AN IN-SHOE INSOLE TO PROVIDE COMFORT AND REDUCE PAIN IN HIGH HEELED SHOES AND BOOTS, CONSTRUCTED FROM AN ANATOMICALLY SHAPED LAST

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application No. 62/981,714, filed on February 26, 2020 and titled “In-Shoe Insole and Insert to Provide Comfort and Reduce Pain in High Heeled Shoes and Boots, Constructed from an Anatomically Shaped Last” the entire contents of which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

[0002] An issue that has perplexed shoe companies, shoe designers, insole manufacturers, insert makers and the buying population, is how to make a high heeled shoe or boot more comfortable and reduce fatigue and minimize pain. Despite advances in footwear and orthotics, foot pain and discomfort resulting from wearing of high heeled footwear remains a problem. Adults purchase an infinite number of products to alleviate this pain and discomfort. These expenditures encompass remedies ranging from powders and pain medications to pads and pumice stones. These costs 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. However, some of this pain and discomfort could have been prevented with more effective distribution of mechanical forces that are applied to the forefoot, arch and heel during everyday activities.

[0003] Completely soft insoles are not effective, as the shoe wearer may find that they initially, completely love the feeling of slipping their foot into a shoe with a soft, cushiony insole, but in reality, completely soft types of insoles do nothing to fix the root problem: misalignment of the feet. A good insole should provide a mixture of supportive, hard structures and softer structures which work together to reshape the alignment of your feet. Insoles for the foot work much like braces for teeth, applying pressure to specific areas in order to move them into correct or nearly optimal position.

[0004] An effective insole redistributes weight to reduce “hot spots.” While shoe insoles certainly do help many people overcome foot pain, this is typically not the case with high heeled shoes. Through realignment of the feet, shoe insoles have been shown to help with pain and inflammation in these “hot spots” of the foot, particularly with high heeled shoes.

[0005] Many insoles provide support and stability to the arch while completely ignoring the front and rear of the foot. An effective insole has zones of support and cushioning designed to retrain your muscles and tendons to move in a more natural way.

[0006] There is an anatomically-ideal pattern for foot movement while walking, running and standing. These motions, from the rear lateral heel, through the center of the arch and finally pushing off at the inside of the big toe, cannot be supported by simply bracing the arch. The insoles should encourage the movement with the correct motion through flexibility, stability and alignment. [0007] From a medical perspective, wearing high heels is not advised. High heels drastically change the gait and posture, and prolonged wearing can have lasting and often negative effects on the body. It is realized that for purposes of fashion many people still choose to wear these shoes and creating an insole to minimize the pressure points associated with wearing high heels is desirable such that the insole creates the most effective comfort and biomechanical positioning for the wearer of high heeled shoe.

[0008] The area beneath the metatarsal heads is a common location of forefoot pain, calluses and neuropathic foot pain, and such conditions are often associated with high plantar pressures in high heel shoes. Physical fatigue and injury may be caused by repeated impact and the peak pressure force between the foot and the insole of the shoe during gait in high heels.

[0009] In the normal population, a proper protection mechanism for mechanical stimulation during gait is applied to protect the body, but if the foot peak pressure, shear or stress is concentrated on one spot such as the heel, arch or forefoot, as in a high heel shoes, malformations such as hyperkeratosis (calluses), pain, hallux valgus, claw toe, hammer toe, heel pain, metatarsalgia and plantar fasciitis may develop.

[0010] The plantar fat pad tissue under the heel, aids in the distribution of contact loads and provides shock absorption during locomotion. The heel region is commonly associated with pain in high heel shoes. Plantar fasciitis is the most common cause of this plantar heel pain. It is commonly defined as an overload injury of the proximal plantar fascia at the infra-calcaneal origin. An everted heel may allow for more displacement of the plantar calcaneal fat pad to the sides of the bone and, therefore, less shock absorption directly to the heel during impact (i.e., heel strike). With heel strike, the fat pad no longer rests under the heel but spreads and bulges to the medial and lateral sides, thereby decreasing the shock absorption under the heel

[0011] Several methods of decreasing foot pressure, shear and stress by applying a foot orthosis, insert, wedge, or gait strategies have been used to reduce these forces to varying degrees of success. [0012] Foot orthoses are frequently used in sports for the treatment of overuse complaints with sufficient evidence available for certain foot-related overuse pathologies like plantar fasciitis, heel pain, arthritis and foot pain ( e.g ., metatarsalgia). One important aim is to reduce plantar pressure, shear and stress under prominent areas like metatarsal heads and shock absorbing areas like the heel. For the forefoot region, mainly two common strategies exist: metatarsal pad (MP) and forefoot cushioning (FC), for the rearfoot heel area: a neutral to inverted heel-seat with added cushioning. [0013] A survey conducted by the American Podiatric Medical Association showed some forty- two percent (42%) of women admitted that they would wear a shoe they liked even if it gave them discomfort. The basic inserts of a good shoe must be anchored by a sturdy, invisible shank, supported by a firmly positioned heel and comfortable footbed. A shoe should be rigid so that the woman can rest weight on her heel, without having to balance and throw her weight to the ball of her foot. Basic inserts are unable to fit into the narrow, high heeled shoe, if so, they will create cramping in the shoe.

[0014] A high heeled shoe must meet the ground directly under the center of the heel bone, which carries the majority of a woman's weight at the heel and transfers the weight to the midfoot. This center of gravity is measured by measuring the ankle joint/subtalar joint centered on the sagittal and frontal plane over the heel. This will place more weight in the rearfoot foot and diminish weight to the metatarsal heads. The heel can absorb more shock and compression than the forefoot under the metatarsal heads. The standard high heeled shoe does not reduce peak pressure to the metatarsal heads by transferring weight equally to the rear and midfoot. The standard high heeled shoe forces an increased peak pressure to the metatarsal heads.

[0015] In the world of shoe making, the first tool used is a foot shaped mold called a “Last.”

The Last model determines the toe shape, heel height and fit. There is an old adage used in the footwear industry that “the Last shall come first,” literally meaning that each Last model must be developed before design, patterns and production can take place.

[0016] A mass production Last is a symmetrical pair of Lasts that are straighter and flat one the bottom in design and do not take into consideration the anatomical contoured shape of the human foot. Mass production Lasts are designed for fashion and shelf appeal and the straighter shape allows for ease of manufacturing on mass production machinery. Podiatric physicians often blame the mass production Last for many of the foot related injuries and deformities seen in the wearer’s toes and ball joint areas.

[0017] It is desirable to modify, redesign and/or rearrange the above-described mass production Last to address the deficiencies of the mass production Last.

[0018] The human fat pad of the heel provides three useful functions during gait: shock reduction, increase energy dispersion, and protection against excessive plantar pressure. During the initial contact phase of heel-toe walking, deformation of the heel fat pad lowers the peak force, and rate of loading of the lower limb. The fat pad undergoes considerable vertical deformation, about nine to eleven millimeters (9 to 11 mm), during the typical gait cycle. In addition, at heel strike, the fat pad of the heel, acting as a natural cushion, collapses letting the fat pad bulge away laterally and medially, and losing its cushioning effect on the heel bone. It would be desirable to recreate this biomechanical effect with an improved insole created from an improved Last.

[0019] The above-described limitations of known remedies for addressing foot pain in high heeled shoes result in an opportunity to improve patient comfort and outcomes. The preferred present invention is comprised of an in-shoe insole/insert with an anatomically shaped Last that can reduce the discomfort in the areas of the foot that most men and woman complain of being painful while working, walking and/or standing, particularly in high heeled shoes while addressing the shortcomings of the above-described prior art systems and components.

BRIEF SUMMARY OF THE INVENTION

[0020] Briefly stated, preferred embodiments of the present invention relate to an orthopedic insole and related Last for high heeled footwear that reduces foot pressure to the forefoot, arch and heel while not affecting the design fashion, the size of a shoe Last, size of the shoe and not take up space within the shoe, nor cramp the foot within the shoe. Excess foot pressure is associated with the development of problems intrinsic to the foot such as hyperkeratosis (calluses), pain, hallux valgus, claw toe, hammer toe, heel pain, and plantar fasciitis as well as symptoms extrinsic to the foot such as knee pain and low back pain. The shoe wear industry has attempted through orthotic inserts and insoles to alleviate foot pain and discomfort. However, insole and insert modifications have been relatively ineffective. With the adult population world-wide being extremely active, there is a high incidence of lower extremity fatigue and weakness secondary to onset of foot malformations.

[0021] Orthotics are considered by some to not provide long term cures for foot pain and discomfort, but shoe inserts may provide relief of symptoms. In any case, the value of orthotics is generally known.

[0022] Malalignment 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 hyperkeratosis (calluses), hallux valgus, claw toe, hammer toe, heel pain, and plantar fasciitis.

[0023] The preferred device has a raised portion of the heel that is designed to be of substantially the same configuration as the lower part of the heel bone, or Os Calcis, of a human foot. The under-arched portion of the Last is shaped substantially as indicated in drawings appended hereto. The preferred device is longitudinally arched or convexed upwardly between the heel and the junctions of the metatarsal heads. In short, the under surface of the heel and instep or arched portion of the Last is of such configuration as to form a snug fit with an insole reinforcing plate, steel or relatively rigid shank and firm to rigid material i.e:. fiberglass, carbon fiber. The inferior surface of the Last bears a shape complementary to that of the foot of a wearer of such a shoe that will be properly and comfortably supported. The insole of such a shoe will have a depression corresponding to the projections heel of the Last, this depression being adapted to receive and conform to the heel bone with elevated cupping side walls. Within this depression in the heel and in the forefoot insole of the shoe, an area will house a silicone gel pad, having a durometer to minimize shock or similar shock absorbent material provided or cushions of any suitable soft material reducing impact to the heel and forefoot, under the metatarsal heads.

[0024] The preferred invention relates to an insole constructed from a shoe Last that may be built and preferably conforms to the anatomical shape of an average human foot, not only the upper part of the foot, but the lower portion, as well as to correspond to the conformity of the integrated and mirrored insole. These shoe Lasts provide an improved Last which is employed as a means for forming an insole according to an orthopedic or foot supporting design and also to form the sole itself or to form any other Last members such as arch supports, orthotics and inserts. [0025] A contoured arch-bed insole is then created from the anatomically shaped Last and the insole reduces the vector force of the reactive force of the ground to the high heeled position of the foot and diminishes to the forefoot.

[0026] The heel pad provides three useful functions during gait: shock reduction, energy dissipation, and protection against excessive plantar pressure. During the initial contact phase of heel-toe walking, deformation of the heel fat pad lowers the peak force, and rate of loading of the lower limb. The fat pad undergoes considerable vertical deformation, about nine to eleven millimeters (9 to 11 mm), during the gait cycle. In addition, the heel will be cupped to hold the fat pad of the heel under the honey prominences, acting as a natural cushion, preventing the fat pad from bulging away. To further cushion the heel, a gel pad is incorporated within the insole. The forefoot, plantarflexed metatarsal heads are cushioned with the gel pad.

[0027] The preferred Last shown in the appended drawings has a raised portion of the heel that is designed to be of substantially the same configuration as the lower part of the heel bone,

Calcaneus or Os Calcis, of a human foot. The under-arched portion of the Last is shaped substantially as indicated in the appended drawings; in that the Last is longitudinally arched or convexed upwardly between the heel and the junctions of the metatarsal heads. In short, the under surface of the heel and instep or arched portion of the Last is of such configuration as to form a snug fit with an insole reinforcing plate, steel shank and firm to rigid material i.e.: fiberglass, carbon fiber. The inferior surface of the Last bears a shape complementary to that of the foot of a wearer of such a shoe that will be properly and comfortably supported. The insole of such a shoe will have a depression, corresponding to the projections heel of the Last, wherein this depression is preferably adapted to receive and conform to the heel bone with elevated cupping side walls. Referring to the appended drawings, within this depression in the heel and in the forefoot insole of the shoe, an area houses a gel pad, having a durometer to minimize shock or similar shock absorbent material provided or cushions of any suitable soft material reducing impact to the heel and forefoot, under the metatarsal heads.

[0028] 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 high heel shoe, which may have a height of twenty to one hundred twenty millimeters (20- 120mm) or more, high heel boot or high heeled sandal. This would be part of the construction of the shoe itself and is preferably, generally immovable.

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

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

4- The preferred invention can be constructed and comprised of carbon fiber, fiberglass, resin impregnated fiber composites, leather, or other appropriate materials.

[0029] Preferred embodiments of the present invention relate to an insert that fosters foot comfort by supporting/comfort to the metatarsal heads, the distal central metatarsal shafts, mid-foot arch, and the heel of the foot. 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 decrease fatigue, painful foot ailments and provide support with its mirrored construction from the anatomically shaped Last.

[0030] The preferred embodiments of the present invention further relate to a method of preventing foot fatigue or improving an adult’s foot function. The method preferably comprises providing the adult a shoe product comprising an insole support according to an embodiment of the present invention.

[0031] The embodiment is for a permanently fixed insole/insert in a shoe that can be a high heel shoe, high heel boot or high heeled sandal; this embodiment can also be produced as an over-the counter insole/insert.

[0032] This embodiment can also replace the shank and paperboard insole and be incorporated in the shoe as the new designed insole bed and covered in leather.

[0033] The preferred purpose of the construction of the Last, with insert/insole, is to provide a way to reduce foot pressure, shear or stress to the forefoot, arch and heel, while not affecting the design fashion, size of the shoe and not take up space in the shoe, nor cramp the foot within the shoe and being replicated directly from the inferior surface of the Last.

[0034] The preferred embodiment is for a permanently fixed insole/insert in a high shoe, high heel boot or high heeled sandal, that is mirrored from the bottom surface of the anatomically based Last. This preferred embodiment can also be produced as an over-the counter insole/insert. This preferred embodiment, with its multiple layers, can also replace the shank and paperboard insole and be incorporated in the shoe as the newly designed insole bed and covered in leather. [0035] In another aspect, the preferred invention relates to an insole constructed from an anatomically created Last, that is built and correctly conforms to the average human foot, not only the upper part of the foot, but the lower, inferior portion. The preferred and improved Last corresponds to the conformity of the integrated and mirrored insole with the bottom of the Last. These improved Lasts provide a new design approach, wherein the Last employs features for forming an insole according to orthopedic or foot supporting biomechanical principles.

[0036] A contoured arch-bed insole is preferably created from the anatomically shaped Last and the insole reduces the increased, direct vector force of the reactive force of the ground to the metatarsal heads with the high heeled position of the foot. This is accomplished by allowing the arch and heel position of the Last with its mirrored insole to be in a closely parallel position to the ground. This allows a shift of weight proximally, away from the metatarsal heads and back onto the arch and heel surfaces. This new and improved design diminishes the forefoot peak pressure, particularly in high heeled shoes.

[0037] By mirroring the insole to the anatomically constructed Last of the preferred invention, the insole is cupped on the posterior, medial and lateral borders preventing the fat pad from bulging away from under the heel bone. This maintenance of cushioning the heel, along with a compressible gel pad incorporated within the insole, further reduces peak pressure at heel contact, thereby reducing forces and stresses on the wearer’s feet.

[0038] The preferred Last has been designed and constructed with three-dimensional (“3-D”) renderings of the normal foot. The principal object of the preferred invention is to provide the preferred Last, in conjunction with a conformed insole, by means of press molding or injection molding, whereby the shoe is completed on this anatomical Last and mirrored insole.

[0039] The above is addressed with the steel shank or is comprised of Fiber reinforced materials, i.e.: carbon fiber, fiberglass, resin impregnated fiber composites, leather, gel, silicon durometers or other appropriate materials.

[0040] Briefly stated, the preferred invention is directed to an orthopedic insole for support of a wearer’s foot in a high-heeled shoe. The orthopedic insole includes a first portion with a first supporting/comfort pad, a second portion having a front end and a rear end, and a third portion with a second supporting/comfort pad. The second portion has a front end and a rear end. The third portion has a second end and a heel end. The first portion has a first end and a toe end. The first portion also has a first pad cavity configured to receive the first supporting/comfort pad. The first end is connected to the front end and the second end connected to the rear end. The third portion has a second pad cavity configured to receive the second supporting/comfort pad. The first, second and third portions are integrally formed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0041] 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:

[0042] Fig. l is a side perspective view of an insole support and an anatomical Last in accordance with a preferred embodiment of the present invention;

[0043] Fig. 2 is a top plan view of the insole support of Fig. 1, without a leather or other top cover in accordance with the preferred embodiment of the present invention;

[0044] Fig. 3 is a side perspective view of the insole support of Fig. 1 overlaid under a generally phantom foot, demonstrating affixing the preferred insole support with screws to an outsole of a shoe in accordance with the preferred embodiment of the present invention;

[0045] Fig. 4 is a side elevational view of the insole support of Fig. 1, positioned under a phantom foot demonstrating affixing the insole with screws to an outsole of a show in accordance with the preferred embodiment of the present invention;

[0046] Fig. 5 is a bottom plan view of the preferred insole support of Fig. 1;

[0047] Fig. 6 is a side perspective, partial cross-sectional view of the insole support of Fig. 1 overlaid within the high heeled shoe, wherein the insert is positioned within the shoe with fasteners and the shoe is partially cut-away for clarity;

[0048] Fig. 7 is a side perspective view of an anatomically contoured Last in accordance with a preferred embodiment of the present invention; and

[0049] Fig. 8 is a bottom plan view of the anatomically contoured Last of Fig. 7.

DETAILED DESCRIPTION OF THE INVENTION [0050] 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 “below”, “above”, “under” “bottom”, top”, "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” 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.

[0051] 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.

[0052] Referring to the drawings in detail, wherein like numerals indicate like elements throughout, there is shown in Figs. 1-8 an orthopedic system, generally designated 10, that is designed for providing support for a person’s shoes, particularly high heeled shoes. The orthopedic system 10 includes an orthopedic device or insole 10A that is configured to be adapted to a shoe, preferably as an integral part thereof, but may alternatively be designed and configured as an insert (See e.g., Fig. 6), thereby supporting/comforting the heel, metatarsal heads, and distal central metatarsal shafts of a foot and provide comfort to the metatarsal heads and heel. The orthopedic system 10 also preferably includes an anatomical Last 10B that is designed and configured for forming the shoe around the insole 10 A.

[0053] The orthopedic insole 10A of the present embodiment, may be comprised of a variety of materials including polyethylene, carbon fiber, fiberglass, resin impregnated fiber composite, plastic, leather, urethane, silicone, gels, combinations of these materials or other appropriate material that is able to take on the general size and shape of the insole 10A, withstand the normal operating conditions of the insole 10A and perform the preferred functions of the insole 10 A. The orthopedic insole 10A preferably includes a top surface 1 la, an internal central piece, a bottom surface 11c, a first portion 14 with a first supporting/comfort pad 12, a second portion 20 with or without a third supporting/comfort pad (not shown), and a third portion 24 with a second supporting/comfort pad 22, where a first end of the first portion 14 is connected to a front end of the second portion 20 and a second end of the third portion 24 is connected to a rear end of the second portion 20. The second portion 20 is positioned between the first and third portions 14, 24 and is oriented at an angle relative to the first and third portions 14, 24 to lift the third portion 24 off of or away from the ground surface on which the wearer is standing. The first portion 14, in the working configuration when the wearer is wearing the shoe, is typically oriented on a plane generally parallel to a ground surface on which the wearer is standing and the second portion 20 is oriented at an angle to the plane or ground surface. A first stiffening rib or medial, gradual arch rise 26 protrudes upwardly from the lateral side to the medial of the second portion 20 and a second stiffening rib or rise 27 protrudes upwardly from a first lateral or the lateral side to the medial side of the second portion 20. The first portion 14 and third portion 24 are substantially planar and the second portion 20 has an arcuate contour that is configured to correspond to an arch support of the shoe. The first portion 14 also preferably includes a toe end spaced forward relative to the first end and the third portion 24 preferably includes a heel end that is spaced rearwardly relative to the second end.

[0054] In the preferred embodiment, the first portion 14 has a first end 14a and a toe end 14b, the second portion 20 has a front end 20a and a rear end 20b and the third portion 24 has a second end 24a and a heel end 24b. The first end 14a is connected to the front end 20a and the second end 24a is connected to the rear end 20b. The first portion 14, the second portion 20 and the third portion 24 of the preferred insole 10A are integrally formed or molded, preferably injection or press molded, such that the first, second and third portions 14, 20, 24 are integrally formed in a single manufacturing operation. In the preferred process, the first, second and third portions 14, 20, 24 of the insole 10A are integrally molded with a polyethylene material, such that the first and front ends 14a, 20a and the rear and second ends 20b, 24a are integrally formed together with the same polymeric material to secure the first, second and third portions 14, 20, 24 together. The insole 10A is not limited to being integrally formed with the first, second and third portions 14, 20, 24 and the first, second and third portions 14, 20, 24 may be separately designed, formed and thereafter connected together to define the insole 10 A, wherein each of the first, second and third portions 14, 20, 24 may be formed of different or the same materials.

[0055] The first portion 14 has a first pad cavity 13 and the third portion has a second pad cavity 23 that are preferably comprised of indentations or cavities in the top surface 1 la of the insole 10A that generally do not extend through the bottom surface 1 lb. The first and second pad cavities 13,

23 preferably include bottoms and cavity edges that have substantially the same peripheral profile as a peripheral profile of the first and second supporting/comfort pads 12, 22, respectively. The first and second pad cavities 13, 23 are preferably so configured to snuggly receive the first and second supporting/comfort pads 12, 22 therein in the working configuration for proper placement of the first and second comfort pads 12, 22 on the insole 10 A. The first and second pad cavities 13, 23 are not so limited and may be comprised of holes that extend through the insole 10A or may be comprised of markings on the insole’s 10A top surface 11a that direct positioning of the first and second supporting/comfort pads 12, 22, respectively. The first and second pad cavities 13, 23 are preferably shaped, designed and configured for receiving the first and second supporting/comfort pads 12, 22 for engagement of the pads 12, 22 to the insole 10A and proper placement of the first and second supporting/comfort pads 12, 22. The first and second pad cavities 13, 23 are preferably sized such that the first and second supporting/comfort pads 12, 22 are positioned such that their top surface is close to or positioned slightly above a plane defined by the top surface 11a adjacent the first and second pad cavities 13, 23 in the assembled configuration, respectively. The first and second pad cavities 13, 23 are not so limited and may be otherwise sized and configured for proper positioning of the first and second supporting/comfort pads 12, 22 on the insole 10 A. The second portion 20 may also include a third pad cavity (not shown) for receipt of or configured to receive the third supporting/comfort pad (not shown) but is not so limited and may be designed and configured without the third supporting/comfort pad and the third pad cavity without significantly impacting the performance and functioning of the preferred insole 10 A.

[0056] The first and third portions 14, 24 are not limited to being substantially planar and may have a certain amount of arc or curvature in portions, particularly at and near edges of the third portion 24, to conform to the wearer’s foot to increase comfort or form to the shape of the wearer’s foot. For example, the third portion 24 may have a cup-shaped configuration that arcs around the sides of the wearer’s heel or at the side borders 19 of the third portion 24. This configuration of the third portion 24 promotes comfort and support of the wearer’s heel and other shapes and sizes may be utilized depending on the shape, size and configuration of the wearer’s heel. Similarly, the first portion 14 may have curves and arcs to support the wearer’s forefoot, including the wearer’s metatarsal heads, phalanges and metatarsal bones and related soft tissue. In the preferred embodiment, the first portion 14 is generally positioned slightly above and on a first portion plane generally parallel to a plane of the floor or the ground the wearer is standing on, the third portion 24 is positioned above the floor and typically on a third portion plane that is oriented at a slight angle sloping downwardly toward the floor and the second portion 20 is positioned on a second portion plane at a greater angle relative to the floor and the first and second portion planes sloping at a greater angle relative to the floor to connect the first and third portions 14, 24, typically depending on the height of the heel of the associated shoe.

[0057] The preferred insole 10A also preferably includes a first pad cavity 13 in the first portion 14 and a second pad cavity 23 in the third portion 24. The first and second pad cavities 13, 23 are preferably sized and configured to receive the first and second supporting/comfort pads 12, 22 therein to ensure proper placement and positioning of the first and second supporting/comfort pads 12, 22 during assembly. The first and second pad cavities 13, 23 of the preferred embodiment are integrally formed with the insole 10A and include a bottom such that the first and second pad cavities 13, 23 do not extend through the insole 10 A, however, the first and second pad cavities 13, 23 are not so limited and may extend completely through the integrally formed insole 10A or may be comprised of a target or marking on the insole 10A that provides a target or template for attachment or engagement of the first and second supporting/comfort pads 12, 22 on the insole 10A. The insole 10A may further include a third pad cavity (not shown) to assist with positioning, placement and attachment of the third supporting/comfort pad. The first, second and third pad cavities 13, 23 preferably have the same or nearly the same peripheral shape as the first, second and third supporting/comfort pads 12, 22 for relatively simple positioning and engagement of the first, second and third supporting/comfort pads 12, 22 to the insole 10A. The first pad cavity 13 may specifically extend through the first portion 14 from the top surface 1 la to the bottom surface 1 lb of the first portion 14 but is not so limited and may be comprised of the preferred first pad cavity 13 with the bottom that does not extend through the bottom surface 1 lb. In addition, the second pad cavity 23 may specifically extend through the third portion 24 from the top surface 1 la to the bottom surface 1 lb of the third portion 24 but is not so limited and may be comprised of the preferred second pad cavity 23 with the bottom that does not extend through the bottom surface 1 lb. [0058] The first, second and third portions 14, 20, 24 of the preferred orthopedic insole 10A are preferably integrally constructed of a single, relatively rigid material that receives the first and second supporting/comfort pads 12, 22 thereon. The first second and third portions 14, 20, 24 of the preferred embodiment are integrally formed with a polyethylene material, graphite or other relatively rigid polymeric material, but are not so limited and may be integrally formed by machines metals, wooden materials, powdered metals or combinations of materials, such as relatively rigid polymeric materials and a steel or other metal shank positioned thereon. The preferred first, second and third portions 14, 20, 24 may specifically be integrally molded with a polyethylene material with the pad cavities 13, 23 that receive the first and second supporting/comfort pads 12, 22, as well as the optional third supporting/comfort pad (not shown). The first, second and third portions 14,

20, 24 may alternatively be integrally formed by three-dimensional (“3D”) printing but are not so limited. The integrally formed first, second and third portions 14, 20, 24 preferably define a backbone of the orthopedic insole 10A that has a significantly reduced weight when compared to prior art insoles, resulting in an approximately eighty percent (80%) reduction of weight when compared to conventional insoles. The preferred orthopedic insoles 10A define the insole of the shoe and are not positioned in the shoe as an after-market product, in that the orthopedic insoles 10A are constructed as part of the shoe with the sole, heel, counter, upper, liner, vamp and other portions of the manufactured shoe. The first, second and third portions 14, 20, 24 define medial, lateral and posterior edges 25 of the orthopedic insole 10A that are at the edges of the show adjacent the liner for supporting the bottom of the wearer’s foot during use. The medial, lateral and posterior edges 25 preferably rise up and are configured to form a cupping around inferior sides of the wearer’s heel to provide stability to the wearer’s heel when wearing the shoe with the preferred insole 10 A. The lateral and posterior edges 25 have a height. The lateral edges 25 run or extend distally and are incorporated into a medial arch rise on the second portion 20.

[0059] The first supporting/comfort pad 12 may be comprised of a supporting material, such as urethane, gel, silicon, rubber, foam, a fluid gel, a viscoelastic gel material, combinations of these materials or other materials that would be appropriate for the first supporting/comfort pad 12 based on a review of the present disclosure and is configured to support the metatarsal heads by absorption of shear forces with proper pressure distribution in a working configuration. Particularly, the first supporting/comfort pad 12 is positioned within an opening in the first portion 14 of the orthopedic insole 10A such that the first supporting/comfort pad 12 traverses the top and bottom surfaces 11a,

1 lc of the orthopedic insole 10 A. This arrangement permits a top surface of the first supporting/comfort pad 12 to extend from the top surface 11a of the orthopedic insole 10A to contact the metatarsal heads and a bottom surface of the first supporting/comfort pad 12 to extend from the bottom surface 1 lc of the orthopedic insole 10A to contact an interior of the shoe, thereby mechanical forces between the shoe and the metatarsal heads are directly transmitted in an uninterrupted manner. In the preferred embodiment, the first, second and third portions 14, 20, 24 define the upper and lower surfaces 11a, 1 lb of the insole 10A. The first supporting/comfort pad 12 is preferably configured for positioning proximate metatarsal heads of the wearer’s foot in the working configuration when the user is wearing the shoe.

[0060] The second supporting/comfort pad 22, similar to the first supporting/comfort pad 12, is comprised of a supporting material, such as urethane, gel material, silicon, rubber, foam, a fluid gel, a viscoelastic gel, combinations of these materials or other materials that would be appropriate for the second supporting/comfort pad 22 based on review of the present disclosure and is configured to support and position proximate the wearer’s heel in a working configuration. Particularly, the second supporting/comfort pad 22 is positioned within an opening in the third portion 24 of the orthopedic insole 10A such that the second supporting/comfort pad 22 traverses the top and bottom surfaces of the orthopedic insole 10A. This arrangement permits a top surface of the second supporting/comfort pad 22 to extend from the top surface 1 la of the orthopedic insole 10A to contact the heel and a bottom surface of the second supporting/comfort pad 22 to extend from the bottom surface 1 lc of the orthopedic insole 10A to contact an interior of a shoe, thereby mechanical forces between the shoe and the heel are directly transmitted in an uninterrupted manner. The second supporting/comfort pad 22 is preferably configured for positioning proximate a heel of the wearer’s foot in the working configuration when the user is wearing the shoe.

[0061] The third supporting/comfort pad (not shown), similar to the first and second supporting/comfort pad 12, 22, is comprised of a supporting material, such as urethane, gel material, silicon, rubber, foam, a fluid gel, a viscoelastic gel, or other appropriate materials that would be appropriate for the third supporting/comfort pad and is configured to support the midfoot and distal central metatarsal shafts of the wearer’s foot in the working configuration. Particularly, the third supporting/comfort pad is positioned on the second portion 20 of the orthopedic insole 10A such that a top surface of the third supporting/comfort pad extends from the top surface 1 la of the orthopedic insole 10A to contact the distal metatarsal shafts and related soft tissue, preferably proximal to the second, third and fourth metatarsal heads, and a bottom surface of the third supporting/comfort pad contacts the bottom surface 1 lc of the orthopedic insole 10 A. The first, second and third supporting/comfort pads 12, 22 may be constructed of a silicone, rubber, foam, fluid gel or viscoelastic gel material to provide cushioning, comfort and support to the wearer’s foot. The third supporting/comfort pad is preferably configured for positioning proximate the distal central metatarsal shafts of the wearer’s foot in the working configuration when the user is wearing the shoe.

[0062] A fourth supporting/comfort deep seated heel cup or rear foot cupped heel has side borders 19 and is comprised of fiber reinforced composite material, silicon, rubber, foam, a fluid gel, a viscoelastic gel, combinations of these materials or other appropriate materials that would be appropriate for the fourth supporting/comfort deep seated heel cup or rear foot cupped heel. The fourth supporting/comfort deep seated heel cup, including the side borders 19, is configured to cup the heel seat of the wearer with the silicone or gel second supporting/comfort pad 22 placed within the center of the cup within the side borders 19. The cup of the third portion 24 is preferably configured to have a cup-shape defined at its edges by the side borders 19 that supports and engages the wearer’s heel or rear foot area during use. The cup of the third portion 24 comprises a relatively large portion of the third portion 24 to support the wearer’s heel and generally encompasses the second supporting comfort pad 22 but is not so limited. The second and third portions 20, 24 preferably include the first and second supporting ribs 26, 27 and the side borders 19 that rise up and are configured to for a cupping around inferior sides and mid-foot sides of the wearer’s heel and mid-foot. The first and second supporting ribs 26, 27 and side borders 19 provide stability to the wearer’s heel. The posterior edge of the third portion 24 at the side border 19 has a height that extends above the upper surface 11a. The first and second supporting ribs 26, 27 or the lateral edges run distally and are incorporated into a medial arch rise on the second portion 20.

[0063] The first and second supporting/comfort pads 12, 22 and first and second pad cavities 13, 23 of the preferred orthopedic insole 10A have a generally oval-shape with the first pad 12 having a greater first pad width W1 relative to a first pad length Li and the second supporting/comfort pad 22 having a greater first pad length L2 relative to a second pad width W2. In an exemplary embodiment, the first pad width Wi is approximately fifty-one to sixty-one millimeters (51-61 mm), the first pad length Li is approximately thirty-three to forty-three millimeters (33-43 mm), the second pad length L2 is approximately fifty-six to sixty-six millimeters (56-66 mm) and the second pad width W2 is approximately thirty-eight to forty-eight millimeters (38-48 mm), but are not so limited and may have alternative dimensions depending on the size of the shoe and orthopedic insole 10 A. The first and second supporting/comfort pads 12, 22 are preferably sized and shaped in this manner to support for forefoot and heel of the wearer, respectively, but are not so limited and may be otherwise sized and configured to support the wearer’s forefoot and heel, fit into the appropriately sized shoe and withstand the normal operating conditions of the first and second pads 12, 22. In a relatively narrow portion of the second portion 20 between the first and third portions 14, 24 of the preferred orthopedic insole 10A, the third portion has a central width Wc, an arch width W _a and a medial width Wm. In the preferred embodiment, the central width Wc is approximately twenty -three and one-half to twenty-seven and one-half millimeters (23 ½ - 27½ mm), the arch width W _a is approximately thirteen to seventeen millimeters (13-17 mm) and the medial width Wm is approximately five to nine millimeters (5-9 mm) but are not so limited and may be otherwise sized and configured based on the size, shape and configuration of the shoe.

[0064] In an alternative preferred embodiment that is not shown, the first pad cavity 13 and the second pad cavity 23 may extend through the first and third portions 14, 24 from the top surface to the bottom surface 11a, 1 lc of the insole 10A, respectively. The first and second supporting/comfort pads 12, 22 are preferably positioned and secured in the first and second pad cavities 13, 23, respectively, in this alternative preferred embodiment to provide comfort and support to the user’s foot in the high heeled shoe.

[0065] The preferred shoe that is assembled with the orthopedic insole 10A may include screws 50 that attach the orthopedic insole 10A to the heel and outsole of the shoe. The orthopedic insole 10A may, alternatively, be adhesively bonded, stapled, clamped or otherwise secured to the heel, outsole or other portion of the shoe.

[0066] The medial, lateral and posterior edges 25 of the orthopedic insole 10A rise up to form a cupping around the inferior sides of the heel, providing stability of the wearer’s heel within the shoe. The medial cup height runs distally and incorporates into the medial arch rise on the orthopedic device or insole 10 A.

[0067] In the preferred embodiment, to complete and finish the orthopedic insole 10A, a top cover of leather and gel or a sheath of relatively thin shock absorbing foam is preferably used or covers the orthopedic insole 10A. The top cover of the described materials is not limiting and the orthopedic insole 10A may be designed and configured without the cover or may be constructed of alternative materials that are able to take on the general size and shape of the cover, withstand the normal operating conditions of the cover and perform the preferred functions of the cover.

[0068] The bottom of the orthopedic insole 10A is preferably covered and sandwiched over a shank 28 that extends along the second portion 20, as well as into the first and third portions 14, 24. The shank 28 is preferably constructed of a solid, relatively rigid material, such as steel, aluminum, polymeric or other related materials that are able to take on the general size and shape of the shank 28, withstand the normal operating conditions of the shank 28 and perform the preferred functions of the shank 28. The shank 28 may alternatively be comprised and constructed of a fiber reinforced composite material and followed underneath with leather to be bonded to the outsole 30 of the shoe. [0069] The preferred orthopedic system 10 may utilize three-dimensional (“3D”) scanning methods for collecting foot anthropometric data, gait and clinical analysis. The system 10 may utilize standard averages for feet to construct an anatomically contoured Last 10B. The system 10 may utilize 3D motion capture systems that have accurately modeled gait motions, which is useful for identifying suboptimal and optimal gait features. By utilizing sensor technology, insole development can be undertaken to optimize gait control within the high heeled shoe. The optimized gait control can be utilized to optimize the Last 10B and the orthopedic insole 10A to improve comfort for the wearer.

[0070] In the preferred embodiment, foot pressure mapping may be synchronized with 3D motion capture to reveal the foot’s typical pressure distribution and center of pressure in real-time. By incorporating 3D renderings into the anatomical Last 10B, modifications are made to compensate for “hot spot” peak pressure points and redistribute those pressures within the Last 10B, which are then incorporated into the orthopedic insole 10A of the preferred embodiment.

[0071] Referring to Figs. 1, 7 and 8, the Last 10B, which generally maps or is equivalent to the human foot, has three arches including two longitudinal arches (medial 32-36 and lateral 33-36) and a transverse arch (34-35) that are defined generally in a bottom medial 31a portion of the Last 10B. The two longitudinal arches 32-36, 33-36, which are generally referred to as the medial and lateral arches, are formed in the human foot anatomical equivalent between the tarsal bones and the proximal end of the metatarsals. The medial higher arch 36-32 is preferably formed by the calcaneus, talus, navicular, three cuneiforms and first three metatarsal bones. The lateral arch 33-36 is typically the flatter of the two longitudinal arches and lies on the ground in the standing position. The lateral arch 33-36 is formed in the human foot anatomical equivalent by the calcaneus, cuboid and fourth and fifth metatarsal bones. The bottom medial 3 la of the Last 10B is preferably positioned between a forefoot 31c portion and a posterior 3 le portion. The forefoot 31c, bottom medial 31a and posterior 3 le portions of the Last 10B are preferably separated from an upper portion of the last 1 OB by a demarcation line 33 that defines an upper edge of the upper, counter and top box of the show during construction of the shoe.

[0072] The transverse arch 34-35 is located in the coronal plane of the foot. The transverse arch 34-5 is preferably formed in the hum foot anatomical equivalent at the metatarsal bases, the cuboid and the three cuneiform bones.

[0073] The orthopedic insole 10A is preferably constructed of a tri-component insole comprised of the following materials: polyethylene biobased carbon content, derived from renewable sources and urethane, silicone or similar material gel pads that are attached to the first and third portions 14, 24. The materials of the tri-component insole 10A is preferably completely innovative, ecological, biodegradable and recyclable, but is not so limited and may be comprised and constructed of nearly any material that is able to take on the general size and shape of the orthopedic insole 10A, withstand the normal operating conditions of the orthopedic insole 10A and perform the preferred functions of the preferred orthopedic insole 10 A. In addition, the orthopedic insole 10 A, including the first, second and third portions 14, 20, 24, can be constructed of carbon fiber, fiberglass, resin impregnated fiber composites, a fiber reinforced composite material, polyethylene, plastic, leather, metals, such as steel and aluminum, foams, rubbers, gels, combinations of these materials or other appropriate materials. The fiber reinforced composite material may include a carbon material or a fiberglass material.

[0074] The orthopedic insoles 10A of the preferred embodiment will create an interface and is preferably pressed to the Last 10B. Potential modifications to the orthopedic insole 10A may include (1) modifying insole geometry; (2) increasing contact area; (3) adjusting resilience and strength to provide for shock absorption and greater for reusing mechanical energy; (4) treating insole surface (e.g., gel installation); and (5) providing assistive support (e.g., deep heel seat).

[0075] There’s a reason why the term ‘comfortable high heel’ tends to be such an oxymoron. When a person stands flat on a floor or ground surface, their body weight is distributed evenly throughout the heel, arch, metatarsals and toes of the foot. When the foot is elevated in a high heeled shoe, however, this pitched position of the foot transfers the majority of the wearer’s body weight squarely onto the metatarsal heads, which is commonly referred to as “the ball of the foot.” Most high heeled shoes offer little to no relief from this extra pressure on the metatarsal heads or the ball of the wearer’s foot, thereby often creating discomfort in the wearer’s metatarsal heads or other portions of the foot due to redistribution of the body weight without an associated adaptation by the design of the shoe or, particularly, the insole of the shoe.

[0076] Using 3D modeling, the preferred insole 10A was developed and also led to the creation of the anatomically accurate Last 10B that corresponds to the molded insole 10A of the preferred embodiment. Together the combination of the insole 10A and the Last 10B facilitate redistribution of the weight of the body uniformly throughout the foot of the wearer when standing on the preferred insole 10A incorporated into the high heeled shoe. The preferred high heeled shoes are designed to divert weight away from the metatarsals and the metatarsal heads and transfer the weight to the padded heel and arch of the feet in the third and second portions 24, 20 of the insole 10 A, thus reducing metatarsal strain that occurs from wearing high heeled shoes for long periods of time. In addition, the insole 10A of the preferred embodiment is preferably designed and constructed without the heavier rigid metal shank therein and constructing the preferred insole 10A from the biodegradable polyethylene biobased carbon content material creates a much lighter, more shock-absorbent shoe when compared to conventional insoles. The result is an elegant pair of high heels with built-in anatomical comfort that produces comfort, health and weight improvements over known high heeled shoes, particularly based on the improvements to the preferred insole 10 A. [0077] 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.