Patent Publication Number: US-2022211530-A1

Title: Orthopedic Device Providing Metered Toe Traction with Variable Adduction, Dorsiflexion and Rotation Angles, Including Lateral Glide of the First Metatarsal Head

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/162,777, filed on May 24, 2016, which claims priority on U.S. Provisional Application Ser. No. 62/172,934 filed on Jun. 9, 2015, the disclosures of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to apparatus for treating various conditions of a person&#39;s toes, and more particularly to apparatus which are capable of providing a measured amount of traction to a toe, which may be adjusted in terms of traction force and adduction, dorsiflexion, and medial and lateral rotation angles, in addition to lateral glide of the head of the first metatarsal head angle. 
     BACKGROUND OF THE INVENTION 
     There are many medical problems that affect the toes of a person&#39;s feet. A common problem is known colloquially as a bunion, and is termed Hallux Abducto Valgus within the medical community. Hallux Valgus, also known as “Jaccoud&#39;s Arthropathy,” is characterized by progressive deterioration of the first metatarsal (MT) joint of the great (big) toe. 
     Normal great, or big toe alignment is characterized by a Hallux Valgus Angle (HVA) of between 5 and 10 degrees of the long axis of the proximal phalanx bone of the toe relative to the long axis of the metatarsal bone at the metatarsophalangeal (MTP) joint. (Hart et al 2008). A clinical diagnosis of Hallux Valgus is made when this angle exceeds 15 degrees. The first phase of the disorder involves modest lateral drifting of the great toe (greater than 20 degrees) towards the other toes. This phase is accompanied by early stage inflammation and swelling, which may go unnoticed as it is often relatively painless. However, the patient may begin to notice the lateral drift, but the resultant aesthetic loss is minor. 
     The second phase begins with reddening and puffiness of the skin over the metatarsal head. The skin soon becomes inflamed and scar tissue forms. The resulting bunion makes wearing narrow toed shoes, and many other types of shoes, painful if not impossible. The second phase is also characterized by mild to moderate pain, stiffness (hypomobility) of the metatarsal phalangeal joint (MTP) and further lateral drift of the great toe (HVA&gt;30 degrees). The deformity becomes very noticeable, and patients tend to find it acutely embarrassing. 
     The third phase is characterized by increasing lateral drift (HVA&gt;40 degrees—see  FIG. 2 ) and further deformity. The bunion becomes large and painful, and the toe becomes even more hypomobile (i.e., stiff), having a diminished range of motion in all directions due to scarring and decreased activity. The big toe may also suffer from arthritis. The drift deformity is now extreme and shoe options are severely limited to very wide toe box shoes, which are decidedly unfashionable. Walking is painful and the patient often seeks surgical intervention at this point. 
     It is generally agreed that certain inherited foot traits—flat feet, excessive ligamentous flexibility, abnormal bone structure, and some nerve conditions—may tend to make a person more susceptible to developing bunions, which is evidenced by appearance of the deformity in younger individuals. However, hallux valgus is most prevalent in women from western cultures, particularly women over the age of 35. So, while experts may be divided on whether ill-fitting footwear may be attributable as being the principle cause of bunions, it is agreed that the problem is at least exacerbated by prolonged wearing of high heeled, narrow toe box shoes. It may also be precipitated or compounded by foot injuries. Studies show that bunions are less prevalent in individuals who tend to go barefoot, while women are 10 time more likely to develop bunions than are men, with this disparity lending further weight as to the causation/exacerbation being attributable to the tendency of women to wear high-heeled, narrow-toes shoes. Bunions are also quite common for ballet dancers—individuals who are often plagued by foot injuries, and who also regularly wear tight leather or canvas slippers. 
     Current non-surgical treatment options now generally include custom-made orthoses. However, a recent report shows that these “appear to have no effect in the evolution of mild and moderate HV during a 12 month period . . . ” Reina M, Lafuente G, and Munuera PV, “ Effect of Custom - made Foot Orthoses in Female Hallux Valgus After One - year Follow Up ,” Prosthetics and Orthotics International, April 2013; 37(2):113-9. 
     Another treatment option includes the use of custom insoles with toe separators (night splints), however studies have shown that the use of a “night splint seems to have no effect on painful hallux valgus deformity,” and “was not effective in improvement of the great toe angles . . . ” Tehraninasr A, Saeedi H, Forogh B, Bahramizadeh M, and Keyhani MR, “ Effects of Insole with Toe - Separator and Night Splint on Patients with Painful Hallux Valgus: A Comparative Study ,” Prosthetics and Orthotics International, March 2008; 32(1):79-83. 
     Treatment for a severe deformity may include surgery. However, before a deformity progresses to the severity that may only be countered with corrective surgery, treatment nonetheless calls for the use of an orthopedic device. The present invention provides an improved orthopedic device that may be used for the treatment of hallux valgus, as well as other for other conditions (i.e., hammer toe, mallet toe, and claw toe). 
     OBJECTS OF THE INVENTION 
     It is an object of the invention to provide an orthotic device capable of placing one or more toes of a patient&#39;s foot in traction. 
     It is another object of the invention to provide an orthotic device in the form of a shoe. 
     It is also object of the invention to provide a measured amount of traction to the patient&#39;s toe or toes. 
     It is a further object of the invention to provide traction to one or more toes of the patient and to be capable of adjusting the adduction, dorsiflexion, rotation angles thereto, and further capable of providing a lateral glide to the head of the metatarsal. 
     It is another object of the invention to provide an orthotic device that the patient may be capable of independently applying and wearing without the assistance of a medical practitioner. 
     Further objects and advantages of the invention will become apparent from the following description and claims, and from the accompanying drawings. 
     SUMMARY OF THE INVENTION 
     This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. 
     In accordance with at least one embodiment of the present invention, a device for use in placing a toe of a patient&#39;s foot in traction may broadly include a shoe portion; a toe attachment apparatus (e.g., a Chinese finger trap, a finger stall, and the like); a cable having a first end and a second end, the first end of the cable coupled to the toe trap; a pulley, with the cable configured to wrap about the pulley; and an apparatus (e.g., a ratchet, an actuator that may be pneumatic, with a pressure gauge, and the like) configured to apply tension to the cable to create traction in the toe. 
     The device may also include an actuator that may be configured to adjust lateral positioning of the pulley relative to the shoe portion to set a desired angle of adduction for the traction provided to the toe by the cable. The device may also include a meter coupled to the cable and configured to indicate an amount of tension provided thereto by the ratchet. The device may further include a second actuator configured to adjust elevational positioning of the pulley relative to the sole of the shoe portion to set a desired angle of dorsiflexion for the traction provided to the toe by the cable. Where a ratchet is used to apply tension to the cable, the wheel of the ratchet may be configured to receive a tool to actuate the ratchet. The wheel of the ratchet may have a fine set of teeth formed thereon to allow for small adjustment to be made to the tension in the cable. The shoe portion of the device may broadly include a sole; a counter configured to brace the back of the patient&#39;s foot; and one or more straps configured to secure the patient&#39;s foot within the shoe portion, to brace the foot with respect to the counter, using hook and loop materials (or a buckle) on the one or more straps. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top view of the bones of a normal foot. 
         FIG. 2  is a top view of the bones of a foot that is affected by hallux valgus, resulting in an outward facing deformation of the big toe. 
         FIG. 3  is a side view of a first embodiment of a toe traction device of the present invention, which is capable of providing traction to a patient&#39;s toe using an adjustment of various angles of the toes. 
         FIG. 4  is a top view of the device of  FIG. 3 . 
         FIG. 5  is a bottom view of the device of  FIG. 3 . 
         FIG. 6  is a side view of an alternate embodiment of the toe traction device of  FIG. 3 . 
         FIG. 7  is top view of the device of  FIG. 6 . 
         FIG. 8  is a bottom view of the device of  FIG. 6 . 
         FIG. 9  is a perspective view of an alternate embodiment of the toe traction device of  FIG. 6 . 
         FIG. 10  is a side view of the device of  FIG. 9 . 
         FIG. 11  is a perspective view of an alternate embodiment of the device of  FIG. 9 . 
         FIG. 12  is a perspective view of an alternate embodiment of the device of  FIG. 11 . 
         FIG. 13  is a photograph showing a perspective view of a prototype of a toe traction device of the present invention. 
         FIG. 14  is a photograph showing a side view of the prototype traction device of  FIG. 13 . 
         FIG. 15  is a photograph showing a top view of the prototype traction device of  FIG. 13 . 
         FIG. 16  is a top view of an embodiment of a toe traction device of the present invention. 
         FIG. 17  is a top view of an alternate embodiment of the toe traction device of  FIG. 16 , which includes a tension meter. 
         FIG. 18  is a top view of another embodiment of the toe traction device of  FIG. 17 , in which the ratchet may be driven by a separate removable handle. 
         FIG. 18A  is a side view of a handle that may be used with the toe traction device of  FIG. 18 . 
         FIG. 19  is a top view of an alternate embodiment of the toe traction device of  FIG. 17 , in which a linear actuator may be used to adjust an angle of adduction for the traction provided to the toe. 
         FIG. 19A  is a top view of an alternate embodiment of the toe traction device of  FIG. 19 , in which the ratchet has been replaced with a linear type of actuator. 
         FIG. 20  is a top view of an alternate embodiment of the toe traction device of  FIG. 19 , in which a second linear actuator may also be used to adjust a height of the device that provides traction to the toe. 
         FIG. 21  is a top view of an alternate embodiment of the toe traction device of  FIG. 20 , in which a metered tension wrench is coupled to the ratchet to provide a direct means for applying a desired amount of traction to the toe. 
         FIG. 22  illustrates a side perspective view of another embodiment of a traction apparatus of the present invention. 
         FIG. 23  shows a second side perspective view of the traction apparatus shown in  FIG. 22 . 
         FIG. 24  is an exploded view showing the component parts of the traction apparatus of  FIG. 22 . 
         FIG. 25  is a front view of the traction apparatus of  FIG. 22 . 
         FIG. 26  is a rear view of the forward portion of the traction apparatus of  FIG. 22 , with the slidable adjustment plate shown at a lower position. 
         FIG. 27  is a rear view of the forward portion of the traction apparatus of  FIG. 22 , with the slidable adjustment plate shown at an elevated position. 
         FIG. 28  is a top perspective view of the traction apparatus of  FIG. 22 , with the arm positioned on a first side of the apparatus. 
         FIG. 29  is the top perspective view of  FIG. 28 , but shown with the arm positioned on a second side of the apparatus. 
         FIG. 30  illustrates a side perspective view of another embodiment of the traction apparatus of  FIG. 22 , which includes a clamp device. 
         FIG. 31  illustrates a top perspective view of the traction apparatus of  FIG. 30 . 
         FIG. 32  illustrates a front perspective view of an alternate embodiment of the traction apparatus of  FIG. 30 , which includes a block that is releasably securable to the sole of the shoe, and has a vertical surface that may be suitably positioned to impart a lateral force to the head of the first Metatarsal bone. 
         FIG. 33  is the front perspective view of  FIG. 32 , but showing the block rotated 180 degrees so that an angled surface thereon may be used to impart rotation to the proximal phalangeal bone of the great toe. 
         FIG. 34  is a top view of the sole of the shoe of the traction apparatus of  FIGS. 33-33 , showing a pegboard or area for application of Velcro that may be used to selectively position the block thereon. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As used throughout this specification, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. 
     The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “one or more of A, B, and C”, and “A, B, and/or C” mean all of the following possible combinations: A alone; or B alone; or C alone; or A and B together; or A and C together; or B and C together; or A, B and C together. 
     Also, all references (e.g., patents, patent application publications, and non-patent literature) that are cited within this documents are incorporated herein in their entirety by reference. 
     Furthermore, the described features, advantages, and characteristics of any particular embodiment disclosed in the following specification, may be combined in any suitable manner with any of the other embodiments disclosed herein. 
       FIG. 3  shows a side view of a toe traction shoe/device  10  of the present invention. It should be noted at the outset that each embodiment of the apparatus described herein is configured to be secured to the patient&#39;s foot, and several embodiments being compactly configured may closely resemble a shoe or sandal. However, although it may be possible, the patient would not likely be walking about while wearing the device to applying traction to one of his/her toes. Therefore, throughout this document, the terms “shoe” and “device” are used interchangeably, without intending to detract from the advantageously compact configuration of those particular shoe-like embodiments. 
     Toe traction shoe  10  may include a sole portion  20 , which may extend from a first end  21  to a second end  22 . Extending upwardly from the second end  22  of the sole  20  may be a counter  23  that may be used to brace the back of the foot  5 . One or more straps may be used to secure the foot  5  within the shoe  10 , to brace the foot with respect to the sole to permit traction to be applied to one of the toes. In this embodiment, a single strap  24  may be used to secure the foot with respect to the counter  23 . One end of the strap  24  may be fixedly connected to a first side of the shoe  10 , and the other end of the strap may be adjustably connected to a second side of the shoe using Velcro® (i.e., respective hook and loop fastening materials), or using a buckle, or using any other securing means known in the art. Alternatively, two straps may be used, where each strap has a first end fixedly connected to a respective side of the shoe, and the second ends of the straps are releasably coupled together using the Velcro materials (e.g.,  224 Vh and  224 VL in  FIG. 9 ). 
     To treat a hallux valgus condition, traction would necessarily be applied to the big toe. Therefore, without intending this specification to be so limiting, the remainder of the discussion is directed to applying traction to the big toe. However, it may be understood that the present invention may furthermore be constructed and adjusted to be utilized for applying traction to any one, or more, of the different toes of a patient&#39;s foot. 
     A toe of the patient&#39;s foot (e.g., the big toe) may receive an attachment means thereon, which may be used for applying tension to that toe. The attachment means may simply be a first string (or a cable, elastomeric member, rubber band, etc.), and a second such string or member being secured to opposite sides of the toe using medical tape. The attachment means may also be in the form of the “Extension Bandage” taught by U.S. Pat. No. 1,268,932 to Corrigan. The attachment means may also be any one of the devices/finger traps taught by U.S. Pat. No. 2,688,961 to Thomas, U.S. Pat. No. 3,872,861 to Tamny, and U.S. Pat. No. 5,451,203 to Lamb, and the like. The “Finger Trap” of the &#39;861 patent to Tamny may be used on the toes of the patient herein, as it is known to simply be a plurality of strands braided together in a substantially cylindrical form, so that when the end of a central strand or strands is pulled, it results in a contraction of the diameter of the cylinder and clamping upon the digit of the patient. 
     The toe trap  27  shown in  FIG. 3  may terminate in a single strand or cable  28 , which when pulled may cause contraction of the trap upon the toe of the patient. The strand  28  may wrap around a first pulley  29  to be directed downwardly, and may then wrap around part of a second pulley  30 , to be directed rearward with respect to shoe  10 . The pulleys  29  and  30  may each be rotatably mounted to a support bracket  31  that may protrude forward of the shoe  10 . The strand  28  may be coupled to a tension meter, which may be used to indicate the amount of traction being applied to the toe of the patient. Such tension meters are shown, for example, by U.S. Pat. No. 1,650,603 to Burton, and U.S. Pat. No. 2,925,734 to Gorgens. A ratchet arrangement  34  may be actuated by an Allen key or other tool  35  to add tension to the strand  28 . Another strand  28 A may couple the other side of the tension meter to a geared tensioning handle  38 , with the strand being directed thereto by pulleys  36  and  37 , each of which may be rotatably mounted to another support bracket. The handle  38  may be turned to add tension in the cables  28  and  38 . Rather than a geared tensioning handle, the handle may be coupled to a screw actuator that may adjust the positioning of the end of the cable with respect to pulley  37  (e.g., rotating the handle to decrease tension, and counter-rotating to increase tension). The actuator may be a screw actuator, such as the actuator shown in any of U.S. Pat. No. 2,831,363 to Lohr, U.S. Pat. No. 3,128,634 to Eastman, U.S. Pat. No. 5,154,091 to Bianco, U.S. Pat. No. 6,321,611 to Szu; or may be a hand-operated pneumatic actuator, such as the one shown by U.S. Pat. No. 5,980,528 to Salys, and the like. 
     The support bracket  31 , to which pulleys  29  and  30  are rotatably mounted, may itself be pivotally mounted to the sole  20  of shoe  10  at axis  31 P ( FIGS. 3 and 5 ). The support bracket  31  may be releasably secured at a suitable angular Θ with respect to an axial direction  39  (lengthwise direction) of the shoe, to provide a desired adduction angle for the traction applied to the toe. The angular orientation of the bracket  31  may be releasably secured using a wing nut  32 . Matching radial serrations may also be used on the bracket  31  and the sole  20 , to reduce the torque that may be needed for the wing nut  32  to releasably secure the bracket to the sole, particularly at greater abduction angles. 
       FIGS. 6-8  show a shoe embodiment  100  constructed similar to the embodiment of  FIGS. 3-5 , but which does not utilize the tension meter. 
       FIGS. 9-10  show a shoe embodiment  200  of the present invention constructed similar to the embodiment of  FIGS. 6-8 , in which a universal joint  231  is utilized to permit more complex adjustments to the orientation of the strand  228 . The universal joint may be the same as, or be similar to, the universal joint taught by U.S. Pat. No. 5,062,730 to Tomii. 
       FIG. 11  shows a shoe embodiment  300  of the present invention constructed similar to the embodiment of  FIGS. 3-5 , in which a universal joint  331  is utilized to permit more complex adjustments to the orientation of the strand  328 . The universal joint may be the same as, or be similar to, the universal joint taught by U.S. Pat. No. 5,062,730 to Tomii. 
       FIG. 12  shows a shoe embodiment  400  of the present invention, in which a pair of flaps ( 423 F 1  and  423 F 2 )—one extending from each side of the shoe- and a pair of top straps  423 S 1  and  423 S 2  may be used to secure the shoe with respect to the top of the patient&#39;s foot. The straps  423 S 1  and  423 S 2  may be releasably coupled across to the other side of the shoe using Velcro. 
       FIG. 16  shows a shoe embodiment  500  of the present invention that may compactly incorporate hardware components into a front portion of the shoe, to accomplish traction of a toe therein. Shoe  500  may have one or more ankle straps  524  and one or more top straps (e.g.,  524 T 1  and  524 T 2 ), to secure the patient&#39;s foot within the shoe, the top of which may otherwise be generally open. Shoe  500  may have a spool  550  rotatably mounted at  551  to the sole  520 . The end of strand  528  of the toe trap  527  may be coupled to the spool  550 , so that rotation of the spool may cause the strand to slowly be coiled thereon, and increase the traction force applied to the toe. Incremental increases in the traction force from the coiling of the strand  528  on the spool  550  may be accommodated by the use of the ratchet arrangement similar to the one disclosed by U.S. Pat. No. 3,109,314 to Morisawa. 
     A toothed ratchet wheel  555  may be concentrically mounted to the spool  550 . Clockwise movement of the spool may generally be prevented by a release arm  560 . The release arm  560  may be pivotally mounted to the sole  520  of the shoe, and its engagement end  560 E may engage any one of the teeth of the ratchet wheel  555 , and may be prevented from clockwise rotation, along with the ratchet wheel, by contact with stop  565 , which may protrude up from the sole  520 . A torsion spring may normally bias the engagement end  560 E of the release arm  560  into contact with the stop  565 . 
     A finger actuable lever  550 L may extend from one side of the spool  550 . A patient&#39;s finger may thereby apply a force to the lever  550 L so that it may be moved away from the toe, to cause joint rotation of the spool  550  and ratchet wheel  555 , so that the curved (cam) side of one or more successive teeth of the ratchet wheel may drive the engagement end  560 E of the release arm  560  to pivot counterclockwise, and incrementally increase the tension in the strand  528 . This increased tension in the strand  528  would cause an increase in the traction force applied to the toe. Once the force is removed from lever  550 L, the tension in the strand  528  would cause the spool and ratchet wheel to rotate clockwise, which may occur only briefly, until the flat side of the nearest tooth of the ratchet wheel engages with the engagement end  560 E of the release arm  560  and causes it to rotate clockwise until contacting stop  565 . 
     The diameter of the spool that takes up (i.e., coils) the strand  528  may be smaller than the diameter at which the lever  550 L is coupled thereto, to step down the take up thereby provided. This may permit for very small changes in the amount of the strand that is taken up by the displacement of the lever  550 L, so that small incremental increases in traction may be provided to the patient&#39;s toe. This would also require a significant plurality of teeth on the ratchet wheel, to accommodate the small incremental changes to the strand tension/toe traction force. 
     It may be desirable to apply up to approximately 10 kilograms (22 pounds) of traction force to the toe, so the components of shoe  500  would need to be constructed to safely accommodate the resulting loads. Furthermore, the number of teeth used on the ratchet wheel  555 , the root diameter of the teeth, and at least the degree of elasticity that may be inherent to the material utilized for the strand  528 , may be coordinated and calibrated so that each successive tooth that may be captured by the engagement end  560 E of the release arm  560  may add a small incremental amount of tension to the strand, which may be in the range of 0.1 kilograms to 0.5 kilograms, and may preferably be in the range of 0.2 kilograms (0.55 pounds) to 0.3 kilograms. To accomplish small changes to the tension in the cable, a fine to very fine set of teeth may be used on the ratchet wheel. The effect of the number of teeth formed on the ratchet wheel upon its rotation angle when limited by a pawl may be seen in the following chart: 
     
       
         
           
               
               
               
             
               
                   
                   
               
             
            
               
                   
                 24 Teeth 
                 15 Degrees per tooth  
               
               
                   
                 36 Teeth 
                 10 Degrees per tooth  
               
               
                   
                 45 Teeth 
                 8 Degrees per tooth 
               
               
                   
                 60 Teeth 
                 6 Degrees per tooth 
               
               
                   
                 72 Teeth 
                 5 Degrees per tooth 
               
               
                   
                 80 Teeth 
                 4.5 Degrees per tooth   
               
               
                   
                 100 Teeth  
                 3.6 Degrees per tooth   
               
               
                   
                   
               
            
           
         
       
     
     Therefore, to accomplish small changes to the tension in the cable, the number teeth used on the ratchet wheel may preferably be at least 45 or 60 teeth, and more preferably may be 72 teeth or 80 teeth, and most preferably may be 100 teeth. 
     After the user has applied traction to the toe for a recommended period of time, and desires to remove the shoe  500 , a small force may be applied to lever  550 L, being just sufficient so that a tooth of the ratchet wheel  555  no longer engages and drives the engagement end  560 E of the release arm  560  into contact with stop  565 . The release end  560 R of the release arm  560  may then be actuated so that the engagement end  560 E of the release arm  560  moves clear of the ratchet wheel  555 , and upon releasing of the force applied to the lever  550 L, the tension in the strand  528  may thereby be released, and the toe trap  527  may be removed from the patient&#39;s toe. 
       FIG. 17  shows a shoe embodiment  600  of the present invention. For shoe  600 , the ratchet wheel and levers  655  may be constructed substantially the same as shown by U.S. Pat. No. 7,374,152 to Ruan. The spool  650  may be positioned the same as it was for shoe  500 , or instead, it may be more centrally positioned with respect to the lateral extent of the user&#39;s foot, as seen in  FIG. 17 , and the strand  628  of the toe trap  627  may wrap around a portion of a pulley  601  before being received onto the spool  650  of the ratchet  655 . The ratchet  655  for shoe  600  may not be fixedly secured to the sole  620 , and instead a tension meter  675  may be fixedly secured to the sole, and a cable may connect an end of the ratchet being distal from the spool  650 , with the tension meter. The scale of the tension meter  675  may be oriented so that it may be easily read by the patient seeking to apply traction to his or her toe, or it may be at an orientation that would enable a practitioner to easily read the scale. 
       FIG. 18  shows a shoe embodiment  700  of the present invention. Shoe  700  may be constructed similar to shoe  600 , except that the ratchet assembly may not include an integral handle to actuate the ratchet wheel, and instead, a separate handle  770 , as seen in  FIG. 18A , may be used. The end  771  of the handle  770  may be inserted into the corresponding opening  755 A of the wheel, and the handle may be turned like a crank to actuate the wheel. 
       FIG. 19  shows a shoe embodiment  800  of the present invention. Shoe  800  may be constructed similar to shoe  600 , except that the pulley  801  may be mounted to an actuator  880 , using a universal joint. The actuator  880  may be a ball screw actuator, or any other similar type of actuator configured to provide linear motion, and may be constructed similar to the axial actuator of U.S. Pat. No. 4,938,090 to Brusasco. Actuator  880  may have a shaft  881 , the ends of which may be rotatably supported by supports  882  and  883 , which may protrude up from sole  820 . The shaft may include threading between the supports  882  and  883 , and a knob  884  at one end. The knob  884  may be actuated to rotate the shaft  881  to drive the universal joint  885 , which may be threadably coupled thereto. The strand  828  being looped about the pulley  801  may prevent the universal point  885  from co-rotating with the rotating shaft  881 , so that the relative movement of the threaded connection therebetween may cause translation of the universal joint in a desired direction. This translation may be used to set a desired adduction angle for the tension applied to the toe using the toe trap  827 . 
       FIG. 19A  shows a shoe embodiment  800 ′ of the present invention. Shoe  800 ′ may be constructed similar to shoe  800 , except that rather than using a ratchet to add tension to the cable, the end of the cable (which may include a tension meter) may instead be actuated by a linear actuator (e.g., any of the actuators disclosed herein). The embodiment may provide for a compact arrangement with the cable being directed by the pulley to be at an angle comparable to that formed by at front of the foot, by the decreasing size/positioning of the toes. 
       FIG. 20  shows a shoe embodiment  900  of the present invention. Shoe  900  may be constructed similar to shoe  800 , except that the support posts  982  and  983  that rotatably support the shaft  981  may protrude upward from a plate  995 . The plate may be configured to be adjusted up or down with respect to the sole  920  using a second linear actuator  996 , to make an elevational adjustment to the pulley relative to the sole, and thereby set a desired dorsiflexion or plantarflexion angle for the traction provided to the toe by said cable. 
       FIG. 21  shows a shoe embodiment  1000  of the present invention. Shoe  1000  may incorporate aspects of the shoe embodiment  500  shown in  FIG. 16 , and aspects of the shoe embodiment  900  shown in  FIG. 20 . As with shoe  500 , the shoe  1000  may have a toothed ratchet wheel  1055  concentrically mounted to a spool  1050 , except that the ratchet  1055  may be driven by an integral tension wrench  1099  that may be constructed similar to the wrench shown in U.S. Pat. No. 2,256,478 to Hill, which has an integral tension meter upwardly disposed thereon. In addition, rather than manually actuating such a wrench, a rotary actuator may instead be used to precisely apply an amount of torque to the strand  1028  of trap  1027 , which produces the desired traction force. The rotary actuator may be constructed in accordance with the teachings known in this art, including, but not limited to, those of U.S. Pat. No. 5,363,025 to Colling for “Actuator Employing Unidirectional Motor for Bidirectional Rotational Positioning; U.S. Pat. No. 5,650,704 to Pratt for “Elastic Actuator for Precise Force Control”; and U.S. Pat. No. 5,368,112 to Mount for “Tensioning Apparatus for Tie Down Lines.” In addition, rather than manually actuating the shaft  1081  of the ball screw actuator arrangement to adjust the abduction angle, as with knob  984  for shoe  900 , a rotary actuator  1084  may instead be used to move the universal joint laterally in either direction. Furthermore, it should be understood that any of the actuators that may be utilized by this invention may be take any suitable form, and may include, but not be limited to, pneumatic actuators, hydraulic actuators, electric actuators, etc., any of which may include tension gauges thereon. 
       FIGS. 22-29  show a traction apparatus  1100  of the present invention. Apparatus  1100  may have a plate  1105  to which a shoe  1110  may be fixedly secured. The bottom of the plate  1105  may have one or more platforms  1111  that may be used to elevate the plate above the floor. Although there are only two platforms  1111  shown throughout the figures, additional platforms may also be used, or alternatively, a single platform that may extend around a substantial portion of the periphery of the plate  1105  may instead be used to elevate the plate  1105 . 
     A support bracket  1131  may be pivotally mounted to the bottom of the plate  1105 , using, for example, the rod  1132  shown in the exploded view of  FIG. 24 . A wing-nut  1133  may be threaded onto the rod to secure the arm  1132  thereto. Applying a sufficient amount of torque to the wing-nut  1133  may also serve to releasably secure the angular orientation of the arm with respect to the shoe. Alternatively, a block  1106  and/or a flexible cylindrical member  1107  may be interposed between the bottom of the plate  1105  and the wing-nut, which may serve to generally allow the arm to remain pivotally secured to the plate, without restricting its angular positioning. In this case, a bolt and a second wingnut combination  1134  may be used to releasably secure the angular positioning of the arm  1131  with respect to the plate  1105 , as seen in  FIG. 22 , with the bolt being received through a semi-circular opening  1105 C in the plate  1105 , which may be seen in  FIG. 24 . Instead of the semi-circular opening, a plurality of individual holes may be positioned thereat, which would require removal of the bolt for repositioning of the arm. A secondary platform  1112  ( FIG. 22 ) may be used to support the arm  1131 . 
     The arm  1131  may have a 90 degree bend formed therein, to create a vertical arm portion  1131 V. The strand of a toe trap may be secured to an adjustment plate  1136 , using any of the means previously disclosed herein. A slot  1131 S in the vertical arm portion  1131 V of the arm  1131  may permit the adjustment plate  1136  to be releasably and adjustably secured thereto using a bolt and a wing-nut combination  1136 B. The adjustment plate  1136  may thus be moved and secured to any desired elevated position with respect to the sole of the shoe  1110 , to provide for application of traction to the toe at a desired dorsiflexion angle, in addition to a desired adduction angle. The adjustment plate  1136  is shown in  FIG. 26  secured at a lower position on the vertical arm portion  1131 V of the arm  1131 , and is shown at a more elevated position with respect to the vertical arm portion within  FIG. 27 . 
     This embodiment, as with other embodiments described hereinabove, is not restricted to use for only one foot or the other (i.e., only the left foot, or only the right foot), as the design is universal, and is adjustable for use with either foot, as the arm  1131  may be pivoted and secured to provide a desired adduction angle for any toe for the left foot or the right foot ( FIGS. 28-29 ). 
       FIGS. 30-31  show a traction apparatus  1200  of the present invention, which may be constructed the same as apparatus  1100 , but may additionally include a modified C-clamp  1250 . The bottom leg  1251  of the clamp  1250  may be received within a cylindrical member  1207 , which may be a rigid member. The bottom leg  1251  may be releasably secured thereto using the wing-nut  1233 , and may pivot about the rod, the same as does the arm  1231 . A threaded shaft  1255  may be threadably received within the upstanding leg  1252  of the clamp  1250 , and may be advanced using knob  1256  until a padded end  1257  is moved into contact against the metatarsal head of the great toe, to impart a lateral force thereat. The lateral force applied by the padded end  1257  of the threaded shaft  1255  may work in combination with the force applied by the toe trap at the adduction angle provided by the particular angular orientation of the arm  1231 . 
       FIGS. 32-33  show a traction apparatus  1300  of the present invention, which may be constructed to operate similar to apparatus  1200 , and may include a block  1350  that is configured to be selectively positioned with respect to the sole of the shoe (which may be oversized). The block  1350  may be padded and may be made of a high density plastic. As seen in  FIG. 32 , the block  1350  may be shaped to include a vertical surface and an angled surface. The vertical surface, as positioned in  FIG. 32 , may be used to impart a lateral force upon the head of the first metatarsal bone. The block  1350  is shown rotated 180 degrees in  FIG. 33  and repositioned, so that the angled surface may be used to impart rotation to the proximal phalangeal bone of the great toe, which may rest thereon, and may augment use of the clamp, which is not shown therein. An additional strap may be used across the top of the shoe, where the block is positioned. 
     The positioning of the block  1350  may be accomplished by having one or more pegs protrude from the bottom of the block, which may be received within one or more of a plurality of corresponding openings formed in a “pegboard” in roughly the front one-third of the sole of the shoe, as seen in  FIG. 34 . To permit greater freedom and flexibility with respect to the positioning of the block  1350 , hook and loop fastening materials (i.e., Velcro®) may be used on the bottom of the block and on the sole of the shoe, instead of the peg and pegboard. 
     The examples and descriptions provided merely illustrate several embodiments of the present invention. Those skilled in the art and having the benefit of the present disclosure will appreciate that further embodiments may be implemented with various changes within the scope of the present invention. Other modifications, substitutions, omissions and changes may be made in the design, size, materials used or proportions, operating conditions, assembly sequence, or arrangement or positioning of elements and members of the preferred embodiment without departing from the spirit of this invention.