INSERT AND SUPPORT FOR PREVENTING FOOT FATIGUE AND WEAKNESS

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application No. 62/335,181, filed on May 12, 2016 and titled "Insert and Support for Preventing Foot Fatigue and Weakness" the entire contents of which are incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION [0002] Many children and adults have flat feet and it is widely recognized as a cause of generalized foot pain and fatigue. Adults purchase a multitude of products to alleviate aches, pains and fatigue symptoms resulting from flat feet. These expenditures encompass remedies ranging from powders and pain medications to pads and pumice stones. These expenditures also encompass expensive custom molded orthotics and invasive surgery. Adults commonly try to palliate what they believe to be the effect of normal wear and tear on their feet. Some of the pain and fatigue from flat feet could have, however, been prevented with more attention being paid to foot function at an earlier age, especially in childhood.

[0003] Children with flat feet often grow into adults with flatter feet. Developmental flatfoot is a common condition affecting the musculoskeletal system of children under six years of age. Though children with flatfeet may not have the same complaints or symptoms as their adult counterparts, this does not mean that their condition should go undiagnosed or untreated. Children may not present with the chief complaint of "arch pain" or "heel cord tightness." Children's symptoms are often disguised as tired, achy feet with the inability to run and keep up during play activities. Children often complain of foot and leg cramps, this being associated with overpronation of the foot and leg muscles, which can result from flat feet.

[0004] The development of the normal pedal arch is the topic of some debate. Some authorities contend that the arch is present at birth and that it is obscured by a fat pad, which later disappears to reveal the skeletal arch. Others contend that the arch is absent at birth and slowly develops over the next five years of a child's life. The clinical absence or collapse of the patient's medial longitudinal arch is commonly referred to as flatfoot. This collapse may be defined as the abnormal pronation of the entire foot which occurs at the subtalar joint. Abnormal pronation may be caused by compensation for structural abnormalities of the foot or leg, response to forces that load the medial side of the foot, muscle imbalances caused by neuromuscular disease or other factors that result in collapse of the arch.

[0005] There are many classifications for flatfoot, including pathological versus physiological, congenital versus acquired and rigid versus flexible, etc. For example, the flexible flatfoot describes a foot that has a normal arch during non-weight bearing conditions that collapses during stance or during other weight bearing conditions. An overwhelming majority of beginning standers and walkers present with the flexible flatfoot.

[0006] Diagnosis of a flexible flatfoot in the adult and pediatric population goes beyond clinical observance and visual inspection. A biomechanical examination of the child is typically required, which includes measurements of the lower extremities from the hips to the toes or other techniques accepted by those having ordinary skill in the art. This examination typically includes tests in both open and closed chain kinetics and an analysis of the child's gait pattern.

[0007] Evaluation of the lower extremities generally begins at the level of the hip. During the first year of development, the ratio of external to internal rotation of the hip is typically 2: 1, respectively. By the age of one, this ratio typically becomes closer to 1 : 1 with the internal rotation of the hips. Infants are generally born with approximately thirty-one to thirty-eight degrees (31 -38°) of femoral neck anteversion, which clinically presents as greater internal rotation of the hips past the age of three. Normal ontogeny dictates that this medial femoral torsion will typically reduce to approximately sixteen to twenty-one degrees (16-21 °) by adulthood. These events culminate in generally symmetrical hip rotation by about age six. At the same time the distal one-third of the tibia is undergoing external torsion starting at an axis approximately zero to ten degrees (0-10°) from the frontal plane and finishing at approximately twenty -two degrees (22°). These developments of the patient's anatomy work in conjunction to bring the human foot plantar-grade for ambulation. Two causes of compensatory flexible flatfoot may be internal tibial and femoral torsion. It should also be noted that increased medial load causing flexible flatfoot has been attributed to the converse, external tibial and femoral torsion.

[0008] Measuring ankle dorsiflexion in the young child can diagnose primary equinus as a cause of flexible flatfoot; correction of which is preferred for normal foot function. Typically less than twenty degrees (20°) of ankle dorsiflexion from the approximate ages of birth to five years old may lead to primary equinus later in life. Indeed, a normal range of ankle dorsiflexion at age three is approximately twenty to twenty-five degrees (20-25°), which typically diminishes to approximately ten degrees (10°) by about the age of fifteen. Dorsiflexion at this joint should be attempted with both knee extended and knee flexed. Decreased ankle dorsiflexion with both the knee extended and flexed indicates a gastro- soleal equinus; while limited dorsiflexion with knee extended only, is indicative of gastrocnemius equinus. Limited ankle dorsiflexion can lead to compensatory and abnormal subtalar joint pronation and later, flexible flatfoot.

[0009] The forefoot to rearfoot relationship is important when evaluating the flexible flatfoot. This relationship is measured while the subtalar joint is in neutral and the midtarsal joint is locked on the rearfoot complex. In forefoot varus the forefoot is inverted to the sagittal bisection of the calcaneus, while in forefoot valgus, it is everted. Both are etiologies of flexible flatfoot. Embryological development, typically dictates that the foot is in an inverted position in utero and begins to evert at the sixteenth week. This eversion continues through the early childhood years but, the forefoot may not become fully plantar-grade in time for ambulation. The resulting forefoot varus is compensated by pronation at the subtalar joint and subsequent eversion of the calcaneus. It has been estimated that an approximate four-degree (4 ^° ) forefoot varus will cause maximal pronation at the subtalar joint by shifting the axis of body weight medially. For this reason, forefoot varus may be the most destructive cause of flexible flatfoot.

[0010] During ambulation or static stance, the abnormal pronatory motion or pronated position of the foot may be responsible for chronic low grade foot and postural

symptomatology when compared to any other type of foot problem. As has been mentioned, the etiology of the pronation is very important and furthermore, pronation, which everts the calcaneus, is considered more pathological than that which allows the calcaneus to remain vertical during weight bearing.

[0011] The angle of the posterior vertical axis of the calcaneus to the supporting surface, during stance, is called the relaxed calcaneal stance position ("RCSP"). The RCSP is a measurement that indicates the position of the calcaneus in the frontal plane after all compensatory pronation has taken place at the subtalar joint. In essence, this measurement is a quick method to scientifically determine the amount of pronation that is present in a given foot. The normal foot, while relaxed instance, should have a bisection of the posterior surface of the calcaneus that is perpendicular to the supporting surface. If the calcaneus is inverted to the transverse plane then it is considered to be in varus, if it is everted then it is in valgus. One of the criteria set forth for flatfoot includes relaxed calcaneal valgus.

[0012] Misalignment of the foot can often be present at birth and continues to deform through growth to adulthood. Proper alignment of the foot during development improves the child's function and prevents future foot problems associated with flatfoot. Thus, there is a need for devices and methods for preventing excessive pronation as soon as a child is old enough to stand and should be used in adults who have developed these problems through their development.

[0013] It would be desirable to design, develop and implement a device that addresses the described flatfoot and excess pronation in children and adults.

BRIEF SUMMARY OF THE INVENTION

[0014] Briefly stated, preferred embodiments of the present invention relate to an orthopedic device for the prevention of excess pronation in children and adults. Excess pronation or flattening of the longitudinal arch of the foot is associated with the development of problems intrinsic to the foot such as heel spurs, bunions and hammertoes as well as symptoms extrinsic to the foot such as knee pain and low back pain. The shoe wear industry has attempted through corrective shoes to control some of the excess pronation of certain users. Insert modifications as well as heel modifications, such as the Thomas heel, have been utilized for years but have been relatively ineffective. The development of an in-shoe modification based upon biomechanical principles and design can control excess pronation and prevent or limit symptoms from developing in a large percentage of the patient population. With the adult and child population world-wide being extremely active, there is a high incidence of lower extremity fatigue and weakness secondary to excess pronation.

[0015] One recognized treatment of the flexible flatfoot is the supportive and functional foot orthosis. Four criteria that a pediatric orthotic should meet include:

(i) accommodate structural deformity and protect the foot during growth;

(ii) be rigid enough for support but be flexible enough to allow for normal foot motion;

(iii) restore proper postural alignment of the foot; and

(iv) the materials create a secure foot-orthotic interface.

[0016] In addition, goals of the pediatric orthotic may include: (a) reduction of discomfort;

(b) increased participation in activity;

(c) reduction of normal shoe wear; and

(d) reduction of abnormal pronation and less calcaneal eversion at RCSP.

[0017] Orthotic therapy for the pediatric flatfoot is based upon a simple premise. By maintaining the child's foot in its proper biomechanical alignment during development, foot function improves and deforming forces are limited. For this reason, it is essential that excessive pronation be neutralized as soon as a child is old enough to stand. With proper alignment of the foot during development, the goals are to improve the child's function and to prevent future foot problems associated with flatfoot. Some of the problems associated with flatfoot are painful heel spurs, bunions and hammertoes.

[0018] Many practitioners base their use of pediatric orthotics on research that indicates orthotics can limit pronation and correct RCSP and, with time, can improve the osseous relationships of the longitudinal arch. This improvement may be attributed to establishment of normal equilibrium allowing increased tightness of the ligaments in the arch. Orthotics are considered by some to not provide long term cures for flatfeet, but shoe inserts may provide relief of pediatric flatfoot symptoms. In any case, the value of the pediatric orthotic is generally known.

[0019] Misalignment of the foot causes the foot to hit the ground off balance and leads to foot, knee, leg and back pain, which is typically remedied by surgery, prescribed custom orthotic insoles/inserts or over-the-counter insoles/inserts. For example, various orthotic designs are available for treating pain caused by excess or hyperpronation. The Whitman plate was a steel device that made it uncomfortable to pronate. The Helfet heel seat was made to reinforce the heel cup on the shoe and prevent medial breakdown. The Schaffer design has a medial support but does not provide control of calcaneal eversion. A

University of California Biomechanics Laboratory ("UCBL") shoe insert provides more control but there are reports of sliding in the shoe and the need for modification including a medial outrigger.

[0020] The observation of excess pronation may be made as soon as a child starts to ambulate. The majority of children may go undetected until they bear full weight and wear shoes. Early recognition and detection of excess pronation and its control is essential to allow the foot to develop in a normal position with normal contour of soft tissue and bone.

[0021] Unfortunately, many children continue to function in an abnormal and excessive pronated position throughout their childhood, adolescence and into adulthood. It is for this reason that the insert modification and over-the-counter inserts are indicated for all age groups who are of a weight bearing capacity. Ideally in a younger age category, the concept of preferred embodiments of the present invention deals with restoration of normal position with an allowance of the osseous and soft tissue structures to realign and adjust to the new biomechanically correct positioning of the feet and lower extremities. As age increases, the chance for realignment and remolding of the osseous and soft tissue structures of the patient's foot and leg becomes less and the need for control becomes that much more continuous so that these patients can be maintained in a controlled position with the use of the device of the preferred embodiments of the present invention.

[0022] Sporting activities accelerate and exaggerate pronation, thus increasing symptoms and the need to control becoming greatly preferred. It is for this reason that the preferred embodiments of the present invention are useful in the age category beginning with weight bearing in the child at approximately one to one and one-half years (1-1 ½ yrs.) of age and continuing through the geriatric population, including patients of weight bearing age and of any age wherein the patients are able to ambulate. The preferred invention itself can take on various physical forms that include at least the following:

1- Part of the actual insole of the shoe, whether it is a casual, dress, running,

walking, boot, sandal, loafer, sneaker, wedges, clogs or heels. This would be part of the construction of the shoe itself and would be immovable.

2- A device that can be placed within the shoe (include the above shoe types) and be removable.

3- A prefabricated device size-dependent and age-dependent, which could be

dispensed in the office of a Podiatrist, Orthopedist, Pediatrician, Chiropractor, or Physical Therapist etc., as the need is determined.

4- The availability of the device to be purchased as an insert as an over-the-counter product.

[0023] Preferred embodiments of the present invention relate to an early age insert support that fosters healthy posture, foot alignment and stability in the crucial early years of a child's growth, as well as relating to the adult version of the insert support. Unlike products that focus on the treatment of pain, the insert according to preferred embodiments of the present invention is designed to help prevent and improve fatigue, painful foot ailments and provide on-going support for the adult and as a child's foot grows.

[0024] The information cited concerning the child's treatment with orthoses, applies to the adult as well. Early recognition and early treatment of adult flatfoot disorders will minimize the progression of those deformities secondary to the pathogenesis of

biomechanical abnormalities.

[0025] The insert design according to preferred embodiments of the present invention preferably achieves the following three aspects:

(i) improves foot function and limits deforming forces by maintaining the

child's foot in its preferred and proper biomechanical alignment during development;

(ii) neutralizes excessive pronation in the adult and child; and

(iii) improves the foot function and limits or prevents future foot problems

associated with flatfoot by preferred and proper alignment of the foot.

[0026] Another aspect of the preferred embodiments of the present invention relate to a shoe product comprising the insert support.

[0027] The preferred embodiments of the present invention further relate to a method of preventing foot fatigue or improving a child's foot function. The method comprises providing the child a shoe product comprising an insert support according to a preferred embodiment of the present invention.

[0028] Briefly stated, the preferred present invention is directed to an orthotic device for preventing or limiting hyperpronation in a the child and adult population. The orthotic device includes a heel seat, medial and lateral flanges and medial and lateral pads associated with the medial and lateral flanges. The heel seat is configured for substantially

surrounding a lower side of the calcaneus. The heel seat is laterally tilted at an acute angle and configured to leave the calcaneus in an approximate two to three degree inversion. Edges of the heel seat extend along sides of the foot. The medial and lateral flanges are attached to the heel seat. The medial and lateral flanges are configured to extend along sides of the foot along sides of at least portions of the first and fifth metatarsals of the foot, respectively. The heel seat, the medial flanges and the lateral flanges are configured to stabilize the foot and limit end range motion in sagittal, frontal and transverse planes. The medial and lateral pads are associated with the medial and lateral flanges and define a cutout therebetween. The cutout is positioned at least partially on a longitudinal axis of the orthotic device.

[0029] In another aspect, the preferred present invention is directed to an orthotic device for preventing or limiting hyperpronation in a foot having a calcaneus and a forefoot. The orthotic device includes a heel seat, medial and lateral flanges attached to the heel seat and medial and lateral pads associated with the medial and lateral flanges. The heel seat is configured for substantially surrounding a lower side of the calcaneus. The heel seat is also configured to leave the calcaneus in an approximate two to three degree inversion. Edges of the heel seat extend along sides of the foot. The medial and lateral flanges are configured to extend along sides of the foot along sides of at least portions of the first and fifth metatarsals of the foot, respectively. The heel seat, the medial flanges and the lateral flanges are configured to stabilize the foot and limit end range motion in sagittal, frontal and transverse planes. The medial and lateral pads define a cutout therebetween. The cutout is positioned at least partially on a longitudinal axis of the orthotic device. The medial pad defines a medial pad length measured substantially parallel to the longitudinal axis and the lateral pad defines a lateral pad length measured substantially parallel to the longitudinal axis. The lateral pad length is greater than the medial pad length.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0030] The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0031] Fig. 1 is a front perspective view from a medial aspect of an insert support in accordance with a first preferred embodiment of the present invention;

[0032] Fig. 2 is a top perspective view of the insert support of Fig. 1 ;

[0033] Fig. 2A is a cross-sectional view of the insert support of Fig. 1, taken along line 2A-2A of Fig. 2;

[0034] Fig. 3 is a bottom perspective view of the insert of Fig. 1 ;

[0035] Fig. 3 A is a bottom plan view of an alternative embodiment of the insert of Fig. 1 ;

[0036] Fig. 4 is a top plan view of the insert of Fig. 1, wherein the insert is positioned within a shoe;

[0037] Fig. 5 is a side perspective view of an insert support in accordance with a second preferred embodiment of the present invention;

[0038] Fig. 6 is a top perspective view of the insert of Fig. 5;

[0039] Fig. 6A is a cross-sectional view of the insert support of Fig. 5, taken along line 6A-6A of Fig. 6; and

[0040] Fig. 7 is a bottom perspective view of the insert of Fig. 5. DETAILED DESCRIPTION OF THE INVENTION

[0041] Certain terminology is used in the following description for convenience only and is not limiting. Unless specifically set forth herein, the terms "a", "an" and "the" are not limited to one element but instead should be read as meaning "at least one". The words "right", "left", "lower" and "upper" designate directions in the drawings to which reference is made. The words "inwardly" or "distally" and "outwardly" or "proximally" refer to directions toward and away from, respectively, the patient's body, or the geometric center of the preferred insert and related parts thereof. The words, "anterior", "posterior", "superior," "inferior", "lateral," "medial" and related words and/or phrases designate preferred positions, directions and/or orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import.

[0042] It should also be understood that the terms "about," "approximately,"

"generally," "substantially" and like terms, used herein when referring to a dimension or characteristic of a component of the invention, indicate that the described

dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally the same or similar, as would be understood by one having ordinary skill in the art. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

[0043] Referring to Figs. 1-7, preferred embodiments of a pediatric and adult insert support 10, 10' are comprised of orthopedic devices that control hyperpronation or generally provide stability to the user's foot and leg. Referring to Figs. 1-4, a first preferred insert support or a pediatric insert support 10 is generally designed for use by the pediatric patient population. Referring to Figs. 5-7, a second preferred insert support or an adult insert support 10' is generally designed and constructed for use by the adult patient population. The preferred pediatric and adult insert supports 10, 10' are described herein utilizing the same reference numerals to identify similar features between the two embodiments, with a prime symbol (') utilized to distinguish the features of the adult insert support 10' from the pediatric insert support 10. Hyperpronation (over pronation, excess pronation) is the cause of fatigue pain, joint remodeling and joint degeneration in flatfoot conditions. Flatfeet require a greater deal of energy expenditure due to more muscular effort and instability inherent in this foot type. [0044] The insert supports 10, 10' according to the preferred embodiments of the present invention prevent or limit hyperpronation of the foot by substantially controlling all three planes of motion at the subtalar (above the heel) and midtarsal (posterior of the tarsals and anterior of the talus) joints. The preferred insert supports 10, 10' accommodate structural deformity and protect the foot during growth or during normal use with materials that create a secure foot-orthotic interface.

[0045] Referring to Fig. 3 & 7, the insert supports 10, 10' according to first and second preferred embodiments of the present invention or the pediatric insert support 10 and the adult insert support 10', are fitted with a two to three degree (2-3 ^° ) varus inverted heel post F, F', which pitches the heel of the foot medially to stabilize the intrinsic bones and works to limit calcaneal eversion in the frontal plane and subsequent hyperpronation at the subtalar joint. This further prevents the foot to flatten or pronate into an abnormal position that will create pain and deformity. The varus inverted heels F, F' may have a height of two to three centimeters (2-3 cm), but are not so limited and may have smaller or greater heights, based on patient or clinical need. The pediatric and adult insert supports 10, 10' also have a heel cushion E, E', which prevents or limits injury to the heel growth plate and restores proper postural alignment of the foot. The heel cushion E, E' is preferably located in the heel seat A, A' and is positioned proximate the calcaneus when the foot is positioned on the orthotic device 10, 10' in the working or mounted configuration.

[0046] Referring to Fig. 1-3, 5 & 6, the pediatric and adult insert supports or orthopedic devices 10, 10' also have a cutout D, D' positioned between a medial pad 12, 12' and a lateral pad 14, 14'. The cutouts D, D' are preferably defined by the medial and lateral pads 12, 12', 14, 14'. The medial pad 12, 12' is preferably configured to support at least the first ray of the foot and the lateral pad 14, 14' is preferably configured to support at least the fifth rays of the foot. The medial and lateral pads 12, 12', 14, 14' are also configured to allow independent motion during the gait cycle and restore proper postural alignment of the foot. In the preferred embodiments, the cutouts D, D' are positioned approximately three to seven centimeters (3-7 cm) from the distal edge of the insert supports 10, 10', but are not so limited an may be positioned at a greater or less distance from the distal edge, but are preferably positioned on or along a longitudinal axis Z, Z' of the insert supports 10, 10'. The medial and lateral pads 12, 12', 14, 14', therefore, preferably have a width of three to seven centimeters (3-7 cm), but are not so limited and may be wider or narrower depending on the size of the preferred insert supports 10, 10', the preferred size of the cutouts D, D' and other factors related to the preferred design. [0047] The adult version of the insert support 10' has the split cutout D' positioned over a forefoot extension G' of the insert support 10' (Figs. 5-7). The forefoot extension G' preferably extends beyond a distal or forefoot end of the cutout D' and the medial and lateral pads 12', 14'. The cutout D, D' is preferably positioned on or centered along the

longitudinal axis Z, Z' of the insert supports 10, 10' at the forefoot side of the insert supports 10, 10'. The cutout D, D' preferably has a cutout length L, L' and a cutout width W, W and the insert supports 10, 10' preferably have a forefoot width WF, WF' at the forefoot end. The forefoot width WF, WF' is preferably measured substantially perpendicular relative to the longitudinal axis Z, Z'. In the first and second preferred embodiments, the cutout length L, L' is approximately three to seven centimeters (3-7 cm) from the distal insert edge, the cutout width W, W is approximately two and one-half centimeters (2½ cm) wide at its cutout distal end and preferably tapers to a three-quarter centimeter (¾ cm) width at its cutout proximal end and the forefoot width WF, WF' is sized based approximately on the size of the patent's or user's foot. The cutout width W, W preferably tapers from its cutout distal end width to the cutout proximal end width. Each of these preferred dimensions is not limiting and may be modified based on patient or clinical need. The cutout width W, W is preferably measured substantially perpendicular to the longitudinal axis Z, Z'. The cutout D, D' is preferably positioned on the longitudinal axis Z, Z' and is substantially centered along the longitudinal axis Z, Z' in the preferred embodiments, but is not so limited and may be arranged in an offset arrangement relative to the longitudinal axis Z, Z' depending on patient anatomy and designer or medial professional preferences.

[0048] Referring to Figs. 1-3 A, in the first preferred embodiment, the pediatric insert support 10 is comprised of a left-foot support 10 wherein the medial and lateral pads 12, 14 terminate anteriorly or distally at substantially the same length L along the longitudinal axis Z. Referring to Fig. 3A, in an alternative first preferred embodiment, the pediatric insert support 10 is comprised of a right-foot support 10, wherein the medial pad 12 extends further distally along the longitudinal axis Z than the lateral pad 14. The alternative pediatric insert support 10, accordingly, defines a medial pad length L _M and a lateral pad length LL, wherein the medial pad length LM is greater than the lateral pad length LL. The medial and lateral pad lengths L _M , L _L are preferably measured substantially parallel to the longitudinal axis Z. The alternative preferred insert support 10 is not limited to having the medial pad length L _M being greater than the lateral pad length L _L and may be configured with the lateral pad length L _L being greater than the medial pad length L _M or may be configured similar to the first preferred insert support 10 with the lateral and medial pad lengths L _L , L _M , being substantially the same. Referring to Fig. 3A, in the alternative first preferred embodiment, the lateral pad length L _L is approximately one and one-quarter to two (1 ¼ - 2) times greater than the medial pad length L _M . As a non-limiting example, the lateral pad length L _L may be approximately one and one-half inches (1 ½") and the medial pad length L _M may be approximately one and eight hundredths inches (1.08"). The medial and lateral pad lengths L _L , L _M are not limited to having these non-limiting example dimensions and may be otherwise sized and configured to conform to the size and shape of the patient's foot based on designer and medical professional preferences. Referring to Fig. 6, in the second preferred embodiment, the medial and lateral pads 12', 14' have medial and lateral pad lengths L _M ', L _L ' that are designed and configured similarly to the lateral and medial pad lengths L _L , L _M of the first preferred embodiment and are measured substantially parallel to the longitudinal axis Z'.

[0049] Referring to Figs. 1-7, the pediatric and adult insert supports 10, 10' are also equipped with relatively high medial flanges B, B' and relatively high lateral flanges C, C, as seen in Fig. 1, 4 & 5. The medial and lateral flanges B, B', C, C are attached to the heel seat A, A'. The medial flanges B, B', lateral flanges C, C and heel seat A, A' preferably have a height H, H' of approximately two to three centimeters (2-3 cm), but may be smaller or larger, depending on patient or clinical need and may have the same, similar or a different height when compared to the medial flanges B, B'. Together with the deep heel seat A, A', shown in Fig. 1, 2, 5 & 6, the flanges B, B', C, C generally prevent or limit movement along the transverse plane relative to the insert supports 10, 10' by preventing or limiting abduction of the forefoot at the mi dtarsal joint ("MTJ") and the spreading of the metatarsals, which both occur secondary to pronation at the subtalar joint ("STJ"). The deep heel seat A, A' preferably has the height H, H' of two to three centimeters (2-3 cm), but is not so limited and may have smaller to greater heights based on a particular patient or clinical need. The medial flange B, B' provides support to the medial arch of the foot and inhibits flattening in the sagittal plane. The preferred medial flange B, B' has the height H, H' of approximately two to three centimeters (2-3 cm), but is not so limited and may have a smaller or greater height based on clinical need or patient need. The height H, H' of the medial flange B, B' is preferably, substantially the same as the height H, H' of the deep heel seat A, A', at least where the two components meet at the rear corners of the pediatric and adult insert supports 10, 10'. The deep heel seats A, A' are preferably constructed of a relatively dense and semi-rigid material to a relatively flexible material that is able to take on the general size and shape of the deep heel seat A, A', withstand the normal operating conditions of the deep heel seat A, A' and perform the preferred functions of the deep heel seat A, A', as is described in detail herein. The height H, H' of the medial and lateral flanges B, B', C, C also preferably taper downwardly as they extend toward a distal end of the medial and lateral pads 12, 12', 14, 14', respectively.

[0050] Referring to Figs. 1-2 A, in the first preferred embodiment, the deep heel seat A is laterally tilted and leaves the calcaneus in an approximate two to three-degree (2-3 ^° ) inversion. The deep heel seat A preferably defines an acute angle Δ to accommodate the tilt that is measured relative to a substantially horizontal plane P. The heel seat A is not limited to defining the acute angle Δ, but preferably includes the acute angle Δ to address the patient's hyperpronation.

[0051] Referring to Figs. 1-7, certain preferred inserts 10, 10' may be able to bring an average Resting Calcaneal Stance Position ("RCSP") of approximately six degrees (6°) of valgus to neutral. This orthotic is beneficial to children generally ages two to sixteen (2-16) years old, because, as the foot is held in alignment, the relationships of immature bones and joints are allowed to optimally develop. In this manner the preferred pediatric insert supports 10, 10' not only serve to limit pediatric flatfoot symptoms but also works to prevent painful symptoms from occurring in adulthood.

[0052] The preferred orthotic devices 10, 10' both preferably define the acute angle, Δ, Δ' such that the heel seat A, A' is laterally tilted and configured to leave the calcaneus in an approximately two to three-degree (2-3°) inversion. Edges of the heel seat A, A' preferably extend along sides of the foot, along with the medial and lateral flanges B, B', C, C to support the patient's foot in the mounted or working configuration and to limit end range motion in sagittal, frontal and transverse planes. The medial and lateral flanges B, B', C, C are also configured to extend along sides of the foot in the mounted configuration, preferably along sides of at least portions of the first and fifth metatarsals of the foot, respectively. The deep heel seats A, A' preferably define the acute angle Δ, Δ' to accommodate the tilt that is measured relative to the substantially horizontal plane P. The heel seat A, A' is not limited to defining the acute angle Δ, Δ', but preferably includes the acute angle Δ, Δ' to address the patient's hyperpronation. The acute angle Δ, Δ' is also not limited to being comprised of a two to three-degree (2-3°) angle and may include larger angles, such as five degrees (5°) or ten degrees (10°) for corrective purposes or smaller angles, such as one degree (1°) for more subtle correction or maintenance of the patient's condition. [0053] Custom molded rigid orthotics for small children can become problematic because their feet are constantly growing. This problem may be approached by production of shoe gear that contains a built-in, lightweight, molded insert that corresponds to the size of the shoe and thus the foot. Rubber orthotics or insoles of similar materials are preferably firm enough to resist compression and prevent abnormal arch depression while maintaining normal posting values are excellent examples of suitable materials for children.

[0054] The insert supports 10, 10' according to the preferred embodiments of the present invention can be made of varying durability, strength and stiffness materials, including polymeric materials, such as ethylene vinyl acetate ("EVA"). Shoes containing built-in EVA pediatric and adult insert supports 10, 10' are preferably constructed using methods in view of the present disclosure such that the insert supports 10, 10' are able to take on the general size and shape of the preferred insert supports 10, 10', withstand the normal operating conditions of the insert supports 10, 10' and function in the preferred manner of the insert supports 10, 10', as is described herein. Any child old enough to stand, preferably after the age of two (2) years, to prevent foot fatigue and improve foot function, may wear the shoes, with the preferred insert supports 10 inserted or built into the child's shoes.

[0055] To increase the awareness, the insert supports 10, 10' can be clearly marked, e.g., by a green branded medallion, in the shoe. The shoe box containing the shoe can also be clearly marked, e.g., by a sticker. This will let the parents or users know that their children's or their own feet are Good to Grow or are associated with the shoes that the user is purchasing or wearing.

[0056] Referring to Figs. 1-7, the preferred orthotic devices or pediatric or adult insert supports 10, 10' are designed and configured for limiting hyperpronation in the patient's foot. The preferred orthotic devices 10, 10' are specifically designed and configured to support and align the patient's lower extremities, specifically containing and supporting the calcaneus or heel bone of the patient's foot. The patient's foot also includes the forefoot, which is typically considered to include the anterior aspect of the foot having the five metatarsal bones, the fourteen phalanges and associated soft tissue structures. When the patient's foot is positioned in the preferred orthotic devices 10, 10', the heel seat A, A' substantially surrounds or contains a lower side of the calcaneus.

[0057] The preferred orthotic devices or inserts 10, 10' are configured to reduce fatigue and weakness to muscles of the foot and create a substantially constant secure foundation by limiting excess pronation. The orthotic devices or inserts 10, 10' may be configured for a child or an adult to include a varus inverted heel or heel pad A, A' having the acute angle A, A' of approximately 2-3 degrees (2-3°) or other acute angles A, A', as was described in greater detail above. The heel cushion E, E' is preferably associated with a bottom of the inserts 10, 10' to provide support for the patient's heel bone or calcaneus. The cutout D, D' is preferably positioned forwardly relative to the heel cushion E, E', which is positioned within the heel pad A, A'. Referring to Fig. 4, the orthotic devices or inserts 10, 10' are preferably designed and configured for insertion or integral assembly with a shoe S. The shoe S may be any type and variety of shoe for adult or pediatric use, such as a casual shoe, sneaker, dress shoe, running shoe, walking shoe, boot, sandal, loafer, wedges, clogs, heels or other shoe S. The orthotic devices or inserts 10, 10' preferably prevent foot fatigue in a child or an adult, by providing to the foot of the adult and child, a shoe S or over-the- counter insert 10, 10', as was described above.

[0058] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the present disclosure and as is identified in the claims.