Modified Footwear Article Configured to Retain a Removable Insole

BACKGROUND OF THE INVENTION
Field of the Invention

The present disclosure is directed to an article of footwear configured to receive and support an insole and, in some examples, to an article of footwear designed for use with a customizable insole that can be modified to offload injured tissues on the plantar surface of a wearer's foot.

Description of Related Art

Healing of plantar foot injuries, such as post-surgical incisions and grafts, traumatic foot injuries, and/or diabetic foot ulcers may be impaired in ambulatory wearers due to pressure on injured tissues on the plantar surface of the foot, as occurs when the wearer is walking or standing. A number of devices are available commercially for offloading injuries and/or injured tissues on the plantar surface. For example, the PegAssist™ insole from DARCO International, Inc. of Huntington, West Virginia comprises a flat, ethyl vinyl acetate (EVA) multilayer foam body with removable, hexagonal pegs. Pegs, which would contact the injured tissue, can be removed from the insole, thereby offloading the injury. However, the removable pegs are firm and have sharp contours, which can cause discomfort and/or aggravate existing injuries. Further, the PegAssist™ insole is not anatomically adjustable for arch or metatarsal support. Most other commercially available insoles are not customizable for arch and metatarsal pad height and do not provide offloading of injuries on the plantar surface of the wearer's foot. Similarly, post-operative shoes, like the DARCO product, are bulky, flat, and do not completely offload grafted areas. Also, most commercially available insoles and post-procedure shoes cannot be worn in the shower.

In view of the deficiencies of presently available options, there is a need for an insole device that effectively offloads plantar injuries, is non-bulky, is simple to use, can be easily cleaned, and can be worn in a shower or other wet areas. There is also a need for footwear articles that are designed to support customizable insoles so that insoles can be worn by ambulatory patients while performing normal daily activities. The footwear articles, assemblies, and methods of use disclosed herein are intended to address such issues.

SUMMARY OF THE INVENTION

According to an aspect of the present disclosure, an article of footwear includes a sole having a bottom surface configured to contact ground when the article is worn by a wearer, a top surface opposite the bottom surface, and an inwardly directed rim extending about at least a portion of a periphery of the sole. The rim defines a channel sized to receive a peripheral edge of an insole for retaining the insole over the top surface of the sole. The article also includes an upper attached to the sole defining an opening sized to receive a foot of a wearer, the upper being configured to secure the sole to the wearers' foot.

According to another aspect of the present disclosure, an assembly includes the previously described article of footwear and the insole configured to be retained by the channel defined by the rim of the sole of the article of footwear. The insole is a customizable insole for offloading injuries on an area of a plantar surface of a patient's foot. The insole includes a body having a shape corresponding to the plantar surface of the patient's foot having a top surface, a bottom surface, and a peripheral edge sized to be received within the channel of the sole. The insole further includes at least one supportive, deformable, deflatable bubble chamber extending from the top surface of the body. The at least one bubble chamber is configured to be deflated to relieve pressure on the plantar surface of the wearer's foot.

According to another aspect of the present disclosure, a method of relieving pressure on a portion of a plantar surface of a foot of a wearer includes providing a customizable insole for offloading injuries on an area of a plantar surface of a wearer's foot. The insole includes: (i) a body having a shape corresponding to the plantar surface of the patient's foot comprising a top surface, a bottom surface, and a substantially flat peripheral edge; and (ii) at least one supportive, deformable, deflatable bubble chamber extending from the top surface of the body. The at least one bubble chamber is configured to be deflated to relieve pressure on the plantar surface of the patient's foot. The method further includes deflating the at least one bubble chamber of the insole. The at least one bubble chamber is located at a position on the insole corresponding to the portion of the patient's plantar surface requiring pressure relief. The method further includes placing the insole with the deflated at least one bubble chamber in the previously described article of footwear, such that the peripheral edge of the insole is at least partially received within the channel defined by the rim of the sole. The method further includes positioning the wearer's foot in the article of footwear, such that the portion of the wearer's plantar surface in need of pressure relief is over the deflated at least one bubble chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The Figures provide exemplary and illustrative aspects of the invention as described herein, and are not intended to be limiting. Further, the drawings are schematic in nature, and for ease of illustration, certain elements depicted in the figures are not necessarily drawn to scale.

FIG. 1A is a top view of an assembly including a removable insole and an article of footwear supporting the insole, according to an aspect of the present disclosure;

FIG. 1B is a cross-sectional view of the assembly of the assembly of FIG. 1A taken along line 1B-1B;

FIG. 1C is a cross-sectional view of another example of an assembly including a removable insole and an article of footwear supporting the insole, according to an aspect of the present disclosure;

FIG. 2A is a side view of a footwear article including features of a shower shoe for supporting a customizable insole, according to an aspect of the present disclosure;

FIG. 2B is a side view of a footwear article including features of a walking boot for supporting a customizable insole, according to an aspect of the present disclosure;

FIG. 2C is a side view of a footwear article including features of a sock, according to an aspect of the present disclosure;

FIG. 2D is a side view of another example of a footwear article including features of athletic shoe, according to an aspect of the present disclosure;

FIG. 2E is a cross-sectional view of the footwear article of FIG. 2D;

FIG. 3 is a top plan view of an insole illustrating different areas of a foot, according to an aspect of the present disclosure

FIG. 4A is a perspective view of a customizable insole, according to an aspect of the present disclosure;

FIG. 4B is a top plan view of the insole of FIG. 4A;

FIG. 4C is a cross-sectional view of the insole of FIG. 4A taken along line 4C-4C; and

FIG. 5 is a flow chart showing steps of a method of relieving pressure on a portion of a plantar surface of a wearer's foot, according to an aspect of the present disclosure.

DESCRIPTION OF THE INVENTION

The use of numerical values in the various ranges specified in this application, unless expressly indicated otherwise, are stated as approximations as though the minimum and maximum values within the stated ranges are both preceded by the word “about”. In this manner, slight variations above and below the stated ranges can be used to achieve substantially the same results as values within the ranges. Also, unless indicated otherwise, the disclosure of these ranges is intended as a continuous range including every value between the minimum and maximum values.

As used herein, the terms “comprising,” “comprise” or “comprised,” and variations thereof, are meant to be open ended. The terms “a” and “an” are intended to refer to one or more.

As used herein, the “treatment” or “treating” of a condition, wound, or defect means administration to a wearer by any suitable dosage regimen, procedure and/or administration route of a composition, device or structure with the object of achieving a desirable clinical/medical end-point.

As used herein, the terms “patient,” “wearer,” or “subject” refer to members of the animal kingdom including but not limited to human beings and “mammal” refers to all mammals, including, but not limited to human beings.

As used herein stating that a layer is said to be disposed “over” a referenced layer, or “about a periphery of” a referenced layer, or “about at least a portion of the periphery of” a referenced layer, does not imply the layer is directly adjacent to the referenced layer, and may comprise one or more additional layers therebetween, and further does not imply that the layer completely covers the referenced layer, and may only cover, surround, contact, etc., only a portion of the referenced layer. That said, if a layer is said to be disposed “directly about” or “directly over” a referenced layer, it is meant the two layers contact each other, though an intermediary layer, such as an adhesive layer, or a blended layer that results from directly contacting the two layers during the process of formation of the device may be present between the two stated layers. Also, if a layer is said to “completely cover” a referenced layer, it is meant the second layer covers the entirety of the referenced layer. Stating that a layer is said to be disposed “over” another layer, or “about a circumference of” a referenced layer, or “about at least a portion of the circumference of” a referenced layer includes where the stated layers are directly contacting each other and/or that the layer completely covers the referenced layer.

With reference to the figures, an article of footwear or footwear article 110 is provided that is configured to hold a removable insole 10 in place beneath a wearer's foot. As used herein, the “article” can be any wearable item or device sized to fit under, over, or around a wearer's foot. For example, a “footwear article” or an “article of footwear” can be a covering for the foot comprising a sole 112 and an upper 114. The upper 114 covers or surrounds at least a portion of the dorsal side of the wearer's foot, and holds the sole 112 in place against the plantar side of the foot. Footwear articles can include, without limitation, shoes (e.g., athletic shoes, casual shoes, dress shoes, high-heel shoes, sneakers, water shoes, shower shoes, surgical shoes, etc.), boots, sandals, flip-flops, slides, walking casts, slippers, clogs, skates, or any combination thereof. The footwear article 110 can also include a sock or stocking including portions of the insole 10.

The insole 10 and footwear articles 110 described herein can be configured for either the left foot or the right foot of the wearer. Further, the insole 10 can be provided in standard sizes, such as small, medium, large, or extra-large sizes, using standard size cutoffs. Alternatively, the insole 10 can be provided as a “one size fits all” size with multiple cutaway ridges or regions for modifying the insole 10 to fit a particular wearer's foot and so that the insole 10 fits within the footwear article 110.

As used herein, the “insole” (also referred to as an insert or orthopedic) can refer to any mass-produced, customizable, or custom-made insole as are known in the art. As used herein, a “mass-produced insole” refers to an insole 10 made to be used by a number of different wearers or patients and which is not modified, optimized, or re-sized prior to use. A “customizable” insole refers to an insole 10 including structures and features that can be modified by, for example, the wearer or a caregiver to adapt the insole 10 for a particular wearer's foot. For example, the wearer or caregiver may cut the customizable insole 10 to a particular size and/or deflate certain portions of the insole 10 so that the insole 10 more accurately matches a size and shape of a wearer's foot. By contrast, a “custom-made” or “customized” insole 10 refers to an insole 10 that is designed and made for a particular wearer taking into account the size and shape of the wearer's foot. The footwear article 110 of the present disclosure can be used with the customizable insole 10 illustrated in FIGS. 3-4C or with any other mass-produced, customized, or customizable insoles, as are known in the art.

An exemplary customizable insole 10 that can be used with the footwear article 110 of the present disclosure is described in PCT Appl. Pub. No. WO 2020/061466, entitled “Adaptive insole for rehabilitation of foot injuries,” which is incorporated herein by reference in its entirety. Other insoles can also be used with the footwear articles 110 within the scope of the present disclosure.

Footwear Article that Receives an Insole

FIGS. 1A-2E illustrate examples of footwear articles 110 includes the sole 112 and the upper 114 modified or designed to retain and support the removable insole 10. The sole 112 can be any base, bottom, or lower portion of a footwear article 110 that is an appropriate size and shape to support at least a portion of the wearer's foot. In some examples, the sole 112 includes a top surface 120 and an opposing bottom surface 116 configured to contact ground when the article 110 is worn by the wearer. In some examples, the bottom surface 116 of the sole 112 contacts the ground directly. In other examples, there may be a coating, liner, and/or protective films or layers covering the bottom surface 116 that contact the ground.

In some examples, the portion of the sole 112 that contacts the ground can include tacky or non-slip portions on the bottom of the footwear article 110 to provide traction for the wearer. For example, the bottom surface 116 of the sole 112 can be textured to provide a non-slip surface. The bottom surface 116 can also include treads, ridges, protrusions, and other structures for improving grip. The texturing, treads, and other structures can be present in a mold used for forming the sole 112. In other examples, the bottom surface 116 of the sole 112 may be modified after molding to create, for example, the ridges, channels, and other structures on the bottom surface 116 of the sole 112 for reducing slipping and improving performance of the footwear article 110.

In some examples, the sole 112 can also include through-holes, openings, or perforations extending through the sole 112, such as between the top surface 120 and the bottom surface 116 of the sole 112. The through-holes, openings, or perforations can be configured to permit fluid to drain from interior portions of the article 110 so that fluid does not collect around the wearer's foot. For example, a shower slide (e.g., a wearable article intended to be worn in the shower) can include perforations in the sole 112 for draining water away from the wearer's foot.

In some examples, the sole 112 further comprises a liner 118 attached to at least a portion of the bottom surface 116 of the sole 112. The liner 118 can be formed from a slip resistant and water resistant material, such as synthetic or natural rubber. In some example, the liner 118 resembles a standard rubber or synthetic rubber sole found on conventional athletic shoes and sneakers. In other examples, the liner 118 can be formed from other tacky materials as are known in the art. In some examples, the liner 118 covers the entire bottom surface 116 of the sole 112. Alternatively, the liner 118 or multiple liners can cover some portions of the bottom surface 116 of the sole 112, while other portions of the sole 112 are uncovered.

In some examples, a bottom surface of the sole 112 and/or the liner 118 is substantially flat, as shown in FIGS. 1B and 1C, matching a shape of the bottom surface 116 or sole 112 of many conventional shoes, boots, slippers, and other footwear articles. In other examples, the bottom surface 116 of the sole 112 and/or linear 118 can be shaped to affect, for example, the wearer's stride length, step cadence, and/or leg position. For example, the sole 112 can be a curved or rocker sole (e.g. a rocker bottom sole) having a thicker than normal central portion of the sole 112 and rounded heel and toe cap portions. The rocker sole can be configured to strengthen muscle groups or portions of a wearer's foot or leg that are not impacted when wearing normal shoes. Applying pressure to and/or strengthening such different or underused muscle groups can improve a wearer's posture and tighten muscles of the foot or leg. In other examples, the sole 112 and/or liner 118 can comprise an extension or raised portion as found, for example, in a high-heeled shoe (e.g., a kitten heel, loafer, stiletto, wedge, pump, ankle boot, or other heel designs known in the art).

The sole 112 also includes a raised rim 122 extending about at least a portion of a periphery of the sole 112. The rim 122 can include a substantially vertical portion 124 extending around at least a portion of the periphery of the sole 112 and a horizontal and/or inwardly-directed portion 126 that extends from the vertical portion 124 over a portion of the top surface 120 of the sole 112. The horizontal portion 126 of the rim 122 can include a lower surface 128 that contacts the insole 10, thereby securing the insole 10 between the lower surface 128 of the rim 122 and the top surface 120 of the sole 112.

In some examples, the rim 122 extends inwardly by a distance D1 (shown in FIG. 1B) of about 0.25 inch to about 0.75 inch to define a channel 130 sized to receive a peripheral edge 22 of the insole 10 for retaining the insole 10 in place over the top surface 120 of the sole 112. The peripheral edge 22 of the insole 10 is a substantially flat area extending about at least a portion of the insole 10 that corresponds in size to the channel 130. For example, the width W1 (shown in FIG. 1B) of the peripheral edge 22 can be 0.20 inch to about 1.0 inch.

The rim 122 can be sized or configured to engage insoles 10 of different sizes, variations, and designs. In particular, the rim 122 can be configured to engage insoles 10 of different thicknesses. For example, portions of the rim 122 can be deformable, bendable, or inwardly biased in order to receive and engage insoles 10 that are thinner or thicker than the insoles 10 shown in FIGS. 1B and 1C. The rim 122 can also be configured to engage insoles 10 of different lengths and/or widths. For example, as shown in FIGS. 1B and 1C, the insole 10 contacts inner surfaces of the vertical portion 124 of the rim 122 meaning that a width of at least a portion of the insole 10 is substantially equal to an inner width of the rim 122. In some examples, the rim 122 can be configured to also engage larger or smaller insoles 10, such as insoles 10 that are narrower or wider than the rim 122. For example, portions of the rim 122 can extend farther inward from the vertical portion 124 than the distance D1 shown in FIGS. 1B and 1C to accommodate smaller insoles 10. In other examples, portions of the vertical portion 124 of the rim 122 can be configured to bend radially outwardly to accommodate wider or longer insoles 10.

In some examples, portions of the sole 112 can be formed from substantially rigid materials that do not substantially deform when weight of the wearer is applied to the sole 112. For example, the sole 112 can comprise and/or can be manufactured, at least in part, from one or more of: a foamed (e.g., closed or open cell foam) or thermoplastic polymer composition, such as ethylene-vinyl acetate (EVA); leather; rubber; and combinations thereof, as are broadly-known in the shoe making and sandal making arts.

With specific reference to FIGS. 1B and 1C, in some examples, the rim 122 can include structures for pressing against the peripheral edge 22 of the insole 10 to prevent the insole 10 from sliding out of the channel 130. For example, the rim 122 can include one or more protrusions 132 extending downwardly from a lower surface 128 of the rim 122 configured to contact the insole 10 pressing the insole 10 against the top surface 120 of sole 112 to secure the insole 10 in place within the channel 130. The protrusions 132 can be configured to contact and engage different types of insoles 10, such as insoles 10 made from different materials. For example, the protrusions 132 can be a rounded bead or other raised surface, which may be sufficient for engaging insoles 10 that comprise rather soft or deformable materials. The protrusion 132 can also include an annular or partially annular ridge extending around at least a portion of the lower surface 128 of the rim 122. In other examples, the protrusion 132 can come to a dull or sharpened point and may perforate the peripheral edge 22 of the insole 10 to hold the insole 10 in place. In particular, a sharpened protrusion 132 may be used with insoles 10 formed from harder materials that cannot be grasped or deformed by dull or rounded protrusions 132.

In some examples, the rim 122 is integral with other portions of the sole 112. For example, the sole 112 and rim 122 can be molded together forming the integral structure. In that case, the rim 122 is formed from the same material as other portions of the sole 112. For example, the rim 122, along with other portions of the sole 112, can be formed form an elastomeric material and/or can be an open cell or closed cell foam. In some examples, the rim 122 can be formed from a different more resilient material compared to other portions of the sole 112. In such cases, the rim 122 can be biased in a downward direction to apply pressure against the insole 10 to retain the peripheral edge 22 of the insole 10 within the channel 130.

In some examples, as shown in FIG. 1B, the sole 112 also includes a comfort layer or cover layer 144 extending over the top surface 14 of the insole 10 for separating a top surface 14 of the insole 10 from the wearer's foot, allowing the foot to rest on a smoother and/or softer surface than the top surface 14 of the insole 10. As shown in FIG. 1B, the cover layer 144 can be secured to portions of the rim 122 to hold the cover layer 144 in place below the wearer's foot. For example, the cover layer 144 can be secured to the rim 122 to prevent the cover layer 144 from bunching up or forming uncomfortable folds or creases below the wearer's foot. The cover layer 144 can be formed from any soft, comfortable material, such as cotton and other natural or synthetic fabrics. In some examples, the cover layer 144 can include padded portions for increasing comfort. In other examples, the insole 10 may include a thin layer or liner over the top surface 14 of the insole 10 to provide a smooth contour below the wearer's foot. The liner or layer could be made from materials that are water-wicking, anti-bacterial, or anti-fungal. The liner or layer can be fixed to the top surface 14 of the insole 10. In that case, the liner or layer may not need to be attached to any portions of the sole 112.

In other examples, as shown in FIG. 1C, the sole 112 does not include a cover layer. Instead, the wearer's foot directly contacts the top surface 14 of the insole 10. In some cases, not including a cover layer can make it easier to remove and replace the insole 10 when desired. Also, when the cover layer is not present, the wearer can see the configuration of the insole 10 prior to inserting his or her foot into the footwear article 110 allowing the wearer to confirm that the insole 10 is properly configured for any physical conditions or injuries that need to be addressed. Also, in some examples, when the cover sheet is not in place, the wearer can modify or customize the customizable insole 10 while the insole 10 is engaged to the rim 122 within the footwear article 110. By contrast, for soles 112 including the cover layer 144 (as shown in FIG. 1B), it may be difficult to reconfigure, modify, or adjust the insole 10 once the cover layer 144 is in place.

With reference again to FIGS. 1A-2E, the footwear article 110 further comprises the upper 114 attached to the sole 112 configured to secure the sole 112 to the wearer's foot. As used herein, an “upper” can be any structure that passes over the dorsal side of the foot or toes in a footwear article 110 and which holds the sole 112 and insole 10 in place on the plantar surface of the wearer's foot. The upper 114 includes or defines an opening 134 sized to receive the wearer's foot for sliding the foot into the footwear article 110. For example, a shoe may include an opening 134 near a top of the footwear article 110 of a sufficient size so that the wearer can slide his or her foot through the opening 134. For a sandal, the opening 134 may be defined by a strap 136 or band extending over the top surface 120 of the sole 112 and insole 10. The wearer slides his or her foot under the strap 136 or band to secure his or her foot to the footwear article 110.

FIGS. 1A and 1B illustrate a footwear article 110 including the strap 136 or band. As shown in FIGS. 1A and 1B, the strap 136 extends from one side of the sole 112 to the other side of the sole 112, similar to straps and bands found in conventional sandals and slides. In some examples, the strap 136 is adjustable to accommodate wearer's with feet of different sizes. The strap 136 can be a single strap passing through and fixedly attached to opposite sides of the sole 112. In other examples, the strap 136 is formed from two separate pieces or segments, each of which is anchored to a slot on the sole 112. The two separate pieces or portions can be attached together by, for example, a hook and loop fastener, buckle, closure, clasp, or latch, as are common in footwear to secure the wearer's foot to the sole 112. For example, the footwear article 110 can comprise a hook-and-loop fastener system (e.g., VELCRO®), with a hook portion at an end of a strap 136 and a loop portion at an end of another strap 136. In other examples, the footwear article 110 can include more than two straps and/or segments of straps, and may fasten by any suitable closure, clasp, latch, buckle, or fastener, as are known in the art. In other examples, the upper of the footwear article 110 may take any useful shape and configuration, as are used for articles of footwear, such as a shoe, sandal, slide, or boot. The footwear article 110 can be connected to the wearer's foot using any suitable fastening method, such as tie, buckle, snap, hook-and-loop, or fixed (e.g., loafer) configurations as are broadly-known.

As previously described, the footwear article 110 of the present disclosure can be provided in variety of different forms and configurations depending upon needs of particular wearers. In one example, as shown in FIG. 2A, the footwear article 110 is a shower shoe intended to be worn in the shower so that the wearer's foot is appropriately supported by the insole 10 during showering. In that case, the upper 114 of the footwear article 110 can be a waterproof enclosure that surrounds the wearer's foot so that the foot remains substantially dry during the shower. The bottom surface 116 of the sole 112 of the shower shoe can include tacky or non-slip surfaces for safety. As previously described, in some examples, the sole 112 of the shower shoe can also include holes, openings, or perforations extending through the sole 112 for draining shower water away from the wearer's foot during a shower.

In another examples, as shown in FIG. 2B, the footwear article 110 can be a medical support device, such as a walking boot or waking cast, for supporting an injured foot. As shown in FIG. 2B, the upper 114 of the walking boot or walking cast can comprise a rigid shell 138, 140 and flexible straps 136 or bands for securing the walking boot or walking cast to the wearer's foot. As in previous examples, the upper 114 and the rigid shell 138, 140 are connected to the sole 112 of the footwear article 110. In some examples, the rigid shell 138, 140 includes a front portion or piece 138 that extends over a top portion of the wearer's foot and over a front portion of the wearer's lower leg. The shell 138, 140 also includes a rear portion or piece 140 extending vertically from a heel portion of the sole 112 covering the wearer's calf.

In another example, as shown in FIG. 2C, the footwear article 110 comprises a sock or stocking configured to receive the insole 10. For example, the upper 114 of the footwear article 110 can comprise a cloth or fabric portion 142 attached to the sole 112 formed, for example, from cotton or wool. The cloth or fabric portion 142 can surround the foot to secure the footwear article 110 to the wearer's foot. The cloth or fabric portion 142 can also include or attach to a tubular portion 144 that extends over a lower portion of the wearer's leg. In some examples, the sole 112 can be formed from a soft fabric material similar to other portions of the sock or stocking. In other examples, the sole 112 is formed from a more rigid material similar to the sole of a shoe or slipper. The fabric portion 142 of the sock can be attached to the more rigid sole 112 forming a footwear article 110 with a sock-like upper 114 and a sole 112 similar to a sole of a shoe or slipper.

In another example, as shown in FIGS. 2D and 2E, the footwear article 110 comprises an athletic shoe, such as a cross-training shoe, court shoe, cleat, or running shoe. The athletic shoe can be adapted for use with different sports and athletic activities, such as walking, jogging, running, skiing, skating, or playing sports, such as basketball, football, soccer, tennis, racquetball, or squash. The athletic shoe comprises a sole 112 with a bottom surface 116 covered by a liner 118 (e.g., a rubber liner 118 with treads adapted for a particular sport or athletic activity) and an upper 114 extending from the sole 112 formed from a natural material (e.g., leather) or synthetic materials. The upper 114 is generally more rigid and supportive than in previous examples in order to support the wearer's foot while participating in the athletic activity or sport. In some examples, the upper 114 includes a closure, such as a lacing system 150, for tightly securing the wearer's foot within the footwear article 110. As shown most clearly in the cross-sectional view of FIG. 2E, the athletic shoe is adapted to removably retain the insole 10, in a manner similar to previous examples. In particular, as shown in FIG. 2E, the rim 122 protrudes radially inward from a portion of the upper 114, extending over a peripheral edge of the insole 10. As in previous examples, the rim 122 can include protrusions 132 (not shown in FIG. 2E) for pressing against the insole 10, thereby securing the insole 10 in place over the top surface 120 of the sole 112. Also, the sole 112 can include the cover layer 144 over the insole 10 for separating the wearer's foot from the insole 10. As in previous examples, the cover layer 144 can be formed from a soft and/or cushioning material for enhancing wearer comfort. The cover layer 144 can also comprise an absorbent and/or moisture-wicking material for absorbing sweat and other fluids proximate to the wearer's foot.

Customizable Insole for Offloading Plantar Injuries

With reference to FIGS. 3-4C, an exemplary customizable insole 10 that can be used with and/or are configured to be retained in the footwear articles 110 of the present disclosure can comprise a body 12 having a shape corresponding to at least a portion of the plantar surface of the wearer's foot. The body 12 comprises a top surface 14 and a bottom surface 16. The insole 10 further comprises one or more supportive, deformable, deflatable bubble chambers 18 extending from the top surface 14 of the body 12. The bubble chambers 18 are configured to be deflated to relieve pressure on the plantar surface of the wearer's foot.

The bubble chambers 18 are positioned on the insole 10 for offloading injuries to specific anatomical regions of the wearer's foot. For example, the chambers 18 can be positioned at a metatarsal portion or at a heel or calcaneus bone portion of the insole 10 to relieve pressure from the metatarsal portion or heel portion of the wearer's foot. As used herein, the “portion of the insole” for a specified anatomical structure refers to the portion of the insole 10 located under and/or that would be contacted by the anatomical structure of the wearer's foot when the insole 10 is in use. Further, as used herein, the specified anatomical structure on the wearer's foot refers to a position on an opposite side of the wearer's skin to the stated anatomical structure, such as a bone, ligament, tendon, or plantar fascia. For example, the metatarsal portion of the foot refers to the area of the wearer's skin on the plantar surface opposite the metatarsal bones of the foot. However, reference to anatomical structures of the foot and anatomical directions, such as anterior, posterior, axial, or medial, as well as references to position relative to a user of the product, such as distal and proximal, are merely used to describe the relative orientation, configuration, adaptation, and arrangement of elements of the insole 10. Such anatomical and directional terms are not intended to be otherwise limiting. For example, specified anatomical structures and directions are not intended to require a fixed, spatial orientation of the insole 10, such as relative to a specific wearer or end user of the insole 10.

In some examples, the bubble chambers 18 are configured to be partially or fully deflatable to offload the injured tissues, thereby relieving pressure to the injured tissues on the wearer's foot. For example, a bubble chamber 18 can be pierced or punctured to evacuate fluid (e.g., gas or suitable liquids) from the bubble chamber 18 to deflate and decrease a height of the bubble chamber 18. Generally, one or more bubble chambers 18 can be pierced or punctured on portions of the insole 10 corresponding to injured portions of the wearer's foot. Accordingly, deflated bubble chambers 18 do not contact or have reduced contact with the injured tissues compared to when the chamber 18 is inflated, thereby relieving the pressure from the injured tissues. For example, for a wearer having an injury on the metatarsal portion of the plantar surface of the foot, bubble chambers 18 on the metatarsal portion of the insole 10 can be deflated to offload the injury and to protect the injured portions of the wearer's foot.

In some examples, a user may deflate the bubbles chambers 18 through the bottom surface 16 of the insole 10 by, for example, inserting a needle or another pointed member through the bottom surface 16 of the insole into the chamber 18. After a bubble chamber 18 is pierced and the needle or another pointed member removed, the user may place an adhesive member, such as a waterproof adhesive sticker or tape, over the perforation(s) or hole(s) to prevent the deflated bubble chamber 18 from re-inflating. In other examples, liquid or fluid adhesives, such as glue, could be provided over any perforations or holes of the bubble chambers 18 to prevent deflated chambers 18 from re-inflating. In some examples, if the adhesive member (e.g., a sticker or tape) is removed soon after piercing the bubble chamber 18, the bubble chamber 18 will refill with air. In that case, a new adhesive member can be applied over the perforations or openings so that the bubble chamber 18 remains inflated. In this way, piercing of the bubble chamber 18 can be somewhat reversible. However, once the bubble chamber 18 is deflated for a substantial period of time, and/or if the insole 10 is worn for an extended period after the bubble chamber 18 is pierced, the bubble chamber 18 is less likely to re-inflate or return to its previous fully inflated size and shape.

The bubble chambers 18 can be positioned to treat injuries to many different regions of the foot. FIG. 3 is a schematic drawing of the insole 10 showing relative position for a number of different regions of the foot that can be treated using the insole 10. It is noted, however, that FIG. 3 is schematic in nature and that the illustrated portions are merely exemplary of an insole 10 in accordance with the present disclosure. A person skilled in the art can modify the insole 10 to treat different regions of the plantar surface and/or to relieve pressure to different regions of the wearer's foot. As shown in FIG. 3, the insole includes an anterior end portion A, a posterior end portion P, a lateral side portion L, and a medial side portion M. The insole also includes a toe portion 2, a distal metatarsal head portion 3, a medial arch portion 4, a metatarsal (or anterior transverse arch) portion 5, and a heel (or calcaneus) portion 6. The insole 10 also includes a plantar fascia insertion and tendon portion 7, which is depicted overlapping the depicted heel portion 6, metatarsal portion 5, and medial arch portion 4. Bubble chambers 18, as well as other supportive structures described herein, can be positioned at any of the insole portions 2, 3, 4, 5, 6, 7 to provide specific treatment and offloading of injuries for specified areas of the wearer's foot.

With reference to FIGS. 4A-4C, the body 12 of the insole 10 is a substantially planar structure comprising the top surface 14 and the opposing bottom surface 16. The body 12 is an appropriate size and shape to fit within the footwear article 110. For example, the body 12 can be about 1 mm to about 25 mm (0.05 inch to about 1.0 inch) thick, about 20 cm to about 30 cm (about 7.8 inches to 11.8 inches) long, and about 9 cm to about 13 cm (about 3.5 inches to 5 inches) wide.

In some examples, the body 12 of the insole 10 is fabricated from one or more elastomeric layers, which can be connected and/or laminated together to form a substantially unitary structure. The elastomeric layers can comprise any elastomeric polymer composition that can be adapted to be used for the purposes described herein. Elastomeric materials can be selected giving consideration to one or more physical parameters of the insole 10 including tensile strength, elongation at break, resilience, elasticity (e.g., modulus), impermeability to the fluid (e.g., gas or liquid) contained within the bubble chambers 18 of the insole 10, and/or lack of toxicity (non-toxic, non-inflammatory, and/or non-irritating). Material properties of selected polymer composition(s) desirably fall within acceptable values for each physical parameter, such that any combination of physical parameters yield an insole 10 able to function as described herein. Choice of polymer composition, the method of forming the composition (e.g., molding, 3D printing, etc.), thickness of the insole body 12, thickness of walls of the bubble chambers 18, the size and shape of the bubble chambers 18, the placement of the bubble chambers 18, and methods of testing suitable polymer compositions for use in the insole 10 described herein, are within the abilities of a person of ordinary skill in the art (see, e.g., “Elastomer Engineering Guide” James Walker Sealing Products and Services Ltd 2017). In some examples, as shown in FIGS. 4A-4C, a height of the bubble chambers 18 (e.g., a vertical distance between the top surface 14 of the body 12 and the top of the bubble chamber 18) may be different for different groups of bubble chambers 18 of the insole 10. For example, bubble chambers 18 configured to contact the arch, metatarsal pad, or peripheral portions of the wearer's foot may be higher than bubble chambers 18 on other portions of the insole 10. Further, topography of the insole 10 may vary or be customized for wearers of different heights, weights, activity levels, and other physical characteristics.

As used herein, the term “polymer composition” is a composition comprising one or more polymers. As a class, “polymers” includes homopolymers, heteropolymers, co-polymers, block co-polymers, and can be both natural and synthetic. Homopolymers contain one type of building block, or monomer, whereas co-polymers contain more than one type of monomer. The term “(co) polymer” and like terms refer to either homopolymers or copolymers. A polymer “comprises” or is “derived from” a stated monomer if that monomer is incorporated into the polymer. Thus, the incorporated monomer (monomer residue) that the polymer comprises is not the same as the monomer prior to incorporation into a polymer, in that at the very least, certain groups (e.g., functional/active groups or leaving groups) are missing and/or modified when incorporated into the polymer backbone. A polymer is said to comprise a specific type of linkage if that linkage is present in the polymer.

As indicated previously, the choice of polymer composition useful in preparation of the insole 10 described herein is limited to polymer compositions having suitable physical characteristics for use in an insole 10 to function as described herein, including strength, flexibility, resilience, deformability, etc., and are not limited by the specific examples of useful polymer types and compositions listed below. Useful polymer compositions can have any topology, including linear, star, comb, dendrimer, etc., as are broadly-known, and can be crosslinked, as is broadly-known, so long as the crosslinked polymer composition has suitable physical characteristics. Useful polymer compositions include, without limitation: thermoplastic polymer compositions, homopolymers, copolymers, and block copolymers. Non-limiting examples of polymer compositions include: polyolefins, polyurethanes, polyesters, silicone (e.g., silicone rubbers), and siloxanes. Specific, non-limiting examples of polymer compositions include: polyalkylenes, such as polyethylene, polypropylene, polyvinyl chloride, and thermoplastic polyurethanes, such as, for example and without limitation, block polyurethane copolymers with polyester, polyether, or polycarbonate segments, such as Desmopan® (Covestro) or Elastollan® (BASF) polymer compositions.

In some examples, the body 12 of the insole 10 further comprises one or more additional coating layers 20 (shown in FIG. 4C) on its exterior, such as a layer of a silicone or other suitable cushioning polymeric material. The additional coating layers 20 may cover one major surface (e.g., the top surface 14) of the body 12 of the insole 10, both major surfaces (e.g., the top surface 14 and the bottom surface 16) of the body 12, or the entire surface and sides of the insole 10, and may be of any suitable thickness so long as it does not interfere with operation of the insole 10. For example, the additional coating layers 20 can be from 0.1 mm to 2 mm thick.

With continued reference to FIGS. 4A-4C, in some examples, the bubble chambers 18 are configured to be supportive, deformable, and deflatable. By “supportive, deformable, deflatable bubble chambers,” it is meant sealed chambers being “deformable” by virtue of having walls made from a flexible, clastic, and/or resilient material and filled with a fluid, such as a gas or a suitable liquid. The bubble chambers 18, in aggregate, support a wearer's weight, and are, therefore, “supportive.” Further, the deformable, flexible, clastic, and/or resilient nature of the bubble chamber 18 results from compression of the fluid (e.g., gas within the chamber) and/or flexion and expansion of side walls of the bubble chamber 18. Under the weight of a wearer, the chamber 18 is flattened, and thereby shortened in height, resulting in an increase in the diameter of the chamber 18. The fluid (e.g., gas) can be released from the chamber 18 by piercing the wall of the bubble chamber 18, thereby “deflating” the chamber 18, as in popping a bubble.

In some examples, the bubble chambers 18 are spaced apart so that when no pressure is applied to the insole 10, the bubble chambers 18 do not touch. When pressure is applied to the insole 10, adjacent bubble chambers 18 may or may not touch. Further, a layout of the bubble chambers 18 in the insole 10 may be optimized based on a variety of criterion, such as: foot size, bubble size, wearer weight, aesthetics, support of bubble chambers 18 adjacent to deflated chambers, materials used to make the bubble chambers 18, the fluid filling the bubble chambers 18, the location of the bubble chambers 18 in the insole 10 relative to a wearer's foot, and/or the location of an injury on a plantar foot surface, among other variables. In some examples, the bubble layout can be designed or configured to support a wearer's foot to address specific medical conditions, such as to protect and/or reduce pain from diabetic foot ulcers.

In some examples, the bubble chamber(s) 18 can be stacked on top of one another to provide greater flexibility in adjusting a height of different portions of the insole 10. For example, a plurality of outermost bubble chambers 18 may be stacked on (e.g., connected to an outwardly facing surface of) a larger inner bubble chamber 18. A user may deflate one or more of the outermost bubble chambers 18, while leaving the larger inner bubble chamber 18 intact. Alternatively, if there is a need to fully offload an injury from a particular portion of the insole 10, the user could deflate the larger inner bubble chamber 18, which would substantially reduce a height of the portion of the insole 10.

In some examples, the insole 10 further comprises one or more rigid and/or solid support members, such as an arch support 30 located at the medial arch portion of the insole 10 and a metatarsal support 32 located at the metatarsal portion of the insole 10. The supports 30, 32 extend from the top surface 14 of the body 12 and can comprise a rounded or concave surface sized to support the wearer's foot. The supports 30, 32 may independently comprise a single support, such as a support molded from a polymer or thermoplastic material, or multiple layered supports stacked on top of one another.

The supports 30, 32 may be formed from a thermoplastic material. The supports 30, 32 may also be formed from suitable foams (e.g., an ethylene vinyl acetate (EVA) foam), gels, and/or elastomers, as are known in the art, to form a substantially rigid and/or solid structure capable of supporting the plantar surface of the foot. In some examples, the arch support 30 and/or the metatarsal support 32 comprise a bubble chamber 26, similar in structure and function to the previously described bubble chambers 18, so that a height of the supports 30, 32 can be adjusted. Where the arch support 30 and/or the metatarsal support 32 comprise a bubble chamber 26, the bubble chamber 26 may be independently deflatable to allow for customizable arch height and metatarsal pad height. In one example, the arch support 30 and metatarsal support 32 both comprise bubble chambers 26 and are manufactured from the same elastomer as the primary body 12 of the insole 10.

In some examples, the arch support 30 and the metatarsal support 32 can include a groove or notch 50 extending through a portion of the support 30, 32. For example, the groove or notch 50 can extend along and be accessible through an outer surface of the support 30, 32. The groove or notch 50 can be used to access one of the bubble chambers 26 of the support 30, 32, such as a bubble chamber 26 overlying a padded portion of the arch support 30 or the metatarsal support 32. More specifically, the groove or notch 50 can be positioned to allow a user to insert a pointed object or needle through the groove or notch 50 and into the bubble chamber 26 to deflate the bubble chamber 26.

In some examples, the arch support 30 and metatarsal support 32 are integral with the body 12 of the insole 10. When integral with the body 12 of the insole 10, the arch support 30 and the metatarsal support 32 are not separable from, and are contiguous with, the insole 10. The supports 30, 32 may also be separable from the body 12 of the insole 10. In such cases, the body 12 of the insole 10 is adapted or configured to receive or mate with the separable arch support 30 and/or metatarsal support 32. For example, the arch support 30 and/or metatarsal support 32 can be configured to nest within mating structures on the body 12 with, for example and without limitation, a slip-fit, friction-fit, snap-fit, or another structure, and/or using an adhesive, hook and loop fasteners, or any other suitable fittings and/or fasteners.

The separable supports 30, 32 may be independently manufactured from the same material as the insole body 12, or from different materials. For example and without limitation, the arch support 30 and the metatarsal support 32 can be independently manufactured from a solid layer of the elastomer of the insole body 12. The supports 30, 32 can also comprise additional polymer and/or thermoplastic compositions, such as a foamed polymer. The foamed polymer may comprise EVA.

In some examples, the insole 10 may comprise both a separable arch support 30 and separable metatarsal support 32. The separable supports 30, 32 can be manufactured from the same material as the insole body 12 or from different materials. Further, the body 12 can comprise sections, such as openings or spaces, configured to receive the separate supports 30, 32. In some examples, the supports 30, 32 can be formed from multiple inserts configured to be connected together to form the supports 30, 32. For example, the arch support 30 can comprise a first insert comprising a rigid support and/or bubble chambers, a second insert comprising a rigid support and bubble chambers, and/or a third insert comprising a rigid support and/or bubble chambers. The bottom of the first insert can be configured to receive the second insert and/or the third insert, such that when the inserts are connected together, additional support for the foot is provided. The user can decide whether to use multiple inserts (e.g., the first, second, and third inserts), one insert (e.g., only the first insert), or no inserts with the insole 10 based on the therapeutic needs of the wearer. The second and/or third insert may be manufactured from the same material as the insole body 12 and/or first insert or from different materials.

In some examples, the insole 10 further comprises a supportive ridge 34 configured to provide additional stability for peripheral portions of the wearer's foot. The supportive ridge 34 may extend from the top surface 14 of the body 12 and may extend about at least a portion of a periphery of the insole 10. The supportive ridge 34 may be in any suitable configuration, size, or shape. For example, the ridge 34 can be a rounded, elongated structure extending about the periphery of the insole 10. In some examples, the supportive ridge 34 comprises a plurality of concentric ridges about at least a portion of the periphery of the insole 10. For example, the insole 10 can comprise an outer ridge, an inner ridge, and/or a middle ridge about the periphery of the insole 10. The supportive ridge 34 may be a single continuous ridge extending about the periphery of the insole 10. Alternatively, the supportive ridge 34 may be made up of a plurality of segments 36 arranged around the periphery of the insole 10 to provide sufficient support for the foot. The support ridge 34 and/or segments 36 may be made from the same elastomer as the rest of the insole 10. The ridge 34 and/or segments 36 may be solid or hollow to achieve a desirable level of support for the foot. In some examples, the insole 10 can be trimmed for larger or shorter feet, and to appropriately tailor the anatomical portions of the insole 10 to a specific wearer's foot. As such, supportive ridge 34, when present, may be trimmed away to match the features of the insole 10 to a wearer's foot. Also, the insole 10 can be trimmed to match a size of the rim of the footwear article 110. In some examples, in order to facilitate trimming away portions of the ridges 34 and/or insole 10, the ridges 34 can comprise perforated portions or perforated lines. The perforated portions or perforated lines can be a guide for trimming or cutting the insole 10 to remove certain segments 36 of the ridges 34 and to conform the insole 10 to a desired size and/or shape.

In some examples, the insole 10 further comprises peripheral bubble chambers 38, similar in structure to the previously described bubble chambers 18, configured to provide support for peripheral portions of the wearer's foot. For example, the peripheral bubble chambers 38 can be elongated structures having a substantially rectangular base extending from the top surface 14 of the body 12. The peripheral bubble chambers 38 are arranged adjacent to the supportive ridge 34 around the periphery of the insole 10. In some examples, the peripheral bubble chambers 38 are arranged in a single line around the periphery of the insole 10, as shown in FIGS. 4A-4C. In other examples, the insole 10 can include additional peripheral bubble chambers 38 at selected portions of the insole 10 to provide increased support for specific portions of the wearer's foot. In some examples, the insole 10 can comprise multiple rows of peripheral bubble chambers 38 arranged about the periphery of the insole 10. If needed, the peripheral bubble chambers 38 provide support for the peripheral portions of the wearer's foot. If the peripheral bubble chambers 38 are not needed (e.g., the peripheral portions of the wearer's foot do not require additional support) and/or if peripheral portions of the wearer's foot are injured, the peripheral bubble chambers 38 can be deflated.

The insoles 10 described herein may be manufactured by any useful method, such as by 3D printing, molding of top and bottom portions of the insole 10, as in the case of bubble wrap, by molding a top layer over a shaped mold to form the upper profile of the insole, and applying and adhering a flat, bottom layer over the top layer, thereby trapping air in the formed bubble chambers 18. Layers of the insole body 12 can be laminated by any method, such as by heat or solvent welding, or by use of an adhesive. If the manufacture process, such as the 3D printing or lamination process, and therefore sealing of bubble chambers 18, is done under pressure of greater than one atmosphere, the bubble chambers 18 can be pressurized. Likewise, if the manufacture process, such as the 3D printing or lamination process, and therefore scaling of bubble chambers 18, is done under an atmosphere different from air, different gas mixtures can be introduced into the bubble chambers 18. The bubble chambers 18 also can be partially or fully filled with any suitable liquid during formation. In some examples, the bubble chambers 18 do not need to be fully inflated to be functional and/or to offer cushioning benefit.

Methods of Use for a Footwear Article for Pressure Relief

The footwear articles 110 and customizable insoles 10 described herein reduce occurrences of foot injuries by proving additional support for certain portions of a wearer's foot, while relieving pressure for portions of the foot that are especially susceptible to pressure injuries. For example, the footwear articles 110 and insoles 10 of the present disclosure can be used for a method of relieving pressure on a portion of a plantar surface of a foot of a wearer. More specifically, the method can relieve pressure from injuries and conditions including wound(s), graft(s), lesion(s), or defect(s) on the plantar surface of the wearer's foot.

With reference to FIG. 5, at step 210, the method can comprise providing a customizable insole 10 for offloading injuries on areas of a plantar surface of a wearer's foot, such as the previously described insoles 10 illustrated in FIGS. 3-4C. As previously described, the customizable insole 10 can include the body 12 having a shape corresponding to the plantar surface of the wearer's foot with the top surface 14, an opposing bottom surface 16, and the supportive, deformable, deflatable bubble chamber(s) 18 extending from the top surface 14 of the body 12. The bubble chamber(s) 18 of the insole 10 are configured to be deflated to relieve pressure on the plantar surface of the wearer's foot. As previously described, the body 12 can include the flat peripheral edge 22 sized to be received within the channel 130 defined by the rim 122 of the sole 110.

In some examples, the insole 10 is provided as a kit of parts including, for example, the insole 10, a pen for tracing a wearer's foot in order to size the insole 10 for the wearer, a push pin for deflating the bubble chambers 18, and stickers for covering holes or pierced portions of the bubble chambers 18. In some examples, a specially designed footwear article 110 can also be provided along with the kit. In other cases, a user or wearer may use a personal footwear article or a footwear article from another source with the insole 10 of the present disclosure.

At step 212, the method further comprises deflating the bubble chamber(s) 18 of the insole 10. In particular, a user (e.g., the wearer or a medically trained or untrained caregiver) may deflate the bubble chamber(s) 18 located at positions on the insole 10 corresponding to the portions of the wearer's plantar surface that are susceptible to injury and/or require pressure relief.

At step 214, the method further comprises placing the insole 10 with the deflated bubble chamber(s) 18 in a footwear article 110 including features of any of the previously described footwear articles. In particular, placing the insole 10 within the footwear article 110 can include inserting the peripheral edge 22 of the insole 10 into the channel 130 defined by the rim 122, such that the peripheral edge 22 is received and retained within the channel 130. As previously described, in some examples, the rim 122 includes protrusions 132 or other structures that engage the peripheral edge 22 to hold the peripheral edge 22 within the channel 130.

At step 216, the method further comprises positioning the wearer's foot in the footwear article 110 over or on the insole 10. When the wearer's foot is properly positioned, the portion(s) of the wearer's plantar surface in need of pressure relief should be over the deflated bubble chamber(s) 18 of the insole 10 to provide pressure relief for sensitive areas of the wearer's plantar surface.

The embodiments have been described with reference to various examples. Modifications and alterations will occur to others upon reading and understanding the foregoing examples. Accordingly, the foregoing examples are not to be construed as limiting the disclosure.

Preferred and non-limiting aspects or embodiments of the present invention will now be described in the following numbered clauses:

Clause 1: An article of footwear comprising: a sole comprising a bottom surface configured to contact ground when the article is worn by a wearer, a top surface opposite the bottom surface, and an inwardly directed rim extending about at least a portion of a periphery of the sole, wherein the rim defines a channel sized to receive a peripheral edge of an insole for retaining the insole over the top surface of the sole, and an upper attached to the sole defining an opening sized to receive a foot of the wearer, the upper being configured to secure the sole to the wearer's foot.

Clause 2: The article of clause 1, wherein the footwear article comprises athletic shoes, casual shoes, water shoes, surgical shoes, dress shoes, high-heel shoes, skates, ski boots, sneakers, boots, sandals, flip-flops, slides, walking casts, slippers, clogs, socks, stockings, and combinations thereof.

Clause 3: The article of clause 1 or clause 2, wherein the sole is formed from a substantially rigid material that does not substantially deform when weight of the wearer is applied to the sole.

Clause 4: The article of any of clauses 1-3, wherein the sole comprises an open cell or closed cell foam.

(Clause 5: The article of any of clauses 1-4, wherein the bottom surface of the sole is textured to provide a non-slip surface.

Clause 6: The article of any of clauses 1-5, further comprising a liner formed from a slip resistant and water resistant material, such as synthetic or natural rubber, attached to at least a portion of the bottom surface of the sole.

Clause 7: The article of any of clauses 1-6, wherein the rim extends radially inwardly by a distance of about 0.25 inch to about 0.75 inch over the top surface of the sole.

Clause 8: The article of any of clauses 1-7, wherein a lower surface of the rim contacts the insole, thereby securing the insole between the lower surface of the rim and the top surface of the sole.

Clause 9: The article of any of clauses 1-8, wherein the rim comprises one or more protrusions extending downwardly from the lower surface of the rim configured to contact the insole pressing the insole against the top surface of the sole to secure the insole in place within the channel defined by the rim.

Clause 10: The article of any of clauses 1-9, wherein the rim comprises a resilient material and is biased in a downward direction to press against the insole.

Clause 11: The article of any of clauses 1-10, wherein the rim extends about an entirety of the peripheral edge of the sole.

Clause 12: The article of any of clauses 1-11, wherein the upper comprises at least one strap for securing the sole to the wearer's foot.

Clause 13: The article of any of clauses 1-11, wherein the upper comprises a plastic shell forming a walking boot.

Clause 14: The article of any of clauses 1-11, wherein the upper comprises a waterproof enclosure.

Clause 15: The article of any of clauses 1-14, further comprising a cover layer secured to the rim and extending over the insole for separating a top surface of the insole from the wearer's foot.

Clause 16: The article of clause 15, wherein the cover layer comprises fabric.

Clause 17: The article of any of clauses 1-16, wherein the insole comprises an insole for offloading injuries on an area of a plantar surface of a patient's foot, the insole comprising: a body having a shape corresponding to the plantar surface of the patient's foot comprising a top surface and a bottom surface; and at least one supportive, deformable, deflatable bubble chamber extending from the top surface of the body, the at least one bubble chamber being configured to be deflated to relieve pressure on the plantar surface of the wearer's foot.

Clause 18: The article of clause 17, wherein the at least one supportive, deformable, deflatable bubble chamber comprises at least one notch extending inwardly from an outer surface of the at least one bubble chamber configured for a user to insert a needle through the notch and into an interior of the at least one bubble chamber to deflate the at least one bubble chamber.

Clause 19: An assembly comprising the article of footwear of any of clauses 1-18 and the insole configured to be retained by the channel defined by the rim of the sole, wherein the insole comprises a customizable insole for offloading injuries on the area of the plantar surface of the patient's foot comprising: a body having a shape corresponding to the plantar surface of the patient's foot comprising a top surface, a bottom surface, and a peripheral edge sized to be received within the channel of the sole; and at least one supportive, deformable, deflatable bubble chamber extending from the top surface of the body, the at least one bubble chamber being configured to be deflated to relieve pressure on the plantar surface of the wearer's foot.

Clause 20: The assembly of clause 19, comprising a plurality of the at least one supportive, deformable, deflatable bubble chambers, wherein at least one of the bubble chambers is independently deflatable.

Clause 21: The assembly of clause 19 or clause 20, wherein the at least one supportive, deformable, deflatable bubble chamber is positioned in a heel or calcaneus bone portion of the insole to relieve pressure on at least a portion of the heel of the patient's foot over the calcaneus bone.

Clause 22: The assembly of any of clauses 19-21, wherein the at least one supportive, deformable, deflatable bubble chamber is positioned in a plantar fascia portion of the insole to relieve pressure on at least a portion of the plantar fascia.

Clause 23: The assembly of any of clauses 19-23, wherein the at least one supportive, deformable, deflatable bubble chamber comprises at least one notch extending inwardly from an outer surface of the at least one bubble chamber configured for a user to insert a needle through the notch and into an interior of the at least one bubble chamber to deflate the at least one bubble chamber.

Clause 24: A method of relieving pressure on a portion of a plantar surface of a foot of a wearer, the method comprising: providing a customizable insole for offloading injuries on an area of the plantar surface of the foot, the insole comprising: (i) a body having a shape corresponding to the plantar surface of a patient's foot comprising a top surface, a bottom surface, and a substantially flat peripheral edge; and (ii) at least one supportive, deformable, deflatable bubble chamber extending from the top surface of the body, the at least one bubble chamber being configured to be deflated to relieve pressure on the plantar surface of the patient's foot; and deflating the at least one bubble chamber of the insole, wherein the at least one bubble chamber is located at a position on the insole corresponding to the portion of the patient's plantar surface requiring pressure relief; placing the insole with the deflated at least one bubble chamber in the article of footwear of any of clauses 1-18, such that the peripheral edge of the insole is at least partially received within the channel defined by the rim of the sole; and positioning the wearer's foot in the article of footwear such that the portion of the plantar surface in need of pressure relief is over the deflated at least one bubble chamber.

Clause 25: The method of clause 24, wherein the method relieves pressure from at least one of a wound, graft, or other damage, lesion, or defect on the plantar surface of the wearer's foot.

Modified Footwear Article Configured to Retain a Removable Insole

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