, the Dr. Ignacio Ponseti, a world-renowned expert in the treatment and management of club feet, has advocated use of a foot and ankle abduction orthosis (AFO) to prevent relapses of the deformity after the club-foot is corrected. Such a device consists of a bar of about the length between the baby&#39;s shoulders with high top open-toed shoes attached at the end of a bar in about 70 degrees of outward rotation. The splint is worn full time for two to three months, and thereafter at night and naps for 2 to 4 years. Corrective adjustments to the foot alignment are often necessary. 
   For many years, Dr. Ponseti used, with great success, the well-designed round-heeled high-top commercial shoes made by Penney&#39;s with soft leather. These are no longer available, and companies supplying much of the industry today don&#39;t produce adequate shoes attached to the bar. They often cause pressure sores and blisters on the baby&#39;s tender feet. Short and chubby clubfeet, even when well corrected, slip inside the shoe and even out of it, causing sores, loss of correction, great discomfort to the child and anguish to the parents. 
   Another problem is that it is often difficult to properly put the shoes on the patient&#39;s feet. In some instances, parents try to put the child&#39;s feet in the shoes while the shoes remain attached to the Dennis Browne splint. It is not only difficult for the parent, but uncomfortable for the child. Others have proposed shoes which have a simple latch mechanism which is attached to the sole of a shoe. Such a combination allows the parent to put the shoes on the child first and then latch the shoes to the Dennis Brown splint. These mechanisms attached to the bottom of the shoe are not only unsightly, but they are clumsy for the child to handle. 
   Consequently, there is an urgent need for improved methods and systems that will prevent relapses and sores while allowing free knee and ankle motion necessary to develop leg muscle strength. 
   SUMMARY OF INVENTION 
   It is an object of the present invention to provide a system and method for retaining a child&#39;s foot in an efficient manner. 
   It is a feature of the present invention to utilize a shoe with a sole and heel combination having an integrated attachment mechanism for connecting to a foot and ankle abduction splint (or orthosis) (AFO). 
   It is an advantage of the present invention to permit a child to wear a non-conspicuous and a normal use interference-free shoe which is readily attachable to an AFO splint. 
   It is another feature of the present invention to include a shoe having an opening at the heel which permits viewing of both sides of the heel when disposed in the shoe. 
   It is an advantage of the present invention to achieve improved efficiency in fully inserting a child&#39;s foot into a shoe. 
   It is yet another feature of the present invention to include a relatively inflexible sole section, a pliable interior foot cradling segment, and a relatively flexible shoe upper section. 
   It is an advantage of the present invention to provide comfort and firm support to a patient&#39;s feet. 
   The present invention is an apparatus and method for holding a child&#39;s feet in a predetermined therapeutic arrangement where the apparatus and method are designed to satisfy the aforementioned needs, provide the previously stated objects, include the above-listed features, and achieve the already articulated advantages. The present invention is carried out in a “discomfort-less” manner in a sense that much of the patient discomfort often associated with wearing, donning, and securing to an AFO splint, a pair of shoes, has been greatly reduced. 
   Accordingly, the present invention is a system and method including a shoe having a sole and heel with an integral mating mechanism for mating with an AFO splint, a comfortable pliable inner foot cradle and a comfortable shoe upper for ankle support. 

   
     BRIEF DESCRIPTION OF DRAWINGS 
     The invention may be more fully understood by reading the following description of the preferred embodiments of the invention, in conjunction with the appended drawings wherein: 
       FIG. 1  is a side view of a shoe of the present invention. 
       FIG. 2  is a side to rear view of the shoe of  FIG. 1  with the straps elevated for display purposes. 
       FIG. 3  is a perspective view of the in-foot cradle of  FIG. 1 . 
       FIG. 4  is a front view of the foot cradle of  FIG. 3 . 
       FIG. 5  is a top view of the foot cradle of  FIG. 4 . 
       FIG. 6  is a bottom view of the sole portion of the shoe of  FIG. 1 . 
       FIG. 7  is a bottom view of the clip mechanism of the present invention. 
       FIG. 8  is a side view of the clip mechanism of  FIG. 7 . in combination with an adjustment end of the bar of  FIGS. 11 and 12 . 
       FIG. 9  is a top view of a central joining piece of the splint of  FIG. 10 , where the dashed lines refer to the edges of the elongated portions of the splint halves of  FIG. 11 . 
       FIG. 10  is a perspective view of a splint of the present invention, including a central joining piece of  FIG. 9  and opposing splint halves of  FIG. 11 . 
       FIG. 11  is a perspective view of one of the opposing splint halves of the present invention. 
       FIG. 12  is a cross-sectional view of the central joining piece of  FIG. 9  taken on line  12 — 12 . 
       FIG. 13  is a perspective view of the central joining piece of  FIG. 13 . 
       FIG. 14  is an exploded view of the angular adjustment mechanism of the present invention. 
       FIG. 15  is a drilled horizontal cross piece for a splint of the present invention. 
       FIG. 16  is an exploded view of the foot wear, angular adjustment/quick release member and adjustable splint assembly of the present invention. 
   

   DETAILED DESCRIPTION 
   Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to  FIG. 1 , there is shown an article of footwear  100 , of the present invention. Footwear  100  is shown having a upper  102  which could be any type of material, including leather, fabric, vinyl or other material suitable for a shoe or sandal. Footwear  100  further includes a sole  104 , which is preferably a single molded piece of plastic material, such as a flexible polymer. Other material suitable for shoe or sandal soles could be used as well. Also shown is insole  106 , which is disposed above upper  102  and generally within upper  102 . Preferably, insole  106  is a single piece of molded polyurethane or rubber-like material. Preferably, insole  106  is pliable enough so as to permit it to conform to the shape of a child&#39;s foot when inserted therein and secured thereon by upper  102 . 
   Insole  106  is secured to sole  104  by glue and may be supplemented, if necessary, providing an insole side protuberance  162  to extend through a sole side hole  142  in sole  104 . Similarly, insole heel protuberance  164  extends through sole heel hole  144  and thereby holds insole  106  stable with respect to sole  104 . Insole  106  is also shown having an insole heel right viewing hole  166 , which is located near the heel of the insole  106 , so that it can readily be seen that a child&#39;s foot is in contact with the insole  106 . In a preferred embodiment, the insole heel right viewing hole  166  is a pair of holes on opposite sides of the heel or is a single hole which spans to both sides of the heel. In either embodiment, it would be possible to view the placement of the child&#39;s foot with respect to the insole  106  from a vantage point on either side of the heel. 
   Now referring to  FIG. 2 , there is shown an opposite side of footwear  100  of  FIG. 1 . 
   Now referring to  FIG. 3 , there is shown a perspective view of the insole  106  of  FIG. 1  when it is separated from footwear  100 . Insole  106  is shown having an insole toe end  302  and an insole sole foot side  304 . Preferably, insole sole foot side  304  is generally a flat surface without substantial contours to fit to an arch of a foot. Insole  106  includes an insole heel and ankle support  306  with an insole strap support  308  which keeps an ankle support strap from slipping downward. Insole  106  further includes insole side wall  310  on opposing sides of insole sole foot side  304 . In a preferred embodiment, insole sole foot side  304 , insole side wall  310  and insole heel and ankle support  306  all are portions of a single molded piece of urethane, pliable rubber-like material or flexible polymer material. 
   Now referring to  FIGS. 4 and 5 , there are shown front and bottom views, respectively of the insole  106  of  FIGS. 1 ,  2  and  3 . 
   Now referring to  FIG. 6 , there is shown a perspective view of the bottom of sole  104  of the footwear  100   FIG. 1 . Sole heel  602  is shown disposed at an opposite end of sole  104  from sole toe end  604 . Sole heel  602  has a sole attachment receiving groove  606  therein, which is separated from quick release push button receiving void  608  by quick release button barrier  610 . Preferably, all of these features, sole heel  602 , sole toe end  604 , sole attachment receiving groove  606 , quick release push button receiving void  608  and quick release button barrier  610 , are integrally formed in a single piece of durable plastic or other material suitable for a rigid shoe sole. This material may need to be more rigid than a typical shoe sole material because of the need for increased lateral forces owing to the use of the splint between the shoes. 
   Now referring to  FIG. 7 , there is shown an angular adjustment/quick release member  700 , which is configured to be inserted into sole attachment receiving groove  606  and quick release push button receiving void  608  of  FIG. 6 , by first inserting quick release front end  704  into sole attachment receiving groove  606  and sliding in further until quick release button  708  snaps into a locked position in quick release push button receiving void  608 . Quick release button  708  is preferably biased outward by a spring-like structure or arrangement. Angular adjustment/quick release member  700  includes angular adjustment base  702 , which is coupled to quick release back end  706  by angular adjustment/quick release riser  802  ( FIG. 8 ). Angular adjustment base  702  has a plurality of angular adjustment fixing screw mating holes  710  therein. Angular adjustment base  702  further has a pair of angular adjustment grooves  712  therein for receiving portions of groove penetrating portion  1402  ( FIG. 14 ). 
   Now referring to  FIG. 8 , there is shown a side view of the angular adjustment/quick release member  700  of  FIG. 7 . 
   Now referring to  FIG. 9 , there is a cross-section view of a shoe separation setting device  900 , also shown in  FIGS. 10 ,  12  and  13 . The dashed lines show the shoe separation bar-receiving cavity edges  906 . Shoe separation setting device  900  has a shoe separation setting device back side  902  and a shoe separation setting device front side  904 , as well as a first set screw  908  and a second set screw  910 . Preferably, shoe separation setting device  900  is made of a strong and rigid plastic material. First set screw  908  and second set screw  910  are shown extending through the shoe separation setting device front side  904  of shoe separation setting device  900 . The purpose of first set screw  908  and second set screw  910  is to function as a set screw fixing the location of adjustable splint right rigid bar  1020  and adjustable splint left rigid bar  1040  ( FIG. 10 ) at a set point. The therapeutic benefits of the Ponseti Method require that the separation of the feet be adjustable to differing fixed amounts during the treatment. The first set screw  908  and the second set screw  910  permit this adjustment. These set screws function similarly to the set screws found in the AFO or Markell Dennis Browne Splint discussed above. 
   Now referring to  FIG. 10 , there is shown an adjustable splint assembly  1000  which includes a shoe separation setting device  900 , an adjustable splint right rigid bar  1020 , having an adjustable splint right angular adjustment end  1022  and an adjustable splint left rigid bar  1040  having an adjustable splint left angular adjustment end  1042 . Preferably, adjustable splint right rigid bar  1020  and adjustable splint left rigid bar  1040  are rigid and strong metal bars; however, other suitable materials could be used as well. 
   Now referring to  FIG. 11 , there is shown a close-up view of the adjustable splint right rigid bar  1020  of  FIG. 10 . Adjustable splint right rigid bar  1020  has a plurality of adjustable splint right angular adjustment end adjustment screw holes  1102  and an adjustable splint right angular adjustment end center screw hole  1104  in the adjustable splint right angular adjustment end  1022 . Adjustable splint right rigid bar  1020  has a right rigid bar shank  1106 , which extends into the shoe separation setting device  900  of  FIG. 10 . Adjustable splint right rigid bar  1020  is designed to be used with the shoe separation setting device  900 . 
   Now referring to  FIG. 12 , there is shown a cross-sectional view of the shoe separation setting device  900  of  FIGS. 9 and 13 . 
   Now referring to  FIG. 13 , there is shown a perspective view of the shoe separation setting device  900  of  FIGS. 9 ,  10  and  12 . 
   Now referring to  FIG. 14 , there is shown an exploded view of a complete assembly of the present invention in the area around the angular adjustment section of one end of the adjustable splint assembly  1000 . There is shown the angular adjustment/quick release member  700  with its angular adjustment fixing screw holes  710 . Adjustable splint left angular adjustment end  1042  is then disposed on angular adjustment base  702 , so that it fits inside the angular adjustment grooves  712  and that the center hole in adjustable splint left angular adjustment end  1042  aligns with the center of the angular adjustment fixing screw holes  710 . Then, the adjustable splint left angular adjustment end  1042  is held in place with respect to the angular adjustment/quick release member  700  when angular adjustment guide cap  1400  is placed over the adjustable splint left angular adjustment end  1042  and the groove penetrating portion  1402  fits into one of the angular adjustment grooves  712 . The rigid bar clearance riser  1404  gives space for the adjustable splint left angular adjustment end  1042  to rest on the angular adjustment base  702 . The center of the angular adjustment screw holes  1410  is aligned with the center of the angular adjustment fixing screw holes  710  and the center hole in adjustable splint left angular adjustment end  1042 , and a screw is inserted therein. With this arrangement, the quick release front end  704  and the adjustable splint left rigid bar  1040  are able to be moved to and locked into a series of discrete angular adjustments. 
   Now referring to  FIG. 15 , there is shown a bolt through rigid bar  1520  which is similar in overall function to adjustable splint right rigid bar  1020  except that it is designed to have a bolt extend through the plurality of bolt through rigid bar bolt receiving holes  1530  therein. The bolt or bolts could perform the same function as the shoe separation setting device  900 , namely, fixing the overall combined length of the two bars and, therefore, the separation distance between the patient&#39;s feet. 
   Now referring to  FIG. 16 , there is shown an exploded view of the present invention with two shoes coupled together. 
   In operation, the present invention can be used to carry out the Ponseti method of club foot treatment as follows: 
   Adjustable splint right rigid bar  1020  and adjustable splint left rigid bar adjustable splint left rigid bar  1040  are coupled together using a bolt or shoe separation setting device  900 . The angular adjustment mechanisms on each end of the adjustable splint assembly  1000  are assembled as described with respect to  FIG. 14 . The angle is set by inserting a second screw through one of the adjustable splint right angular adjustment end adjustment screw holes  1102 . The footwear  100  is attached to the angular adjustment/quick release member  700  by insertion of the quick release front end  704  into the sole attachment receiving groove  606  and quick release push button receiving void  608  until the quick release button  708  snaps into place beyond the quick release button barrier  610 . At this point, the patient&#39;s feet can be placed in the footwear  100  and secured. Proper placement of the feet in the footwear  100  can be assured by viewing through the insole heel right viewing hole  166 . 
   In an alternate approach, the footwear  100  can be secured to the patient&#39;s feet and then the angular adjustment/quick release member  700  is coupled to the footwear  100 . 
   Throughout this description, reference is made to the Ponseti method and to Dennis Browne splints, because these methods and apparatuses are well known in the art and are believed to be the environment where the present invention would most likely be used. However, the novel aspects of the present invention could be used with other methods and in splints other than Dennis Browne splints. 
   It is thought that the method and apparatus of the present invention will be understood from the foregoing description and that it will be apparent that various changes may be made in the form, construct steps, and arrangement of the parts and steps thereof, without departing from the spirit and scope of the invention or sacrificing all of their material advantages. The form herein described is merely a preferred exemplary embodiment thereof.