CORRECTIVE ORTHOPEDIC INSOLE

Abstract

A corrective orthopedic device aimed at preventing excessive pronation, specifically designed for children between the ages of 3 and 16, as well as for adults with flexible flat feet. It features an array of components including a deep heel cup, a substantially elongated medial arch support, and a variably angled medial wedge extending to the ball of the foot. The wedge comes in different levels of correction, such as 3 mm, 6 mm, or 9 mm, with the intent of fostering proper arch support and encouraging better alignment in the sub-talar and ankle joints, which in turn improves overall lower body joint posture. The extended medial or varus wedge starts from the heel and extends to the first metatarsophalangeal (1st MTP) joint, aligning both the rear, midfoot and proximal forefoot in a corrective position. Additional features include a high medial flange and a full-length cushioned top cover for enhanced comfort.

Claims

1. A corrective orthopedic device for a foot composed of multiple supportive and corrective components comprising: a. a rigid thermoplastic shell extending from a heel to a ball of the foot or proximal to metatarsal heads of the foot, comprising a rearfoot portion, a midfoot portion, and a forefoot portion having a shell-edge, wherein the rearfoot portion comprising a concave deep heel cup that extends in a semi-circumferential manner around the heel and configured to support the heel in a neutral position; the midfoot portion extends between the rearfoot portion and the forefoot portion having a sloped-longitudinal-arch portion to support a medial longitudinal arch of the foot; b. a plantar portion extending substantially along a length of the rigid thermoplastic shell and merges upwardly on its sides to create a soft medial flange and a lateral flange; c. a neutral arch fill affixed to the thermoplastic shell having an initial thickness and a first length, to obtain a flat surface for a medial corrective wedge portion to provide stability to the heel, wherein the medial corrective wedge portion secured underneath the neutral arch fill that extends from the heel to the forefoot portion and passing beyond the shell-edge of the thermoplastic shell in a predefined degree of correction, and wherein the medial corrective wedge portion is configured to extend to a first metatarsal-phalangeal (MTP) joint and is configured to create a medial arch alignment and align subtalar, midtarsal, tarsometatarsal and metatarsal-phalangeal joints to improve lower body joint posture; the medial corrective wedge portion having a second thickness and a second length comprising a layer of angled wedge material configured to extend from the rearfoot portion to the first metatarsal-phalangeal (MTP) in the forefoot portion configured to extend further or past the shell-edge of the thermoplastic shell and angles the rearfoot, midfoot and forefoot portions, whereby the corrective orthopedic device improves ankle alignment, thereby limiting or preventing hyperpronation in children and adults.

2. The orthopedic device of claim 1, wherein the plantar portion has a cushioned top cover.

3. The orthopedic device of claim 1, wherein the heel cup has a depth of 20 mm to 35 mm measured from a center portion of the heel cup.

4. The orthopedic device of claim 1, wherein the soft medial flange is configured to extend to the first metatarsal-phalangeal joint from a distal medial calcaneus configured to contain a medial soft tissue splay that occurs with a flat foot type.

5. The orthopedic device of claim 1, wherein the lateral flange configured to extend from a distal lateral calcaneus to a fifth metatarsal base configured to support a lateral arch of the foot.

6. The orthopedic device of claim 2, wherein the soft medial flange has a height of approximately 40-50 mm including the top cover.

7. The orthopedic device of claim 2, wherein the lateral flange has a height of approximately 30-40 mm including the top cover.

8. The orthopedic device of claim 1, wherein the medial corrective wedge portion is configured to extend to the ball of the foot and extend further or past the shell-edge of the thermoplastic shell in the predefined degree of correction.

9. The orthopedic device of claim 8, wherein the predefined degree of correction is between 1.5 mm to 9 mm, preferably 3 mm, 6 mm or 9 mm for user compliance.

10. The orthopedic device of claim 1, wherein the device is constructed from a rigid and durable shell material and wherein the rigid and durable shell material has a maximum thickness between 1.5-4 mm and terminates before the metatarsal heads or ball of the foot.

11. The orthopedic device of claim 10, wherein the rigid and durable shell material is constructed from a thermoplastic shell material that is heat molded to maintain a fixed contour.

12. The orthopedic device of claim 1, wherein the height of the neutral arch fill creates a neutral plantar surface for ankle stability and medial corrective wedge portion addition.

13. The orthopedic device of claim 1, wherein the medial corrective wedge portion and the arch fill are combined as one unit to build the orthopedic device.

14. The orthopedic device of claim 1, wherein the orthopedic device is constructed from the group of materials consisting of polymeric materials, foam, rubber, thermoplastic and cork.

15. The orthopedic device of claim 1, wherein the medial corrective wedge portion is constructed from the group of materials consisting of polymeric materials, EVA, foam, polyurethane, thermoplastic and cork.

16. (canceled)

17. The orthopedic device of claim 1, wherein the arch fill is constructed from the group of materials consisting of polymeric materials, EVA, foam, polyurethane, thermoplastic and cork.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Embodiments herein will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the scope of the claims, wherein like designations denote like elements, and in which:

[0033] FIG. 1 is a perspective view of the corrective orthopedic device showing the full length cushioned top cover and high medial flange, according to the present invention;

[0034] FIG. 2 is a perspective front view of the corrective orthopedic device showing the deep heel cup and the medial arch support, according to the present invention;

[0035] FIG. 3 is a lateral side view of the corrective orthopedic device, according to the present invention;

[0036] FIG. 4 is a plantar top view of the corrective orthopedic device showing the wedge body and arch fill, according to the present invention;

[0037] FIG. 5A is a cut-away side view of the corrective orthopedic device, according to the present invention;

[0038] FIG. 5B is a side view of the corrective orthopedic device in which the wedge profile is hidden under the cover, according to the present invention;

[0039] FIG. 6 is a perspective back view of the corrective orthopedic device showing the wedge body and the arch fill, according to the present invention;

[0040] FIG. 7 is a back view of the corrective orthopedic device showing the medial corrective wedge that can be in varied heights of angled correction, according to the present invention;

[0041] FIG. 8 is a back view of the corrective orthopedic device showing the wedge body and the arch fill, according to the present invention;

[0042] FIG. 9 is a perspective view showing the wedge body and varied wedge body length, according to the present invention;

[0043] FIG. 10 is a perspective view showing the wedge body and varied wedge body length, according to the present invention;

[0044] FIG. 11 is a picture of plantar top view of the corrective orthopedic device showing the wedge body and arch fill, according to FIG. 4;

[0045] FIG. 12 is a picture showing the wedge body and wedge body length, according to FIG. 9;

[0046] FIG. 13A is a back view showing another embodiment of the present invention in which the wedge body and arch fill are combined as one unit due to manufacturing purposes, and

[0047] FIG. 13B is a side view of the present invention according to FIG. 13A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0048] Referring to FIGS. 1 to 13B the corrective orthopedic device of the present invention 100 is illustrated. The device 100 is designed in a single one piece to fully support a foot that exhibits varied degrees of pronation in children and adults using a novel combination of components. The device 100 comprises a rear foot portion 11, a midfoot portion 12 and a forefoot portion 13. The midfoot portion 12 extends between the forefoot portion 13 and the rear foot portion 11.

[0049] The rear foot portion 11 comprises a heel portion 10 that runs medially from the back of the heel portion 10 to the forefoot 13 and includes a concave deep heel cup 16 extending in a semi-circumferential manner around the sides and back of the heel cup 16. Heel cup 16 ranges from 20 to 35 mm high as measured from the center of the heel cup 16. The device 100 further comprises a plantar portion 15 that merges with the soft medial flange 17 and lateral flange 18 of the device 100. Similarly, medial and lateral flanges 17 and 18 merge with heel cup 16.

[0050] According to FIG. 2 the heel portion 10 has a greater thickness at medial edge of the heel portion 22 than at the lateral edge of the heel portion 24 and is tapered there between to provide a sloped top surface. In use, the heel portion 10 will support the heel of the foot to a greater degree. With this construction, the heel cup 16 supports the heel in a neutral position. The deep heel cup 16 provides a better ankle and arch support throughout the foot.

[0051] According to FIGS. 3 to 6 the device 100 includes a corrective profile 20 fixed beneath the plantar portion 15. Corrective profile 20 contains a shell material 21 of a maximum thickness of 1.5-4 mm constructed of a thermoplastic semi-rigid material that is heat molded and cured to maintain a fixed contour. The corrective profile 20 is also comprised of a neutral plantar arch fill 32, a corrective wedge body 30 in varied heights of angled correction. The corrective wedge body 30 extends forward pass the end of the shell 21 to align rearfoot, midfoot and proximal forefoot which is not visible under bottom cover 7. Corrective profile 20 comprises wedge layers in varied heights. The height of the neutral arch fill creates a neutral plantar surface for ankle stability and corrective wedge body addition.

[0052] According to FIG. 4 corrective profile 20 has a wedge body 30 to reduce and correct varied degrees of pronation. The height of the wedge body 30 can be varied to 3 mm, 6 mm or 9 mm to obtain full angled position of foot from rearfoot all the way to forefoot portion.

[0053] Wedge body 30 comprises a layer of wedge material that extends from the rearfoot portion 11 to the first Metatarso-phalangeal joint (MTPJ) 14 in forefoot portion 13 which angles the entire rearfoot 11, midfoot 12 (sub talar joint) and proximal forefoot 13 in a corrective aligned position. These angles would vary from 3 mm-9 mm of correction which can be translated directly to degrees if required. Wedge transition plane tapers from wedge body 30 to the forefoot portion 13 so as to provide a smooth transition. Wedge body 30 has a varied degrees of inclines. This layer 30 is not visible from outside or lateral aspect of the device 100.

[0054] According to FIGS. 4 to 10 the wedge body length extends to the end of the supportive shell at MTPs area 14, addressing rearfoot 11, midfoot 12 and proximal area of forefoot 13. The wedge body 30 provides full angled correction to the majority of the foot and ankle complex (outside of distal forefoot 13).

[0055] According to FIGS. 4, 5A and 5B the medial corrective wedge 30 is in varied heights of angled correction and extends forward toward the forefoot 14 under the plantar portion 15 to the end of the device 100 to support ankle position. Corrective profile 20 contains semi-rigid shell material 21 which is preferably constructed of 1.5 to 4 mm rigid thermoplastic material which is heat molded and cured to maintain a fixed contour. This part of the device as shown in FIG. 5B is not visible under the bottom cover 7.

[0056] The corrective profile 20 further has a neutral plantar arch fill 32 to obtain flat surface for wedge addition and provide neutral rearfoot stability. The height of the arch fill 32 may be increased or decreased to accommodate different degrees of forefoot varus deformities and foot flexibility and provides a lateral longitudinal arch support 28 to stabilize the mid and rearfoot.

[0057] According to FIGS. 5A and 5B the corrective profile 20 extends forward toward the forefoot 14 under the plantar portion 15 to the end of the device 100 to support ankle position and is covered under the bottom cover 7.

[0058] According to the FIGS. 1 to 5B it will be seen that the device 100 is rounded where the medial flange 17 and lateral flange 18 meet plantar portion 15. Medial flange 17 extends from the first metatarsal to the calcaneus to form and contain the medial longitudinal arch and medial soft tissue. Medial flange 17 has a height of approximately 40-50 mm including the top cover 25. In this way the device conforms to, contains, and provides support for, the medial arch of the foot. Lateral flange 18 extends from the proximal end of the calcaneus to about the base of the 5.sup.th metatarsal. The lateral flange 18 has a height of approximately 30-40 mm including the top cover 25 to provide support for the lateral arch of the foot. In addition to providing support for the medial and lateral arches of the foot, medial and lateral flanges 17 and 18 provide support for the sides of the foot, and substantially reduce rotation of the heel in the heel cup 16 and decrease sheer forces on the medial arch due to soft tissue splay. Thus, medial and lateral flanges 17 and 18 of the device 100 extend from plantar portion 15 upward to support the foot. Flanges 17 and 18 should generally be of a shape and size in order to conform to the shoe that the device 100 is integrated into.

[0059] Flanges 17 and 18 are generally higher near heel cup 16. By having heel cup 16, attached to plantar portion 15 and medial and lateral flanges 17 and 18, the device of the invention 100 functions as a single unit to control the movement of the foot in the shoe. The device 100 provides support to the heel portion 10, midfoot portion 12 and forefoot portion 13 of the foot entirety in a medial or varus angle to reduce varied degrees of sub-talar joint and midtarsal joint pronation (i.e. mild, over and hyperpronation). The key feature of the invention is the combination of a deep and supportive corrective orthopedic device with a 20 mm+ heel cup depth 16, long and pronounced medial arch support 26, high medial flange 17 (to contain soft tissue splay), full length cushioned top cover 25 and the corrective wedge profile 20 (in varied degrees).

[0060] In shoes with traditional insole the heel cup can twist and expand relative to the rest of the shoe. This twisting of the heel cup allows the heel to rotate, resulting in misalignment of the foot. In contrast, and referring again to FIGS. 1 and 2, any twisting movement of heel cup 16 in the present invention 100 is significantly impeded by high medial and lateral edges 22 and 24, and plantar portion 15 and twisting of the heel cup 16 requires significant torque on the side walls and plantar aspect. The reduced ability of the heel cup 16 to twist significantly reduces misalignment of the foot.

[0061] In conventional shoes with standard insoles, the heel cup has a tendency to twist and expand in relation to the shoe's overall structure. This allows the heel to rotate, leading to foot misalignment. However, in the present invention, as illustrated in FIGS. 1 and 2, the design features high medial and lateral edges 22 and 24 as well as a plantar portion 15. These elements significantly restrict any twisting motion of the heel cup 16. To achieve such a twist would require considerable torque applied to the side walls and plantar surface. This design limitation substantially decreases the likelihood of foot misalignment.

[0062] In contrast with the existing devices and according to FIGS. 1 and 2 again the heel portion 10 in the present device 100 has a deep heel cup 16 about 20-35 mm. The heel cup portion 10 has a high medial edge to contain soft tissue splay and provide pronounced medial arch support. The deep heel cup 16 holds the heel in a neutral position and supports the whole foot by helping to reduce and prevent pronation while keeping the heel as vertical as possible.

[0063] The present invention 100 supports the majority of the bones in the foot and ankle including: distal tibia, distal fibula, talus, calcaneus, cuneiforms, navicular, cuboid, metatarsal bones (5), proximal phalanges (5). Joints supported by this device are the following: Rearfoot: talocrural joint, subtalar joint, midtarsal joint (calcaneo-cuboid & talo-navicular joints), Midfoot: tarsometatarsal joints5, Forefoot: MTP joints (metatarsal-phalangeal joints5).

[0064] According to FIG. 1 and corrective profile 20 increments are 3 mm, 6 mm and 9 mm of angled correction and can be converted into degrees if required, in combination with a deep heel cup 16 (20-35 mm), high medial/lateral flanges 17 and 18. The corrective orthopedic device 100 provides a combination of a medial/inside angled wedge profile 20 that combines wedges and angled correction of device to assist in improved ankle alignment and thereby reduced juvenile and adult hyperpronation.

[0065] Referring to FIG. 1 again the upper portion 15 includes a full length cushioned top cover 25 for improved acceptance and comfort of the device 100. The top cover is constructed of a soft density cushioned material with an absorbable top cover i.e. microsuede or velvet bound to med-soft density EVA or polyurethane. The material from which top cover 25 is made may vary depending on its location and intended use. Top cover 25 may also be provided in different thicknesses to provide the desired cushion or fit in a particular area.

[0066] The device 100 is made from a material that strikes a balance between rigidity and flexibility. It's rigid enough to maintain its shape, offering structural support particularly during the growth phases in children. Simultaneously, the material is flexible enough to permit normal foot movement. The device realigns the foot's posture, minimizes discomfort, and curtails abnormal pronation while still allowing for the natural flexing of the plantar portion, arches, and joints during walking. The chosen material is lightweight to avoid adding significant weight to the shoe. Suitable materials may include foam, rubber, thermoplastic, and cork. In one specific embodiment, the device is fabricated from polypropylene, which possesses the requisite rigidity for sustaining arch support. Compression molding is one technique employed to manufacture the device.

[0067] Given that individuals differ in both the degree of pronation in their walking style and body weight, the device 100, may be custom made. One approach involves creating a mold of a person's foot and adjusting that mold to yield a device that offers therapeutic benefits for the user. This device can be positioned between the inner and outer layers of a shoe, either during the shoe's manufacturing process or added to existing footwear. During the production of device 100, AI-powered foot scanning technology can be employed to identify the most suitable fit, thereby minimizing issues related to improper sizing.

[0068] According to FIGS. 13A and 13B in another embodiment due to manufacturing purposes the wedge body and arch fill can be combined as one unit to build a corrective profile for ease of manufacturing, volume, etc.

[0069] The device can be produced on a large scale using various molding methods, such as thermoforming, injection molding, or vacuum molding, and can either be integrated into the shoe during the manufacturing process or inserted into prefabricated shoes.

[0070] In an embodiment, an array of devices, varying in both size (corresponding to shoe sizes) and shape (differing arch configurations), are created using vacuum molding. To do this, a set of master molds mimicking preferred foot shapes for different sizes are produced using established orthotic techniques. A distinct mold is prepared for each foot size. These molds could be crafted by starting with a standard-sized foot model and making necessary adjustments to accommodate larger or smaller feet. Alternatively, these master molds could be created from negative impressions taken directly from real feet.

[0071] In an embodiment, the device 100, is mass-produced using injection molding. This method involves both a positive mold, shaped like a foot, and a surrounding negative cast. The configuration allows for a gap between the positive and negative elements, into which molten plastic is injected. Once solidified, this plastic forms a molded piece that serves as the rigid component of device 100.

[0072] The foregoing should be viewed only as an illustrative guide to understanding the invention's principles. As the field is subject to constant changes and adaptations, the invention is not limited to the precise details described. Instead, all appropriate modifications and equivalents that fall within the invention's scope are accepted.

[0073] With respect to the above description, it's understood that experts in the field will find the ideal relationships between the invention's components in terms of dimensions, form, materials, functionality, and operation methods both apparent and straightforward. All such relationships, whether depicted in the drawings or described herein, are intended to be included within the scope of the current invention.