Abstract:
This invention generally relates to a shoe where an orthopedic adjustment is integrated into the construction of the shoe itself. The invention entails adjusting one or more of the soles or other construction features of the shoe in order to accommodate a medical condition or treatment regimen. For instance, in abnormalities of the knee joint, there is a need to redistribute the weight of the body from an afflicted symptomatic compartment of the knee to an un-afflicted and asymptomatic, or lesser effected and less symptomatic compartment so as to relieve the pain and stress at the most afflicted and most symptomatic compartment. The present invention achieves this by pitching the sole or heel, or both, of a shoe, where the pitching region depends on the portion of the knee that is afflicted, and the angle is chosen to counter and redistribute the weight of the body accordingly.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    (a) Technical Field of the Invention 
         [0002]    This invention generally relates to a shoe in which an orthopedic adjustment has been integrated into the construction of the shoe itself. More specifically, the invention entails adjusting one or more of the soles, heels, or other construction features of the shoe itself in order to accommodate a medical condition or treatment regimen. 
         [0003]    The shoe substrate has a direct impact on the knee and ankle joints. A knee joint has three compartments—an inner, medial femorotibial compartment; an outer, lateral femorotibial compartment; and a frontal, anterior femoropatellar compartment. A normal knee joint has collateral ligaments that strap together the medial and lateral sides of the joint and cruciate ligaments that provide crossing within the joint. Together, these ligaments stabilize and strengthen the knee. 
         [0004]    Within the knee joint there are two types of joint cartilage: fibrous cartilage (the meniscus) and hyaline cartilage. Cartilage is a thin, elastic tissue that protects the bone and makes certain that the joint surfaces can slide easily over each other ensuring smooth painless knee movement. The meniscus has tensile strength and can resist pressure essentially acting as a shock absorber. The hyaline cartilage covers the surface along which the joints move. In addition, the joint is lubricated by a fluid produced by the synovial membrane. The meniscus serves to distribute the load of the body evenly, and also aids in disbursing this synovial fluid for joint lubrication. 
         [0005]    There are two primary ways in which the knee joint may lose its normal functionality—traumatic injury or age related degeneration. Consequently, depending on the degree of a traumatic injury and what part of the knee was injured, the injury itself may lead to post traumatic degeneration. In either case the cartilage inevitably will wear over time and has a very limited capacity for self-restoration. Any newly formed tissue will generally consist of a fibrous cartilage of a lesser quality than the original hyaline cartilage. As a result, new cracks and tears will continue to form in the cartilage progressively causing inflammation and a loss of lubrication from reduced or lost synovial fluid. In turn this then leads to varying degrees of knee pain that is proportional to the degree of degeneration. 
         [0006]    Among the more common traumatic knee injuries that lead to degeneration of the knee joint would be a meniscal tear, an anterior cruciate ligament (“ACL”) tear, or an intra-articular bone fracture. The first two are often seen in sports related injuries. The intra-articular bone fracture conversely is usually seen in hard falls and motor vehicle accidents. In this type of injury, the break crosses through and negatively affects the smooth surfaces of the involved articulating cartilage. 
         [0007]    As joint degeneration progresses, so comes the development of osteoarthritis. This in essence is caused by the general wear and tear of the joint. As the hyaline cartilage and the meniscus break down and wear away, this causes the bones to rub together, causing pain, swelling, and stiffness. Bony spurs or extra bones may also form around the joint, and the ligaments and muscles around the knee become weaker. 
         [0008]    The biomechanical aspects of gait and impact alignment have been medically recognized. It is well-known and well documented that improved alignment and altering the dynamic forces on the relevant compartment in the knees can significantly alleviate the symptoms, reduce and slow disease progression, and in some cases, allow the joint to heal to some degree. In this respect, well-known biomechanical and clinical studies have established the usefulness of a lateral wedge in reducing the load on the medial knee compartment. 
         [0009]    The present invention is generally directed at various uses and positions of a wedge angle to alleviate symptoms of pain at the knee and ankle joints, especially knee pain associated with degenerative joint disease, to slow the progression of degenerative joint disease in the knee, and to help prevent premature degeneration of the knee joints in susceptible persons. The wedge angle is integrated into the design of the shoe&#39;s midsole, thereby not interfering with the normal functionality, safety, fit, or comfort of a shoe. This contrasts with the majority of current practice and prior-art devices wherein adjustments to shoes are made by means of an insert, an external attachment, or other devices worn by a user in addition to the shoe. 
         [0010]    In this invention, it is the shoe sole construction and design itself that is being modified to accommodate some orthopedic goal which has been medically prescribed. In this sense, the shoe would be custom-made to accommodate the orthopedic condition being treated, accommodated, or prevented. However, stating that this shoe would be custom-made, does not mean that it would be custom-made for each individual and or further adjusted in a trial and error fashion like a great many of the prior-art. Rather, it would be custom-made in its unique and novel fabrication and design, but would be universal in its application for all persons regardless of their individual symptoms and degree of their orthopedic condition. 
         [0011]    (b) Description of the Relevant Art 
         [0012]    A considerable number of patents relate generally to adjusting a shoe to accommodate a medical condition by the wearer. Many of these inventions take the form of an insert, or external device added or attached to the shoe, and some feature integrated adjustments. 
         [0013]    In U.S. Pat. No. 6,205,685 B1, Kellerman discloses an adjustable orthotic insole to be used for therapeutic adjustment, and which is customized to the user. The Kellerman insole can be modified by the user such as to adjust elevated areas within the orthotic insert and relieve areas of pressure on the foot, much like an orthotic insert. By trial and error placement of pads of varying thicknesses on the bottom surface, the user can create a customized therapeutic device capable of relieving pain and stress. The trial and error method of adding and removing pads appears to be the primary essence of the invention. The Kellerman specification does state that expert alignment can be provided by a doctor adjusting the pads to correct particular misalignments or problems with the feet. 
         [0014]    Kellerman states that an infinite number of adjustment features can be included and that the custom shape of his invention can be a permanently prescribed orthotic, or it can be a temporary device used until a permanent orthotic is fabricated. The Kellerman device begins with a base insert comprised of a non-compressible sheet of flexible but deformable material in the range of 10 to 100 mils in thickness. Vinyl resin, polyethylene and polypropylene are all identified as optimum materials for the base. The base material is attached to the inside of the shoe in a variety of ways, including the use of Velcro and other commercial loop materials. 
         [0015]    U.S. Pat. No. 5,138,774 by Sarkosi is similar to the Kellerman invention in many respects. However, Sarkosi attempts to set forth an adjustable shoe insole for providing therapeutic relief by including an assortment of thin, removable, stackable support pads. In essence, the user is enabled to stack a series of small pads onto various regions of the insole in order to build up support in particular areas as required for greater comfort. Sarkosi states that by choosing specific materials set forth in the patent, and constructing the pads to be thin, the result is an insole that is non-skid such that it stays appropriately in place when stacked. The adjustable pads are not sewed or glued together, and additional pads may be added, and pads removed over time, as needed. In this sense, the Sarkosi invention is essentially the use of inserts comprised of thin, stackable comfort pads in a shoe insole. 
         [0016]    U.S. Pat. No. 4,841,648 by Shaffer, et al. is directed to a personalized insole kit for a shoe. The basic idea behind this patent is to develop an insole kit comprised of a collection of specific foot regions, each of which can be modified for a specific therapeutic effect. The thrust of this patent is also directed to a shoe insole kit that can be modified and adjusted by the end-user consumer. The summary section states that the Shaffer article is a personalized insole self-made by the patient for relief of foot discomfort, including a plurality of corrective components, each having a shape formed for a specific correction. The six primary adjustment regions identified in the application include an arch pad, a heel pad, a metatarsal pad, a lesion pad and others. The various regional components assemble together to form the general outline of the insole. The claims of the patent are all directed to a device defined by a plurality of removable and replaceable corrective components which are to be personalized for comfort by the end-user. 
         [0017]    Another patent similar to Shaffer is U.S. Pat. No. 4,633,877 by Pendergast. This patent also sets forth an orthopedic insole component which is to be added to the interior of a shoe for a therapeutic effect. As with Shaffer, Pendergast also divides the insole into specific and discreet regions. All of the Pendergast segments are of the same thickness such that when assembled, the device will be “flat” from side to side and from posterior to anterior. However, although the overall device is of the same thickness, the various segments are constructed such that they are each made from materials having a predetermined range of firmness. Each of the specific regions has its own durometer selected from one of a group of ranges of durometers set forth in the patent. Accordingly, the various insole regions have a different hardness, which can be selected for specific desired therapeutic effect. The Pendergast invention is an insert article as opposed to an integrated shoe sole custom-designed for a particular effect. 
         [0018]    U.S. Pat. No. 5,042,175 by Ronen is titled “User-Specific Shoe Sole Coil Spring System and Method”. The Ronen device is a user-specific shoe sole that is customized to the individual to achieve a specific orthopedic goal. The customized shoe sole of Ronen is achieved by a specific coil spring construction. The coil spring system layout and stiffness characteristic may be customized to serve the needs of different users and different applications. A user&#39;s weight and particular comfort and/or orthopedic requirements are met by fitting the sole with a greater or lesser quantity of springs with different levels of stiffness. Ronen states that the result is a shock-absorbing distribution pattern that suits the requirement of a particular application. All of the Ronen claims are limited to the coil spring element. 
         [0019]    U.S. Pat. No. 4,756,096 by Meyer is directed to a custom-molded insert for footwear, and the patent is more particularly directed to an insert to be used with ski boots. The Meyer insole is a one-piece, thin, contoured blank of semi-rigid, bendable, resilient material molded such as to include the complete detail of the full plantar surface of the foot. As such, the Meyer insole provides a four-point contact with a supporting surface of the footwear at the heel, great toe, and at least two, spaced metatarsal heads. According to the inventor, this arrangement provides natural balance and a proper dynamic positioning of the foot and immediate energy transfer between the foot and the footwear, such as a boot or ski. In essence, the problem Meyer is attempting to address is the fact that looseness, or sloppiness, inside a ski boot can lead to loss of control, or rubbing, or other repetitive stress injuries to the feet. The claims are all limited to a one-piece insert that is constructed such as to mold closely to the foot. Meyer does not address customizing a shoe for a therapeutic effect. 
         [0020]    U.S. Pat. No. 5,014,706 by Philipp is titled “Orthotic Insole with Regions of Different Hardness”. With this invention, the title of the patent says it all. As shown in  FIGS. 1 through 6  of the patent, regions of the insole may be selected to have different hardnesses by altering the type of material used to comprise that portion of the insole. The regions which are specifically defined in the drawings are selected by the inventor to be those areas in which a particular therapeutic adjustment may be needed for some users. Each of the regions of the insole is constructed of a deformable material, but a particular durometer, or hardness, is assigned to each of the regions as needed. The claims of the patent are all directed to specified regions of differing hardnesses. 
         [0021]    U.S. Pat. No. 4,813,157 by Boisvert, et al. is another variation of adjustable shoe insole wherein a plurality of adjustable thickness layers are used to build up certain regions of the insole. Boisvert states that the insole comprises superimposed pad layers made of a flexible material for the top layers and a cork material for the remaining pad layers. This patent states that a pressure adhesive, such as hot-melt glue, could be used to releasably interconnect the superimposed pad layers in order to allow repeated peel-off removal and reconnection of the layers. The patent consists of a single, independent claim and thirteen dependent claims, and the feature of multiple layers of support which may be peeled off and reapplied is a required feature of all of the claims. 
         [0022]    U.S. Pat. No. 2,909,854 by Edelstein is an older patent directed to pressure-relieving insoles. As shown in the drawing, Edelstein accomplishes the goal of relieving pressure by having a cut-away portion of the insole. The aperture areas of the insole are used to provide relief, and the inventor specifically notes the relief of calluses by enabling the callused area to extend into the aperture such as to relieve walking pressure on the callus. 
         [0023]    The patents mentioned above, and other prior-art devices, fail to adequately solve the problems associated with painful or arthritic knees. The prior-art devices fall into three broad categories—those that attach an external corrective material to the outsole or bottom of the shoe, those that add an insert inside the shoe, and those that might chemically engineer the soles in their fabrication to have a variability of durometry or hardness. 
         [0024]    In the first category, external corrective materials, wedged or otherwise, that are attached to the outsole or bottom of the shoe are especially wrought with problems. The least of these problems would be that the overall comfort and feel of the shoe would be changed by adding something foreign. More so, any external attachment will also change the height of the shoe sole. This height increase will be directly transferred to the entire leg. If used on only one shoe, this will increase the overall leg length compared to the opposing side. The effect would be that of a leg length discrepancy. The result will be an awkward gait, a pelvic shift, and undue stress or discomfort over time referred to the hip and spine. 
         [0025]    In addition, external attachments may not be universal for all types of shoes, meaning they may not fit all shoes and tread patterns. For the shoes they do fit, the degree of fit may vary greatly by the shoe. These can be difficult to apply and in some instances it may require much trial and error, and adjustment by the wearer, or a medical provider. They are not universal to the patient or the degree of arthritis either. 
         [0026]    Most importantly however, these external attachments may actually be dangerous for the wearer. Since they are attached to the outside of the shoe, they are not part of the shoe. By raising the height of the shoe from the ground, this changes the center of gravity and stability of the shoe potentially leading to balance issues, falls, and foot, ankle or other injury. Because shoe tread contacts the ground, any attachments to the bottom of a shoe are going to be prone to getting caught on obstacles or uneven walking surfaces during ambulation as well. Furthermore, if the attachment becomes loose, this will increase this risk and or the device may just fall off. Another important danger is that external materials change the traction of the shoe because it will cover all or a portion of the shoe&#39;s natural tread. Essentially any external attachment to a shoe is a danger to the wearer for these reasons, and can potentially cause a person to fall leading to serious injury. Most of these external attachments are not custom made to the individual shoes either. By default, given the countless shoes in existence, this makes their compatibility and fit highly variable and primitive at best. 
         [0027]    In the second category, those that add an additional insole or insert, wedged or otherwise, inside the shoe, are wrought with problems as well. By default these are additions to existing shoes that are placed on or attached to the native insole inside the shoe instead of to the outsole outside the shoe. Shoe inserts of all types are likely as numerous as there are shoes. Most are very similar and claim to aid in some ailment. These types of orthotics in majority are primarily for foot ailments and rarely for the knee or ankle ailments. When adding these inserts into an existing shoe, this will decrease the inside height and space of the shoe box that is available for the foot. This significantly changes the overall fit and feel of the shoe. Frequently, this will cause the need to loosen the shoe laces to accommodate the loss of foot space. Simultaneously, as these inserts decrease the height inside the shoe, they will increase the overall height of the shoe sole because they are positioned over the shoe&#39;s native insole. This height increase will be directly transferred to the entire leg. If used on only one shoe, this will increase the overall leg length compared to the opposing side. The effect would be that of a leg length discrepancy just as it is with adding an external device to the shoe&#39;s native outsole in the prior category. The result will be an awkward gait, a pelvic shift, and undo stress or discomfort over time referred to the hip and spine. In situations where inserts cover the shoe&#39;s entire native insole, they must be cut and adjusted in accordance with the size of the wearer&#39;s foot, the size of the shoe&#39;s native insole over which they will be placed, and the amount of available interior shoe space. If the type of inserts being used do not cover the shoe&#39;s entire native insole, they must either sit freely inside the shoe or be adhered to the inside of the shoe. This makes position placement and maintenance of that position very problematic as well. 
         [0028]    With both types of inserts, those that cover the shoe&#39;s entire native insole and those that do not, they frequently tend to slide around changing positions within the shoes. This causes the burdensome and continual need for the inserts to be repositioned or replaced. In general when using any inserts, the need for sizing, placement, positioning, and maintenance is very cumbersome and time consuming. Their use will usually require much trial and error and adjustments. Although inserts can be made somewhat universal to the shoe, it&#39;s only after this tedious modification by the patient or healthcare provider. More importantly however are the potential risks associated with their use. By raising the height of the foot from the ground as it sits on the added insert, this too, as with the first category, changes the center of gravity and stability of the shoe potentially leading to balance issues, falls, and foot, ankle or other injury. Furthermore, any insert, being foreign to a prefabricated shoe that makes direct contact with a wearer&#39;s foot can cause pressure points, friction blisters, or skin breakdown. This is particularly dangerous to wearer&#39;s who have healing or vascular compromise, or peripheral neuropathy due to Diabetes Mellitus, Peripheral Vascular Disease, or immuno-compromise. These persons are at a much higher risk for developments of skin ulcerations leading to severe infections that can lead to a need for amputations. If the inserts are cut or sized inappropriately, this can increase these risks and cause further discomfort by uneven contours, and pressure points against the foot inside the shoe. 
         [0029]    In the third category, those that might chemically engineer the soles in their fabrication to have a variability of durometry or hardness, also have a host of problems. Although the fit and feel of the shoe may not be grossly affected, it greatly affects the overall durability and performance of the shoe. By changing the chemical makeup of the sole itself in this way, although a wedge effect may occur after weight and pressure is applied causing it to compress more on the softer portion, this changes the wear ability of the shoe and the tread. The softer less firm side will wear out much faster, and the harder firmer side by default will wear out more slowly. So ultimately uneven tread wear increased on the softer side of the sole will cause the wedge effect to increase and not remain constant or therapeutic. This causes the desired corrective measure to become less effective and can potentially cause knee, foot, and ankle pain to increase proportionally as the angle increases out of the desired therapeutic range. Moreover, as the shoes wear out quickly, they would need to be replaced, adding unnecessary cost to the therapeutic process. 
         [0030]    These shoes would likely be more expensive than the normal shoe also because of the complex chemical engineering that must be used during fabrication. For that matter, if any of the other two categories were custom made to the individual, the cost would rise significantly as well. Most importantly however with this third category are the risks and dangers to the wearer associated with the varying sole hardness and the uneven tread wear. Firstly, during normal ambulation, stability of gait is determined greatly by the expected plantar of equal durometry against the bottom of the foot transferred to the ankle medial to lateral. By having unequal durometry with one side of the sole more or less firm than the other side, this creates a problem for the foot and ankle to compensate especially during ambulation over uneven surfaces. This can lead to foot and ankle injury, or even falls resulting in further more serious injury. Furthermore, the durometry and wear-ability directly affects the grip and traction of the shoe&#39;s outsoles. The softer side will have much more grip and traction prior to it wearing out, but decreased wear-ability by default. The harder firmer side, although having greater wear-ability, by default will have less grip and traction. This can potentially cause loss of traction thereof during ambulation resulting in a fall or serious injury. It is a fact that there is a great population of people with many ailments, particularly involving the knees. As stated, the patents mentioned above, and other prior-art, although they make an attempt, fail to adequately solve the problems associated with painful or arthritic knees and in many cases add additional problems or risks to the equation by their design. 
         [0031]    Therefore, there is a great need for a safe, effective, and universal orthopedic adjustment that is integrated into the construction and design of a shoe itself, so that the outsole and insole may remained unchanged, and the shoe fits comfortably without altering its performance. The present invention solves all these problems and more. It combines or encompasses all the benefits of the prior-art, it enhances and improves the all the benefits of the prior art, but has none of the detriments or drawbacks of the prior-art. 
       SUMMARY OF THE INVENTION 
       [0032]    The present invention provides a unique, safe, effective, and universal orthopedic adjustment that is integrated into the construction and design of the shoe itself, so that the outsole and insole may remained unchanged, and the shoe fits comfortably, without altering its performance. More specifically, the invention entails adjusting one or more of the soles, heels, or other construction features of the shoe itself in order to accommodate a medical condition or treatment regimen. The present invention is generally directed at various uses and positions of a wedge angle to alleviate symptoms of knee pain associated with degenerative joint disease, to slow the progression of degenerative joint disease in the knee, and to help prevent premature degeneration of the knee joints in susceptible persons. The invention is applicable to similar considerations at the ankle joints as well. The wedge angle is integrated into the design of the shoe&#39;s midsole, thereby not interfering with the normal functionality, safety, fit, or comfort of a shoe. This contrast with the majority of current practice and prior-art wherein adjustments to shoes are made by means of an insert, or an external attachment, or other additional devices worn by a user in addition to the shoe. In this invention, it is the shoe sole construction and design itself that is being modified to accommodate some orthopedic goal which has been medically prescribed. In this sense, the shoe would be custom-made to accommodate the orthopedic condition being treated, or accommodated, or prevented. However, stating that this shoe would be custom-made, does not mean that it would have to be custom-made for each individual and or further adjusted in a trial and error fashion like a great many of the prior-art. Rather it means that it would be custom-made in its unique and novel fabrication and design, but would be universal in its application for all persons regardless of their individual symptoms and degree of their orthopedic condition. 
         [0033]    One embodiment of the invention is directed primarily to the treatment of knee pain related to knee joint degeneration and/or arthritis in all stages. In a person with normal knees, the load is equally distributed between the medial and lateral compartments of each knee. However, in the presence of congenital or acquired knee deformities such as varus (bow leg) or valgus (knock knee), this distribution is skewed. Therefore, the weight load needs to be redistributed. This may be achieved by pitching the feet and ankles at an appropriate angle. 
         [0034]    In the present invention, during a shoe&#39;s construction and design, as part of the standard sole, the normal angulation would be modified to have an alternate predetermined desired and suitable pitch wedge angulation. In one embodiment, the angled or wedged portion of the sole will be the midsole. This is the body of the sole between the cushioned upper portion or insole, and the treaded lower portion or outsole. In this way, the tread, traction and grip remains unchanged, there are no inserts or attachments, and the pitch is integrated into the construction of the shoe itself. Different regions of the sole may be fabricated with a pitch wedge angle to accommodate various conditions, leading to greater control over the redistribution of the load within the compartments of the knee joint, or at the ankle joint. 
         [0035]    These and other features, variations and advantages which characterize this invention, will be apparent to those skilled in the art, from a reading of the following detailed description and a review of the associated drawings. 
         [0036]    Additional features and advantages of this invention will be understood from the detailed descriptions provided. This description, however, is not meant to limit the claims or embodiments, and merely serves the purpose of describing some structural claims and embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0037]    A better understanding of the present invention will be had upon reference to the following description in conjunction with the accompanying drawings, wherein: 
           [0038]      FIG. 1  shows different views of an embodiment of the shoe sole with a lateral pitch angle spanning the length of the shoe from front to back and side to side. 
           [0039]      FIG. 1A  shows the pitch angle on the left shoe;  FIG. 1B  shows the pitch angle on the right shoe;  FIGS. 1C and 1D  illustrate the manner in which the pitch or wedge is integrated into the design of the midsole of the left and right shoe, respectively.  FIGS. 1E and 1F  are blow-ups of the sole showing the angled wedge; 
           [0040]      FIGS. 2A-F  are the counterparts to  FIGS. 1A-F  for a medial pitch angle; 
           [0041]      FIGS. 3A-B  are schematic diagrams of an embodiment of the right sole illustrating some ways in which different regions of the sole may be pitched to redistribute the weight; 
           [0042]      FIG. 4A  is the frontal-view of a right knee with medial knee arthritis. The figure illustrates where the increased load is distributed on the medial joint compartment compared to the decreased or lesser load on the lateral joint compartment from a weight bearing level surface.  FIG. 4B  illustrates how this load is redistributed in part to the lateral side of the knee in effect decreasing the problematic load on the medial side of the knee when standing on a weight bearing surface with a lateral pitch or wedge angle. The same would be true for its counterpart of a knee with lateral compartment arthritis if standing on a weight bearing surface with a medial pitch or wedge angle. 
           [0043]      FIGS. 5A-C  show various embodiments of combinations of a shoe with a sole and or a heel as described in this invention.  FIG. 5A  shows a shoe with a sole that has a wedged middle portion.  FIG. 5B  shows a shoe with a heel that has a wedged middle portion. Finally,  FIG. 5C  shows a shoe with a sole and a heel, each of which has a wedged middle portion. 
           [0044]      FIG. 6  shows an embodiment of a shoe of this invention where an additional insert may be placed inside the body of the shoe sole. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0045]      FIG. 1A  shows a schematic view of the lateral pitch angle  12  on the left sole  10 , while  FIG. 1B  shows the lateral pitch angle  12  on the right sole  20 .  FIG. 1C  is an illustration of one embodiment of the invention, showing a view from the back of the shoe toward the heel. A left shoe sole  10  is shown. The sole comprises three basic portions; the upper or inner portion  14 , the middle portion  16 , and the lower or outer portion  18 . The upper portion or insole  14  meets the foot and shoe. The lower portion or outsole  18  meets the walking surface and may additionally have a treaded underside that is in contact with the walking surface. The portion between the upper portion  14  and the lower portion  18  is the middle portion or midsole  16 , and is the part that has the wedged or angled pitch. In this embodiment, the middle portion comprises one section, and this section comprises one angled region that is wedged with a lateral pitch angle spanning the length of the shoe from front to back and side to side. In other embodiments, there may be several angled regions that are wedged, and the wedged angle may be independent of the geometry of the adjacent regions. In yet other embodiments, the middle portion, or the outer or inner portions, independently, or together, may comprise multiple layered sections, with one or more sections comprising regions. One or more of these regions may be angled. The angled region is shaped substantially like a wedge. The position, alignment, and degree of each angle may vary depending on the appropriate load distribution. The selection of regions, angled regions and angles is made so as to form a contoured surface that redistributes the load at the knee or ankle joint of a person wearing a shoe fitted with an embodiment of the sole, the heel, or a combination thereof. 
         [0046]    Although some pitching of the sole or the heel may be visible to the naked eye, it is likely that the pitching angle may be small enough so that it may be almost imperceptible to the naked eye. For this reason, a blow-up for the sole  10   a  is shown in  FIG. 1E . It illustrates how the middle portion  16  is wedged through an angle alpha.  FIGS. 1D and 1F  show the corresponding features in a right shoe showing the lateral pitch angle. 
         [0047]    It should be noted that these drawings are not intended to represent a separate material bonded to or within a shoe&#39;s native sole but rather to show how the normal material in any midsole itself is simply angled by this design. The wedged regions and the pitch angle are determined to counter the load bearing weight on the afflicted medial side of the knee and redistribute it to the lateral to alleviate pain, as will be explained subsequently. 
         [0048]      FIG. 2A  shows a schematic view of the medial pitch angle  13  on the left sole  10 , while  FIG. 2B  shows the medial pitch angle  13  on the right sole  20 .  FIG. 2C  is an illustration of one embodiment of the invention, showing a view from the back of the shoe toward the heel. A left shoe sole  10  is shown. The sole comprises three portions. The upper portion or insole  14  that meets the foot and shoe, a lower portion or outsole  18 , and the angled pitch in this invention being the mid portion or midsole  16 . The lower portion  18  may additionally have a treaded underside that is in contact with the walking surface. Wedged between the upper portion  14  and the lower portion  18  is the angled pitch  16 . The pitch angle is determined to counter the load bearing weight on the afflicted lateral side of the knee and redistribute it to the medial to alleviate pain, as will be explained subsequently. 
         [0049]    Although some pitching of the sole or the heel may be visible to the naked eye, it is likely that the pitching angle will be small enough so that it will be imperceptible. For this reason, a blow-up for the sole  10   a  is shown in  FIG. 2E . It illustrates how the middle portion  16  is wedged through an angle gamma.  FIGS. 2D and 2F  show the corresponding features in a right shoe showing the medial pitch angle. 
         [0050]    In inventions of the prior art, the pitch is generally achieved by placing a separate insert inside the shoe on top of the shoe&#39;s native insole, or the pitch is achieved by attaching a separate device to the bottom of the shoe or outsole after the shoe has been manufactured. One of the many disadvantages of doing this is that due to constant wear and tear, the sole loses its tread and the pitch angle is changed. Also, since the pitch may be attached to different regions of the sole, many tread designs may be incompatible with the pitch. While such arrangements of the soles and heels are not disclaimed in this invention, one of the advantages of one of the embodiments of the present invention is that the pitch  16  is between the upper portion  14  and the lower portion  16  of the sole. Thus, the tread designs can be independent of the pitch, and the pitch angle itself will be less prone to changes due to wear and tear of the upper and lower portions of the sole and will not have the safety issues associated with an external attachment. Also, the contact between the foot and the sole is at the upper portion  14  and this remains unchanged. This eliminates the discomfort due to inserts that is prevalent in many shoes of the prior art. However, it should be noted that in some embodiments of this invention, the pitch may be incorporated into the lower portion  18  of the sole (the outsole) being the tread that contacts the ground, or the upper portion  14  of the sole (the insole) that contacts the foot. There could also be a shoe created with a sole that would have a space to accommodate the addition of separate wedges of various thickness and varying material into the middle portion  16  for greater or lesser pitch or effect. 
         [0051]    In the present invention, there are no alterations or variations of hardness, or firmness of any region of the sole to achieve this angle or effect. The sole itself is of uniform consistency throughout its construction as in any normal sole design of any normal shoe with the exception of the pitch wedge angle. A normal shoe is typically level medially and laterally being parallel to the ground. In the present invention the desired angle is achieved and determined by the area in which the pitch wedge of the sole itself is integrated. In some embodiments of this invention however, alterations or variations in hardness, or firmness of any region of the sole could be used to achieve this angle or effect. 
         [0052]      FIGS. 3A and 3B  are schematic diagrams of the bottom of the right sole  30  showing different regions that may be pitched due to the therapeutic needs of an individual.  FIG. 3A  shows eight regions  32 ,  34 ,  36 ,  38 ,  40 , and  42 . The region  44  may be formed by joining points  44   a  and  44   b . Similarly region  46  may be formed by joining points  46   a  and  46   b.    
         [0053]    Other regions, of varying shapes and sizes, may be formed on any part of the sole to achieve a desired wedge angle or effect. Any individual region or a combination of regions may be pitched through an appropriate angle for the treatment of knee pain, knee joint degeneration, or knee arthritis, or ankle joint ailments. Also, it may be desirable to pitch the sole or the heel for only one foot, or pitch different regions of the sole or heel for each foot. It may also be desirable to pitch the sole on one foot and the heel on the other foot, or pitch both the sole and the heel on both feet. By choosing the regions, angled regions, and the shapes and angles of the wedges, the contoured load bearing surface may be configured to redistribute the load at the knee or ankle joint of a person wearing a shoe comprising the sole or heel of this invention, or a combination of both, for the purposes of treating ailments in the knee, to slow the progression of degenerative joint disease in the knee, or to improve athletic or ambulatory performance during lateral cutting, lateral cornering, or lateral push off, or to decrease risk of ankle eversion or inversion injuries. 
         [0054]      FIGS. 4A and 4B  are frontal views of the right knee  50  with medial knee arthritis, where the afflicted region is generally shown on the medial side  52 . Referring to  FIG. 4A , when a normal person with no medial knee arthritis stands on a weight bearing level surface  56 , the load is equally distributed over the medial side  52  and the lateral side  54 . However, when medial knee arthritis is present, then the load is borne largely by the medial side  52  which will also be true prior to development of arthritis in a person with a congenital varus (bow leg) knee deformity. This increased medial load is illustrated by the two vectors  52   a  and  52   b . Vector  52   a  represents the weight of the body, whereas vector  52   b  represents the opposite force acting from the weight bearing surface.  FIG. 4B  shows the effect of lateral pitching on the load bearing ability of this same afflicted knee with medial compartment arthritis. The figure shows a weight bearing surface with an angled pitch  58 . When a person with medial knee arthritis stands on such a weight bearing surface, the load on the medial side  52  of the knee is redistributed in part to the lateral side  54 . This is shown by the vector  54   a  which represents the weight of the body, whereas vector  54   b  represents the opposite force acting from the pitched weight bearing surface. Such a redistribution of the load takes the stress off the afflicted medial side  52 , thereby alleviating the pain, and in some instances, aids in the healing of the knee. The pitch angle  60  is chosen to counter the load on the medial side. This may depend on several factors, including, but not limited to, the extent of the disease, the strength of the muscles, the shape of the leg, and the type of shoe while still being universal to the general population. 
         [0055]      FIGS. 5A-C  illustrate side views of different shoes with the embodiments of this invention.  FIG. 5A  shows a sandal  80 , with a shoe interior  81  and an undersurface  82 . The sole  84  is in contact with the undersurface  82 . In this particular embodiment, the sole comprises three portions, the upper portion  14 , the lower portion  18 , and the middle portion  16 . The middle portion  16  is illustrated as being wedged, in this particular embodiment. A heel from the prior art may also be attached to this sole  80 . 
         [0056]      FIG. 5B  shows a shoe  90 , with a shoe interior  81  and an undersurface  82 . A sole  88  is in contact with the undersurface  82 . This sole  88  may be from the prior art. In this particular embodiment, the heel  86  comprises three portions, the upper portion  14 , the lower portion  18 , and the middle portion  16 . The middle portion  16  is illustrated as being wedged, in this particular embodiment. 
         [0057]      FIG. 5C  shows a shoe  100 , with a shoe interior  81  and an undersurface  82 . A sole  84  is in contact with the undersurface  82 . In this particular embodiment, the sole  84  and heel  86  are embodiments of the present invention. Each comprises of three portions, the upper portion  14 , the lower portion  18 , and the middle portion  16 . The middle portion  16  is illustrated as being wedged, in this particular embodiment. 
         [0058]      FIG. 6A-D  illustrate a few different embodiments of a wedge  110  that may be used in the construction of the sole and or the heel.  FIG. 6A  shows a blunt wedge  110  comprising a top boundary  112  and a bottom boundary  114 . The blunt edge  116  is shown with an imaginary extension into a sharp corner  120 . The wedge is pitched through an angle alpha as shown.  FIG. 6B  shows a sharp wedge  110  comprising a top boundary  112  and a bottom boundary  114 . The sharp edge  118  is shown. The wedge is pitched through an angle alpha as shown. 
         [0059]      FIG. 6C  shows a wedge  110  comprising a top boundary  112  and a bottom boundary  114 . The top boundary  112  is shown to be contoured with contour lines  124 . Although this wedge is shown to be substantially sharp, it could also have a blunt edge. The wedge is pitched through an angle alpha as shown. Also shown is a wedged section  122  within the wedge  110 . 
         [0060]      FIG. 6D  shows a wedge  110  comprising a top boundary  112  and a bottom boundary  114 . The wedge is pitched through an angle alpha as shown. Although this wedge is shown to be substantially sharp, it could also have a blunt edge. 
         [0061]    Although a few embodiments of a wedged section are illustrated here, it should be apparent to a person of ordinary skill that other shapes and geometries will also be compatible with different designs of the sole, the heel and the shoe, consistent with the shape required for a contoured load bearing surface. The angle of the wedge may be determined by the angle between the top boundary  112  and the bottom boundary  114 . When the top and bottom boundaries do not meet at a sharp corner, the angle between them may be determined by taking imaginary extensions of the boundary lines to the point where they meet, and by measuring the angle at this corner. This is illustrated in  FIG. 6A . Similarly, when either the top boundary  112  or the bottom boundary  114  or both are curved, and or their surfaces are contoured, an appropriate angle may still be determined, as illustrated in  FIGS. 6C and 6D . 
         [0062]    By choosing the regions, angled regions, and the shapes and angles of the wedges, the contoured load bearing surface may be configured to redistribute the load at the knee or ankle joint of a person wearing a shoe comprising the sole or heel of this invention, or a combination of both, for the purposes of treating ailments in the knee, to slow the progression of degenerative joint disease in the knee, or to improve athletic or ambulatory performance during lateral cutting, lateral cornering, or lateral push off, or to decrease risk of ankle eversion or inversion injuries. 
         [0063]    Although the preceding discussion was about medial knee arthritis in the right knee, it should be apparent that a similar description applies to the left knee as well. Similarly, it should also be apparent that a similar description applies to lateral knee arthritis. In this case, a medial pitch would transfer the load from the afflicted lateral side to the medial side. Furthermore, it should be apparent to those skilled in the art that the sole and or the heel may be suitably adjusted to alleviate suffering in other regions of the knee as well, by choosing appropriate pitching region or regions of the sole, and appropriate pitching angle or angles. Additionally, it should be apparent to those skilled in the art that the sole and or the heel may be suitably adjusted to alleviate suffering in ankle joints as well. 
         [0064]    Although the sole and the heel have been described separately, it should be noted that they may be attached separately, or they may form one composite entity. In particular, all the angled regions may be integrated into the sole and the heel during the manufacturing process itself. Additionally, the heel may be itself wedged and may be removably attached to the bottom of the sole, for the purpose of determining an appropriate wedge angle. In such a design, the sole would act as a female receiver, and a separate external wedge may be placed into the sole. 
         [0065]    It should be apparent to those skilled in the art that the heel, the sole and the shoe itself may be of any color, texture, or combinations thereof. Similarly, the shoe may be of any type or style, including, but not limited to, shoes with or without heels, open or closed back shoes, tennis shoes, dress shoes, running shoes, walking shoes, hiking shoes, men&#39;s or women&#39;s shoes, sandals, clogs, boots, etc. The soles and heels of the present invention may be designed into the fabrication of any such shoe. 
         [0066]    While many novel features have been described above, the invention is not that that those skilled in the art may understand all other embodiments that may arise due to modifications, changes in the placement of the relative components, omissions and substitutions of these embodiments that are still nonetheless within the scope of this invention.