Abstract:
The foot fulcrum orthotic includes a semi-compressible ring and attachment method to the foot. When worn around the midfoot, said semi-compressible ring forms a fulcrum to raise the ball of the foot up off the mattress and provides compression relief to the ball of the foot. This compression relief, when combined with other treatments, speeds the healing of metatarsalgia including Morton&#39;s neuroma, corns, calluses, and bunions. A plurality of ring styles are disclosed including continuous (FIGS.  7 A,  7 B,  7 C), non-continuous (FIGS.  3, 4, 6 A,  6 B) with a gap for foot circumference size adjustment. A plurality of attachment methods are disclosed including single heel straps (FIGS.  7 A,  7 B,  7 C), multiple heel straps (FIGS.  3, 4 ), socks (FIGS.  10 A,  10 B,  10 C,  11 A,  11 B), and single-piece molded boot (FIGS.  9 A,  9 B).

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of provisional patent application Ser. No. 61/184,425 filed 2009 Jun. 5 by the present inventor. 
     
    
     FEDERALLY SPONSORED RESEARCH 
       [0002]    Not applicable. 
       SEQUENCE LISTING OR PROGRAM 
       [0003]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    This invention is a device for treating metatarsalgia, or ailments associated with the ball of the foot. Such ailments include Morton&#39;s neuroma, calluses, corns, and bunions. 
         [0006]    2. Description of the Related Art 
         [0007]    Morton&#39;s neuroma is a painful swelling of the tissue around a nerve in the foot and is generally caused by pressure between two metatarsals on the common digital nerve between the bones. The most common location is between the third and fourth metatarsals. This pressure can come from a variety of sources such as inappropriate footwear, activities such as dance or tennis, and physical problems with the foot that affect gait. 
         [0008]    A corn or callus is a thickening of the skin that occurs in an area of pressure. Corns appear as a horny thickening of the skin on the toes. This thickening appears as a cone shaped mass pointing down into the skin and can be very painful. Bunions are most commonly caused by inflammation and thickening of the bursa (fluid-filled sac in the connective tissue) and cause abnormal bone formation and misalignment of the toe. The location between the first toe and the metatarsal head is the area where bunions typically form. Symptoms include redness, swelling and a “bump” at the site. 
         [0009]    The art related to treating metatarsalgia is old and crowded. Included herein are a few patents for prior art reference however, there are many similar patents related to the examples included. For example, the act of padding a corn or callus is well known to those skilled in the art. The comments regarding the referenced prior art are applicable across all the similar patents. 
         [0010]    An example of treating corns, calluses and bunions is U.S. Pat. No. 5,497,789 (Zook, 1996) where he teaches a corn, bunion or blister pad incorporating a gel. His prior art discussion is detailed and goes back to padding patents from 1858. Padding is intended to minimize friction and pressure on the corn, callus or bunion. In most cased, the padding is worn over the afflicted area. The method of padding the area can be used while resting at night; however, the mattress can still apply pressure to the area. The padding just distributes the pressure so it is not focused on the afflicted area. The current invention involves removing the ball of the foot from the mattress surface entirely so there is nothing to come in contact with the area and no pressure to be distributed. 
         [0011]    Prior art for the treatment of Morton&#39;s Neuroma pain has includes padding and strapping (taping), orthotics, shoe modifications, oral anti-inflammatory medications (NSAIDs), anti-inflammatory injectables (i.e., corticosteroids), injection of local injectables (i.e., peripheral nerve block), injection of sclerosing agents (i.e., Vitamin B-12, alcohol), analgesics, and physical therapy. If none of these treatments work, surgery to remove the neuroma is normally recommended. 
         [0012]    The main focus of apparatus, as opposed to methods, for treating Morton&#39;s neuroma pain involves mitigating the pain while walking or wearing shoes. An example of this type of patent is U.S. Pat. No. 7,140,130 (Brooks, 2006) disclosing an insole with a neuroma pad. This insole is to be used while wearing shoes or sandals. The neuroma pad is intended to separate the metatarsals and relieve pressure on the neuroma. This type of treatment is not very comfortable to wear and is marginally useful to relieve some pain while walking. Brooks&#39; invention offers no benefits when worn at night while resting in bed. There are a number of other patents that involve metatarsal pads incorporated directly into shoes. U.S. Pat. No. 4,250,886 (Riso et al., 1981) teaches a shoe with a built-in metatarsal pad. Again, these are a means to treat neuroma pain while walking, not resting. 
         [0013]    The current invention is worn while resting or sleeping so some discussion regarding night orthoses is in order. Prior art for foot/ankle night orthoses is again a crowded field. Mainly, the focus has been on maintaining the foot and/or ankle in a fixed position while sleeping. A recent example of this is U.S. Pat. No. 7,182,743 (Slautterback et al., 2007) in which a foot splint is disclosed to maintain dorsiflexion when worn at night. U.S. Pat. No. 6,517,505 (Veldman, 2003) is a foot orthotic for treatment of foot pronation. Orthoses designed to treat plantar fascitis can be rigid as U.S. Pat. No. 7,182,743 (see above) or can take the form of a sock as U.S. Pat. No. 5,399,155 (Strassburg et al., 1995) where another method of maintaining dorsiflexion is disclosed. U.S. Pat. No. 6,468,239 (Mollura et al., 2002) teaches a device which attaches to the calf and keeps the foot elevated. While this device could possibly help a Morton&#39;s neuroma by keeping all pressure from the ball of the foot, a cursory look at the device shows no comparison with the current invention. Mollura&#39;s device attaches to the calf, using padding, straps, and a rigid frame. The current invention is much more simple and attaches to the foot, not the calf. The manufacturing costs of Mollura&#39;s invention would be substantially greater than the current invention. There are a number of other night orthoses to correct other types of problems, but none address a Morton&#39;s neuroma as the invention of this patent. 
         [0014]    The current invention combines an innovative, non-obvious method of treating metatarsalgia pain using an apparatus worn while sleeping. The innovation of suspending the ball of the foot so no pressure is directed to the corn, callus, bunion, or neuroma in unique and non-obvious. 
       BRIEF SUMMARY OF THE INVENTION 
       [0015]    This invention relates to ailments of the ball of the foot that include but are not limited to Morton&#39;s neuroma, calluses, corns, and bunions and a device that when worn promotes and speeds the healing when used along with more traditional treatments. 
         [0016]    The widest part of the foot is the ball of the foot. If one looks at the position the ball of the foot while a person is lying on one&#39;s side in bed, it can be easily seen that the ball of the foot receives the majority of the pressure created by the weight of the foot and ankle. This weight is being transferred from the ball of the foot to the surrounding mattress and causes compression on the metatarsal area. 
         [0017]    This is typically the area of the neuroma, corn, callus, or bunion. In many situations, this foot and mattress alignment is consistent with sleeping in a prone position as well. The feet are splayed to the side putting even more pressure on the ball of the foot. A person sleeping exclusively on their back with their feet pointed straight up would not typically experience the benefits of this invention. 
         [0018]    For Morton&#39;s neuroma, corns, calluses, and bunions, relief can be found in reducing the pressure at the ball of the foot. During waking hours, this can be achieved by adding padding to the affected area, adding insoles, or changing footwear or activities. During sleeping hours, the mattress can exert pressure in such as way as to exacerbate the problem. This invention addresses the problem of pressure on the ball of the foot when resting or sleeping. 
         [0019]    The invention consists of a ring of semi-compressible material, such as closed cell foam, that when worn around the midfoot forms a fulcrum, which relieves pressure on the ball of the foot when the wearer is sleeping in bed or resting. The weight of the ankle and calf cause the ball of the foot to be raised off the mattress by the fulcrum. There are a plurality of methods for holding this ring in place. 
         [0020]    Among the embodiments of this invention, a common thread is maintained: A semi-compressible ring or pad around the instep of the foot creating a fulcrum while leaving the ball of the foot to hang free in an uncompressed state while in bed. This is important because the compressed nerve or other ailment will experience relief for the duration of the rest/sleep period. The invention is not trying to address the specific cause of the metatarsalgia as with the prior art, such as poor footwear or incorrect foot biomechanics. It is assumed that the person with the painful ailment will be taking steps to mitigate these causes. The purpose of the invention is to facilitate the healing of the neuroma or other metatarsalgia while the person sleeps. In many cases, the relief from pain facilitated by wearing this invention will obviate the need for risky and expensive surgery. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is a bottom view of a foot showing relevant bones and nerves; 
           [0022]      FIG. 2A  is a view of the pressure on a foot while resting in bed; 
           [0023]      FIG. 2B  is a view of the pressure on a foot while wearing an embodiment of the device and resting in bed; 
           [0024]      FIG. 3  is a view of one embodiment of the device; 
           [0025]      FIG. 4  is the right-hand view of one embodiment of the device shown as worn on the foot; 
           [0026]      FIG. 5A  is the left-hand view of one embodiment of the device shown as worn on the foot; 
           [0027]      FIG. 5B  is the left-hand view of one embodiment of the device shown as worn on the foot with an alternate attachment point for heel strap; 
           [0028]      FIG. 6A  is the bottom view of another embodiment of the device with the circumference adjustment located at the bottom of the device; 
           [0029]      FIG. 6B  is the top view of another embodiment of the device with the circumference adjustment located at the bottom of the device; 
           [0030]      FIG. 7A  is a view of another embodiment of the device shown with a continuous ring and a single long strap; 
           [0031]      FIG. 7B  is a left-hand view of another embodiment of the device shown with a continuous ring with the single long strap wrapped around a heel; 
           [0032]      FIG. 7C  is a right-hand view of another embodiment of the device shown with a continuous ring with the single long strap wrapped around a heel; 
           [0033]      FIG. 8A  is another embodiment of the device with a continuous ring and a short and long strap; 
           [0034]      FIG. 8B  is a left-hand view of another embodiment of the device shown with a continuous ring with the short and long strap fastened behind a heel; 
           [0035]      FIG. 8C  is a right-hand view of another embodiment of the device shown with a continuous ring with the short and long strap fastened behind a heel; 
           [0036]      FIG. 9A  is a view of another embodiment of the device shown as a single molded piece; 
           [0037]      FIG. 9B  is view of the single piece molded piece as worn on a foot; 
           [0038]      FIGS. 10A ,  10 B, and  10 C are views of another embodiment of the device showing a partial sock attached to a continuous ring; and 
           [0039]      FIGS. 11A and 11B  are views of the invention using two pads and a partial sock. 
         REFERENCE NUMBERS 
         [0000]    
         
           
             
               M 1  First metatarsal 
               M 2  Second metatarsal 
               M 3  Third metatarsal 
               M 4  Fourth metatarsal 
               M 5  Fifth metatarsal 
                 102  Medial plantar nerve 
                 104  Lateral plantar nerve 
                 105  Navicular bone 
                 106  Cuneiform bones 
                 107  Cuboid bone 
                 108  Morton&#39;s neuroma 
                 110  Phantom of invention shown around midfoot 
                 202  Mattress 
                 204  Pressure force from mattress on ball of the foot 
                 206  Foot 
                 208  Pressure force from mattress redirected to midfoot by invention 
                 210  Ball of foot allowed to expand in uncompressed state 
                 302  Hook and loop closure for circumference adjustment 
                 303  Top strap for circumference adjustment 
                 304  Right-hand heel strap 
                 304 A Right-hand heel strap loop closure 
                 304 B Right-hand heel strap hook closure 
                 304 C Right-hand heel strap loop alternate closure 
                 304 D Right-hand heel strap hook alternate closure 
                 305  Left-hand heel strap 
                 305 A Left-hand heel strap loop closure 
                 305 B Left-hand heel strap hook closure 
                 306  Fulcrum ring with circumference adjustment cutout on top 
                 602  Bottom hook and loop closure for circumference adjustment 
                 604  Bottom strap for circumference adjustment 
                 606  Fulcrum ring with circumference adjustment cutout on bottom 
                 702  Continuous fulcrum ring 
                 704  Long single strap 
                 704 A First step in heel wrap of  704   
                 704 B Second step in heel wrap of  704   
                 704 C Third step in heel wrap of  704   
                 704 D Fourth step in heel wrap of  704   
                 704 E Fifth step in heel wrap of  704   
                 704 F Sixth step in heel wrap of  704   
                 706 A Loop closure for long strap 
                 706 B Hook closure for long strap 
                 804  Medium strap with connector 
                 806  Mated connector of medium and short strap 
                 806 A Connector for medium strap 
                 806 B Connector for short strap 
                 808  Short strap with connector 
                 902  Ankle part of molded boot 
                 904  Ankle closure strap of molded boot 
                 905  Hook and loop closure for ankle strap closure of molded boot 
                 906  Foot closure strap of molded boot 
                 907  Hook and loop closure for foot strap closure of molded boot 
                 908  Foot part of molded boot 
                 1002  Back of half sock 
                 1004  Front of half sock extending from under fulcrum 
                 1104 A Foot pad 
                 1104 B Foot pad 
             
           
         
       
       
    
    
     DETAILED DESCRIPTION 
       [0096]      FIG. 1  of the drawings shows the bones and nerve structure of the foot. The figure shows the medial plantar nerve  102  and the lateral plantar nerve  104 . M 1 -M 5  designate the metatarsal bones. Also shown are the cuneiform bones  106  and navicular bone  105 . The cuboid bone is show by item  108 .  107  show the position of a neuroma. Phantom  110  shows the outline of the invention as worn on a person&#39;s foot. 
         [0097]    The benefits of the invention are shown in  FIGS. 2A and 2B .  FIG. 2A  shows the foot resting on a mattress  202 . As shown, the widest part of the foot is the ball. A force vector  204  shows the pressure from the mattress. With respect to corns, calluses, and bunions, this pressure is applied to the ailment and causes pain. With respect to Morton&#39;s neuroma, this pressure is directed into the ball of the foot and in fact, compresses the metatarsals together. Thus, the neuroma of  FIG. 1 , item  107 , is additionally compressed when the person is resting or sleeping. The invention basically relieves the pressure on the ball while resting as shown in  FIG. 2B . 
         [0098]      FIG. 2B  shows the foot at rest on a mattress  202 , but in this figure, the person is wearing what amounts to a fulcrum  208  around their instep. This fulcrum shifts the pressure from the mattress  204  away from the ball and moves it to the midfoot, behind the metatarsals. The weight of the foot is carried on the cuneiform, navicular and cuboid bones. The shift, then allows the ball to be in an uncompressed state during rest as shown with the force vector  210 . This is the key to the effectiveness of the invention. 
         [0099]    There are many ways to implement this invention and some of the embodiments of this invention are illustrated in  FIGS. 3 through 11 . These are only representational and are not intended to be restrictive in scope. In figures where a semi-compressible ring is mentioned, the ring can vary in diameter based on the foot size of the wearer. In general, the diameter can vary from 6 to 4 inches and the width of the ring can vary from 2 inches to 1 inch. The inner hole size will again vary based on the size of the wearer&#39;s foot. The size of the inner hole should leave a balance of material, basically the fulcrum aspect of the ring to be 2 inches to 1 inch per side. 
         [0100]      FIG. 3  shows one embodiment of the invention. The circular ring  306  creates the fulcrum effect when worn around the foot by placing the weight of the ankle and foot on the cuneiform, navicular, and the cuboid bones. This circular ring can be made of but is not limited to fabric covered semi-compressible foam. The fabric could be fleece or terry cloth for example and the ring could be made from closed call foam. The art of covering an item with cloth is well known in the art. Item  302  is an adjustable closure. It can be made from hook and loop material, a buckle, tied laces, or any simple method of closure. Item  303  is a strap that is used to join the two sides of the padded circular ring  306  together. The strap could be made either with some form of stretch material such as elastic or non-stretchable cloth tape webbing. This adjustment is not necessary and could be eliminated to save production costs. In this case, item  306  could be a continuous ring of material. The adjustment is provided as a means to accommodate the circumference differences of individual feet and to ensure a snug fit. The strap  305  and the closure made by the hook and loop  305 A and  305 B form the length adjustment to accommodate a variety of foot sizes. It should be noted that the closure for  305  is located on the opposite side of the ring  306 . This is to allow the strap  305  to wrap around the ankle of the wearer and attach on the opposite side as shown in  FIGS. 4 ,  5 A and  5 B. Strap  304  and hook and loop closures  304 A and  304 B offer an equivalent function for the opposite side of the foot. This method of straps and closures form a snug fit and prevent rotational and longitudinal shifting of the ring  306 . One could easily imagine a version of this embodiment whereas the padding is slipped into two fabric pockets on the sides. One skilled in the art could also imagine a version with the padding being created from a bladder inflated with either air or some inert liquid or gel material. 
         [0101]      FIG. 4  is a right side view of the embodiment shown in  FIG. 3  and shows the device as worn on a foot. The items are as described in  FIG. 3  with more detail shown of the straps  304  and  305 . As shown, strap  305  wraps around the heel and attaches to item  306  on the side using hook and loop closure  305 A and  305 B. The straps  304  and  305  provide rotational and longitudinal stability of the padded circular element  306 . The attachment point for the strap  304  is occluded in this figure and is shown in  FIGS. 5A and 5B . Items  303  and  302  form an adjustable closure as described in  FIG. 3 . The key to the adjustment of elements  303 ,  304 , and  305  and their associated hook and loop closures is to keep the padded circular element pulled back on the foot firmly to the heel. This location keeps the fulcrum effect on the cuneiform bones, the navicular bone, and the cuboid bone and allows the metatarsals to decompress while resting. 
         [0102]      FIGS. 5A and 5B  are left side views of the embodiment show in  FIG. 3 .  FIG. 5A  shows the straps  304  and  305  wrapping around opposite sides of the wearer&#39;s ankle and strap  304  attaching with the hook and loop closure  304 A and  304 B. An alternative to the  304 A and  304 B hook and loop closure is shown in  FIG. 5B . In this figure, the strap  304  is looped under the ring  306  and folded over before being attached with the hook and loop closure  304 C and  304 D. This has the added benefit of more leverage being applied to ring  306  and less force trying to open the hook and loop closure  304 C and  304 D. 
         [0103]      FIGS. 6A and 6B  show an embodiment similar to  FIG. 3 . In this embodiment, the ring element  606  is closed at the bottom of the foot rather than the top. This creates a more flat area on the bottom of the foot and makes it easier for the wearer to walk with the invention.  FIG. 6A  is a bottom view with strap  604  and hook and loop closure  602  used to cinch the ring closed around the foot. Straps  304  with hook and loop closures  304 A and  304 B wrap around the foot and function in a similar manner as described in  FIG. 3 . The same is true of elements  305 ,  305 A and  305 B.  FIG. 6B  shows a top view with the circumference adjustment on the bottom and the straps  304  and  305  being attached to the top. 
         [0104]      FIG. 7A  shows another embodiment of the invention wherein the ring  702  is a continuous loop. A single strap  704  is either attached to the ring  702  or is looped over and attached to itself via sewn joint or similar method. The end of the strap  704  has both genders of hook and loop tape so it will adhere to itself when looped around the ring  702  in the final step of the attaching the device to wearer&#39;s foot. 
         [0105]      FIGS. 7B and 7C  show right hand and left hand sides of the foot while wrapping the strap  704 . The first step is  FIG. 7B . The strap is  704 A. The strap is wrapped around the heel and becomes  704 B in  FIG. 7C . The next step is to wrap the strap under the ring and is shown as  704 B turning into  704 C as it passes under the ring.  704 C wraps behind the heel and becomes item  704 D in  FIG. 7B. 704D  then passes under the ring and wraps back to the heel as item  704 E and in  FIG. 7C  becomes item  704 F.  704 F loops around the top of the ring and fastens back on to itself using the hook and loop closure  706 A and  706 B. 
         [0106]      FIG. 8A  is an additional embodiment of the invention showing another attachment method. In this embodiment, the ring&#39; 702  is the same as  FIG. 7A , however there is a single strap going behind the heel. This strap is made from two pieces, items  804  and  808 . Each end of the strap has the mating ends for the other end shown as  806 A and  806 B.  FIG. 8B  shows the right hand side of the embodiment and  FIG. 8C  shows the left hand side. In  FIG. 8C , item  806  shows the mated connectors  806 A and  806 B. This connector can be hook and loop or any industry known equivalent such as a mating plastic connector, buttons, snaps or tied laces. 
         [0107]      FIG. 9A  is another embodiment of the invention. It consists of a form created from one or more pieces of semi-compressible foam, such as closed cell foam, that creates a boot form to surround the foot made with an ankle  902  and a shoe  908 . The instep of the foot has a thicker band that forms the fulcrum. The ankle  902  is closed with a strap  904  and a hook and loop closure  905 . The shoe element is closed with strap  906  and the hook and loop closure  907 . This embodiment does away with the straps around the back of the foot for position stabilization and instead uses the boot form to hold the fulcrum ring in place. This embodiment also has the advantage of low production cost, as the material could be one step molded. One could also fabricate this embodiment with or without a fabric cover. If the base foam was left exposed, the wearer could pad the foot by using a standard sock.  FIG. 9B  shows a right hand side view of the embodiment on a foot. 
         [0108]      FIG. 10A  is another embodiment shown with a half sock  1002  attached to a continuous semi-compressible ring  702 . The sock could be made from standard sock material such as cotton, or it could be made of a material such as neoprene. The front of the sock  1004  is made long to fold around the semi-compressible ring and get attached back to itself and thus, stabilize the position of the ring.  FIG. 10B  shows the front of the sock  1004  being wrapped around the ring  702  and  FIG. 10C  shows the wrap completed and the front of the sock forming a pocket around the ring  702 . This pocket secures the position of the ring  702 . 
         [0109]      FIG. 11A  is another embodiment shown with two pads  1104 A and  1104 B. These pads reside on the medial and lateral sides of the foot. The pads are held in place by the half sock  1002  to which they are attached.  FIG. 11B  is a frontal view of the embodiment shown in  FIG. 11A . The thickness of the pad will vary based on the size of the wearer&#39;s foot but should range from 2 inches thick to 1 inch thick. 
       CONCLUSION, RAMIFICATIONS, AND SCOPE 
       [0110]    Accordingly the reader will see that, according to at least one embodiment of the invention, I have provided a unique, novel, and unobvious approach to dealing with metatarsalgia. This invention is very easy to use, has a minimum number of adjustments to be made for proper use. It can be safely worn for the duration of a nights rest without interfering with normal sleep. It is inexpensive to manufacture and provides an alternative to risky, painful, and oft times ineffectual surgery. 
         [0111]    While the above description contains many specificities, these should not be construed as limitations on the scope on any embodiment, but as exemplifications of the presently preferred embodiments thereof. Many other ramifications and variations are possible within the teachings of the various embodiments. In many cases throughout the drawing descriptions, the term hook and loop closure is used. This is meant to be typical yet non-restrictive in nature. There are many ways to achieve the closures indicated such as snaps, buttons, and/or laces. Also, the semi-compressible ring could be made from closed cell foam or any other semi-compressible material such as bladders containing air, water, or gel. The semi-compressible ring can be continuous or have one or two gaps. In the case of a single gap, the gap can reside at the top or bottom of the foot. With two gaps, basically two pieces of padding are formed and they reside on the medial and lateral sides of the foot, over the midfoot bones. If material is used to cover the ring, or in the case of two pads mentioned above, the material can be made as pockets to contain the semi-compressible material so the ring or pads can be removed and the cover material can be laundered. 
         [0112]    Thus the scope of the invention should be determined by the appended claims and their legal equivalents, not by the examples given.