ORTHOTIC INSERT FOR DECREASED FOREFOOT LOADING

Abstract

The present teachings provide orthotic inserts, methods of employing the same, and footwear comprising the same, for decreased forefoot loading. The insert can be configured to-fit in a footware such as a surgical boot or other footwear. The inserts are useful in any application in which decreased forefoot loading is desirable. The insert can be used as an adjunct in the healing of and pain relief from various medical conditions relating to the forefoot.

Description

FIELD

The present disclosure generally relates to orthotic inserts, methods of employing the same, and footwear comprising the same, for decreased forefoot loading.

BACKGROUND

The human foot is a complex bio-mechanical appendage that facilitates locomotion by adapting to a variety of surfaces. By a series of complex kinematics, the foot acts initially as a shock absorber at heel strike, then as a mobile adapter during mid-stance, next as a rigid lever during late stance, and finally provides propulsion at toe-off. Forefoot and digital maladies are common and difficult to protect during treatment, because patients often continue to walk, which carries with it forefoot loading.

Some known treatments of forefoot and digital injuries include padding, cushioning, innersoles with and without cut-outs, surgical shoes and CAM walkers, casts, crutches, and/or wheelchairs to facilitate protective comfort and immobilization. Other approaches have addressed the problem of guarded weight bearing by a plethora of cushioned supports.

U.S. Pat. No. 2,598,217 to Bronson describes a removable boot for an invalid's foot and relies on a uniform rubber layer for cushioning with no appreciable gait altering mechanism. U.S. Pat. No. 5,078,128 to Grim et al. describes a removable leg walker with inflatable bladders that relies primarily on cushioning with immobilization to provide adequate protection. U.S. Pat. No. 5,329,705 to Grim et al. describes a removable leg walker and bladders in conjunction with removable sections corresponding to the “injured” area. All these methodologies rely on cushioning for attempted pressure relief. The pocket accommodations do not, unfortunately, address the dynamic nature of human gait, and the constantly changing moment of force that is dependent upon the particular stage of gait and the foot's adaptation to ground reactive forces.

U.S. Pat. No. 6,481,120 B1 to Xia et al. describes a standard shoe insole for patients suffering from diabetes or arthritis, but also relies on cushioning rather than a true bio-mechanical altering device. U.S. Pat. No. 4,546,557 to Barouk et al. describes a shoe for patients having undergone a surgical operation on the forefoot, but does not provide support to forefoot. U.S. Pat. No. 5,138,777 to Darby also describes a shoe for patients having undergone a surgical operation on the forefoot, but relies on a wedge undersole of triangular shape and a mid-sole that has both flat top and bottom surfaces.

Unfortunately, with the increase of obesity and diabetes, associated neuropathic disease is also on the rise. Neuropathic disease can lead to neurotrophic ulcers in the foot, which commonly progresses to osteomyelitis and need for costly hospitalization and life-altering amputation. In the United States alone, in 2004, approximately 71,000 lower extremity amputations occurred with people with diabetes, the majority of which were the result of forefoot and digital ulcerations. The International Diabetes Federation reports a lower extremity amputation occurs every 30 seconds worldwide. This trend is unsustainable, both morally and financially.

Whether due to injury, disease, or surgery, patients often experience significant pain and/or healing complications when applying pressure to the forefoot. Existing footwear and available orthotic inserts fail to provide adequate relief in such situations. Pain, diminished mobility, and time away from both work and active recreational pursuits, cause patients physical and psychological trauma, while also adversely affecting patient productivity. Accordingly, a need exists for medical devices that provide diminished load to the forefoot, as well as, generally relieving foot pain and aiding in the healing of foot pathologies.

SUMMARY

The devices, sets, and methods described herein address that need by providing an orthotic insert for a footwear. The insert can comprise the following elements. A top portion spans a length and a width of the insert. A bottom portion spans the length and the width of the insert. A heel portion begins at a back edge of the length of the insert and has an average thickness comprising the top and bottom portions. A forefoot portion terminates at a front edge of the length of the insert and has an average thickness, comprising the top and bottom portions, that is greater than the average thickness of the heel portion. A transition portion, between the heel and forefoot portions, has an average thickness, comprising the top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and is inclined from the heel portion to the forefoot portion. A footwear comprising the insert is also provided. An orthotic insert set comprising two or more inserts is provided. The set can provide left and right inserts, multiple left inserts, multiple right inserts, or any combination thereof. Sets of footwear comprising sets of inserts are also provided. A method of preparing a footwear for minimizing pressure on a forefoot of a user is further provided. The method can comprise inserting an orthotic insert into at least one footwear for a user.

According to various embodiments, an orthotic footwear device is provided that blocks forefoot and digital loading by limiting motion. The device can include a thickened elastomeric forefoot and digital cushion in an elevated platform configuration. According to various embodiments, a biomedical device is provided for insertion into protective foot gear such as surgical shoes or CAM walkers. The device can temporarily support the human foot and be constructed in such a manner as to limit forefoot and digital loading thereby providing treatment to injured skin, soft tissue, and bony structures. When forefoot and digital structures are compromised or injured, excessive forefoot loading prevents healing and restoration of integrity to these structures. Indications for usage can include, but not be limited to, skin ulcerations, metatarsalgia, capsulitis, tendonitis, neuralgia, arthritis, and bony fractures either traumatic or surgical in origin.

It is one object of the present invention to provide a generic shoe size-dependent bio-mechanical blocking device easily fitted into a surgical shoe or CAM walker and that can be dispensed to patients as an adjunct to therapy in the treatment of forefoot and digital injuries albeit skin, soft tissue, and bony structures.

Another object of the present art is to substantially alter the transfer of weight to the forefoot and digits by blocking and limiting mid-tarsal joint motion and re-supination.

A further object of the present invention is to provide a forefoot plateau to accept any residual loading that may occur, wherein the plateau can comprise a combination of a thickened elastomeric resilient layer covered with a sheer dispersing material.

It is still a further object of the present art to provide an inexpensive, readily available aid that can be immediately dispensable at the time of a consultation. Further, and in the case of open wounds, the easily removable device can provide real time visual assessment by both a healthcare practitioner and a patient, and can be particularly beneficial in monitoring signs of potential infection. The decrease in forefoot loading is especially pertinent in the neuropathic/insensitive foot where a protective sense of pain is greatly diminished or absent thereby reducing the probability of compliance.

Besides the obvious physical therapeutic advantages provided by the present teachings, the psychological benefits are at least equally beneficial. As discussed, the difficulties with patient compliance with the prior art is compromised, if not physically impossible, with the co-morbidities of the aged, obese, and the disabled. The psychological ramification of noncompliance by the patient can damage self-image and promote denial of the disease process, further reducing the probability of good outcomes. The present teachings allow for a real opportunity for compliance and thereby allow the patient to become co-responsible and an active participant in their own rehabilitation. Other objects and advantages of the present invention will be pointed out specifically or will become apparent from, and in conjunction with, the appended claims and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the present disclosure will be obtained by reference to the accompanying drawings, which are intended to illustrate, not limit, the present teachings.

FIG. 1 is a front perspective view of an orthotic insert in accordance with an embodiment of the present teachings.

FIG. 2A is a top view of the orthotic insert shown in FIG. 1.

FIG. 2B is a bottom view of the orthotic insert shown in FIG. 1.

FIG. 3A is a right side view of the orthotic insert shown in FIG. 1.

FIG. 3B is a left side view of the orthotic insert shown in FIG. 1.

FIG. 4A is a back view of the orthotic insert shown in FIG. 1.

FIG. 4B is a front view of the orthotic insert shown in FIG. 1.

FIG. 5 is a right side view of an orthotic insert according to various embodiments of the present teachings, and a skeletal foot resting on the insert.

FIG. 6 is a top view of the orthotic insert shown in FIG. 1 with a skeletal foot resting on the insert.

DETAILED DESCRIPTION OF THE DISCLOSURE

The orthotic insert of the present teachings can support the human foot, while the foot is in a weight-bearing position, both in stance and/or functioning throughout gait in a manner that reduces forefoot loading of the metatarsal heads. This support can be accomplished by shifting the weight to the proximal metatarsal arch and thereby inhibiting forefoot pronation and greatly reducing normal forefoot loading during the stance and propulsive phase of gait.

According to various embodiments, the present teachings provide an orthotic insert for a footwear, an embodiment of which is shown by reference numeral 20 in FIG. 1 in an unbiased configuration, that is, without the weight of a foot applied to the insert. FIG. 1 shows a perspective view of insert 20 with FIGS. 2A, 2B, 3A, 3C, 4A, and 4B, showing bottom view, right side view, left side view, back view, and front view, respectively. FIGS. 5 and 6 show a skeletal foot resting on the insert from two different views. A left insert is shown in the FIGS., for illustrative purposes, but a right, mirror image, insert, is also provided by the present teachings. A universal insert suitable for insertion into either a left footwear, a right footwear, or both, is provided.

Insert 20 can comprise a top portion 22 spanning a length and a width of the insert; a bottom portion 24 spanning the length and the width of the insert; a heel portion 26 beginning at a back edge 28 of the length of the insert and having an average thickness comprising the top and bottom portions; a forefoot portion 30 terminating at a front edge 32 of the length of the insert and having an average thickness, comprising top portion 22 and bottom portion 24, that is greater than the average thickness of the heel portion; and a transition portion 34, between the heel and forefoot portions, having an average thickness comprising the, top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and inclined from the heel portion to the forefoot portion.

The insert can comprise two or more layers, top portion 22 can comprise a first material 36, bottom portion 24 can comprise a second material 38, and the first material can be softer than the second material. For example, top portion 22 and bottom portion 24 can intersect or meet at an intersection 35. Intersection 35 can delineate the bottom of top portion 22 and the top of bottom portion 24. For example, intersection 35 can delineate where the first material 36 ends and where the second material 38 ends. A third material 37 can also be provided, for example, inside of the insert, as shown in phantom by the dashed line. Third material 37 can be softer than second material 38. The first material, the second material, and the third material can comprise a foam, a rubber, or any combination thereof. The foam can comprise an open cell foam, a closed cell foam, or both. The first, second, and/or third materials can comprise elastomeric, polymeric, resilient, and other types of materials. Examples of materials for the first, second, and third materials can comprise leather, leatherboard, fabric, wool, cotton, thermoplastic elastomers, polyester, polypropylene, polyethylene, polyurethane, polyurea, cellular urethane, polystyrene, latex, nylon, carbon or glass fibers with thermosetting or thermoplastic resins, plastizote, ethylene vinyl acetate (EVA) foams, expanded vinyl foam, flocked vinyl film, coagulated polyurethane, latex foam on scrim, supported polyurethane foam, polyurethane film, styrene-butadiene-rubber, acrylonitrile-butadiene, acrylonitrile terpolymers and copolymers, styrene-butadienestyrene, acrylonitrile-butadiene-styrene, polyvinyl chloride (PVC), ethylenepropylene rubber, silicone rubber (SiR), silicone elastomer, acrylic rubber (ACM), butadiene rubber (BR), butyl rubber (IIR), chlorosulfonated polyethylene (CSM)/hypalonthylene propylene diene monomer (EPM, EPDM), fluoroelastomers (FKM), isoprene rubber (IR), nitrile rubber (NBR), perfluoroelastomer (FFKM), polychloroprene (CR), polysulfide rubber (PSR), styrene butadiene rubber (SBR), or any combination thereof Third material 37 can be provided in a portion of forefoot portion 30 that comprises a cushioning substance, for example, a silica gel, and second material 38 can comprise EVA. One example of a position for third material 37 is shown in FIGS. 2A, 3A, and 3B, however, the positioning of material 37 can be adjusted to provide a suitable cushioning support for the forefoot and/or other portions of the foot.

The orthotic device can comprise one or more of the materials described, for example, in U.S. Pat. No. 6,481,120 B1 to Xia et al., and U.S. Pat. No. 5,329,705 to Grim et al., which are incorporated herein in their entireties by reference. Any PORON material may be used, for example, a PORON 4000 series material, a PORON 5015 material, a PORON 9612 material, a combination thereof, and the like. For example, the orthotic insert can be constructed of three basic materials. PORON, a cellular urethane available from Rogers Corporation of Rogers, Conn., is a semi-firm material that can run the entire length and base of the insert and provide stability and substrate for a supportive core. This configuration shifts the weight-bearing surfaces to the arch and thereby limits forefoot loading. PORON can extend upward as medial and lateral flanges (sidewalls) that can provide stability and prevent transverse motion of the forefoot to occur. These flanges can follow from about a 5 degree to about a 50 degree, from about a 10 degree to about a 40 degree, or from about a 20 degree to about a 30 degree rise and extend from about one eighth inch, from about one quarter inch, from about one half inch, from about three quarter inches, or from about one inch higher than the top surface, thereby gently locking the mid-foot. As the rise plateaus into a soft, flat cushioning surface for the metatarsal head and digital regions, the side wall can blend into the forefoot portion. PORON can also provide the substrate for other materials, such as silicone gel in the form of an elastomere and a thin layer of plastizote top covering, a protective cushion that is known to prevent excessive irritation and pressure in the insensitive foot.

Bottom portion 24 can comprise at least one arch region 40. The bottom portion can bend upwardly at back edge 28 providing an upwardly bent heel portion 42. The bottom portion, top portion, or both can be configured to provide arches and other geometries to accommodate the need of a particular user.

Transition portion 34 can be inclined at an angle from about 10 degrees to about 80 degrees, from about 20 degrees to about 60 degrees, from about 25 degrees to about 50 degrees, or from 30 degrees to 40 degrees relative to horizontal. The insert can be constructed in such a fashion where it is generally flat in the calcaneal (heel) region of the foot and then angulated up between about 20 degrees to 30 degrees, or other range specified herein, to a rise of at least one eighth inch, at least one quarter inch, at least one half inch, at least three quarter inches, or at least one inch, firmly supporting the entire metatarsal arch, then transitioning to a soft cushion for the weight bearing areas of the metatarsal heads. Transition portion 34 can comprise at least one side wall for centering a foot on the top portion of the insert. An outer side wall (flange) 44, an inner side wall (flange) 46, or both can be provided. Transition portion 34 can comprise an outer region 48 along the top portion and an inner region 50 along the top portion, and outer region 48 can have a greater angle of inclination than inner region 50. The average angle of inclination of outer region 48 can be from about 0.5 degrees to about 25 degrees, from about 0.75 degrees to about 15 degrees, from about 1 degree to about 10 degrees, and about 2 degrees to about 5 degrees steeper than the average angle of inclination of inner region 50.

The forefoot portion generally slopes downwardly, relative to horizontal, from the transition portion to the front edge. The downward slope can be less than about 1 degree, less than about 5 degrees, less than about 10 degrees, or less than about 25 degrees relative to horizontal. The forefoot portion can have an average thickness from about 5% to about 5000%, from about 25% to about 2500%, from about 50% to about 1000%, from about 75% to about 750%, from about 125% to about 500%, from about 150% to about 450%, from about 200% to about 400%, from about 250% to about 350%, or about 300% of the average thickness of the heel portion. The forefront portion can comprise from about 10% to about 90%, from about 20% to about 80%, from about 30% to about 75%, or from about 45% to about 70% of the length of the insert, and the heel portion can comprise from about 1% to about 75%, from about 5% to about 50%, from about 10% to about 40%, or from about 20% to about 35% of the length of the insert. The forefoot portion can have an average width, the heel portion has and average width, and the average width of the forefoot portion is from about 100% to about 500%, from about 125% to about 500%, from about 125% to about 400%, from about 150% to about 350%, from about 150% to about 250%, from about 200% to about 300%, or greater than about 500% of the average width of the heel portion.

In some embodiments, the orthotic insert can comprise a substrate or unitary layer which runs heel to toe and absorbs shock, partially controls foot motion, and provides a lattice for the elastomeric and sheer resistive materials. Its bottom surface can be flat, interfacing and fitting contiguously with the upper layer of a surgical shoe or CAM walker. The heel portion of the insert can be flat and horse-shoe shaped which secures the heel, the device, and a supportive shoe or walker as a single functional unit. The mid-arch portion can rise abruptly convexly in the sagittal plane at approximately a 30 to 50 degree angulation. This buttress can elevate dramatically distally in the entire transverse tarsal arch region to just proximal to the panmetatarsal head region, limiting pronation, loading, and propulsion during gait and thus affording forefoot and digital protection.

In some embodiments, the forefoot and digital component can flatten out into a plateau and the device can become soft and accommodative. The insert can comprise one or more thick elastomeric layers. In some cases, the entire device from heel to toe can be covered by a protective top cover which prevents damaging sheer and frictional reactive forces. The convex mid-foot region can also have elevated medial and lateral flanges to prevent side to side transverse forefoot and digital motion. The flanges can be comprised of the same semi-fine unitary substrate layer as the convex rise.

With respect to a surgical shoe or CAM walker, these typically are stand-alone devices, commonly used in post-traumatic or post-surgical applications. In some embodiments of the present teachings, the shoe or walker secures the device to the foot by Velcro straps as a single functional unit providing a weight bearing device that protects the foot from varying external ground surfaces and liabilities.

In some embodiments, a footwear is provided comprising the orthotic insert of the present teachings. Any type of footwear can be used with the insert while accommodating the geometry of the insert. The footwear can comprise a boot, a shoe, a sneaker, a sandal, a clog, or any combination thereof. The orthotic insert can be made to fit into a standard type, flat surgical shoe, for example a surgical shoe available from DARCO International, Inc. of Huntington, West Va. The orthotic inserts can be provided, distributed and/or sold separately, or as pre-inserted into a single or pair of footwear. The orthotic insert can be made full or partial length from heel to toe. The orthotic insert can be provided in different sizes, for example, extra-small, small, medium, large and extra-large to accommodate different size feet. The orthotic insert can be provided in custom sizes. The orthotic insert can be provided in sizes matching or compatible with standard shoe sizes such as one or more of the shoe size systems employed in U.S., Canada, Mexico, Europe, Great Britain, Russia, the Ukraine, Australia, Japan, Korea, or elsewhere in the world.

The orthotic inserts can be provided with a graphic design in any color or variety of colors, with or without letters, numbers, pictures, or any other kind or combination of graphic elements. The graphic design of the insert can be provided to match or complement that of a footwear in which it is inserted. Graphic design can also relate to any other or combination of parameters such as foot size, insert thickness, and the like.

According to various embodiments of the present teachings, in combination, an orthotic insert set comprising two or more inserts is provided, each insert can comprise the following elements. A top portion spans a length and a width of the insert. A bottom portion spans the length and the width of the insert. A heel portion begins at a back edge of the length of the insert and has an average thickness comprising the top and bottom portions. A forefoot portion terminates at a front edge of the length of the insert and has an average thickness, comprising the top and bottom portions, that is greater than the average thickness of the heel portion. A transition portion, between the heel and forefoot portions, has an average thickness comprising the top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and is inclined from the heel portion to the forefoot portion. The two or more inserts of the combination set can comprise at least one insert having a left foot configuration and at least one insert having a right foot configuration. In some embodiments, instead of a set, one or more universal (compatible with both left and right feet) inserts can be provided. In some embodiments, multiple left inserts, multiple right inserts, or any combination thereof, can be packaged together. In some embodiments, a package comprising a single insert or one or more sets of inserts can be provided.

According to various embodiments of the present teachings, a method of preparing a footwear for minimizing pressure on a forefoot of a user is provided. The method can comprise inserting an orthotic insert into at least one footwear for a user. The insert employed in the method can comprise the following elements. A top portion spans a length and a width of the insert. A bottom portion spans the length and the width of the insert. A heel portion begins at a back edge of the length of the insert and has an average thickness comprising the top and bottom portions. A forefoot portion terminates at a front edge of the length of the insert and has an average thickness, comprising the top and bottom portions, that is greater than the average thickness of the heel portion. A transition portion, between the heel and forefoot portions, has an average thickness comprising the top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and is inclined from the heel portion to the forefoot portion. The method can comprise the step of placing a foot of a user in the prepared footwear. In accordance with the method, the insert can be inserted by anyone. For example, the insert can be inserted by the user; a family member; a medical professional such as a surgeon, an orthopedist, a physical therapist, a nurse, or a physician; a health care provider; a medical device manufacturer, distributor, or retailer or provider; a footwear retailer, distributor, or manufacturer; an orthotics retailer, distributor, or manufacturer; or any combination thereof.

The orthotic insert can be used in any application where decreased forefoot loading is desirable. The insert can be an adjunct in the healing of neuropathic forefoot and digital ulcerations in the insensitive foot, for forefoot metatarsalgia conditions such as bursitis/capsulitis, sesamoiditis, stress fractures, forefoot neuromas, and possibly fractures either posttraumatic or post-surgical in origin. The orthotic insert can be employed as a temporary adjunct for healing forefoot and digital, bone, soft tissue and skin injuries. As shown, for example, in FIG. 5, the orthotic insert can be in contact with and lift the base 53 of the metatarsal. In some embodiments, a foot would rest on the orthotic insert in a configuration as shown in FIG. 6. In some embodiments, a method is provided that can comprise first performing a surgical operation on a forefoot of a user. The method can comprise diagnosing a foot malady of the user. The method can comprise identifying a susceptibility to forefoot strain or damage in an individual. The method can be coupled with one or more other methods for treating, ameliorating, or preventing foot ailments, for example, those commonly associated with diabetes.

The orthotic insert, or set of inserts, can be used for any duration of time from minutes, hours, days, months, or even years. The orthotic insert can be worn from about 1 minute to about 1 year, from about 1 hour to about 6 months, from about 12 hours to about 4 months, from about one day to about 3 months, from about 1 week to about 2 months, from about 2 weeks to about 1 month, or more than a year, or any combination thereof. If left and right inserts are employed, each insert can be worn for the same amount of time as the other or for different times. For example, the orthotic insert can be used for several months where prolonged protection and support is desirable.

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

While embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. An orthotic insert for a footwear, comprising:

a top portion spanning a length and a width of the insert;

a bottom portion spanning the length and the width of the insert;

a heel portion beginning at a back edge of the length of the insert and having an average thickness comprising the top and bottom portions;

a forefoot portion terminating at a front edge of the length of the insert and having an average thickness, comprising the top and bottom portions, that is greater than the average thickness of the heel portion; and

a transition portion, between the heel and forefoot portions, having an average thickness comprising the top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and inclined from the heel portion to the forefoot portion.

2. The orthotic insert of claim 1, wherein the insert comprises two or more layers, the top portion comprises a first material, the bottom portion comprises a second material, and the first material is softer than the second material.

3. The orthotic insert of claim 1, wherein the first material is a foam and the second material is a rubber.

4. The orthotic insert of claim 1, wherein the bottom portion comprises at least one arch region.

5. The orthotic insert of claim 1, wherein the bottom portion bends upwardly at the back edge.

6. The orthotic insert of claim 1, wherein the transition portion is inclined at an angle from 30 degrees to 40 degrees relative to horizontal.

7. The orthotic insert of claim 1, wherein the transition portion comprises at least one side wall for centering a foot on the top portion of the insert.

8. The orthotic insert of claim 1, wherein the transition portion comprises an outer region along the top portion and an inner region along the top portion, and the outer region has a greater angle of inclination than the inner region.

9. The orthotic insert of claim 8, wherein the average angle of inclination of the outer region is from about 2 degrees to about 5 degrees steeper than the average angle of inclination of the inner region.

10. The orthotic insert of claim 1, wherein the forefoot portion generally slopes downwardly, relative to horizontal, from the transition portion to the front edge.

11. The orthotic insert of claim 10, wherein the downward slope is less than about 10 degrees relative to the horizontal.

12. The orthotic insert of claim 1, wherein the forefoot portion has an average thickness, the heel portion has an average thickness, and the average thickness of the forefoot portion is from about 125% to about 500% of the average thickness of the heel portion.

13. The orthotic insert of claim 1, wherein the forefoot portion has an average width, the heel portion has an average width, and the average width of the forefoot portion is from about 150% to about 250% of the average width of the heel portion.

14. The orthotic insert of claim 1, wherein the forefront portion comprises from about 45 percent to about 70 percent of the length of the insert and the heel portion comprises from about 20 percent to about 35 percent of the length of the insert.

15. A footwear comprising the orthotic insert of claim 1 inserted therein.

16. The footwear of claim 15, wherein the footwear comprises a boot.

17. In combination, an orthotic insert set comprising two or more inserts, each insert comprising:

a top portion spanning a length and a width of the insert;

a bottom portion spanning the length and the width of the insert;

a heel portion beginning at a back edge of the length of the insert and having an average thickness comprising the top and bottom portions;

a forefoot portion terminating at a front edge of the length of the insert and having an average thickness, comprising the top and bottom portions, greater than the average thickness of the heel portion; and

a transition portion, between the heel and forefoot portions, having an average thickness comprising the top and bottom portions, greater than the average thickness of the heel portion and less than the average thickness of the forefoot portion, and inclined upward from the heel portion to the forefoot portion.

18. The combination set of claim 17, wherein the two or more inserts comprise at least one insert having a left foot configuration and at least one insert having a right foot configuration.

19. A method of preparing a footwear for minimizing pressure on a forefoot of a user, the method comprising:

inserting an orthotic insert into at least one footwear for a user, the insert comprising a top portion spanning a length and a width of the insert, a bottom portion spanning the length and the width of the insert, a heel portion beginning at a back edge of the length of the insert and having an average thickness comprising the top and bottom portions, a forefoot portion terminating at a front edge of the length of the insert and having an average thickness, comprising the top and bottom portions, that is greater than the average thickness of the heel portion, and a transition portion, between the heel and forefoot portions, having an average thickness comprising the top and bottom portions, that is greater than the average thickness of the heel portion, less than the average thickness of the forefoot portion, and inclined upwardly from the heel portion to the forefoot portion.

20. The method of claim 19, further comprising:

placing a foot of a user in the footwear prepared according to claim 19.

21. The method of claim 19, further comprising first performing a surgical operation on a forefoot of a user.

22. An orthotic insert for a footwear, comprising:

a top portion spanning a length and a width of the insert;

a bottom portion spanning the length and the width of the insert;

a heel portion beginning at a back edge of the length of the insert and having an average thickness comprising the top and bottom portions;

a forefoot portion terminating at a front edge of the length of the insert and having an average thickness, comprising the top and bottom portions, that is from about 150% to about 450% the average thickness of the heel portion; and

a transition portion, between the heel and forefoot portions, having an average thickness comprising the top and bottom portions, greater than the average thickness of the heel portion, and comprising an inner side wall and an outer side wall for centering a foot on the top portion of the insert.