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.
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.
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.
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.
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
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
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
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
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
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
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
In other examples, as shown in
With reference again to
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
In another examples, as shown in
In another example, as shown in
In another example, as shown in
With reference to
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.
With reference to
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
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
With continued reference to
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
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.
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
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.
The present application claims the benefit of U.S. Provisional Patent Appl. No. 63/285,534, filed Dec. 3, 2021, the disclosure of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/051686 | 12/2/2022 | WO |