Patent Application
20250134209
The invention relates in general to orthopedic devices designed to enhance the alignment of the foot and ankle and in specific, it focuses on correcting flat feet in children aged 3-16 as well as adults with flexible flat-feet.
The foot is an intricate marvel of human anatomy, with its development in children spanning from birth to roughly the age of 16. This is the period when all bones and growth plates finalize their dimensions and positioning. The most pivotal stage of this development occurs up to age 7, during which a child's arch takes shape. Remarkably, at the age of 3, over half of the general pediatric population exhibits an undefined arch-a number that decreases to 24% by age 6. However, most footwear designed for children between the ages of 2 and 7 lacks essential support in the medial arch and stability features, leading to heightened muscle strain and overall foot fatigue.
When a foot exhibits excessive flexibility, it struggles to adequately support the body. As weight shifts from the lateral to the medial aspect of the foot, the medial longitudinal arch (MLA) may collapse, potentially leading to a forefoot varus deformity in one or both feet; a condition commonly referred to as “flat feet.” It's estimated that 75% of the population will experience foot issues at some point, and within this group, 25% will contend with varying degrees of flat feet or pes planus.
“Flat feet” refers to the abnormal pronation of the entire foot, originating at the subtalar joint. This condition often begins in childhood and tends to persist into adulthood, resulting in progressively flatter feet. Known as developmental flatfoot, this common musculoskeletal issue predominantly affects children under the age of 7 and is identified as a contributing factor to adult foot pain.
In cases of forefoot varus, the forefoot tilts inward relative to the sagittal plane cutting through the calcaneus, while in forefoot valgus, it tilts outward. Both conditions can manifest as flexible flatfoot. Forefoot varus, in particular, prompts excessive pronation at the subtalar joint by directing the body's weight axis medially. Consequently, forefoot varus stands as perhaps the most detrimental underlying cause of flatfoot. This misalignment often originates at birth and can worsen progressively through to adulthood.
Flat feet and varying degrees of ankle pronation pose a range of challenges for individuals across all age groups, including pain, postural abnormalities that may lead to arthritis, activity limitations, and occupational constraints. During the formative years between ages 3 and 16, young individuals can benefit from corrective devices aimed at improving alignment in the foot, ankle, and lower body. Consistent daily usage of these devices offers a proactive approach to guide and enhance bone alignment before reaching skeletal maturity.
Proper foot alignment during a child's formative years not only enhances overall biomechanical function but also mitigates the risk of future foot issues, including flat feet. Therefore, the introduction of devices and methods to curb excessive pronation is essential as soon as a child can stand. For adults who missed out on early interventions, the use of corrective devices remains crucial in minimizing further deterioration of ankle and joint health, particularly as they age and maintain active lifestyles.
Custom orthotic inserts are often created to accommodate the broad spectrum of foot sizes. These can be fabricated using various techniques such as plaster of Paris casts, impression foam, or 3D imaging. These custom insoles typically originate from a mold that replicates the 3D capture, employing synthetic resins or other suitable materials. A typical custom orthotic features a sturdy, resilient base that includes a heel and an arch section, designed to conform to the foot's underside. These orthotic inserts can be placed in footwear to help minimize foot pronation and offer therapeutic and corrective relief for various foot conditions.
What is required is a system of orthotic inserts that address unique anatomical features, offering appropriate arch height to stabilize the foot while providing overall structured support. While solutions exist, they are not without issues. The density and user experience of mass-produced options often result in discomfort and non-compliance (discontinued use). Moreover, custom solutions provided by healthcare professionals like doctors, orthotists, and podiatrists can be prohibitively expensive.
The University of California Biomechanics Laboratory (UCBL) shoe insert offers enhanced ankle control, although there have been instances of slippage within the shoe due to its abbreviated design or short insole length. Modifications such as adding plantar adhesives have been cited as potential solutions, although the durability of this approach may be short lived due to wear and tear.
In light of these limitations, there is a pressing need for advancements in orthopedic technology. A more effective solution would merge full-length devices with varying angles of correction, aiming to enhance ankle alignment and thereby mitigate both juvenile and adult hyperpronation. The goal is to conceive, refine, and introduce a device that effectively tackles the issues of flexible flatfoot and excessive pronation for both children and adults.
The current invention introduces a corrective orthopedic device designed to mitigate varying degrees of pronation in both adult and pediatric populations. The key features include a deep heel cup with a depth exceeding 20 mm, a long and pronounced medial arch support, and a full-length medial wedge. These elements collectively target the hindfoot, midfoot, and proximal forefoot to limit and prevent diverse degrees of pronation.
The device integrates a medial wedge with variable angles that extend to the ball of the foot, offering different correction levels i.e. 3 mm, 6 mm, or 9 mm. This feature aids in shaping the medial arch and promotes better alignment in the sub-talar and other lower body joints. The device combines both UCBL type deep-heeled devices with angled wedges, to promote optimal ankle alignment through growth phases and into adulthood. By encouraging the realignment of joints and bone structures in the foot and ankle complex, the device serves as a long-term corrective measure that minimizes the risk of pain, arthritis, and activity limitations.
The orthotic approach to flat feet hinges on the straightforward concept of sustaining proper biomechanical foot alignment. Therefore, counteracting excessive pronation becomes a priority as soon as a child is able to stand and walk independently. Proper foot alignment during development enhances overall foot function and minimizes the likelihood of future flatfoot related conditions. The current invention is structured to safeguard against deformities during growth; offer sufficient rigidity for support yet enough flexibility for natural foot movement, restore correct postural foot alignment, alleviate discomfort, and curb abnormal or excessive pronation.
The current invention in corrective orthopedic devices focuses on an combination of wedges and angled elements designed to enhance ankle alignment, thereby mitigating juvenile hyperpronation and promoting superior alignment in adults. The invention encompasses the following key components:
Equipped with full-length cushioning, the device is designed for enhanced comfort, thus garnering higher user acceptance. It features a comprehensive plantar section engineered to align seamlessly with the inner sole of footwear. Moreover, the lateral and medial sidewalls, originating from at least a section of the plantar and heel cup components, unify to form a single structure that offers significant metatarsal and lateral arch support.
Early identification of excessive pronation is vital for children, as it helps foster proper foot development. The current invention aims to re-establish optimal biomechanical foot positioning, offering a solution for early intervention. By maintaining correct biomechanical alignment from a young age, this device sets the stage for healthy postural development and foot alignment throughout a child's formative years. For adults, the device works to reconfigure the feet into a biomechanically sound position, enhancing ankle alignment and overall stability while counteracting deforming forces.
The innovation fundamentally revolutionizes the field of orthopedic appliances by emphasizing a proactive, corrective and preventive approach to foot and ankle alignment. This stands in stark contrast to older, accommodative orthotic devices that primarily serve a reactionary role, offering temporary relief from pain without targeting the underlying misalignment issues. These older devices often operate on a symptom-driven basis, focusing on immediate comfort rather than long-term structural correction. The current invention not only alleviates symptoms but actively works to correct the anatomical irregularities in growing children between the ages of 3 and 16, as well as in adults with flexible flat feet. Thus, the invention marks a paradigm shift from merely managing discomfort to fundamentally correcting and preventing musculoskeletal issues, promising more sustainable outcomes for lower body joint health in the long term.
Designed as a single, integrated unit, the device can be incorporated directly into footwear during manufacturing. Various molding techniques such as thermoforming, injection molding, or vacuum molding make mass production feasible either as an integral part of the shoe or as a separate insert that can be added to pre-existing footwear.
In one embodiment, the device is crafted from a durable, malleable, lightweight material, ideally polypropylene. Utilizing mobile camera scans and AI technology, the method involves determining the most suitable fit for the pre-manufactured device to enhance long-term compliance and minimize fitting issues. This device can either be integrated between a shoe's inner and outer linings during its creation or retrofitted into existing footwear. Alternatively, it can be custom-molded for individual orthotic needs and then added to a pre-existing shoe.
Engineered to offer both motion control and foot stabilization, the device mitigates foot pronation through a novel combination of components. It provides targeted support at the metatarsal heads, along the medial longitudinal arch, and at the heel.
A primary aim of this invention is to create a device that corrects flat foot conditions and addresses varying levels of pronation in both children and adults.
It is further another object of the present invention to not merely prevent misalignment but also to actively reposition existing bone structures for improved biomechanical results over time, with regular and consistent daily use.
It is further another object of the present invention to deliver a more cost effective solution compared to currently available custom solutions.
It is further another object of the present invention to provide a solution with enhanced cushioning features, thereby increasing comfort and user acceptance in comparison to existing market options.
It is further another object of the present invention to provide a device that can alleviate pain, enhance walking mechanics, boost sports and athletic performance, minimize wear on ankle and knee joints, and generally improve skeletal alignment in the lower body.
Embodiments herein will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the scope of the claims, wherein like designations denote like elements, and in which:
Referring to
The rear foot portion 11 comprises a heel portion 10 that runs medially from the back of the heel portion 10 to the forefoot 13 and includes a concave deep heel cup 16 extending in a semi-circumferential manner around the sides and back of the heel cup 16. Heel cup 16 ranges from 20 to 35 mm high as measured from the center of the heel cup 16. The device 100 further comprises a plantar portion 15 that merges with the soft medial flange 17 and lateral flange 18 of the device 100. Similarly, medial and lateral flanges 17 and 18 merge with heel cup 16.
According to
According to
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Wedge body 30 comprises a layer of wedge material that extends from the rearfoot portion 11 to the first Metatarso-phalangeal joint (MTPJ) 14 in forefoot portion 13 which angles the entire rearfoot 11, midfoot 12 (sub talar joint) and proximal forefoot 13 in a corrective aligned position. These angles would vary from 3 mm-9 mm of correction which can be translated directly to degrees if required. Wedge transition plane tapers from wedge body 30 to the forefoot portion 13 so as to provide a smooth transition. Wedge body 30 has a varied degrees of inclines. This layer 30 is not visible from outside or lateral aspect of the device 100.
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The corrective profile 20 further has a neutral plantar arch fill 32 to obtain flat surface for wedge addition and provide neutral rearfoot stability. The height of the arch fill 32 may be increased or decreased to accommodate different degrees of forefoot varus deformities and foot flexibility and provides a lateral longitudinal arch support 28 to stabilize the mid and rearfoot.
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Flanges 17 and 18 are generally higher near heel cup 16. By having heel cup 16, attached to plantar portion 15 and medial and lateral flanges 17 and 18, the device of the invention 100 functions as a single unit to control the movement of the foot in the shoe. The device 100 provides support to the heel portion 10, midfoot portion 12 and forefoot portion 13 of the foot entirety in a medial or varus angle to reduce varied degrees of sub-talar joint and midtarsal joint pronation (i.e. mild, over and hyperpronation). The key feature of the invention is the combination of a deep and supportive corrective orthopedic device with a 20 mm+ heel cup depth 16, long and pronounced medial arch support 26, high medial flange 17 (to contain soft tissue splay), full length cushioned top cover 25 and the corrective wedge profile 20 (in varied degrees).
In shoes with traditional insole the heel cup can twist and expand relative to the rest of the shoe. This twisting of the heel cup allows the heel to rotate, resulting in misalignment of the foot. In contrast, and referring again to
In conventional shoes with standard insoles, the heel cup has a tendency to twist and expand in relation to the shoe's overall structure. This allows the heel to rotate, leading to foot misalignment. However, in the present invention, as illustrated in
In contrast with the existing devices and according to
The present invention 100 supports the majority of the bones in the foot and ankle including: distal tibia, distal fibula, talus, calcaneus, cuneiforms, navicular, cuboid, metatarsal bones (×5), proximal phalanges (×5). Joints supported by this device are the following: Rearfoot: talocrural joint, subtalar joint, midtarsal joint (calcaneo-cuboid & talo-navicular joints), Midfoot: tarsometatarsal joints×5, Forefoot: MTP joints (metatarsal-phalangeal joints×5).
According to
Referring to
The device 100 is made from a material that strikes a balance between rigidity and flexibility. It's rigid enough to maintain its shape, offering structural support particularly during the growth phases in children. Simultaneously, the material is flexible enough to permit normal foot movement. The device realigns the foot's posture, minimizes discomfort, and curtails abnormal pronation while still allowing for the natural flexing of the plantar portion, arches, and joints during walking. The chosen material is lightweight to avoid adding significant weight to the shoe. Suitable materials may include foam, rubber, thermoplastic, and cork. In one specific embodiment, the device is fabricated from polypropylene, which possesses the requisite rigidity for sustaining arch support. Compression molding is one technique employed to manufacture the device.
Given that individuals differ in both the degree of pronation in their walking style and body weight, the device 100, may be custom made. One approach involves creating a mold of a person's foot and adjusting that mold to yield a device that offers therapeutic benefits for the user. This device can be positioned between the inner and outer layers of a shoe, either during the shoe's manufacturing process or added to existing footwear. During the production of device 100, AI-powered foot scanning technology can be employed to identify the most suitable fit, thereby minimizing issues related to improper sizing.
According to
The device can be produced on a large scale using various molding methods, such as thermoforming, injection molding, or vacuum molding, and can either be integrated into the shoe during the manufacturing process or inserted into prefabricated shoes.
In an embodiment, an array of devices, varying in both size (corresponding to shoe sizes) and shape (differing arch configurations), are created using vacuum molding. To do this, a set of master molds mimicking preferred foot shapes for different sizes are produced using established orthotic techniques. A distinct mold is prepared for each foot size. These molds could be crafted by starting with a standard-sized foot model and making necessary adjustments to accommodate larger or smaller feet. Alternatively, these master molds could be created from negative impressions taken directly from real feet.
In an embodiment, the device 100, is mass-produced using injection molding. This method involves both a positive mold, shaped like a foot, and a surrounding negative cast. The configuration allows for a gap between the positive and negative elements, into which molten plastic is injected. Once solidified, this plastic forms a molded piece that serves as the rigid component of device 100.
The foregoing should be viewed only as an illustrative guide to understanding the invention's principles. As the field is subject to constant changes and adaptations, the invention is not limited to the precise details described. Instead, all appropriate modifications and equivalents that fall within the invention's scope are accepted.
With respect to the above description, it's understood that experts in the field will find the ideal relationships between the invention's components in terms of dimensions, form, materials, functionality, and operation methods both apparent and straightforward. All such relationships, whether depicted in the drawings or described herein, are intended to be included within the scope of the current invention.
