ORTHOTIC DEVICE AND METHOD OF USE

Abstract

An orthotic device and method of use are disclosed for suspending toes of a wearer's foot off of a sole of footwear. The orthotic device includes a bottom surface, a top surface, and a distal end. The bottom surface is adapted to be affixed to a sole of protective footwear. The top surface is adapted to be adjacent to the foot when the foot is within the protective footwear and to suspend toes of the foot off of the sole when the foot is in a resting position within the protective footwear. The distal end defines ends of the bottom surface and the top surface, the distal end being substantially aligned with metatarsophalangeal joints of the foot when the foot is within the protective footwear.

Description

FIELD OF THE INVENTION

The present disclosure generally relates to an orthotic insert for footwear, a method of using the same, and footwear including the same.

BACKGROUND

Foot maladies can be difficult to treat and heal because of the continued need of the patient to ambulate. Particularly for maladies of the phalanges (toes), repeated loading on the toes can cause delays and sometimes even prevent proper healing, which may lead to serious issues (e.g., digital amputation). Further, diabetic foot problems, such as ulcerations, infections, and gangrene, remain a common cause of hospitalization for people that suffer from diabetes (e.g., diabetes mellitus types I and II). Medical costs associated with routine ulcer care, infection treatment, and amputations cost billions of dollars annually.

Certain protective footwear can be worn to offload areas of the foot post operatively, and in other situations necessitating offloading, such as when treating foot fractures and ulcers. Traditionally, such protective footwear has a firm, rocker bottom to minimize bending through the entire foot by rocking during gait, as opposed to pushing off. Specific protective footwear may have soles that have cut-out sections under the heel or the forefoot to transfer more weight to the forefoot or the heel. Other footwear has removable foam pegs within the insole to off-weight selected areas of the foot. Yet, in such protective footwear, a thin fabric section still exists at the locations where the foam pegs have been removed. Thus, such protective footwear cannot float the toes.

Although the above-described protective footwear generally offloads weight, such protective footwear does not offload weight specifically from the toes of the foot. Accordingly, proper offloading, specifically with respect to the toes, remains a large challenge for physicians and clinicians dealing with diabetic foot ulcers and other similar maladies of the foot, such as the result of surgery and/or fractures.

A need exists, therefore, for an orthotic insert, sole, and/or footwear that suspends the toes.

SUMMARY

Aspects of the present concepts include an orthotic device adapted to be placed beneath metatarsals of a foot. The device includes a bottom surface, a top surface, and a distal end. The bottom surface is adapted to be affixed to a sole of protective footwear. The top surface is adapted to be adjacent to the foot when the foot is within the protective footwear and to elevate toes of the foot off of the sole when the foot is in a resting position within the protective footwear. The distal end defines ends of the bottom surface and the top surface; the distal end being substantially aligned with metatarsophalangeal joints of the foot when the foot is within the protective footwear. The proximal ends of the bottom surface and the top surface can be under the central arch area of the foot.

Additional aspects of the present concepts include an orthotic apparatus including a soft insole and a wedge. The soft insole is adapted to be placed on a rigid sole of footwear. The wedge is adapted to be placed beneath a foot wearing the footwear. The wedge includes a first end and a second end opposite the first end. The first end is substantially aligned with metatarsophalangeal joints of the foot. The second end is proximal to the first end relative to the foot, and the wedge suspends toes of the foot above a lower surface of the footwear.

Another aspect of the present concepts is a method of elevating one or more toes of a foot within footwear. The method includes attaching a wedge having a top surface and a bottom surface to a sole of the footwear such that a distal end of the wedge relative to the foot is aligned with and below metatarsophalangeal joints of the foot with the foot within the footwear. The method further includes suspending the one or more toes off of the sole based on the wedge being within the footwear and aligned with the metatarsophalangeal joints of the foot when the foot is within the footwear.

The above summary is not intended to represent each embodiment or every aspect of the present disclosure. Rather, the foregoing summary merely provides an exemplification of some of the novel aspects and features set forth herein. The above features and advantages, and other features and advantages of the present disclosure, will be readily apparent from the following detailed description of representative embodiments and modes for carrying out the present embodiments when taken in connection with the accompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure will be better understood from the following description of exemplary embodiments together with reference to the accompanying drawings, in which:

FIG. 1 shows protective footwear, in accord one embodiment.

FIG. 2 shows a soft insole of the protective footwear of FIG. 1, in accord one embodiment.

FIG. 3A shows a perspective view of a wedge that suspends toes of a foot, in accord with some aspects of the present concepts.

FIG. 3B shows a cross-section view of the wedge of FIG. 3A, in accord with some aspects of the present concepts.

FIG. 4A shows a perspective view of the wedge of FIGS. 3A and 3B positioned on the soft insole of FIG. 2, in accord with some aspects of the present concepts.

FIG. 4B shows a cross-section view of the wedge and soft insole of FIG. 4A, in accord with some aspects of the present concepts.

FIG. 5A shows a perspective view of a wedge relative to a soft sole, in accord with some additional aspects of the present concepts.

FIG. 5B shows a cross-section view of the wedge and soft sole in FIG. 5A, in accord with some additional aspects of the present concepts.

FIG. 6A shows a perspective view of a wedge relative to a soft sole with an insert, in accord with some additional aspects of the present concepts.

FIG. 6B shows a cross-section view of the wedge relative to the soft sole with the insert in FIG. 6A, in accord with some additional aspects of the present concepts.

FIGS. 7A-7C show cross-section views of wedges having various shapes, in accord with some additional aspects of the present concepts.

FIG. 8A shows a perspective view of a wedge and soft sole within the footwear of FIG. 1, in accord with some aspects of the present concepts.

FIG. 8B shows a cross-sectional slice of the wedge, soft sole, and rigid base of the footwear of FIG. 8A, in accord with some aspects of the present concepts.

FIG. 8C shows a cross-sectional slice of the wedge, soft sole, and rigid base of the footwear of FIG. 8B, in accord with some additional aspects of the present concepts.

FIG. 9 shows a cross-section view of a foot within the footwear of FIGS. 8A-8C, in accord with some aspects of the present concepts.

While the disclosure is susceptible to various modifications and alternative forms, specific implementations thereof have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit of the present disclosure.

DESCRIPTION

The elements and features within the present disclosure are susceptible to embodiment in many different forms. There are shown in the drawings, and will herein be described in detail, representative embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principles of the present element and features disclosed herein and is not intended to limit the broad aspects to the embodiments illustrated. To that extent, elements and features that are disclosed, for example, in the Abstract, Summary, and Detailed Description sections, but not explicitly set forth in the claims, should not be incorporated into the claims, singly or collectively, by implication, inference, or otherwise. For purposes of the present detailed description, unless specifically disclaimed: the singular includes the plural and vice versa; and the word “including” means “including without limitation.”

Referring to FIG. 1, FIG. 1 shows a perspective view of protective footwear 100, according to one embodiment. The protective footwear 100 is worn on a foot (not shown) of a wearer during treatment and/or healing of a malady of the foot. Such protective footwear 100 represents one example of the above-described, currently existing protective footwear worn by patients suffering from foot maladies. By way of example, and without limitation, the protective footwear 100 can be various protective footwear made by DARCO, such as the MedSurg™ shoe, the OrthoWedge® off-loading shoe, the HeelWedge™, and the PegAssist™ insole.

The protective footwear 100 includes a rigid sole 102 that spans from the front 100a of the protective footwear 100 to the rear 100b of the protective footwear 100. The rigid sole 102 is a firm, rocker bottom that minimizes bending through the entire foot and provides for overall support of the foot during ambulation. The protective footwear 100 includes straps 104 to secure the protective footwear 100 to the foot. The straps 104 can include, for example, straps 104a and 104b that selectively engage across the top of the midfoot/forefoot and straps 104c and 104d that selectively engage around the hindfoot/ankle. However, according to some embodiments, the protective footwear 100 can include other mechanisms for securing the protective footwear 100 to the wearer, such as laces, buttons, Velcro®, etc.

Above the rigid sole 102 is a soft insole 106. The soft insole 106 spans from the front 100a of the protective footwear 100 to the rear 100b of the protective footwear 100. According to some embodiments, the rigid sole 102 includes a raised ridge 102a that spans the perimeter of the rigid sole 102. The raised ridge 102a forms a recess (not shown) of the rigid sole 102 that accepts the soft insole 106 such that the soft insole 106 lays on the rigid sole 102 and is surrounded by the raised ridge 102a.

FIG. 2 shows the soft insole 106 removed from the protective footwear 100, according to one embodiment. Thus, according to some embodiments, the soft insole 106 is removable from the rigid sole 102. Generally, the protective footwear 100 and, therefore, the soft insole 106 come in several sizes (e.g., small, medium, and large) to accommodate for different foot sizes. Thus, the dimensions of the rigid sole 102 and the soft insole 106 vary depending on the size of the protective footwear 100 used for the wearer.

Although the protective footwear 100 with the soft insole 106 configured as shown in FIGS. 1 and 2 allows for offloading weight with respect to the foot in general, such protective footwear 100 does not offload weight from the toes of the wearer. Moreover, regardless of whether weight is offloaded from the toes, such protective footwear 100 contacts the toes during ambulation and use in general. The continued contact can exacerbate and/or prevent proper healing of the toes, such as in the case of ulcers. By way of example, and without limitation, although the soft insole 106 provides cushioning to a foot when the foot is secured to the protective footwear 100, the cushioning may not be sufficient to allow for proper treatment and/or healing of maladies of the toes, such as ulcers, and the soft insole 106 still contacts the toes.

According to aspects of the present concepts, a wedge is disclosed that suspends the toes of the wearer's foot off of a surface of protective footwear, or footwear in general. The toes are suspended forward from the metatarsophalangeal joints of the foot. By the wedge being positioned from behind the ball of the foot and inclining to just behind the toes, the wearer can ambulate without contact between the toes and a bottom portion of the footwear below the toes. Thus, the toes do not experience loading and/or wear by contact with the footwear and are placed in a position to maximize healing.

As described in greater detail below, according to some embodiments, the wedge can be added to currently existing footwear, such as by being attached to existing soft insoles 106 of the protective footwear 100. Alternatively, the wedge can be integral with a soft insole that replaces the currently existing soft insole 106 within the protective footwear 100. Additionally, according to some embodiments, the wedge can be integral with the soft insole 106, or a similar soft insole, that is also integral within similar footwear as the protective footwear 100. According to the various embodiments, the wedge positions the toes during ambulation and can be used, for example, post operation and/or during healing of one or more maladies of the toes.

FIGS. 3A and 3B show a wedge 300 for insertion within footwear, with FIG. 3B showing the wedge 300 in cross section along the line 3B-3B in FIG. 3A, in accord with aspects of the present concepts. The wedge 300 includes a front 300a and a rear 300b. The wedge 300 further includes a top surface 302. The top surface 302 includes a level portion 302a and an inclined portion 302b. The top surface 302 is adapted to interface with the foot when the foot is within footwear such that the top surface 302 elevates and suspends the toes of the foot off of a sole of the footwear below the toes. The inclined portion 302b begins at the rear 300b of the wedge 300 and extends to, for example, a point 304 between the rear 300b and the front 300a of the wedge 300. The point can be at various points between the rear 300b and the front 300a of the wedge 300, and can also be referred to as a midpoint 304 without requiring that the point 304 be in the middle of the top surface 302. The angle of the incline θ₁ of the inclined portion 302b can be 5 to 40 degrees, such as 10 degrees.

The level portion 302a begins at the distal end of the inclined portion 302b at the point 304, and extends to the front 300a of the wedge 300. The level portion 302a spans a length of the top surface 302 to provide a contact surface for the ball of the foot to distribute weight evenly and to reduce or prevent pressure points. According to some embodiments, the level portion 302a spans two thirds of the length of the top surface 302, and the inclined portion 302b spans the remaining one third of the length of the top surface 302. However, the lengths of the level portion 302a and the inclined portion 302b can vary without departing from the spirit and scope of the present disclosure.

According to some embodiments, although the midpoint 304 is illustrated as an abrupt transition from the inclined portion 302b to the level portion 302a, the transition at the midpoint 304 can be gradual, such as rounded, to reduce or prevent any discomfort caused by continued contact of the underside of the foot by the midpoint 304.

The wedge 300 also includes a bottom surface 306. The bottom surface 306 is adapted to interface with the sole of footwear when the wedge 300 is inserted within the footwear. The wedge 300 also includes a vertical edge 300c and, according to some embodiments, also includes a vertical edge 300d. The vertical edges 300c and 300d separate the top surface 302 from the bottom surface at the distal and proximal ends of the wedge 300, respectively.

The overall dimensions of the wedge 300 vary depending on the size of the foot or the footwear. With respect to the length, the length of the top surface 302 of the wedge 300 is configured to provide a base for the ball of the foot to rest on while off-loading and suspending the toes. According to some embodiments, the length of the wedge 300 can be such that the vertical edge 300d or the rear 300b (e.g., proximal end) is under the central arch area of the foot and the vertical edge 300c or the front 300a (e.g., distal end) is aligned with the metatarsophalangeal joints of the foot. By way of example, the length of the wedge 300 can be 2 to 4 cm, such as 2.5 cm, for average foot sizes. The width of the wedge 300 can be substantially the same width as a sole to which the wedge 300 is integral with or affixed. The width is configured to provide a base for substantially the entire ball of the foot to evenly distribute the weight. Further, the wedge 300 can be formed of various materials found within footwear, such as materials generally used for forming soft insoles of footwear including, for example, padding materials.

Although the wedge 300 is illustrated as having a substantially straight front 300a, according to some embodiments the front 300a may have alternative shapes and/or configurations. For example, the dimensions of the foot generally cause the ends of the toes to form a parabolic shape, with the long toe adjacent to the hallux (big toe) at the apex of the parabola. The metatarsals also form a generally parabolic shape, with the distal aspect of the metatarsal of the long toe at the apex of the parabola. According to some embodiments, the front 300a of the wedge 300 can have a similar parabolic shape to correspond to the parabolic shape of the metatarsals within a wearer's foot. According to such embodiments, the vertical edge 300c can be formed according to a parabolic shape to be uniformly positioned with respect to, for example, the distal aspect of all five metatarsals.

Referring to FIG. 4A, FIG. 4A is a perspective view that shows the wedge 300 affixed to the soft insole 106 from the protective footwear 100 of FIG. 1. The wedge 300 is affixed to the soft insole 106 at a location of the soft insole 106 that corresponds to below the metatarsals of the foot. More specifically, the wedge 300 is positioned such that the front 300a of the wedge 300 is aligned with the midpoint to the distal aspect of the metatarsophalangeal joints of the foot when the foot is within the protective footwear 100. By aligning the front 300a of the wedge 300 with the metatarsophalangeal joints of the foot, the wedge 300 elevates and suspends the toes of the foot off of the soft insole 106. Accordingly, pressure is not applied to the toes from the protective footwear 100 with the toes at rest and during general ambulation, and the wedge 300 reduces or prevents contact between the toes and the soft insole 106 below the toes. According to some embodiments, such as the protective footwear 100 including an open top, the toes also do not contact a top surface of the protective footwear 100.

Referring to FIG. 4B, FIG. 4B shows a cross-section view of the wedge 300 affixed to the soft insole 106 along the ling 4B-4B of FIG. 4A, in accord with aspects of the present concepts. According to some embodiments, the thickness T₁ of the soft insole 106 can be, for example ¼ to ½ of an inch, such as ⅜ of an inch, and the thickness T₂ of the wedge 300 can be the same thickness of the soft insole 106, or thicker than the soft insole 106, such as, for example, ⅜ to ¾ of an inch, such as ½ of an inch. However, based on the comfort tolerances of the wearer, the upper limit of the thickness T₂ of the wedge 300 can be larger, such as 1 inch, to suspend the toes farther off of the soft insole 106. Thus, according to some embodiments, the thickness T₁ of the soft insole 106 can be equal to or less than the thickness T₂ of the wedge 300.

As described above, the wedge 300 can be affixed to the soft insole 106. Alternatively, according to some embodiments, the soft insole 106 can be formed to include the wedge 300 as an integral part of the soft insole 106, such that the soft insole 106 and the wedge 300 are formed as a single piece. Further, according to some embodiments, the wedge 300 can be affixed to or be an integral part of other soles.

As illustrated, the soft insole 106 is substantially flat reward from the rear 300b of the wedge 300. By being flat, the soft insole 106 provides a stable platform for the wearer's foot when supported by the combination of the sole 501 and the wedge 300. With the soft insole 106 rearward from the wedge 300 flat rather than, for example, raised relative to the bottom surface 306 of the wedge 300, the weight of the wearer is not shifted forward. Thus, the substantially flat soft insole 106 at the same level as the bottom surface 306 of the wedge 300 reduces or prevents weight from being shifted forward, which could otherwise impact the ability of the toes to remain suspended during ambulation.

Referring to FIG. 5A, FIG. 5A shows the wedge 300 affixed to a sole 501, as an alternative to the soft insole 106, in accord with aspects of the present concepts. The sole 501 can be formed of the same material as the soft insole 106 described above. The sole 501 is formed (e.g., sized) to extend from the rear 100b of the protective footwear 100 to just behind the toes when inserted in, for example, the protective footwear 100 in place of the soft insole 106. Thus, in comparison to the soft insole 106, for example, the sole 501 excludes a portion 503 corresponding to the soft insole 106 forward of the wedge 300 in FIGS. 3A and 3B. By excluding the portion 503 of the soft insole 106, the toes of the wearer's foot can be suspended even farther off of a surface below the toes, such as a surface of footwear.

Referring to FIG. 5B, FIG. 5B is a cross-section view along the line 5B-5B of FIG. 5A, in accord with aspects of the present concepts. The front 300a of the wedge 300 is aligned with the front edge 501a of the sole 501. The thickness T₃ of the sole 501 can be, for example ¼ to ½ of an inch, such as ⅜ of an inch. According to some embodiments, the thickness T₃ of the sole 501 can be the same thickness T₁ of the soft insole 106. The thickness T₄ of the wedge 300 with respect to being positioned on the sole 501 can be the same thickness of the sole 501, or can be thicker than the sole 501, such as, for example, ⅛ to ¾ of an inch, such as ½ of an inch. Similar to above, based on the comfort tolerances of the wearer, the upper limit of the thickness T₄ of the wedge 300 with respect to being positioned on the sole 501 can be larger, such as 1 inch, to suspend the toes farther off of any sole below the toes (e.g., rigid sole 102). According to some embodiments, the thickness T₄ can be less than the thickness T₂ of the soft insole 106 based on the lack of the sole 501 below the toes with the wedge 300 positioned on the sole 501. For example, the toes are suspended the additional thickness T₃ of the sole 501 without the portion 503 as compared to the soft insole 106.

The wedge 300 is positioned relative to the sole 501 such that the front 300a of the wedge 300 is substantially even with the front edge 501a of the sole 501, and the rear 300b of the wedge 300 is positioned to correspond with the rear forefoot or midfoot of the foot when the foot and the sole 501 are within footwear.

As described above, according to some embodiments, the wedge 300 can be integral to the sole 501. Alternatively, according to some embodiments, the wedge 300 can be affixed to the sole 501 according to various methods. By way of example, and without limitation, the wedge 300 can be affixed to the sole 501 using double-sided tape, glue, or any other type of adhesive and/or boding agent.

Although primarily described as a wedge, according to some embodiments, the wedge 300 can instead be in the shape of a slab. For example, rather than having the top surface 302 with the inclined portion 302b, the entire top surface 302 can be level according to the level portion 302a. With the wedge 300 in the shape of a slab, and based on the material that forms the wedge 300, pressure from the foot on the wedge 300 within footwear can shape the slab to have an inclined top surface, such as the inclined portion 302b, after repeated use and pressure from the foot shaping the slab.

According to some embodiments, the sole 501 can be formed by modifying the soft insole 106. Specifically, the soft insole 106 can be modified by removing a portion of the soft insole 106 corresponding to the portion 503 described above. By way of example, and without limitation, a user (e.g., physician, clinician, technician, wearer, etc.) can remove a portion of the soft insole 106 corresponding to the portion 503 that is aligned with the metatarsophalangeal joints and extends forward. The portion of the soft insole 106 can be removed according to any method, such as cutting the soft insole 106 with scissors, to form the sole 501 from the remaining portion of the soft insole 106. Additionally, according to some embodiments, the wedge 300 can be formed based on the portion removed from the soft insole 106. The portion removed from the soft insole 106 can be shaped according to the above-described dimensions and shape of the wedge 300 and can be affixed to a sole as the wedge 300.

FIG. 6A shows the sole 501 of FIG. 5A with an insert 601, in accord with some aspects of the present concepts. As shown, the insert 601 accommodates for the difference in the length of the sole 501 as compared to the soft insole 106. Placement of the insert 601 in front of the sole 501 and beneath the toes can prevent any contact between the toes and another surface beneath the insert 601, such as the rigid sole 102 (discussed below). According to some embodiments, the insert 601 can be formed of a material that is softer than the material that forms the sole 501. By way of example, and without limitation, the insert 601 can be formed of PPT foam padding.

FIG. 6B is a cross-section view along the line 6B-6B in FIG. 6A, in accord with aspects of the present concepts. The front 300a of the wedge 300 is aligned with the front edge 501a of the sole 501. The insert 601 has a thickness T₅ that is less than the thickness T₃ of the sole 501. By way of example, and without limitation, the thickness T₅ of the insert 601 can be 1/16 to 3/16 of an inch, such as ⅛ of an inch. With the addition of the insert 601, the thickness T₄ of the wedge 300 can be increased to compensate for the additional thickness of the insert 601.

According to some embodiments, the shape of the wedge 300 can vary. FIGS. 7A-7C show wedges of varying shapes, in accord with aspects of the present concepts. Although the wedges of varying shapes are all shown with respect to the sole 501, the wedges can be affixed or integral with any sole discussed herein and equivalents thereof.

Referring to FIG. 7A, FIG. 7A shows an embodiment of a wedge 720 in cross-section relative to the sole 501, according to some aspects of the present concepts. The wedge 720 includes a front edge 722a at the front 720a and a back edge 722b at the back 720b. Further, the wedge 720 includes a top surface 724. The top surface 724 is flat and is inclined upward from the rear 720b to the front 720a of the wedge 720. Similar to the wedge 300, the top surface 724 at the rear 720b of the wedge 720 is elevated off of the sole 501 based on the presence of the rear edge 722b. The front edge 722a of the wedge 720 is generally aligned with the front edge 501a of the sole 501. The angle θ₂ of the incline of the top surface 724 provides a gradual incline for comfort of the wearer. By way of example, and without limitation, the angle θ₂ of the incline of the top surface 724 is 5 to 40 degrees, such as 10 degrees.

FIG. 7B shows another embodiment of a wedge 740 in cross-section relative to the sole 501, according to some aspects of the present concepts. The wedge 740 includes a front edge 742a at the front 740a. Further, the wedge 740 includes a top surface 744. The top surface 744 includes a level portion 744a and an inclined portion 744b. The inclined portion 744b begins contiguous to the sole 501 at the rear 740b of the wedge 740. The inclined portion 744b inclines upward toward a midpoint 746 at which the top surface 744 transitions from the inclined portion 744b to the level portion 744a. The position and formation of the midpoint 746 is similar to the midpoint 304 discussed above. The level portion 744a extends from the inclined portion 744b to the front edge 742a of the wedge 740. The front edge 742a of the wedge 740 is generally aligned with the front edge 501a of the sole 501.

The level portion 744a spans a length of the top surface 744 to provide a contact surface for the ball of the foot to distribute weight evenly and to prevent causing any pressure points. According to some embodiments, the level portion 744a spans two thirds of the length of the top surface 744, and the inclined portion 744b spans the remaining one third of the length of the top surface 744. However, the lengths of the level portion 744a and the inclined portion 744b can vary without departing from the spirit and scope of the present disclosure. The angle θ₃ of the inclined portion 744b provides a gradual incline for comfort of the wearer. By way of example, and without limitation, the angle θ₃ can be 5 to 40 degrees, such as 30 degrees.

FIG. 7C shows another embodiment of a wedge 760 in cross-section relative to the sole 501, according to some aspects of the present concepts. The wedge 760 includes a front edge 762a at the front 760a. Further, the wedge 760 includes a top surface 764. The top surface 764 is flat and is inclined upward from the rear 760b to the front 760a of the wedge 760. The top surface 764 begins contiguous to the sole 501 at the rear 760b of the wedge 760 and inclines up to the front edge 760a of the wedge 760. The front edge 762a of the wedge 760 is generally aligned with the front edge 501a of the sole 501. The angle θ₄ of the incline of the top surface 764 provides a gradual incline for comfort of the wearer. By way of example, and without limitation, the angle θ₄ can be 5 to 40 degrees, such as 20 degrees.

FIG. 8A shows protective footwear 800, in accord with aspects of the present concepts. The protective footwear 800 is similar to the protective footwear 100 of FIG. 1, but for the sole 501 being in place of the soft insole 106. FIG. 8B shows a cross-sectional slice of the protective footwear 800 along the line 8B-8B within FIG. 8A, and FIG. 8C shows a cross-sectional slice of the protective footwear 800 along the line 8C-8C within FIG. 8B, in accord with aspects of the present concepts.

The sole 501 with the wedge 300 fits within the protective footwear 800 above the rigid sole 102 and is surrounded by the ridge 102a. With the wedge 300 and the sole 501 within the protective footwear 800, the toes of the foot are elevated upward and suspended off of the rigid sole 102 forward of the wedge 300. Suspending the toes off of a surface of the protective footwear 800 (e.g., the rigid sole 102) reduces or eliminates the extent or the occurrence of contact between the toes and the surface. The reduced or eliminated extent or occurrence of contact maximizes healing of maladies (e.g., ulcers, etc.) of the toes. Contact on the foot is directed away from the toes to other contact surfaces of the foot, such as the ball of the foot or the heel. Moreover, by the wedge 300 suspending the toes above the rigid sole 102 rather than, for example, removing the rigid sole below the toes, the footprint of the protective footwear 800 is not modified and the rigid sole 102 still provides the same length of contact surface with the ground.

FIG. 9 shows a cross-section, such as along line 8B-8B of FIG. 8A, of a foot 900 within the protective footwear 800, in accord with aspects of the present concepts. As shown, the foot includes the metatarsals 901 and the phalanges (toes) 903. The wedge 300 is positioned below the metatarsals 901 such that the front 300a of the wedge 300 is aligned with the metatarsophalangeal joints of the foot 900, such as aligned with the midpoint to distal aspect of the metatarsophalangeal joints. With the wedge 300 positioned as shown and described, the phalanges 903 are suspended off of the rigid sole 102. Moreover, even with the optional insert 601 included within the protective footwear 800, the phalanges 903 also are suspended off of the insert 601. Thus, with the wedge 300 within the protective footwear 800, a wearer of the protective footwear 800 can ambulate while reducing or preventing contact between the toes and a surface of the protective footwear 800 below the toes, such as the insert 601 or the rigid sole 102. Further, with the rigid sole 102 below the toes, the footprint (e.g., length) of the protective footwear 800 remains the same despite the toes being suspended.

While the present disclosure has been described with reference to one or more particular implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present disclosure. The above described implementations, and obvious variations thereof, are contemplated as falling within the spirit and scope of the disclosure.

Claims

1. A device adapted to be placed beneath metatarsals of a foot comprising: a bottom surface being adapted to be affixed to a sole of protective footwear;a top surface being adapted to be adjacent to the foot when the foot is within the protective footwear and to suspend toes of the foot off of the sole when the foot is in a resting position within the protective footwear; anda distal end defining ends of the bottom surface and the top surface, the distal end being substantially aligned with metatarsophalangeal joints of the foot when the foot is within the protective footwear.

2. The device of claim 1, wherein the top surface includes a level portion and an inclined portion, the level portion being substantially level from the distal end to a midpoint of the top surface, and the inclined portion being inclined downward from the midpoint to a proximal end of the top surface.

3. The device of claim 2, wherein the inclined portion of the top surface is contiguous to the sole at the proximal end of the top surface.

4. The device of claim 2, further comprising: a proximal edge defining opposite ends of the top surface and the bottom surface,wherein the proximal edge separates the inclined portion of the top surface from the sole at the proximal end of the top surface.

5. The device of claim 1, wherein the top surface is inclined from a proximal end of the top surface to the distal end.

6. The device of claim 5, wherein the top surface is contiguous to the sole at the proximal end of the top surface.

7. The device of claim 5, further comprising: a proximal edge defining opposite ends of the top surface and the bottom surface,wherein the proximal edge separates the top surface from the sole at the proximal end of the top surface.

8. An apparatus comprising: a soft insole adapted to be placed on a rigid sole of footwear; anda wedge adapted to be placed beneath a foot wearing the footwear, the wedge having a first end and a second end opposite the first end, the first end being substantially aligned with metatarsophalangeal joints of the foot, the second end being proximal to the first end relative to the foot, and the wedge suspending toes above a lower surface of the footwear below the toes.

9. The apparatus of claim 8, wherein the second end is aligned with or forward of a midfoot of the foot.

10. The apparatus of claim 8, wherein the wedge has a top surface and a bottom surface, the bottom surface being adapted for being affixed to the soft insole and the top surface being adapted to be adjacent to the foot and having at least an inclined portion that elevates and suspends the toes off of the soft insole and the rigid sole with the toes in a resting position within the footwear.

11. The apparatus of claim 10, wherein the inclined portion of the top surface is contiguous to the soft insole at a proximal end of the top surface.

12. The apparatus of claim 10, wherein the wedge includes a proximal edge that defines ends of the top surface and the bottom surface, and the proximal edge separates the inclined portion of the top surface from the soft insole at a proximal end of the top surface.

13. The apparatus of claim 10, wherein the top surface is inclined from a proximal end of the top surface to a distal end.

14. The apparatus of claim 13, wherein the top surface is contiguous to the soft insole at the proximal end of the top surface.

15. The apparatus of claim 13, wherein the wedge includes a proximal edge that defines ends of the top surface and the bottom surface, and the proximal edge separates the top surface from the soft insole at the proximal end of the top surface.

16. The apparatus of claim 8, wherein the footwear is protective footwear.

17. A method of suspending one or more toes of a foot within footwear comprising: attaching a wedge having a top surface and a bottom surface to a sole of the footwear such that a distal end of the wedge relative to the foot is aligned with and below metatarsophalangeal joints of the foot with the foot within the footwear; andsuspending the one or more toes off of the sole based on the wedge being within the footwear and aligned with the metatarsophalangeal joints of the foot when the foot is within the footwear.

18. The method of claim 17, wherein the wedge includes a bottom surface that is adapted to be affixed to the sole within footwear, a top surface that is adapted to be adjacent to the foot within the footwear and to elevate the toes off of the sole, and a distal end defining ends of the bottom surface and the top surface, the distal end being substantially aligned with the metatarsophalangeal joints of the foot.

19. The method of claim 17, further comprising: removing a distal portion of the sole corresponding to an area of the sole below the one or more toes of the foot when the foot is within the footwear; andforming the wedge out of the distal portion of the sole.

20. The method of claim 19, further comprising: shaping the distal portion of the sole into a wedge shape, with a thick end of the wedge shape corresponding to the distal end of the distal portion, to form the wedge.