Customizable Component Insole System

- Implus Footcare, LLC

This invention provides for individualized adjustment to a user's specific needs through the use of multiple variable size, thickness and rigidity components that can be placed or integrated into an insole. The current invention is an insole that incorporates, but is not limited to: (1) a base layer with various depressions, (2) a metatarsal dome, (3) a first metatarsal head pad, (2) a forefoot wedge to create a pronation moment around the midfoot joint, (3) a heel cushion, (4) a heel lift to raise the heel area of the foot, (5) a rearfoot wedge to increase the supination moments around the subtalar joint, and (6) an arch support of a specific stiffness or with varying stiffness.

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Description
RELATED APPLICATION DATA

This application is related to Provisional Patent Application Ser. No. 61/929,944 filed on Jan. 21, 2014, and priority is claimed for this earlier filing under 35 U.S.C. §119(e). The Provisional Patent Application is also incorporated by reference into this patent application.

TECHNICAL FIELD

The present invention relates to a shoe insole with customizable cushioning and support to the foot of a wearer.

BACKGROUND OF THE INVENTION

The human foot is a very complex biological mechanism. The many bones, muscles, ligaments, and tendons of the foot, function to absorb and dissipate the forces of impact. The load on the foot at heel strike is typically about one and a half times a person's body weight when a person walks. When running or carrying extra weight, such as a backpack, loads on the foot can exceed three times the body weight.

The many bones, muscles, ligaments, and tendons of the foot function to absorb and dissipate the forces of impact, carry the weight of the body and other loads, and provide forces for propulsion. Properly designed shoe insoles can assist the foot in performing these functions and protect the foot from injury.

Insoles may be custom made by using a molded cast of the end user's foot or may be made of a thermoplastic material that is specifically molded to the contours of the end user's foot in a plasticized cast of the user's foot. Like most custom made items, custom insoles tend to be expensive because of the low volume and extensive time needed to make and fit them properly. As such, it is not practical to make such custom made insoles for the general public. What is needed is an insole that can be modified for individualized adjustment and fitting, but avoiding a molded “one off” cast of the user's foot. There is a present need for a shoe insole that accomplishes the goals to: (1) provide increased ankle and foot stability, (2) cushion the heel and forefoot during push-offs and landings, (3) customization with multiple variable strength and rigidity components, (4) enhanced cushioning capabilities.

The Applicant has received patents for insoles having a stability cradle and multiple pods located thereon. These patents include U.S. Pat. Nos. 7,484,319, 7,665,169, 7,908,768 and 8,250,784. These patents, however, do not address the need for individualized customization of the insole based on the components of the insole that are positioned or integrated into the insole. Possible movement of the insole during shoe operation or provide more enhanced cushioning characteristics.

Insoles in the prior are placed inside shoes, but the various designs in the prior art do not offer individualized customization along with sufficient cushioning and support attributes. There is a present need for a shoe insole that accomplishes the goal of providing customizable treatment for various ailments and prognoses, along with sufficient cushioning and support to the user's foot.

SUMMARY OF THE INVENTION

This invention provides for individualized adjustment to a user's specific needs through the use of multiple variable size, thickness and rigidity components that can be placed or integrated into an insole. The current invention is an insole that incorporates, but is not limited to: (1) a base layer with various depressions, (2) a metatarsal dome, (3) a first metatarsal head pad, (2) a forefoot wedge to create a pronation moment around the midtarsal joint, (3) a heel cushion, (4) a heel lift to raise the heel area of the foot, (5) a rearfoot wedge to increase the supination moments around the subtalar joint, and (6) an arch support of a specific stiffness or with varying stiffness.

The present invention uses these components individually and in various combinations to enhance cushioning and support for the user's foot depending on the user's individual needs. For instance, the present invention provides sufficient cushioning for normal use, or if needed, for more strenuous or technically challenging activities, such as carrying a heavy backpack or traversing difficult terrain.

Moreover, present invention provides control by providing relatively stiff and rigid arch or component support so as to control the bending and twisting of the foot by limiting foot motion. The rigid structure is good at controlling motion, but can be adjusted to provide more forgiving limited motion of the user during use.

The insole in the present invention, with customizable components and support elements, provides customizable cushioning and support to a user's foot subjected to biomechanical etiologies of the most common musculoskeletal pathologies of the lower limb, is herein disclosed. The current invention is an insole that incorporates various components to optimize control and cushioning characteristics to match a user's individual needs, including, but is not limited to, the following components: (1) a base layer with various depressions, (2) a metatarsal dome, (3) a first metatarsal head pad, (2) a forefoot wedge to create a pronation moment around the midfoot joint, (3) a heel cushion, (4) a heel lift to raise the heel area of the foot, (5) a rearfoot wedge to increase the supination moments around the subtalar joint, and (6) an arch support of a specific stiffness or with varying stiffness.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a exploded perspective view of an illustrative embodiment of an insole in accordance with the principles of the present invention;

FIG. 2 is a perspective view showing the bottom of the base layer of the insole;

FIG. 3 is a top (dorsal) view of the insole;

FIG. 4 is a bottom (plantar) view of the insole;

FIG. 5 is a lateral (outer side) view of the insole;

FIG. 6 is a medial (inner side) view of the insole;

FIG. 7 is a rear (proximal) view of the insole;

FIG. 8 is a longitudinal cross sectional view of the insole of FIG. 4;

FIG. 9 is a transverse cross sectional view behind the metatarsal area of the insole of FIG. 4;

FIG. 10 is a transverse cross sectional view along the heel area of the insole of FIG. 4;

FIG. 11 is a view of the bones of the foot superimposed on a bottom (plantar) view of the insole;

FIG. 12 is a bottom (plantar) view illustrating the various areas of the insole;

FIG. 13A is a bottom (plantar) view of the first metatarsal head pad;

FIG. 13B is a medial view of the first metatarsal head pad;

FIG. 14A is a perspective view of a first embodiment of the arch support;

FIG. 14B is a bottom (plantar) view of a first embodiment of the arch support;

FIG. 14C is a rear (proximal) view of a first embodiment of the arch support;

FIG. 14D is a sectional view of a first embodiment of the arch support;

FIG. 15A is a perspective view of a second embodiment of the arch support;

FIG. 15B is a bottom (plantar) view of a second embodiment of the arch support;

FIG. 15C is a rear (proximal) view of a second embodiment of the arch support;

FIG. 15D is a sectional view of a second embodiment of the arch support;

FIG. 16A is a perspective view of a third embodiment of the arch support;

FIG. 16B is a bottom (plantar) view of a third embodiment of the arch support;

FIG. 16C is a rear (proximal) view of a third embodiment of the arch support;

FIG. 16D is a sectional view of a third embodiment of the arch support;

FIG. 17A is a perspective view of a forefoot wedge;

FIG. 17B is a bottom (plantar) view of a forefoot wedge;

FIG. 17C is a rear (proximal) view of a forefoot wedge;

FIG. 18A is a perspective view of a heel cushion;

FIG. 18B is a bottom (plantar) view of a heel cushion;

FIG. 18C is a medial view of a heel cushion;

FIG. 19A is a perspective view of a heel lift;

FIG. 19B is a bottom (plantar) view of a heel lift;

FIG. 19C is a sectional view of a heel lift;

FIG. 20A is a perspective view of a rearfoot wedge;

FIG. 20B is a bottom (plantar) view of a rearfoot wedge;

FIG. 20C is a sectional view of a rearfoot wedge.

 DETAILED DESCRIPTION

All insoles with a heel cup and medial longitudinal arch support will provide a small degree (research suggests 2-3 degrees) of pronation control. Pronation control is the degree of heel eversion and lowering of the medial longitudinal arch.

A number of respected researchers have proposed that kinematic changes in foot function may not be the primary pathway through which musculoskeletal aches, pains, and chronic injuries improve with the use of insoles. The present insole invention disclosed herein is a replacement insole primarily designed to be adaptable to address both the kinematic and kinetic causes of common musculoskeletal pathologies of the foot and leg, thereby providing optimum control and cushioning characteristics for a user's individual needs.

The current invention is an insole that incorporates various components to optimize control and cushioning characteristics to match a user's individual needs, including, but is not limited to, the following components: (1) a base layer with various depressions, (2) a metatarsal dome, (3) a first metatarsal head pad, (2) a forefoot wedge to create a pronation moment around the midfoot joint, (3) a heel cushion, (4) a heel lift to raise the heel area of the foot, (5) a rearfoot wedge to increase the supination moments around the subtalar joint, and (6) an arch support of a specific stiffness or with varying stiffness.

In reference to FIGS. 1 to 20C, an insole constructed in accordance with the principles of the present invention is disclosed. It should be understood that insoles are generally adapted to be inserted inside a user's shoe. A user's right shoe and left shoe are mirror images of one another as are the insoles adapted to be inserted in a right shoe and a left shoe respectively. Only the left insole is illustrated in the Figures. It will be understood by those of skill in the art that the right insole has a mirror image construction of the left insole.

Except as noted herein, the insole of the invention is shaped essentially like the bottom interior of a shoe (and therefore adapted to receive a user's foot which has a generally similar shape when at rest). The insole extends from a heel end (proximal) to a toe end (distal) and has a medial border or side on the arch side of the foot, connecting said toe end to said heel end along the arch side of the insole and a lateral border or side on the other side thereof, connecting said toe end to said heel end on the other side of the insole. The insole also has a forefoot area (area that correlates with the metatarsals and phalanges of the foot), an arch area (along the medial side), a heel area (just forward of the heel end), and a midfoot area (between the heel area and forefoot area). The arch area of the insole does not lay flat on the inside of the user shoe, but provides an elevation support to the arch area of the user's foot.

As shown in the exploded view of FIG. 1, insole 101 preferably comprises a top sheet 103 (top sheet 103 is shown facing up to show surface details) and a base layer 105, said base layer 105 having a top surface 105A secured to said top sheet 103 and an opposite bottom surface 105B. Preferably, said top surface 105A of said base layer 105 defines an upwardly-extending portion or metatarsal dome 138 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsal area of the foot. Base layer 105 also defines a longitudinal arch support 106 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 105 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch support 106 compared to the lateral border.

Base layer 105 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 105 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 105 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 105.

In a preferred embodiment, top surface 105A of base layer 105 is covered with top sheet 103, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 105 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 105. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 105B of base layer 105 defines various depressions or areas: a forefoot wedge area 107 in the rear portion of the forefoot area, a first metatarsal head pad area 109 in the area of the first metatarsal, a heel cushion area 111 and rearfoot wedge/heel lift area 113 in the area of the heel, and an arch support area 117 from the middle of the insole towards the heel area near the medial side.

Base layer 105 also defines a separator wall 120 that divides the first metatarsal head pad area 109 from the arch support area 117. The separator wall 120 helps the base layer 105 define the first metatarsal head pad area 109 and the arch support area 117 for correct placement of the first metatarsal head pad 110 and arch support 118 and to keep the first metatarsal head pad 110 and arch support 118 components from interfering with each other. Accordingly, the first metatarsal head pad 110 placed in the first metatarsal head pad area 109 is separated from the arch support area 117 by the separator wall 120, and as such the first metatarsal head pad 110 does not lie in the same depression area, or any type of recessed area, where the arch support 118 is located.

Alternatively, the bottom surface 105A of base layer 105 may only have one or more of the defined areas: forefoot wedge area 107, first metatarsal head pad area 109, heel cushion area 111, rearfoot wedge/heel lift area 113, and arch support area 117.

Metatarsal dome 138 preferably lies behind the 2nd-4th metatarsals. Metatarsal dome 138 provides a redistribution of pressure away from the lesser metatarsals for general forefoot comfort and relatively increases the depth of the first metatarsal head pad area 109 to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 138 is an extension of base layer 105.

The metatarsal dome 138 preferably has a height of 2.0-3.0 mm above the top surface 105A. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 138 is a conical-like component that is secured to the top surface 105A of base layer 105 in the area behind the 2nd-4th metatarsals with the top sheet 103 secured across the top surface 105A of base layer 105 and either over the metatarsal dome 138 or allowing the metatarsal dome 138 to extend therethrough. Another alternative is to secure the metatarsal dome 138 to the top sheet 103 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 138 is made of the same material as base layer 105. Other materials may be used for metatarsal dome 138 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 138.

The forefoot wedge area 107 begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge 108 is shaped essentially the same as forefoot wedge area 107 and is secured therein. Forefoot wedge 108 has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge 108 extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge 108 to the forefoot wedge area 107.

The forefoot wedge 108 has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge 108 is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge 108 may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area 109 and arch support area 117.

Preferably, for a men's size medium insole, the forefoot wedge 108 has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge 108. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge 108 proportionately.

Preferably the forefoot wedge 108 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge 108 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge 108.

First metatarsal head pad area 109 is an area in the bottom surface 105B of the base layer 105 and lies under the first metatarsal head of the foot. First metatarsal head pad 110 is shaped essentially the same as first metatarsal head pad area 109 and is secured to first metatarsal head pad area 109. An adhesive or bonding agent may be used to secure the first metatarsal head pad 110 to the first metatarsal head pad area 109.

In use, first metatarsal head pad 110 remains under the first metatarsal head (i.e., the medial ball of the user's foot) and moves with it. Removing the pad reduces the GRF beneath the first metatarsal head. This enhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad 110, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad 110 has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area 117, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad 110 has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad 110 comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad 110. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad 110 proportionately.

Preferably, said first metatarsal head pad 110 is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad 110 is about 2-2.5 mm thick or the depth of the first metatarsal head pad area 109. First metatarsal head pad area's 109 basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad 110 is unattached. Other materials may be used for first metatarsal head pad 110 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad 110.

The arch support area 117 is located along the longitudinal arch support 106 and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support 118 partially wraps up the medial side of base layer 105 under the medial longitudinal arch support 106. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support 118 is shaped essentially the same as arch support area 117 and is secured to said arch support area 117 on bottom surface 105B of base layer 105. An adhesive or bonding agent may be used to secure the arch support 118 to the arch support area 117.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs 118A that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs 118A are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support 108.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions 118C that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions 118C are depressed into the arch support 118 about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support 108.

A third embodiment of the arch support comprises a plurality of extending ribs 118A that extend outwardly from said arch support, a plurality of essentially level ribs 118B having a rib outline indented in said arch support, and a plurality of rib-shaped openings 118C that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support 118 defines, from said proximal edge end going toward said distal edge end, one or more extending ribs 118A, one or more essentially level ribs 118B, and one or more rib-shaped depressions 118C. Preferably, three extending ribs 118A, three of said essentially level ribs 118B, and three rib-shaped depressions 118C are used. The width of each rib is approximately 5 mm. The extending ribs 118A are approximately 0.5 mm thick. The rib-shaped depressions 118C are depressed into the arch support 118 about 0.5 mm. The essentially level ribs 118B have a rib outline approximately 0.5 mm deep

Rib-shaped depressions 118C improve flexibility at said distal edge end of arch support 118 without sacrificing longitudinal arch support at the middle and proximal end of arch support 118.

The first three rib-shaped depressions 118C in the distal one-third of the arch support 118 are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support 118 (essentially level ribs 118B and extending ribs 118A) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support 108.

Alternatively, the rib-shaped depressions 118C may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer 105 to extend therethrough. The width of each rib is approximately 5 mm. Base layer 105 is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support 118 and mechanically lock arch support 118 and base layer 105 together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer 105 is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support 118 is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support 118.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 113 is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area 113 is adapted to receive a supplementary pad cushion which can be a rearfoot wedge 114 or a heel lift 115. The rearfoot wedge/heel lift area 113 is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area 117.

The rearfoot wedge 114 has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge 114 is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge 114 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 117.

Preferably, for a men's size medium insole, the rearfoot wedge 114 has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge 114. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge 114 proportionately.

Preferably the rearfoot wedge 114 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge 114 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge 108.

The heel lift 115 approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift 115 is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift 115 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 117.

Preferably, for a men's size medium insole, the heel lift 115 has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift 115. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift 115 proportionately.

Preferably the heel lift 115 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift 115 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift 115.

The heel cushion area 111 is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area 113. The heel cushion 112 may be secured in the heel cushion area 111 between the base layer and the rearfoot wedge 114 or heel lift 115. The heel cushion 112 may also be secured to the heel cushion area 111 without a rearfoot wedge 114 or heel lift 115 secured thereto. The heel cushion 112 provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion 112 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 117.

Preferably, for a men's size medium insole, the heel cushion 112 has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion 112 and preferably smaller than the rearfoot wedge 114 or heel lift 115. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion 112 proportionately.

Preferably the heel cushion 112 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion 112 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion 112.

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 105 in the areas defined by base layer 105 on bottom surface 105B are affixed to base layer 105 using an appropriate means such as an adhesive or bonding agent.

FIG. 2 illustrates a perspective view of the bottom of the base without any pads, pods, or attachments. Base layer 205 has a top surface 205A and an opposite bottom surface 205B. Base layer 205 also defines a longitudinal arch support 206 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 205 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area 206 compared to the lateral border.

Base layer 205 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 205 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 205 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 205.

In a preferred embodiment, top surface of base layer 205 is covered with a top sheet, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 205 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 205. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 205B of base layer 205 defines various depressions or areas: a forefoot wedge area 207 in the rear portion of the forefoot area, a first metatarsal head pad area 209 in the area of the first metatarsal, a heel cushion area 211 and rearfoot wedge/heel lift area 213 in the area of the heel, and an arch support area 217 from the middle of the insole towards the heel area near the medial side.

Base layer 205 also defines a separator wall 220 that divides the first metatarsal head pad area 209 from the arch support area 217. The separator wall 220 helps the base layer 205 define the first metatarsal head pad area 209 and the arch support area 217 for correct placement of the first metatarsal head pad and arch support and to keep the first metatarsal head pad and arch support components from interfering with each other. Accordingly, the first metatarsal head pad placed in the first metatarsal head pad area 209 is separated from the arch support area 217 by the separator wall 220, and as such the first metatarsal head pad does not lie in the same depression area, or any type of recessed area, where the arch support is located.

Alternatively, the bottom surface 205A of base layer 205 may only have one or more of the defined areas: forefoot wedge area 207, first metatarsal head pad area 209, heel cushion area 211, rearfoot wedge/heel lift area 213, and arch support area 217.

The forefoot wedge area 207 begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge area 207 has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge area 207 extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area 207.

The shape of the forefoot wedge area 207 may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area 209 and arch support area 217.

Preferably, for a men's size medium insole, the forefoot wedge area 207 has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge area 207. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge area 207 proportionately.

First metatarsal head pad area 209 is an area in the bottom surface 205B of the base layer 205 and lies under the first metatarsal head of the foot. An adhesive or bonding agent may be used to secure a first metatarsal head pad to the first metatarsal head pad area 209.

The first metatarsal head pad area 209, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad area 209 has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area 217, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad area 209 has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad area 209 comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad area 209. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad area 209 proportionately.

The arch support area 217 is located along the longitudinal arch support 206 and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support area 217 partially wraps up the medial side of base layer 205 under the medial longitudinal arch support 206. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. An adhesive or bonding agent may be used to secure an arch support to the arch support area 217.

For a men's size medium insole, the arch support area 217 is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the arch support area 217.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 213 is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area 213 is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area 213 is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area 217.

The shape of the rearfoot wedge/heel lift area 213 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 217.

Preferably, for a men's size medium insole, the rearfoot wedge/heel lift area 213 has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge/heel lift area 213. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge/heel lift area 213 proportionately.

The heel cushion area 211 is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area 213. A heel cushion may be secured in the heel cushion area 211 between the base layer and the rearfoot wedge or heel lift. The heel cushion may also be secured to the heel cushion area 211 without a rearfoot wedge or heel lift secured thereto. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion area 211 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 217.

Preferably, for a men's size medium insole, the heel cushion area 211 has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion area 211 and preferably smaller than the rearfoot wedge/heel lift area 213. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion area 211 proportionately.

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 205 in the areas defined by base layer 205 on bottom surface 205B are affixed to base layer 205 using an appropriate means such as an adhesive or bonding agent.

FIG. 3 is a top view of the insole illustrating the top sheet 303 and metatarsal dome 338. Line 9-9 indicates a transverse cross section behind the metatarsal area. Line 10-10 indicates a transverse cross section along the heel area. The insole preferably comprises a top sheet 303 and a base layer, said base layer having a top surface secured to said top sheet 303 and an opposite bottom surface. Preferably, said top surface of said base layer defines an upwardly-extending portion or metatarsal dome 338 (also shown in FIGS. 5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsal area of the foot. Base layer also defines a longitudinal arch support 306 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Metatarsal dome 338 preferably lies behind the 2nd-4th metatarsals. Metatarsal dome 338 provides a redistribution of pressure away from the lesser metatarsals for general forefoot comfort and relatively increases the depth of a first metatarsal head pad area to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 338 is an extension of the base layer.

The metatarsal dome 338 preferably has a height of 2.0-3.0 mm above the top surface. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 338 is a conical-like component that is secured to the top surface of the base layer in the area behind the 2nd-4th metatarsals with the top sheet 303 secured across the top surface of the base layer and either over the metatarsal dome 338 or allowing the metatarsal dome 338 to extend therethrough. Another alternative is to secure the metatarsal dome 338 to the top sheet 303 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 338 is made of the same material as the base layer. Other materials may be used for metatarsal dome 338 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 338.

In a preferred embodiment, top surface of base layer is covered with top sheet 303, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

FIG. 4 illustrates the bottom view of the insole. The insole preferably comprises a top sheet and a base layer 405, said base layer 405 having a top surface secured to said top sheet and an opposite bottom surface 405B. Base layer 405 also defines a longitudinal arch support 406 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot. Line 8-8 indicates a longitudinal cross section of the insole. Line 9-9 indicates a transverse cross section behind the metatarsal area. Line 10-10 indicates a transverse cross section along the heel area.

Base layer 405 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area 406 compared to the lateral border.

Base layer 405 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 405 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 405 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 405.

Preferably, for a men's size medium insole, the base layer 405 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 405. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 405B of base layer 405 defines various depressions or areas: a forefoot wedge area 407 in the rear portion of the forefoot area, a first metatarsal head pad area 409 in the area of the first metatarsal, a heel cushion area 411, rearfoot wedge/heel lift area 413 in the area of the heel, and an arch support area 417 from the middle of the insole towards the heel area near the medial side.

Base layer 405 also defines a separator wall 420 that divides the first metatarsal head pad area 409 from the arch support area 417. The separator wall 420 helps the base layer 405 define the first metatarsal head pad area 409 and the arch support area 417 for correct placement of the first metatarsal head pad and arch support and to keep the first metatarsal head pad and arch support components from interfering with each other. Accordingly, the first metatarsal head pad placed in the first metatarsal head pad area 409 is separated from the arch support area 417 by the separator wall 420, and as such the first metatarsal head pad does not lie in the same depression area, or any type of recessed area, where the arch support is located.

Alternatively, the bottom surface of base layer 405 may only have one or more of the defined areas: forefoot wedge area 407, first metatarsal head pad area 409, heel cushion area 411, rearfoot wedge/heel lift area 413, and arch support area 417.

The forefoot wedge area 407 begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area 407 and is secured therein. The forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of the forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area 407.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area 409 and arch support area 417.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for the forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

First metatarsal head pad area 409 is an area in the bottom surface 405B of the base layer 405 and lies under the first metatarsal head of the foot. A first metatarsal head pad is shaped essentially the same as first metatarsal head pad area 409 and is secured to first metatarsal head pad area 409. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area 409.

In use, the first metatarsal head pad remains under the first metatarsal head (i.e., the medial ball of the user's foot) and moves with it. Removing the pad reduces the GRF beneath the first metatarsal head. This enhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area 417, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of the first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area 409. The first metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when the first metatarsal head pad is unattached. Other materials may be used for the first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The arch support area 417 is located along the longitudinal arch support 406 and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. The arch support partially wraps up the medial side of base layer 405 under the medial longitudinal arch support 406. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. The arch support is shaped essentially the same as arch support area 417 and is secured to said arch support area 417 on bottom surface 405B of base layer 405. An adhesive or bonding agent may be used to secure the arch support to the arch support area 417.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of the arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer 405 to extend therethrough. The width of each rib is approximately 5 mm. Base layer 405 is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of the arch support and mechanically lock the arch support and base layer 405 together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer 405 is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 413 is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area 413 is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area 413 is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area 417.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 417.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for the rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. The heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 417.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area 413. A heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift. The heel cushion may also be secured to the heel cushion area without a rearfoot wedge or heel lift secured thereto. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area 417.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for the heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 405 in the areas defined by base layer 405 on bottom surface 405B are affixed to base layer 405 using an appropriate means such as an adhesive or bonding agent.

FIG. 5 illustrates a lateral side view of the insole. The insole preferably comprises a top sheet 503 and a base layer 505, said base layer 505 having a top surface 505A secured to said top sheet 503 and an opposite bottom surface 505B. Preferably, said top surface 505A of said base layer 505 defines an upwardly-extending portion or metatarsal dome 538 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsal area of the foot. Base layer 505 also defines a longitudinal arch support 506 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 505 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area compared to the lateral border.

Base layer 505 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 505 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 505 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 505.

In a preferred embodiment, top surface 505A of base layer 505 is covered with top sheet 503, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 505 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 505. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 505B of base layer 505 defines various depressions or areas: a forefoot wedge area 507 in the rear portion of the forefoot area, a first metatarsal head pad area in the area of the first metatarsal, a heel cushion area (not visible), rearfoot wedge/heel lift area 513 in the area of the heel, and an arch support area from the middle of the insole towards the heel area near the medial side.

Alternatively, the bottom surface 505A of base layer 505 may only have one or more of the defined areas: forefoot wedge area 507, first metatarsal head pad area, heel cushion area, rearfoot wedge/heel lift area 513, and arch support area.

Metatarsal dome 538 preferably lies behind the 2nd-4th metatarsal heads. Metatarsal dome 538 provides a redistribution of pressure away from the lesser metatarsal heads for general forefoot comfort and relatively increases the depth of the first metatarsal head pad area to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 538 is an extension of base layer 505. Preferably the metatarsal dome 538 is an extension of base layer 505.

The metatarsal dome 538 preferably has a height of 2.0-3.0 mm above the top surface 505A. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 538 is a conical-like component that is secured to the top surface 505A of base layer 505 in the area behind the 2nd-4th metatarsals with the top sheet 503 secured across the top surface 505A of base layer 505 and either over the metatarsal dome 538 or allowing the metatarsal dome 538 to extend therethrough. Another alternative is to secure the metatarsal dome 538 to the top sheet 503 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 538 is made of the same material as base layer 505. Other materials may be used for metatarsal dome 538 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 538.

FIG. 6 illustrates a medial side view of the insole. The insole preferably comprises a top sheet 603 and a base layer 605 having a top surface 605A secured to said top sheet 603 and an opposite bottom surface 605B. Base layer 605 also defines a longitudinal arch support 606 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 605 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area 606 compared to the lateral border.

Base layer 605 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 605 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 605 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 605.

In a preferred embodiment, top surface 605A of base layer 605 is covered with top sheet 603, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 605 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 605. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 605B of base layer 605 defines various depressions or areas: a forefoot wedge area in the rear portion of the forefoot area, a first metatarsal head pad area in the area of the first metatarsal, a heel cushion area (not visible), rearfoot wedge/heel lift area in the area of the heel, and an arch support area from the middle of the insole towards the heel area near the medial side.

Base layer 605 also defines a separator wall 620 that divides the first metatarsal head pad area 609 from the arch support area 617. The separator wall 620 helps the base layer 605 define the first metatarsal head pad area 609 and the arch support area 617 for correct placement of the first metatarsal head pad and arch support and to keep the first metatarsal head pad and arch support components from interfering with each other. Accordingly, the first metatarsal head pad placed in the first metatarsal head pad area 609 is separated from the arch support area 617 by the separator wall 620, and as such the first metatarsal head pad does not lie in the same depression area, or any type of recessed area, where the arch support is located.

Alternatively, the bottom surface 605A of base layer 605 may only have one or more of the defined areas: forefoot wedge area, first metatarsal head pad area 609, heel cushion area, rearfoot wedge/heel lift area, and arch support area 617.

Metatarsal dome 638 preferably lies behind the 2nd-4th metatarsal heads. Metatarsal dome 638 provides a redistribution of pressure away from the lesser metatarsal heads for general forefoot comfort and relatively increases the depth of the first metatarsal head pad area to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 638 is an extension of base layer 605. Preferably the metatarsal dome 638 is an extension of base layer 605.

The metatarsal dome 638 preferably has a height of 2.0-3.0 mm above the top surface 605A. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 638 is a conical-like component that is secured to the top surface 605A of base layer 605 in the area behind the 2nd-4th metatarsals with the top sheet 603 secured across the top surface 605A of base layer 605 and either over the metatarsal dome 638 or allowing the metatarsal dome 638 to extend therethrough. Another alternative is to secure the metatarsal dome 638 to the top sheet 603 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 638 is made of the same material as base layer 605. Other materials may be used for metatarsal dome 638 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 638.

A back and medial edge of a first metatarsal head pad extends slightly up the medial side of the insole. The first metatarsal head pad is located under the first metatarsal head of the foot forward of the arch support.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area 609. The first metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The arch support area 617 is located along the longitudinal arch support 606 and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. The arch support partially wraps up the medial side of base layer 605 under the medial longitudinal arch support 606. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. The arch support is shaped essentially the same as arch support area 617 and is secured to said arch support area 617 on bottom surface 605B of base layer 605. An adhesive or bonding agent may be used to secure the arch support to the arch support area 617.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer 605 to extend therethrough. The width of each rib is approximately 5 mm. Base layer 605 is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer 605 together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer 605 is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

FIG. 7 illustrates a rear view of the insole. The insole preferably comprises a top sheet 703 and a base layer 705, said base layer 705 having a top surface 705A secured to said top sheet 703 and an opposite bottom surface 705B. Base layer 705 also defines a longitudinal arch support 706 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 705 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area 706 compared to the lateral border.

Base layer 705 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 705 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 705 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 705.

In a preferred embodiment, top surface 705A of base layer 705 is covered with top sheet 703, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 705 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 705. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The arch support area 717 is located along the longitudinal arch support 706 and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. The arch support partially wraps up the medial side of base layer 705 under the medial longitudinal arch support 706. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. The arch support is shaped essentially the same as arch support area 717 and is secured to said arch support area 717 on bottom surface 705B of base layer 705. An adhesive or bonding agent may be used to secure the arch support to the arch support area 717.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer 705 to extend therethrough. The width of each rib is approximately 5 mm. Base layer 705 is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer 705 together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer 705 is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 705 in the areas defined by base layer 705 on bottom surface 705B are affixed to base layer 705 using an appropriate means such as an adhesive or bonding agent.

Alternatively, the various components can be molded to the base layer 705 during fabrication.

FIG. 8 is a longitudinal cross sectional view of the insole of FIG. 4 along the middle of the insole. The insole preferably comprises a top sheet 803 and a base layer 805, said base layer 805 having a top surface 805A secured to said top sheet 803 and an opposite bottom surface 805B. Preferably, said top surface 805A of said base layer 805 defines an upwardly-extending portion or metatarsal dome 838 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsal area of the foot. Base layer 805 also defines a longitudinal arch support 806 that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 805 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area 806 compared to the lateral border.

Base layer 805 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 805 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 805 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 805.

In a preferred embodiment, top surface 805A of base layer 805 is covered with top sheet 803, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 805 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 805. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 805B of base layer 805 defines various depressions or areas: a forefoot wedge area 807 in the rear portion of the forefoot area, a first metatarsal head pad area in the area of the first metatarsal, a heel cushion area 811 and rearfoot wedge/heel lift area 813 in the area of the heel, and an arch support area from the middle of the insole towards the heel area near the medial side.

Alternatively, the bottom surface 805A of base layer 805 may only have one or more of the defined areas: forefoot wedge area 807, first metatarsal head pad area, heel cushion area 811, rearfoot wedge/heel lift area 813, and arch support area.

Metatarsal dome 838 preferably lies behind the 2nd-4th metatarsals. Metatarsal dome 838 provides a redistribution of pressure away from the lesser metatarsals for general forefoot comfort and relatively increases the depth of the first metatarsal head pad area to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 838 is an extension of base layer 805.

The metatarsal dome 838 preferably has a height of 2.0-3.0 mm above the top surface 805A. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 838 is a conical-like component that is secured to the top surface 805A of base layer 805 in the area behind the 2nd-4th metatarsals with the top sheet 803 secured across the top surface 805A of base layer 805 and either over the metatarsal dome 838 or allowing the metatarsal dome 838 to extend therethrough. Another alternative is to secure the metatarsal dome 838 to the top sheet 803 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 838 is made of the same material as base layer 805. Other materials may be used for metatarsal dome 838 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 838.

The forefoot wedge area 807 begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area 807 and is secured therein. The forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of the forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area 807.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for the forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The rearfoot wedge/heel lift area 813 is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area 813 is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area 813 is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area 811 is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area 813. A heel cushion may be secured in the heel cushion area 811 between the base layer and the rearfoot wedge or heel lift. The heel cushion may also be secured to the heel cushion area 811 without a rearfoot wedge or heel lift secured thereto. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for the heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 805 in the areas defined by base layer 805 on bottom surface 805B are affixed to base layer 805 using an appropriate means such as an adhesive or bonding agent.

Alternatively, the various components can be molded to the base layer 805 during fabrication.

FIG. 9 illustrates a transverse cross section 9-9 of the insole behind the metatarsal region as identified in FIGS. 3 and 4. The insole preferably comprises a top sheet 903 and a base layer 905, said base layer 905 having a top surface 905A secured to said top sheet 903 and an opposite bottom surface 905B. Preferably, said top surface 905A of said base layer 905 defines an upwardly-extending portion or metatarsal dome 938 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsal area of the foot. Base layer 905 also defines a longitudinal arch support that extends upwardly along the medial side of the insole to provide extra cushion and support to the arch area of the foot.

Base layer 905 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area compared to the lateral border.

Base layer 905 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 905 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 905 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 905.

In a preferred embodiment, top surface 905A of base layer 905 is covered with top sheet 903, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 905 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 905. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 905B of base layer 905 defines various depressions or areas: a forefoot wedge area 907 in the rear portion of the forefoot area, a first metatarsal head pad area 909 in the area of the first metatarsal, a heel cushion area and rearfoot wedge/heel lift area in the area of the heel, and an arch support area 917 from the middle of the insole towards the heel area near the medial side. Base layer 905 also defines a separator wall 920 that divides the first metatarsal head pad area 909 from the arch support area 917.

Alternatively, the bottom surface 905A of base layer 905 may only have one or more of the defined areas: forefoot wedge area 907, first metatarsal head pad area 909, heel cushion area, rearfoot wedge/heel lift area, and arch support area 917.

Metatarsal dome 938 preferably lies behind the 2nd-4th metatarsals. Metatarsal dome 938 provides a redistribution of pressure away from the lesser metatarsals for general forefoot comfort and relatively increases the depth of the first metatarsal head pad area 909 to encourage a greater degree of first ray plantarflexion during the propulsive phase of gait. Preferably the metatarsal dome 938 is an extension of base layer 905.

The metatarsal dome 938 preferably has a height of 2.0-3.0 mm above the top surface 905A. The height may vary ±1 mm, but is not recommended to vary more than that as too little or too much of a metatarsal dome may not have the desired effects.

Alternatively, metatarsal dome 938 is a conical-like component that is secured to the top surface 905A of base layer 905 in the area behind the 2nd-4th metatarsals with the top sheet 903 secured across the top surface 905A of base layer 905 and either over the metatarsal dome 938 or allowing the metatarsal dome 938 to extend therethrough. Another alternative is to secure the metatarsal dome 938 to the top sheet 903 in the area of the 2nd-4th metatarsals.

Preferably the metatarsal dome 938 is made of the same material as base layer 905. Other materials may be used for metatarsal dome 938 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the metatarsal dome 938.

The forefoot wedge area 907 begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area 907 and is secured therein. The forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area 907.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area 909 and arch support area 917.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for the forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

First metatarsal head pad area 909 is an area in the bottom surface 905B of the base layer 905 and lies under the first metatarsal head of the foot. The first metatarsal head pad is shaped essentially the same as first metatarsal head pad area 909 and is secured to first metatarsal head pad area 909. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area 909.

In use, first metatarsal head pad remains under the first metatarsal head (i.e., the medial ball of the user's foot) and moves with it. Removing the pad reduces the GRF beneath the first metatarsal head. This enhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area 917, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of the first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area 909. The first metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when the first metatarsal head pad is unattached. Other materials may be used for the first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The arch support area 917 is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. An arch support partially wraps up the medial side of base layer 905 under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area 917 and is secured to said arch support area 917 on bottom surface 905B of base layer 905. An adhesive or bonding agent may be used to secure the arch support to the arch support area 917.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer 905 to extend therethrough. The width of each rib is approximately 5 mm. Base layer 905 is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of the arch support and mechanically lock the arch support and base layer 905 together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer 905 is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

FIG. 10 illustrates a transverse cross section 10-10 of the insole heel area as identified in FIGS. 3 and 4. The insole preferably comprises a top sheet 1003 and a base layer 1005, said base layer 1005 having a top surface 1005A secured to said top sheet 1003 and an opposite bottom surface 1005B.

Base layer 1005 has a raised edge that wraps around the heel and extends partially along the sides of the foot such that the insole has a heel cup, which conforms to the natural shape of the foot. As seen in FIGS. 5-8 and 10, the height of the raised edge is generally higher and thicker on the adjacent the medial border of the insole and is lower and thinner adjacent to the lateral border of the insole. The raised edge is especially higher along the longitudinal arch area compared to the lateral border.

Base layer 1005 is preferably made of foam or other material having suitable cushioning properties. Preferably, base layer 1005 comprises an Ethylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene and vinyl acetate. A preferred EVA foam has a durometer (hardness) of about 55-60 Asker C. Other materials may be used for base layer 1005 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the base layer 1005.

In a preferred embodiment, top surface 1005A of base layer 1005 is covered with top sheet 1003, which is preferably a non-woven fabric layer with a low coefficient of friction so as to minimize the possibility of blisters. In a preferred embodiment, the fabric is treated with an antibacterial agent, which in combination with a moisture barrier reduces odor causing bacteria and fungi. A woven fabric may also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 1005 has an approximate length of 264 mm, an approximate width of 86.5 mm in the forefoot area, an approximate width of 63 mm in the heel area, and an approximate width of 76.5 through the arch and middle area. These widths may vary ±5 mm and still maintain the desired performance of the base layer 1005. The length may vary and may even be shortened by up to 26 mm to fit within the desired shoe. Longer or shorter lengths may also be achieved by altering all the dimensions of the base layer proportionately.

The bottom surface 1005B of base layer 1005 defines various depressions or areas: a forefoot wedge area in the rear portion of the forefoot area, a first metatarsal head pad area in the area of the first metatarsal, a heel cushion area 1011 and rearfoot wedge/heel lift area 1013 in the area of the heel, and an arch support area from the middle of the insole towards the heel area near the medial side.

Alternatively, the bottom surface 1005A of base layer 1005 may only have one or more of the defined areas: forefoot wedge area, first metatarsal head pad area, heel cushion area 1011, rearfoot wedge/heel lift area 1013, and arch support area.

The rearfoot wedge/heel lift area 1013 is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area 1013 is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area 1013 is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. The heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for the heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area 1011 is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area 1013. A heel cushion may be secured in the heel cushion area 1011 between the base layer and a rearfoot wedge or heel lift. The heel cushion may also be secured to the heel cushion area 1011 without a rearfoot wedge or heel lift secured thereto. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for the heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

In a first preferred embodiment of the present invention, the various components of an insole which are secured to base layer 1005 in the areas defined by base layer 1005 on bottom surface 1005B are affixed to base layer 1005 using an appropriate means such as an adhesive or bonding agent.

Alternatively, the various components can be molded to the base layer 1005 during fabrication.

FIG. 11 illustrates the bones of the foot superimposed over a bottom view of the insole of the present invention. The insole areas shown are forefoot pad area 1107, first metatarsal pad area 1109, heel pad area 1111, rearfoot wedge/heel lift area 1113, arch support area 1117, and separating wall 1120. At the heel of the foot is the calcaneus 1170 and forward of the calcaneus 1170 is the talus 1172. Forward of the talus 1172 on the medial side is the navicular 1174 and on the lateral side is the cuboid 1176. Forward of the cuboid 1176 and the navicular 1174 are cuneiforms 1178. Forward of the cuneiforms 1178 and cuboid 1176 are the metatarsals 1180A, 1180B, 1180C, 1180D and 1180E. The first metatarsal 1180A is located on the medial side of the foot and the fifth metatarsal 1180E is located on the lateral side of the foot. Forward of the metatarsals 1180A-1180E are the proximal phalanges 1182. Forward of the proximal phalanges 1182 are the middle phalanges 1184, and at the end of each toe are the distal phalanges 1186.

FIG. 12 shows the bottom view of the insole (similar to FIG. 4) and illustrates the various areas of the insole: hallux area 1251, lesser toe area 1252, first metatarsal area 1253, lesser metatarsal area 1254, distal medial arch area 1255, lateral midfoot area 1256, proximal medial arch area 1257, heel area 1258, forefoot area 1263, toe area 1261, metatarsal area 1262, midfoot area 1264, and rearfoot area 1265. The insole areas of the present invention shown are base layer 1205, base layer bottom surface 1205B, longitudinal arch support 1206, forefoot pad area 1207, first metatarsal pad area 1209, heel pad area 1211, rearfoot wedge/heel lift area 1213, arch support area 1217, and separating wall 1220.

Forefoot area 1263 comprises toe area 1261 and metatarsal area 1262, encompassing the entire width of the insole from the toe end to just behind the metatarsals or “balls” of the feet. Toe area 1261, which comprises the hallux area 1251 and the lesser toe area 1252, has a length extending from the toe end to a diagonal edge that runs generally behind the first distal phalange and second through fifth proximal phalanges and forward of the metatarsals. Toe area 1261 has a width extending from the medial border to the lateral border. Metatarsal area 1262, comprising first metatarsal area 1253 and lesser metatarsal area 1254, has a length extending from a front diagonal edge, adjacent the diagonal edge of toe area 1261, to a back diagonal edge that generally runs behind the metatarsals. Metatarsal area 1262 has a width extending from the medial border to the lateral border.

Hallux area 1251 has a length extending from a front edge near the toe end to a back edge near the joint between the first proximal phalange and first metatarsal and a width extending from the medial border to a lateral edge near the second phalanges. Lesser toe area 1252 has a length extending from a front edge near the toe end to a back edge near the second through fifth proximal phalanges and a width extending from a medial edge, medial of the second phalanges and adjacent the lateral border of hallux area 1251, to a lateral edge near the lateral border. The back edge of lesser toe area 1252 runs generally parallel to the second through fifth metatarsals.

The first metatarsal area 1253 extends from a front edge forward of the first metatarsal and adjacent the back edge of hallux area 1251 to a back edge just behind the first metatarsal and adjacent a front edge of midfoot area 1264. The width of first metatarsal area 1253 extends from the medial border to a lateral edge near the second metatarsal. Lesser metatarsal area 1254 extends from a front edge forward of the second through fifth metatarsals and adjacent the back edge of lesser toe area 1252 or diagonal edge of toe area 1261 to a back edge behind the second through fifth metatarsals and adjacent a front edge of midfoot area 1264. The width of lesser metatarsal area 1254 extends from the lateral edge of the first metatarsal area 1253 to the lateral border.

Midfoot area 1264 comprises distal medial arch area 1255 and lateral midfoot area 1256. Midfoot area 1264 has a front edge adjacent forefoot area 1263 or metatarsal area 1262 and a back edge that runs diagonally from between the talus and navicular on the medial side to just behind the cuboid on the lateral side. Midfoot area 1264 has a width extending from the medial border to the lateral border.

Distal medial arch area 1255 extends from a front edge just behind the first metatarsal and adjacent the back edge of first metatarsal area 1253 or back diagonal edge of metatarsal area 1262 to a back edge between the talus and navicular. The width of distal medial arch area 1255 extends from the medial border to near the middle of the foot. Lateral midfoot area 1256 extends from a front edge just behind the second through fifth metatarsals and adjacent the back edge of lesser metatarsal area 1254 or back diagonal edge of metatarsal area 1262 to a back edge just behind the cuboid. The width of lateral midfoot area extends from near the middle of the foot to the lateral border.

Rearfoot area 1265 comprises proximal medial arch area 1257 and heel area 1258. Rearfoot area 1265 has a front edge adjacent the back edge of midfoot area 1264 and extends proximally to the heel end. Rearfoot area 1265 has a width extending from the medial border to the lateral border.

Proximal medial arch area 1257 extends from a front edge between the talus and navicular or adjacent the front edge of rearfoot area 1265 to a back point along the medial border about midway between the heel end and the talus. The width of proximal medial arch area 1257 extends from the medial border to diagonal lateral edge where the diagonal lateral edge extends from about a third of the insole width laterally from the medial border along the front edge of the rearfoot area 1265 to the back point of proximal medial arch area 1257.

Heel area 1258 extends from a front edge just behind the cuboid or adjacent the front edge of rearfoot area 1265 to the heel end. The width of heel area 1258 extends from the lateral diagonal edge of proximal medial arch area 1257 to the lateral border.

Forefoot wedge area 1207 preferably extends from just behind the lesser metatarsal heads in the lesser metatarsal area 1254 to slightly into the front of lateral midfoot area 1256. A forefoot wedge is secured to the forefoot wedge area 1207.

The majority of first metatarsal head area 1209 is located in the first metatarsal area 1253. Preferably, a front edge of first metatarsal head area 1209 lies slightly proximal of the front edge of first metatarsal area 1253 and adjacent forefoot wedge area 1207. First metatarsal head area 1209 may also extend into the distal medial arch area 1255. First metatarsal head area 1209 also extends into the front lateral portion of distal medial arch area 1255. A first metatarsal head pad is secured to the first metatarsal head area 1209. Separator wall 1220 helps further distinguish the edges of first metatarsal head area 1209 and arch support area 1217.

Arch support area 1217 is located in the majority of both the distal medial arch area 1255 and proximal medial arch area 1257. A front edge of arch support area 1217 is adjacent a back edge of first metatarsal head area 1209. An arch support is secured to arch support area 1217. Separator wall 1220 helps further distinguish the edges of first metatarsal head area 1209 and arch support area 1217.

Rearfoot wedge/heel lift area 1213 is located in the majority of heel area 1258. The front edge of the rearfoot/heel lift area 1213 borders the lateral midfoot area 1256. A portion of the medial edge of rearfoot/heel lift area 1213 borders the proximal medial arch area 1257. The proximal edge of rearfoot/heel lift area 1213 borders the heel end of the insole. The lateral edge of rearfoot/heel lift area 1213 borders the lateral border of the insole. A rearfoot wedge or heel lift is secured to the rearfoot/heel lift area 1213.

Heel cushion area 1211 is located in heel area 1258 with the boundaries of the rearfoot/heel lift area 1213. A heel cushion is secured to the heel cushion area 1211.

FIG. 13A is a bottom (plantar) view of the first metatarsal head pad 1310 and FIG. 13B is a medial view of the first metatarsal head pad 1310.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad 1310 is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad 1310 to the first metatarsal head pad area.

In use, first metatarsal head pad 1310 remains under the first metatarsal head (i.e., the medial ball of the user's foot) and moves with it. Removing the pad reduces the GRF beneath the first metatarsal head. This enhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad 1310, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad 1310 has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad 1310 has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad 1310 comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad 1310. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad 1310 proportionately.

Preferably, said first metatarsal head pad 1310 is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad 1310 is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's 1310 basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad 1310 is unattached. Other materials may be used for first metatarsal head pad 1310 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad 1310.

FIG. 14A is a perspective view of a first embodiment of the arch support 1418, FIG. 14B is a bottom (plantar) view of a first embodiment of the arch support 1418, FIG. 14C is a rear (proximal) view of a first embodiment of the arch support 1418, and FIG. 14D is a sectional view of a first embodiment of the arch support 1418 along line 14D-14D as identified in FIG. 14B.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support 1418 partially wraps up the medial side of the base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support 1418 is shaped essentially the same as the arch support area and is secured to said arch support area on the bottom surface of the base layer. An adhesive or bonding agent may be used to secure the arch support 1418 to the arch support area.

This first embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs 1418A that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs 1418A are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support 1418.

For a men's size medium insole, the arch support 1418 is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support 1418.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

FIG. 15A is a perspective view of a second embodiment of the arch support 1518, FIG. 15B is a bottom (plantar) view of a second embodiment of the arch support 1518, FIG. 15C is a rear (proximal) view of a second embodiment of the arch support 1518, and FIG. 15D is a sectional view of a second embodiment of the arch support 1518 along line 15D-15D as identified in FIG. 15B.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support 1518 partially wraps up the medial side of the base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support 1518 is shaped essentially the same as the arch support area and is secured to said arch support area on the bottom surface of the base layer. An adhesive or bonding agent may be used to secure the arch support 1518 to the arch support area.

This second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions 1518C that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions 1518C are depressed into the arch support 1518 about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions 1518C may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. The base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support 1518 and mechanically lock arch support 1518 and the base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when the base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support 1518 is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support 1518.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

FIG. 16A is a perspective view of a third embodiment of the arch support 1618, FIG. 16B is a bottom (plantar) view of a third embodiment of the arch support 1618, FIG. 16C is a rear (proximal) view of a third embodiment of the arch support 1618, and FIG. 16D is a sectional view of a third embodiment of the arch support 1618 along line 16D-16D as identified in FIG. 16B.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support 1618 partially wraps up the medial side of the base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support 1618 is shaped essentially the same as the arch support area and is secured to said arch support area on the bottom surface of the base layer. An adhesive or bonding agent may be used to secure the arch support 1618 to the arch support area.

This third embodiment of the arch support comprises a plurality of extending ribs 1618A that extend outwardly from said arch support, a plurality of essentially level ribs 1618B having a rib outline indented in said arch support, and a plurality of rib-shaped openings 1618C that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support 1618 defines, from said proximal edge end going toward said distal edge end, one or more extending ribs 1618A, one or more essentially level ribs 1618B, and one or more rib-shaped depressions 1618C. Preferably, three extending ribs 1618A, three of said essentially level ribs 1618B, and three rib-shaped depressions 1618C are used. The width of each rib is approximately 5 mm. The extending ribs 1618A are approximately 0.5 mm thick. The rib-shaped depressions 1618C are depressed into the arch support 1618 about 0.5 mm. The essentially level ribs 1618B have a rib outline approximately 0.5 mm deep

Rib-shaped depressions 1618C improve flexibility at said distal edge end of arch support 1618 without sacrificing longitudinal arch support at the middle and proximal end of arch support 1618.

The first three rib-shaped depressions 1618C in the distal one-third of the arch support 1618 are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support 1618 (level ribs 1618B and extending ribs 1618A) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately 1-2 mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions 1618C may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. The base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support 1618 and mechanically lock arch support 1618 and the base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when the base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support 1618 is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support 1618.

When the foot takes up a “neutral” (i.e., neither pronated or supinated) position, the arch support is inactive or applies a gentle supination (anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies a higher magnitude of GRF against the area beneath the sustentaculum tali (i.e., the proximal arch) increasing the supination (anti-pronation) moment to subtalar joint (i.e., the rearfoot).

FIG. 17A is a perspective view of a forefoot wedge 1708, FIG. 17B is a bottom (plantar) view of a forefoot wedge 1708, and FIG. 17C is a rear (proximal) view of a forefoot wedge 1708.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge 1708 is shaped essentially the same as the forefoot wedge area and is secured therein. Forefoot wedge 1708 has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge 1708 extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge 1708 to the forefoot wedge area.

The forefoot wedge 1708 has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge 1708 is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge 1708 may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge 1708 has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge 1708. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge 1708 proportionately.

Preferably the forefoot wedge 1708 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge 1708 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge 1708.

FIG. 18A is a perspective view of a heel cushion 1812, FIG. 18B is a bottom (plantar) view of a heel cushion 1812, and FIG. 18C is a medial view of a heel cushion 1812.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion 1812 may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift. The heel cushion 1812 may also be secured to the heel cushion area without a rearfoot wedge or heel lift secured thereto. The heel cushion 1812 provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion 1812 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion 1812 has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion 1812 and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion 1812 proportionately.

Preferably the heel cushion 1812 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion 1812 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion 1812.

FIG. 19A is a perspective view of a heel lift 1915, FIG. 19B is a bottom (plantar) view of a heel lift 1915, and FIG. 19C is a sectional view of a heel lift 1915 along line 19C-19C as identified in FIG. 19B.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift 1915. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The heel lift 1915 approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift 1915 is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift 1915 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift 1915 has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift 1915. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift 1915 proportionately.

Preferably the heel lift 1915 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift 1915 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift 1915.

FIG. 20A is a perspective view of a rearfoot wedge 2014, FIG. 20B is a bottom (plantar) view of a rearfoot wedge 2014, and FIG. 20C is a sectional view of a rearfoot wedge 2014 along line 20C-20C as identified in FIG. 20B.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge 2014 or a heel lift. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge 2014 has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge 2014 is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge 2014 may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge 2014 has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge 2014. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge 2014 proportionately.

Preferably the rearfoot wedge 2014 is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge 2014 such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The insole described herein may be delivered to a recipient with the components unattached to allow the recipient to attach the desired components. The insole may also be delivered to a recipient with a predetermined component configuration already attached prior to delivery. Additionally, the invention may allow for a combination of a predetermined component configuration attached to the insole prior to delivery while also providing additional components that may be attached by the recipient.

All diagnoses can utilize one or more of the described components, and all the components can be attached to various positions on the insole to vary the characteristics of the insole. The Examples below only represent a recommended set of components for the described diagnosis. The following are examples of everyday scenarios that can be addressed with the system of the current invention by using one or more of the components in combination with each other:

Example 1

Scenario: Patient reports burning pain beneath the left big toe joint. Intermittent episodes of pain with sports for many years. Worse since starting step classes three times a week. Had to pull out of the last class due to severe soreness.

Examination: Pain with direct pressure beneath the inflamed first metatarsophalangeal joint (MTPJ), especially over the tibial sesamoid. Plantarflexed first metatarsals bilaterally, plus a forefoot valgus on the left foot.

Diagnosis: Tibial Sesamoiditis.

Treatment: A forefoot wedge may be applied to the left insole to further redirect ground reaction forces (GRF) away from the painful first metatarsal head. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heel.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments may need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

Example 2

Scenario: Patient reports painful lump on the ball of the left foot. Calluses have been on the soles of both feet for many years, but the left foot has become increasingly more red, swollen, and painful over the last three months.

Examination: Area of thick callus with edema and erythema beneath the left second MTPJ. Bilateral excessive foot pronation with calcaneal eversion in static stance and gait. 0° ankle joint dorsiflexion bilaterally. Metatarsus Primus Elevatus on the left foot.

Diagnosis: Plantar Metatarsal Bursitis.

Treatment: The metatarsal dome and cushioned forefoot extension will reduce excessive GRF beneath the 2nd MTPJ. Rigid arch supports and rearfoot wedges may be applied to reduce the excessive pronation moments. Heel lifts may be used for the ankle equinus if the shoe style permits. First metatarsal head pads and heel cushions may be applied to maintain the magnitude of GRF forces beneath the first metatarsal heads and central heel.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 3

Scenario: Patient reports painful lumps on the outside of the balls of the feet.

Examination: Bilateral Intractable Plantar Keratosis (IPK) with swelling and erythema beneath the 5th metatarsal head. Inverted heel positions in static stance and gait and bilateral forefoot valgus.

Diagnosis: Plantar metatarsal bursitis with overlying IPK.

Treatment: Forefoot wedges should be applied to both insoles to off-load the 5th metatarsal heads and to reduce the degree of heel inversion. First metatarsal head pads and heel cushions may be applied to maintain the magnitude of GRF forces beneath the first metatarsal heads and central heel. If symptoms persist, adjust the first metatarsal head pads to enhance the effect of the metatarsal dome and forefoot wedges.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

Example 4

Scenario: Patient reports soreness beneath the right big toe at the end of a long day at work. Cushioned insoles help but not enough.

Examination: Inflamed callous beneath the interphalangeal joint (IPJ) of both halluces, with the right being greater than the left. Excessive foot pronantion in static stance and gait with an everted right heel in static stance and a flexible plantarflexed first metatarsal on the right foot. Functional Hallux Limitus (FHL) on the right foot evidenced by a stiff right 1st MTPJ with Hubscher Maneuver.

Treatment: Rearfoot wedges and arch supports may be applied to patient tolerance to counteract the excessive pronation moments may be applied to the right insole. First metatarsal head pad may be applied to the left insole. Heel cushions may be added to maintain the magnitude of GRF forces beneath central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pad of the right insole to reduce the GRF forces beneath the first metatarsal head.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 5

Scenario: Patient reports painful right big toe joint. The right big toe aches in boots at work, but the pain worsens in the evening in soft house slippers.

Examination: Bilateral hallux abducto-valgus (HAV) with bunion, right side greater than left. Right 1st MTPJ is sore at end range dorsiflexion and plantarflexion. Excessive foot pronation with both heels everted, right greater than left, in static stance and gait. Less than 10° ankle joint dorsiflexion bilaterally. 30°-65° hallux dorsiflexion bilaterally. A plantarflexed first ray. A Hubscher Maneuver of <20° on the right.

Diagnosis: Capsolitis right 1st MTPJ.

Treatment: Rearfoot wedges and rigid arch supports may be applied bilaterally for the excessive foot pronation. First metatarsal head pad may be applied to the left insole. Heel lifts may be applied for the ankle equinus if shoe style permits. Heel cushions may be added to maintain the magnitude of GRF forces beneath central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pad of the right insole to reduce the GRF forces beneath the first metatarsal head and accommodate the plantarflexed first ray.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 6

Scenario: Patient reports painful left heel for 3 weeks. Patient has been busier around the house in a new pair of flat house slippers.

Examination: Pain with direct pressure to the medial plantar calcaneal tuberosity (MPCT) of the left foot. Moderate degree of flexible forefoot equinus, left greater than right. A slight reduction in ankle joint dorsiflexion bilaterally. Bilateral plantarflexed first rays, left greater than right. A forefoot valgus on the left. Moderately pronated feet with the heels vertical in static stance and gait.

Diagnosis: Proximal Plantar Fasciitis.

Treatment: Heel lifts may be used to “balance” the forefoot and ankle equinus' if shoe style permits. A forefoot wedge may be applied to the left insole. As the degree of abnormal foot pronation is “moderate,” rearfoot wedges may be omitted in the initial prescription to avoid irritation to the MPCT. The longitudinal arch support may be enough to reduce the excessive pronation moments. Heel cushions may be added to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

Example 7

Scenario: Patient reports pain on the sole of the left heel. Patient hit the sole of the heel on a rock while swimming on holiday.

Examination: Palpable mass in the centre of the left heel, painful to direct pressure. Moderate foot pronation in static stance bilaterally and a left ankle equinus of approximately 0-5°.

Diagnosis: Plantar Calcaneal Bursitis.

Treatment: The longitudinal arch support may be enough to reduce excessive pronation moments and redistribute GRF away from the left heel and into the arch, otherwise use an arch support. A heel cushion may be applied to the right insole. The left insole goes without the heel cushion to reduce the magnitude of GRF beneath the central heel.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the heel cushion of the left insole to reduce the GRF forces beneath the central heel.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

Example 8

Scenario: Patient reports a painful left ankle. Patient has had flat feet for many years, but severe left ankle pain for last 2 months.

Examination: Patient points to the region of the anterior talofibular ligament (ATFL) on the left ankle as the site of pain. Palpation of the ligamentous attachments of the ATFL fails to elite pain, but forceful passive pronation of the foot does. Severe foot pronation with medial and plantar “subluxation” of the talus on the navicular, left greater than right. There is no ankle joint dorsiflexion beyond 90° with the leg.

Diagnosis: Sinus Tarsitis.

Treatment: Flexible arch supports and rearfoot wedges may be applied to reduce the excessive pronation and to reduce the magnitude of compression force at the sinus tarsi. Heel lifts may be applied for the ankle equinus if shoe style permits. Heel cushions and first metatarsal head pads may be applied to maintain the magnitude of GRF forces beneath the first metatarsal heads and central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The rearfoot wedge/heel lift area is located in the heel area of the insole, which extends from about the cuboid of the foot proximally to the heel end of the insole. The rearfoot wedge/heel lift area is adapted to receive a supplementary pad cushion which can be a rearfoot wedge or a heel lift. The rearfoot wedge/heel lift area is longitudinally angled slightly towards the lateral border so that it does not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medial edge of about 4 mm to the thinner lateral edge of about 1 mm. The 4° rearfoot wedge is used to create a supination moment (and reduce the pronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the rearfoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the rearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 9

Scenario: No instability when walking or training on flat surfaces, but recurrent inversion sprains of the right ankle on a bumpy pitch.

Examination: Grade 1 right ankle sprain. Retains good proprioception and peroneal strength. Bilateral forefoot valgus right is greater than left, and a plantarflexed first ray on the right foot. The right foot is slightly supinated in static stance and gait.

Diagnosis: Chronic ankle sprain.

Treatment: A forefoot wedge may be applied to both insoles. A first metatarsal head pad may be applied to the left insole. The right insole goes without the first metatarsal head pad to accommodate the plantarflexed first metatarsal.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the heel cushions of both insoles and first metatarsal head pad of the right insole to reduce the GRF forces beneath the central heels of both insoles, reduce the GRF forces beneath the first metatarsal head on the right insole and accommodate the plantarflexed first metatarsal.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

Example 10

Scenario: Patient reports painful Achilles tendons. Pain on and off for 5 years despite a conscientious stretching program. Pain became worse 2 years ago during training for the National Schools Championship. Physiotherapist prescribed ice, rest, and gave ultrasound 3 times a week, which has helped.

Examination: Both Achilles tendons are tender to direct pressure and appear moderately “thickened”. Passive and active ankle joint dorsiflexion causes pain immediately above the calcaneal insertion and there is tenderness at the myotendinous junction. A moderately cavus foot type with less than 10° of ankle joint dorsiflexion, forefoot equinus, plantarflexed first ray, and forefoot valgus bilaterally.

Diagnosis: Achilles tendonitis.

Treatment: Heel lifts for the ankle and forefoot equinus and forefoot wedges may be applied. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads to accommodate the plantarflexed first metatarsals.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 11

Scenario: Patient reports shin splints. Patient has had a few episodes over the last few years, usually in the high season when the hotel gets busy.

Examination: Pain to direct pressure immediately posterior to the medial borders of the tibae, immediately proximal to the medial malleolus, and with foot inversion against resistance. Bilateral excessive foot pronation (with calcaneal eversion) in static stance and gait, less than 10° ankle joint dorsiflexion, and Functional hallux limitus (FHL) with less than 10° dorsiflexion of both halluces with Hubscher Maneuver.

Diagnosis: Tibialis Posterior Tendinitis.

Treatment: Heel lifts may be applied for the ankle joint equinus. Rigid arch supports and rearfoot wedges may be applied to reduce the magnitude of excessive pronation moments. If the patient complains of arch irritation, the rigid arch supports should be replaced with the semi-flexible arch supports which may be more easily tolerated. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 12

Scenario: Patient tripped off a curb. Pain on the outside of the left shin following a mild ankle sprain. Outside of the left shin became painful 2 days later. No previous treatment.

Examination: Tenderness along the course of the peroneal tendons at the lower third of the left leg. Moderately high arch; cavus feet with forefoot valgus bilaterally. Platarflexed first rays. Slightly inverted heels in relaxed stance.

Diagnosis: Peroneal tendinitis.

Treatment: Forefoot wedges may be applied to reduce the tensile force through the peroneals. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pads to reduce the GRF forces beneath the first metatarsal heads and accommodate the plantarflexed first metatarsals.

The forefoot wedge area begins just behind the 2nd-5th metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edge and a distal (front) edge. The distal edge lies just behind the 2nd-5th metatarsal heads. The medial edge of forefoot wedge extends along a line spaced laterally from said medial border of said insole, essentially extending from the distal edge to the proximal edge. The proximal edge extends from said medial edge transversely (or laterally) to said lateral edge, which is spaced slightly medial from said lateral border of said insole. The lateral edge connects said proximal edge to said distal edge of said forefoot wedge. FIG. 11 shows the placement of foot bones on the insole. An adhesive or bonding agent may be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateral edge of about 4 mm thick to the thinner medial edge of about 1 mm thick. The forefoot wedge is used to create a pronation moment around the midfoot joint. This moment helps stabilize the forefoot against the rearfoot, reduce supination moments caused by a forefoot valgus deformity, offload the metatarsophalangeal joint (MTPJ) by increasing the Ground Reaction Forces (GRF) beneath the lateral aspect of the forefoot and reduce abnormal supination moments around the subtalar joint.

The shape of the forefoot wedge may vary provided that the alternative shapes maintain a distal edge approximately at or behind the lesser metatarsal heads and the medial and proximal edges do not interfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has a length of approximately 55.9 mm and a width of approximately 51.3 mm. This length and width may vary ±5 mm and still maintain the desired performance of the forefoot wedge. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the forefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for forefoot wedge such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the forefoot wedge.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

Example 13

Scenario: Patient reports pain under the right knee cap when playing basketball, when going up and down stairs, and when rising from a seated position. Has been taking Ibuprofen PRN, which causes acid reflux. Physiotherapist has prescribed a knee support with patella aperture and VMO strengthening exercises, which has helped. Patient mentions she always stands with the right knee flexed.

Examination: Pain on compression of the right patella femoral joint and the Patella Apprehension Test. Excessive pronation (with calcaneal eversion) of the right foot only in static stance. Plantarflexed first metatarsal on the right. Reduced right hallux dorsiflexion with the Hubscher Maneuver. Short left leg by approximately 8.0 mm.

Diagnosis: Patello-femoral pain syndrome (PFPS).

Treatment: A rigid arch support and a rearfoot wedge may be applied to the right insole. A first metatarsal head pad should be applied to the left insole only so that the right insole can accommodate the plantarflexed first metatarsal. A heel lift may be applied to the left insole to correct for the limb-length discrepancy. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pad of the right insole to reduce the GRF forces beneath the first metatarsal head and accommodate the plantarflexed first metatarsal.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 14

Scenario: Patient reports pain and swelling over the insides of both shins, worse when running downhill. Insidious onset. No history of knee twists or direct trauma.

Examination: Pain to direct pressure over the medial femoral condyles and slightly inferior to the joint line at the attachment of Pes Anserinus bilaterally. Moderate forefoot equinus. Excessive foot pronation (mostly forefoot abduction) to heel vertical in static stance and gait. Less than 10° ankle joint dorsiflexion bilaterally.

Diagnosis: Pes Anerinus friction syndrome and enthesitis.

Treatment: Heel lifts may be applied to “balance” the forefoot and ankle equinus. The incorporated medial longitudinal arch support may be enough to reduce the associated excessive foot pronation in the first instance, although an arch support to patient tolerance and rearfoot wedge should be considered to reduce the excessive forefoot abduction. Heel cushions and first metatarsal head pads may be applied to maintain the magnitude of GRF forces beneath the first metatarsal heads and central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

Example 15

Scenario: Patient reports pain on the outside of the right knee. Pain started on a skiing holiday where the lateral aspect of right knee became painful on side stepping. Pain now continues during aerobics classes.

Examination: Pain is produced with direct pressure to the lateral femoral condyle and proximally along 4-5 cm of the iliotibial band (ITB). Excessive foot pronation with calcaneal eversion in static stance causing the legs to internally rotate as evidenced by “squinting” patellae. There is no ankle joint equinus.

Diagnosis: ITB friction syndrome and tendinitis.

Treatment: As the symptoms are acute in nature, the patient may begin to wear the insoles may only have the first metatarsal pads and heel cushions applied to see if the incorporated medial longitudinal arch support reduces the symptoms. If the symptoms persist, an arch support may be added to both insoles along with a rearfoot wedge to the right insole to reduce the pronation moments.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user.

First metatarsal head pad area is an area in the bottom surface of the base layer and lies under the first metatarsal head of the foot. First metatarsal head pad is shaped essentially the same as first metatarsal head pad area and is secured to first metatarsal head pad area. An adhesive or bonding agent may be used to secure the first metatarsal head pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregular polygonal shape. Preferably, said first metatarsal head pad has an essentially linear distal edge, a slightly curvilinear medial edge which follows the curve of the medial border of the insole, a proximal edge which is curved or angled to follow the shape of the metatarsal edge of arch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal head pad has a length of approximately 73.5 mm and a width of approximately 29.3 mm at the distal edge. The proximal end of first metatarsal head pad comes to a point at the proximal and lateral edges. This length and width may vary ±5 mm and still maintain the desired performance of the first metatarsal head pad. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the first metatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with a hardness of approximately 40-45 Asker C. Alternatively, the hardness of the first metatarsal head pad can be approximately between 45-55 Asker C, or alternatively 55-60 Asker C. The thickness of the first metatarsal head pad is about 2-2.5 mm thick or the depth of the first metatarsal head pad area. First metatarsal head pad's basic design is to create differential in GRF under the metatarsal heads and allow the first metatarsal head to drop below the plane of the other metatarsals when first metatarsal head pad is unattached. Other materials may be used for first metatarsal head pad such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the first metatarsal head pad.

Example 16

Scenario: Patient reported lower back pain when walking, exacerbated when jogging over one mile, which improves with rest. Prior orthopedic examination and imaging reveals no lesion or pathological condition. Prior diagnosis was idiopathic low-back pain. Core stability exercises prescribed by a physiotherapist have reduced the symptoms by approximately 50%.

Examination: Patient points to the area of the lumbar spine as the site of pain. A short left leg of approximately 8.0-9.0 mm causing a pelvic tilt to the left in static stance. Pronated feet bilaterally with everted heels, left greater than right. A marked plantarflexed first ray on the left foot with restricted left hallux dorsiflexion with the Hubscher maneuver reveals a Functional Hallux Limitus (FHL).

Diagnosis: Gait related low-back pain.

Treatment: A heel lift (with caution and close monitoring) may be applied to the left insole to reduce the pelvic tilt. Arch supports (to patient tolerance) and rearfoot wedges may be applied to reduce the excessive pronation moments. A first metatarsal head pad may be applied to the right insole. Left insole may go without the first metatarsal head pad to improve the hallux dorsiflexion. Heel cushions may be applied to maintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heel cushions and first metatarsal head pads pre-attached before application of additional components by the user. For this example, adjustments need to be made to the first metatarsal head pad of the left insole to reduce the GRF forces beneath the first metatarsal head and improve hallux dorsiflexion.

The arch support area is located along the longitudinal arch support and has a proximal edge end nearest the heel end of the insole and extends toward said toe end of the insole to a distal edge end. Connecting said proximal edge end to said distal edge end is a medial edge and a lateral edge, with said lateral edge having a parabolic-like shape. Arch support partially wraps up the medial side of base layer under the medial longitudinal arch support. In general, it approximately lies in the arch area of the foot or under the talus, navicular, first cuneiform, and proximal part of the first metatarsal. Arch support is shaped essentially the same as arch support area and is secured to said arch support area on bottom surface of base layer. An adhesive or bonding agent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of extending ribs that extend outwardly from said arch support. This embodiment provides a rigid support in the arch area. The extending ribs are approximately 0.5 mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 90-100 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edge end going toward said distal edge end, a plurality of rib-shaped depressions that extend inwardly from said arch support. This embodiment provides a flexible support in the arch area. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Shore A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality of extending ribs that extend outwardly from said arch support, a plurality of essentially level ribs having a rib outline indented in said arch support, and a plurality of rib-shaped openings that extend inwardly from said arch support. This embodiment provides a semi-flexible or semi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward said distal edge end, one or more extending ribs, one or more essentially level ribs, and one or more rib-shaped depressions. Preferably, three extending ribs, three of said essentially level ribs, and three rib-shaped depressions are used. The width of each rib is approximately 5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shaped depressions are depressed into the arch support about 0.5 mm. The essentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end of arch support without sacrificing longitudinal arch support at the middle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of the arch support are provided to allow the area immediately proximal to the first metatarsal head (i.e., the distal shaft of the first metatarsal) to remain flexible in order to encourage unrestricted plantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs and extending ribs) are stiffened by progressively thicker transverse bars to provide improved support to the arch and the application of higher magnitudes of anti-pronation GRF into the area of the sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, for example Nylon 66, having a hardness of about 80-90 Asker A. This thickness of the arch support in the non-rib areas range from approximately mm. Other materials may be used such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings. The rib-shaped openings are defined to allow said base layer to extend therethrough. The width of each rib is approximately 5 mm. Base layer is molded so that portions of its material project into the rib-shaped openings so that such portions are approximately flush with the outer surface of arch support and mechanically lock arch support and base layer together. Advantageously, the base layer material is also able to bulge through rib-shaped openings when base layer is compressed (e.g., while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately 104-105 mm long. The width at the widest point, near the middle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mm and still maintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about 4 mm to the thinner distal edge of about 1 mm. Heel lift is used to adjust the insole on a sagittal plane for the management of forefoot and ankle equinus and their associated kinetic and kinematic effects on the musculoskeletal system of the lower limb or to balance a limb length discrepancy.

The shape of the heel lift may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel lift has a length of approximately 71.8 mm and a width of approximately 46.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel lift proportionately.

Preferably the heel lift is made of a high-density EVA material with a hardness of about 75-80 Asker C. Other materials may be used for heel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel lift.

The heel cushion area is located in the heel area of the insole within the boundaries of the rearfoot wedge/heel lift area. The heel cushion provides shock attenuation and cushioning at heel strike. Leaving the heel cushion unattached reduces the GRF beneath the central heel area to treat certain foot pathologies, and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternative shapes maintain a position within the heel area do not interfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion has a length of approximately 63.3 mm and a width of approximately 38.9 mm. This length and width may vary ±5 mm and still maintain the desired performance of the heel cushion and preferably smaller than the rearfoot wedge or heel lift. For different sized insoles, the dimensions may be achieved by altering all the dimensions of the heel cushion proportionately.

Preferably the heel cushion is made of a high-density EVA material with a hardness of about 75-80 Asker C. Alternatively, the heel cushion may be a lower density material with a hardness of about 45-50 Asker C, or alternatively a medium density of 50-75 Asker C. Other materials may be used for heel cushion such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel that provides the appropriate hardness and material characteristics to maintain the overall structure and resilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between the base layer and the rearfoot wedge or heel lift.

While preferred embodiments of the invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. The embodiments described herein are exemplary only, and are not intended to be limiting. Many variations and modifications of the invention disclosed herein are possible and are within the scope of the invention.

Claims

1. An insole having a top side for contacting a user's foot and a bottom side for contacting the inside of a user's shoe, comprising:

a. a base having a base top surface, a base bottom surface, a heel end, a toe end, a medial border located proximate to an inside medial edge of the base and a lateral border located proximate to an outside lateral edge of the base, said base bottom side having: i. a first metatarsal head pad area extending from the medial border to a position under the first metatarsal, ii. a forefoot wedge area that extends from said first metatarsal head pad area to the lateral border along the second through fifth metatarsals, iii. a heel area that extends from about the cuboid of the foot to said heel end, and, iv. an arch support area that extends longitudinally under the arch of the foot on the medial side of the base,
b. an interchangeable arch support positioned under the arch support area, said interchangeable arch support being made of variable strength material to provide variable strength arch support that extends upwardly along the medial border and under the arch of the foot,
c. a first metatarsal head pad positioned in the first metatarsal head pad area,
d. a forefoot wedge pad located in the forefoot wedge area, and
e. a heel pad cushion located in the heel area, said heel pad cushion is used with a supplementary pad cushion positioned in the heel area with the heel pad cushion.

2. The insole of claim 1, wherein said supplementary pad cushion is a heel lift pad cushion.

3. The insole of claim 1, wherein said supplementary pad cushion is a rearfoot wedge pad cushion.

4. The insole of claim 1, wherein said arch support is a rigid support.

5. The insole of claim 1, wherein said arch support is a flexible support.

6. The insole of claim 1, wherein said forefoot wedge pad tapers from a thicker lateral edge to a thinner medial edge.

7. The insole of claim 1, wherein said heel lift tapers from a thicker proximal edge to a thinner distal edge.

8. The insole of claim 1, wherein said rearfoot wedge tapers from a thicker medial edge to a thinner lateral edge.

9. An insole having a top side for contacting a user's foot and a bottom side for contacting the inside of a user's shoe, comprising:

a. a base having a base top surface, a base bottom surface, a heel end, a toe end, a medial border located proximate to an inside medial edge of the base and a lateral border located proximate to an outside lateral edge of the base, said base bottom side having: i. a first metatarsal head pad area extending from the medial border to a position under the first metatarsal, ii. a forefoot wedge area that extends from said first metatarsal head pad area to the lateral border along the second through fifth metatarsals, iii. a heel area that extends from about the cuboid of the foot to said heel end, and, iv. an arch support area that extends longitudinally under the arch of the foot on the medial side of the base,
b. an interchangeable arch support positioned under the arch support area that possesses variable rigid strength and based one which of one or more interchangeable arch supports are placed in the arch support area to provide variable support in the arch area that extends upwardly along the medial border and under the arch of the foot, and
c. a heel pad cushion located in the heel area.

10. The insole of claim 9, wherein said arch support has a variable strength rigid material to provide a variable strength arch support.

11. The insole of claim 10, wherein said arch support is a rigid support.

12. The insole of claim 10, wherein said arch support is a flexible support.

13. The insole of claim 9, further comprising:

a first metatarsal head pad positioned in the first metatarsal head pad area.

14. The insole of claim 9, further comprising:

a forefoot wedge pad located in the forefoot wedge area

15. The insole of claim 14, wherein said forefoot wedge pad tapers from a thicker lateral edge to a thinner medial edge.

16. The insole of claim 9, wherein said heel pad cushion is used with a heel lift pad cushion, respectively positioned in the heel area with the heel pad cushion.

17. The insole of claim 16, wherein said heel lift tapers from a thicker proximal edge to a thinner distal edge.

18. The insole of claim 9, wherein said heel pad cushion is used with a rearfoot wedge pad cushion, respectively positioned in the heel area with the heel pad cushion.

19. The insole of claim 18, wherein said rearfoot wedge tapers from a thicker medial edge to a thinner lateral edge.

20. A method of making an insole having a top side for contacting a user's foot and a bottom side for contacting the inside of a user's shoe, comprising the steps of:

a. providing a base having a base top surface, a base bottom surface, a heel end, a toe end, a medial border located proximate to an inside medial edge of the base and a lateral border located proximate to an outside lateral edge of the base, said base bottom side having: i. a first metatarsal head pad area extending from the medial border to a position under the first metatarsal, ii. a forefoot wedge area that extends from said first metatarsal head pad area to the lateral border along the second through fifth metatarsals, iii. a heel area that extends from about the cuboid of the foot to said heel end, and, iv. an arch support area that extends longitudinally under the arch of the foot on the medial side of the base,
b. attaching a variable strength arch support to the base under the arch support area, said arch support being interchangeable with one or more variable strength arch support materials to provide variable strength arch support that extends upwardly along the medial border and under the arch of the foot,
c. attaching a first metatarsal head pad to the base positioned in the first metatarsal head pad area,
d. attaching a forefoot wedge pad to the base located in the forefoot wedge area,
e. attaching a heel pad cushion to the base located in the heel area, and
f. attaching a supplementary pad cushion to the base and heel pad cushion, respectively positioned in the heel area with the heel pad cushion.

21. The method of claim 20, wherein said supplementary pad cushion is a heel lift pad cushion.

22. The method of claim 20, wherein said supplementary pad cushion is a rearfoot wedge pad cushion.

23. The method of claim 20, wherein said arch support is a rigid support.

24. The method of claim 20, wherein said arch support is a flexible support.

25. The method of claim 20, wherein said forefoot wedge pad tapers from a thicker lateral edge to a thinner medial edge.

26. The method of claim 20, wherein said heel lift tapers from a thicker proximal edge to a thinner distal edge.

27. The method of claim 20, wherein said rearfoot wedge tapers from a thicker medial edge to a thinner lateral edge.

Patent History
Publication number: 20170027277
Type: Application
Filed: Jan 20, 2015
Publication Date: Feb 2, 2017
Applicant: Implus Footcare, LLC (Durham, NC)
Inventors: Raymond J. Anthony (George Town), Jacob Martinez (Temple, TX), William Sterling Wynn (Crawford, TX), David B. Granger (Lorena, TX)
Application Number: 15/113,233
Classifications
International Classification: A43B 7/14 (20060101); A43B 17/00 (20060101); A43B 3/24 (20060101); A43B 7/24 (20060101); A43B 7/16 (20060101); A43B 17/02 (20060101); A43B 17/14 (20060101);