ORTHOPEDIC INSOLES

FIELD OF THE INVENTION

The present invention generally relates to orthopedic insoles, either aftermarket insoles that can be added onto or exchanged for the insoles that an existing shoe was manufactured with, or insoles that a shoe is built around during shoe manufacture. Specifically, embodiments of the present invention relate to orthopedic insoles wherein the right insole comprises an angled forefoot area for varus correction, and wherein the left insole is neutral at the forefoot (with both insoles neutral at the heel, i.e. without varus or valgus correction). In particular, in embodiments of the present invention, the medial aspect (inner side) of the forefoot area of the right insole, proximal to the metatarsal heads, is inverted by, for example, about 2° to about 4°, to create an angled surface that accommodates forefoot varus. Also, in embodiments of the invention, the insoles may comprise a plantar fascial groove configured longitudinally along the arch of the inner insole, for accommodation of tight fascia. Further, the heel area of the innersole is elevated by about 1.15 mm above the top plane of the sole, in addition to the heel of the shoe, to accommodate for the equinus foot, see FIG. 4. Insoles of the present invention may provide both static and dynamic support. Further, in embodiments of the invention, there may be areas of mild cushioning at the center of the heel and the metatarsal area (i.e. ball) of the foot to allow for shock absorption. Still further, in embodiments of the invention, the left and right insole may be independently configured to conform with a low, medium or high arch profile and thus align each foot comfortably, see FIG. 5-7 for arch profiles. Insoles of the present invention provide both static and dynamic support, in particular dynamic varus support.

BACKGROUND

A significant percentage of slips, trips and falls are attributed to foot related instability, e.g. as much as 40% in the work environment. Orthopedic insoles are specifically customized to a person's particular foot problems and may correct a variety of foot problems, but often are too bulky and/or too rigid to fit into a regular, non-orthopedic shoe. Insoles that fit regular shoes generally focus on static solutions such as arch support, and do not provide dynamic functional gait support. Precision prescription often is required to provide a dynamically functional orthopedic insole.

Specifically, available insoles largely fail to address common forefoot problems, and in particular, forefoot varus. Varus is a term for a medial inward angulation, i.e. toward the body's midline of the distal segment of a bone or joint (the opposite of varus is called valgus). Forefoot varus is the inverted position (i.e. angled inwards) of the bones in the front of the foot in relation to the heel.

The forefoot varus position is the inverted osseous angle of the metatarsals originating from the midtarsal joint, in relation to subtalar joint neutral. Inversion of the plantar plane of forefoot in the frontal plane, relative to the rearfoot, when the subtalar joint is in neutral and the midtarsal joint is maximally pronated about both its axes; is characterized by firm resistance to a pronatory force applied to the dorsum of the talonavicular joint.

Forefoot varus causes the bones on the inside edge of the forefoot (i.e. big toe) to sit higher off the ground than the outside of the foot (i.e. small toes) when they do not bear weight, see FIG. 8, 9, 10 and FIG. 11. Looking at the “tripod” formed by heel, inside edge of forefoot, and outside edge of forefoot, with uncompensated positioning, one point of contact of the “tripod” (i.e. the big toe), is missing in a foot with forefoot varus. The resulting arrangement only has two remaining points of contact (heel and outside edge of forefoot). With only two parts of the tripod effectively balancing, the foot is less stable and secondary problems in position and function of various bones and joints may occur. The right forefoot thus compensates for its varus position by pronating excessively at the end of stance, through propulsion and just prior to toe-off during the gait cycle, rendering the foot an open chain, not a closed chain unit from which to push off. At this point compensatory moments and movements which lead to mal alignment of osseous and soft tissue occur, rendering the person more susceptible to overuse pain and injury of the compensatory segments of the body involved.

Such problems include in particular those of the midtarsal joint, plantar fascia (plantar fasciitis), interdigital nerves (Morton's neuroma), and metatarsal heads (metatarsagia), where excessive and late stage pronation may occur, with either a compensatory propulsive twist, early heel lift or abduction of the foot, or a combination one or more of those. Secondary to this initial compensatory movement to facilitate forward propulsion during gait is a deviation of the ankle, knee, hip, pelvis and lower back from their optimal alignment and function (and subsequent soft tissue involvement). The deviations in the bones of the joints are typically accompanied by alterations of the soft tissue, muscles and ligaments away from their optimal function. This leads to the joints and muscles being compromised and/or fatigued, which in turn leads to foot and/or gait instability, and often leads to injuries.

However, current insoles on the market are designed to address arch support only. While some insoles provide rearfoot varus control, this only exacerbates the secondary problems associated with the right forefoot varus, by further increasing the degree of forefoot varus.

Some off-the-shelf insoles are advertised as made to measure but are based on static measurements only. It typically is not clear to the consumer that insufficient information is gathered with a static imprint to properly design a made-to-measure dynamically functional orthotic. Such “made to measure” insoles are often limited to a particular foot problem and fail to integrate foot type specific zones, in particular those for function and comfort of the forefoot.

Static measurements refers to measurements taken of the foot (e.g. its length, width, arch height and/or force pressure) on standing still (weigh bearing). Means utilized include e.g. pressure force plates, cameras/photographic apps, or an impression material. However, without the foot and its parts undergoing movement or propulsion, such as during walking, dynamic components such as varus cannot be adequately addressed, resulting in either late stage pronation, with a propulsive twist, abduction of both or one of the feet, early heel lift, or a combination of these, contributing to mal-alignment(s) further up the kinetic chain.

Further many insoles including prescription orthotics fail to provide a comfortable fit for feet with tight plantar fascia or forefoot equinus. The plantar fascia is the flat band of tissue/ligament that connects the heel bone to the metatarsal heads/toes and supports and helps maintain the arch of the foot. It can get strained, weak, swollen, irritated and/or inflamed (e.g. plantar fasciitis). Depending on the skill of the Podiatrist prescribing orthotics, their prescription may or may not address any of the above specific points required for optimal dynamic foot function, in particular including forefoot varus, plantar fascia and heel comfort.

Another problem with many insoles, and in particular with orthopedic insoles, is that the corrections can only be applied by building up the depth/thickness of the insole, thus adding bulk and precluding use in regular shoes. More individualized corrections are thus typically available only if wearing orthopedic shoes specifically adapted for use with orthopedic insoles. Orthopedic shoes are typically available to the customer only in a more limited selection, they tend to be bulky, footwear-restrictive and are often visually less appealing. They also require being prescribed, with the added cost of a visit to the prescribing health professional.

Therefore, there is a need in the art for an insole that addresses problems associated with forefoot varus, thus providing dynamic support and preventing compensatory movements, and preferably is compatible with regular non-orthopedic shoes. Also, there is a need for a combined insole-midsole-shoe shank unit configured to replace the insole, the midsole, and the shoe-shank in shoe manufacture, and around which a sandal, shoe or boot can be built. Also, there is a strong need for affordable insoles that address and help alleviate secondary foot problems associated with tight fascia. Further, there is a need for insoles that provides more forefoot function control and comfort. Still further, there is a need for insoles that accommodate the equinus foot.

These and other features and advantages of the present invention will be explained and will become apparent to one skilled in the art through the summary of the invention that follows.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention relate to orthopedic insoles wherein the right insole comprises an angled forefoot area for varus correction, and wherein the left insole is neutral at the forefoot (with both insoles neutral at the heel, i.e. without varus or valgus correction). In particular, in embodiments of the present invention, the medial aspect (inner side) of the forefoot area of the right insole is inverted by an angle of at least 1°, for example about 2° to about 4°, to create an angled surface that accommodates forefoot varus. Also, in embodiments of the invention, the insoles may comprise a plantar fascial groove configured longitudinally along the arch of the inner insole, for accommodation of tight fascia. Further, the heel area of the innersole may be elevated to accommodate for the equinus foot, see FIG. 4. Insoles of the present invention may provide both static and dynamic support. Further, in embodiments of the invention, there may be areas of mild cushioning at the center of the heel and the metatarsal area (i.e. ball) of the foot to allow for shock absorption. Still further, in embodiments of the invention, the left and right insole may be independently configured to conform with a low, medium or high arch profile and thus align each foot comfortably, see FIG. 5-7 for arch profiles. Insoles of the present invention provide both static and dynamic support.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles, wherein the forefoot area of the left insole has a neutral angle, and wherein the forefoot area of the right insole has an angle of at least 1° to correct forefoot varus.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles, wherein the circumferential edge of each insole is beveled at an angle of about 1° to about 20°, for example about 5° to about 15°, or about 5° to about 10°.

According to an embodiment of the present invention, provided is a pair of beveled orthopedic insoles configured with a plantar fascial groove positioned along the length of the arch of the insole to accommodate tight fascia, wherein the plantar fascial groove is positioned substantially parallel to the inner edge of each insole, at a distance of about 9.5 mm to about 16 mm from the inner edge, and wherein the width of the plantar fascial groove is about 10 mm to about 25 mm.

According to an embodiment of the present invention, provided is a pair of beveled orthopedic insoles, wherein the elevated heel area of the insole has an additional height of about 0.75 mm to about 1.55 mm, in addition to the height or thickness of the insole.

According to an embodiment of the present invention, provided is a pair of beveled orthopedic insoles configured with area of lesser density for cushioning at the ball of the foot and at the heel area of each insole.

According to an embodiment of the present invention, provided is a pair of beveled orthopedic insoles wherein each insole is configured to align with an arch profile selected from low, medium or high, wherein each profile forms a flat bell shaped curve having a maximum near the middle of the arch, wherein the maximum of the high arch profile is located posterior to the middle of the arch, and thus its middle is located towards the heel area, wherein the maximum of the medium arch profile is located anterior to the middle of the arch, and thus its middle is located towards the ball of the foot area, wherein the maximum of the low arch profile is located at about the middle of the arch, wherein the distal parts of each curve are gradually increasing from 0 above the insole surface towards the maximum, and decreasing from the maximum to 0, wherein the low profile has a maximum of about 24 mm, and the medium and the high profile each have a maximum of about 27 mm.

According to an embodiment of the present invention, provided is a pair of beveled orthopedic insoles wherein the left and the right insole are configured to align with an arch profile selected from low, medium and high, and wherein the arch profiles of the left and the right insole differ.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles wherein each insole is configured as a unit within a sandal, shoe or boot, and the unit replaces the midsole, the insole, and the shoe shank of the sandal, shoe or boot.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles configured as a unit within a sandal, shoe or boot, and configured with a plantar fascial groove positioned along the length of the arch of the insole to accommodate tight fascia, wherein the plantar fascial groove is positioned substantially parallel to the inner edge of each insole, at a distance of about 9.5 mm to about 16 mm from the inner edge, and wherein the width of the plantar fascial groove is about 10 mm to about 25 mm.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles configured as a unit within a sandal, shoe or boot, wherein the elevated heel area of the insole has an additional height of about 0.75 mm to about 1.55 mm, in addition to the height or thickness of the insole.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles configured as a unit within a sandal, shoe or boot, and configured with area of lesser density for cushioning at the ball of the foot and at the heel area of each insole.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles configured as a unit within a sandal, shoe or boot, wherein each insole is configured to align with an arch profile selected from low, medium or high, wherein each profile forms a flat bell shaped curve having a maximum near the middle of the arch, wherein the maximum of the high arch profile is located posterior to the middle of the arch, and thus its middle is located towards the heel area, wherein the maximum of the medium arch profile is located anterior to the middle of the arch, and thus its middle is located towards the ball of the foot area, wherein the maximum of the low arch profile is located at about the middle of the arch, wherein the distal parts of each curve are gradually increasing from 0 above the insole surface towards the maximum, and decreasing from the maximum to 0, wherein the low profile has a maximum of about 24 mm, and the medium and the high profile each have a maximum of about 27 mm.

According to an embodiment of the present invention, provided is a pair of orthopedic insoles configured as a unit within a sandal, shoe or boot, wherein the left and the right insole are configured to align with an arch profile selected from low, medium and high, and wherein the arch profiles of the left and the right insole differ.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of the inner side of a left insole for in-shoe placement after manufacture, according to an embodiment of the invention.

FIG. 2 shows a schematic view of the inner side of a left insole for use as a combined insole/midsole/shoe shank unit in shoe manufacture, according to an embodiment of the invention.

FIG. 3 shows a schematic perspective view of a left insole and its neutral/flat forefoot area with cushioned ball of foot area, fascial groove and heel cup, according to an embodiment of the invention.

FIG. 4 shows a schematic perspective view of a right insole with its varus correction in the forefoot area, fascial groove, cushioned ball of foot/center of heel and elevated heel, according to an embodiment of the invention.

FIG. 5 shows a schematic side view of a low arch profile, according to an embodiment of the invention.

FIG. 6 shows a schematic side view of a medium arch profile, according to an embodiment of the invention.

FIG. 7 shows a schematic view of a high arch profile, according to an embodiment of the invention.

FIG. 8 shows a schematic front view of a right insole and metatarsal heads, according to an embodiment of the invention.

FIG. 9 shows a schematic front view of the left foot with neutral rearfoot and forefoot, according to an embodiment of the invention.

FIG. 10A shows a schematic bottom (i.e. plantar) view of the right foot. In this illustration, distinct areas of the foot are illustrated, including the forefoot, the ball of the foot (metatarsal heads), the arch and the heel.

FIG. 10B shows a schematic side view from medial direction of the left foot resting on an insole according to an embodiment of the invention.

FIG. 11 shows a schematic side view of the left foot from medial direction, with forefoot, ball of foot, arch and heel areas, according to an embodiment of the invention.

FIG. 12A shows a schematic top, i.e. dorsal, view of the left insole with forefoot area and heel area, according to an embodiment of the invention.

FIG. 12B shows schematic side, i.e. lateral, views of the insoles of FIG. 12A, showing the inner and the outer side, according to an embodiment of the invention.

FIG. 13 shows a perspective view of the left and right insoles, according to an embodiment of the invention.

FIG. 14 shows a top, i.e. dorsal, view of the left and right insoles, according to an embodiment of the invention.

FIG. 15 shows a side view of the left and right insoles from their inner sides, according to an embodiment of the invention.

FIG. 16 shows a side view of the left and right insoles from their outer sides, according to an embodiment of the invention.

FIG. 17 shows a front, i.e. anterior, view of the left and right insoles, according to an embodiment of the invention.

FIG. 18 shows a back, i.e. posterior, view of the left and right insoles, according to an embodiment of the invention.

FIG. 19 shows a schematic view of a left insole of the invention and the location of reference points A-H.

FIG. 20 shows a schematic perspective view of a right and a left insole with fascial groove, according to an embodiment of the invention.

FIG. 21 shows a schematic top view of the right and a left insole of FIG. 20, according to an embodiment of the invention.

FIG. 22 shows an inner side view of the left and right insoles of FIG. 20, according to an embodiment of the invention.

FIG. 23 shows an outer side view of the left and right insoles of FIG. 20, according to an embodiment of the invention.

FIG. 24 shows a front view of the left and right insoles of FIG. 20, according to an embodiment of the invention.

FIG. 25 shows a back view of the left and right insoles of FIG. 20, according to an embodiment of the invention.

DETAILED SPECIFICATION

The present invention generally relates to orthopedic insoles, either aftermarket insoles that can be added onto or exchanged for the insoles an existing shoe was manufactured with, or insoles that a shoe is built on during manufacture. Specifically, embodiments of the present invention relate to orthopedic insoles wherein the right insole comprises an angled forefoot area for varus correction, and wherein the left insole is neutral at the forefoot (both insoles are neutral at the heel, i.e. no varus or valgus correction), see e.g. FIG. 8 (right foot/insole) and FIG. 9 (left foot/insole). In particular, in embodiments of the present invention, the medial aspect (inner side) of the forefoot area of the right insole is inverted by about 2° about 4°, e.g. about 3°, to create an angled surface with the inner “big toe” side tilted upwards to accommodate forefoot varus, see e.g. FIG. 8. Also, in embodiments of the invention, the insoles may comprise a plantar fascial groove configured longitudinally on the arch of the insole, for accommodation of tight fascia. Further, the heel area of the insole may be elevated, for example, by about 1 to about 2 mm, e.g. by about 1.5 mm, relative to the forefoot area of the insole, to accommodate for the equinus foot, see e.g. FIG. 4. Insoles of the present invention may provide both static and dynamic support. Further, in embodiments of the invention, there may be areas of mild cushioning at the center of the heel and the metatarsal area (i.e. ball) of the foot to allow for shock absorption. Still further, in embodiments of the invention, the insoles may be configured to conform with a low, medium or high arch profile and thus align the foot comfortably, see FIG. 5-7 for illustrative arch profiles. Insoles of the present invention provide both static and dynamic support.

Dynamic support refers to support during active and changing movement, during which momentum is propelling the body forwards through motion of the feet and their parts. Dynamic gait is the foot function ranging from heel strike to toe off, during the ‘contact’ phase of the gait cycle, through the swing phase and returning again, in contact with the ground, at the subsequent heel strike. Dynamic measurements can be taken of the foot (e.g. its length, width, arch height and/or force pressure) including during the non-weight-bearing phases, i.e. during gait. Such measurements may help determine the function of the foot during gait, and any issues that require dynamic support, such as support for right forefoot varus. Thus right forefoot varus can be detected and measured, and its effect on subsequent heel strike recognized and recorded during dynamic or gait analysis. The measurements may also allow for the detection of compensatory movements secondary to the forefoot varus position.

In embodiments of the present invention, dynamic support may be provided in particular by means of inverting the right forefoot (bringing the insole up to the foot in the varus gap, thus preventing the compensatory moments). For example, adding about 2° to about 4° inversion within the insole proximal to the metatarsal head area of the medial aspect of the right insole. This may advantageously prevents compensatory movements by the foot, parts of the foot, or in the kinetic chain, and in turn may prevent discomfort and injury of the foot, parts therein, or parts further up the kinetic chain, including e.g. to the pelvis and lower back. An angle of about 2° to about 6°, preferably of about 2° to about 4°, in the right forefoot area may generally provide at least partial advantages to most individuals. Alternatively, the forefoot of the right insole may be provided with an individual adjustment, and be configured with an angle from about 1° to about 15°, e.g. about 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, or about 15°.

In embodiments of the present invention, the insoles may be configured as an insole that may be added on top of a flat insole surface, as illustrated, for example, in FIG. 1. Alternatively, the insole may be exchanged for an existing insole of a shoe or boot. This type of embodiment of the insole will typically be thinner, less deep and narrower than the alternative described below, and will comprise a beveled circumferential edge, for optimal fit within the shoe or boot. The bevel allows the insoles to sit neatly within the shoe they are inserted into, and serves to better align them with the configuration of the existing inside area of the shoe, where the foot sits.

Alternatively, the insoles of the invention may be used to replace the three layers typically used in shoe, boot or sandal construction, namely innersole (as illustrated by the innersole shown in FIG. 2), shoe-shank, and midsole. In this case, the remainder of the shoe, boot or sandal may be constructed around the insole, without need for separate inner sole and sock lining (i.e. no material on which the foot rests apart from the insole), midsole (cushioning layer between inner and outer sole) or shoe shank (supportive structure between the inner sole and outer sole. The features of the insole advantageously prevents the shoe, boot or sandal from collapsing between the heel and forefoot when weight pressure is applied during walking or gait. This is especially beneficial for sandals, which typically are not compatible with conventional insoles or orthotics, especially if they lack a closed heel area. Embodiments of the invention may be used in any footwear including shoes, boots, and sandals. Examples include, without limitation, shoes and boots (which typically have a flat insole), steel-toe-capped safety boots in The Emergency Services (Police, Fire, EMT), Military boots, construction boots, ski boots, athletic shoes, tennis shoes, running shoes. Insoles according to embodiments of the invention can also address needs in environments where shoe shanks cannot be used or are not permitted, for example in prisons and other environments with similar security concerns.

In embodiments of the invention, the insoles may generally be one of two types: 1. Insoles that are thinner, less deep, and beveled around the circumferential edge, and shorter in length compared to type 2, see for example FIG. 1 for in-shoe placement and wear. These can be added to, or exchanged for, the insoles an existing shoe was manufactured with. 2. Alternatively, in type 2, the insoles may form an insole/shoe shank/midsole combined unit around which a shoe may be built during manufacture, see FIG. 2.

In embodiments of the invention, type 1 insoles, see e.g. FIG. 1, may generally have a height of about 15 mm to about 25 mm, depending on shoe size, at the back, and about 6.35 mm to about 10 mm, e.g. about 7 mm, at the flat area at the toe of the left insole (with the right insole being about 6.35 to about 10 mm, e.g. 7 mm at its lowest part, and the elevated part having an additional height corresponding to an angle of about 4° to about 6°, for example about 5°, depending on shoe size and width). The length of the back to the front distal end of the arch may be 7.5 inches, at a total length of 11.5 inches for a US men's insole size 9. Insoles for other shoe sizes will be adjusted accordingly, and the width of the insole can be adjusted as necessary (e.g. regular or wide), as exemplified herein, see e.g. table below for length in mm of various other sizes. The insole may be configured with a beveled circumferential edge, e.g. beveled at an angle of about 1° to about 20°, for example about 5° to about 15°, with the wider aspect being at the top, or dorsal area, and the narrower aspect being located at the base, or plantar area. This has the advantage of allowing the type 1 insole to sit neatly within and be in alignment with the configuration of the existing inside area of the shoe, where the foot sits.

In embodiments of the invention, type 2 insoles, see e.g. FIG. 2, may generally have a height of about ¾ inch at the back, and about ¼ inch at the top. The length of the back to the front distal end of the arch may be 6.25 inches, at a total length of 10 inches for a US women's insole size 8. Insoles for other shoe sizes will be adjusted accordingly, and the width of the insole can be adjusted as necessary (e.g. regular or wide), as will be apparent to a person of ordinary skill in the art. In contrast to type 1 insoles, type 2 insoles are not beveled around their circumferential edge, instead the edge is typically about perpendicular to the top/bottom insole surfaces.

In embodiments of the invention, for both types of insoles, each insole (left and right) may be independently configured to align with a flat bell curve shaped arch profile selected from low, medium and high. For example, the profiles may be dimensioned substantially as shown in FIG. 5, FIG. 6, and FIG. 7 (low, medium and high, respectively). A pair of insoles may thus comprise two insoles of the same or different arch profiles (e.g. low left arch, medium right arch).

In embodiments of the invention, the height of low arch profile has a maximum of about 24 mm at its highest point or maximum, the medium arch profile has a maximum of about 27 mm, and the high arch profile has a maximum of about 27 mm. Thus, the medium arch's maximum is more distal to the heel when compared to the high arch profile, in other words, the high arch profile is more proximal to the heel compare to the medium arch profile.

In embodiments of the invention, see e.g. FIG. 12A and FIG. 12B, the insoles may generally have a height of about 6 to 8 mm, for example about 7 mm, at the back, and the lowest point of the heel cup, and about 28.4 mm at the highest point of the inner side (arch). The total length may be, e.g., 255.71 mm for a US women's size 11. Insoles for other shoe sizes will be adjusted accordingly, as is exemplified in more detail in the table herein-below.

In embodiments of the invention, the insole in its longer and deeper design (relative to the foot size ratio) replaces the insole, midsole and shoe shank in shoe design, thus allowing for a sandal, shoe or boot to be built around it. In other words, the shoe is designed from the inside out. As a result, design options and aesthetics are not compromised, or do not need to be.

In embodiments of the invention, the insoles in their less deep, shorter design (relative to the foot size ratio) allows for placement into a wearer's existing shoes. Shoes or boots will especially benefit from the incorporation of type 1 insoles, in particular shoes that have a stiff outer shoe upper that restricts movement. Due to this restriction in movement, common foot problems are amplified. For example, without limitation, Steel-Toe-Capped Safety Boots and other shoes or boots used in Construction, by Miners, by Police, by Firefighters, by EMT's and also shoes or boots used in sports such as Skiing, ice skating, hiking, mountaineering, and ice climbing. The insoles can also advantageously be worn in non-stiff, i.e. flexible, outer shoe upper footwear.

By offering specific and accurate support in the manner described herein, an ideal alignment of the foot, ankle, knee and hip may be achieved enabling optimal gait, and positive functional effects, on subsequent heel strike. This optimal alignment may allow for joints, tendons and muscles to function at their peak performance, resulting in an ideal/near perfect gait. Up the kinetic chain, this may prevent irritation or fractures of the joints, over-pull or tearing of the muscles and tendons, and injury or irritation of the soft tissue.

According to an embodiment of the present invention, the right insole may be configured with a forefoot varus correction in the forefoot area at the front distal area of the arch, proximal to the metatarsal heads, where the surface of the insole is tilted at an angle of at least about 1°, for example about 1° to about 15°, preferably about 2° to about 6°, more preferably about 2° to about 4°, for example about 3°, in the direction that accommodates forefoot varus (i.e. the angle opens/rises medially/towards the body's midline, where the big toes are). Forefoot varus correction has the advantages of providing unique specific forefoot control, leading to improved stability, dynamic control during gait, and promoting the prime dynamic function of the foot, as well as improved control further up the kinetic chain: the ankle, knee and hips, pelvis and lower back, during the gait cycle. Also it prevents late stage pronation prior to toe-off, and has a positive effect on the subsequent heel-strike.

According to an embodiment of the present invention, the insoles may be configured with a groove configured longitudinally on the arch of the innersole, i.e. from its heel end to its front end towards the toes, see, for example, FIG. 3 and FIG. 4. In this groove, a tight fascia can be accommodated. The plantar fascial groove may be positioned substantially parallel to the inner edge of each insole at a distance of about ⅜ inch to about ⅝ inch from the inner edge. For example, the plantar fascial groove may be about ⅝ inches wide (i.e. 15.875 mm or about 16 mm, e.g. from about 10 mm to about 25 mm), and covering substantially all of the length of the arch area where the fascia are located. The groove generally follows the curvature of the insole surface, and its depth may vary accordingly; the depth at the midpoint of the groove may be from about 1 mm to about 6 mm, for example about 1.65 mm to about 3.65 mm, or about 2.65 mm.

In embodiments of the present invention, the insoles may be configured in three arch sizes or height, for example, see FIGS. 5, 6 and 7 for suitable profiles and dimensions.

In embodiments of the present invention, the insoles may be additionally configured with an elevated heel area to accommodate the equinus foot and/or help those with tight triceps surae (i.e. calf) muscles. The heel area of the insole as compared to the areas further towards the front/toes may be elevated, for example by about 0.75 mm to about 1.55 mm, e.g. by about 1.15 mm at the center of the heel, relative to the forefoot elevation.

In embodiments of the present invention, the insoles may be additionally configured with areas of lesser density to provide comfort, cushioning and/or shock absorption. For example the insole may have a base of higher density material which may be configured with one or more inset area of a material having a lesser density than the base, e.g. at the heel, lateral border of the arch, and ball of the foot. See e.g. FIG. 10 for showing the areas of the foot, and FIG. 3-4 for showing areas of less density.

According to an embodiment of the present invention, the insoles may be configured with an inset at the heel and at the lateral border of the arch (i.e. the border away from the midline of the body, in direction towards the outside edge of the foot) that may be made of a less dense material. This has the advantage of providing better support during the mid-stance phase of gait while avoiding adding more depth to the insole, allowing the insole to fit into regular shoes.

According to an embodiment of the present invention, the insoles may be configured with an inset at the metatarsal heads (area next to the toes, commonly referred to as the ball-of-the-foot) that is made of a less dense material to cushion the ball of the foot during the late stance and propulsive phase of the gait cycle, when the greatest load of pressure is experienced on the metatarsal heads.

According to an embodiment of the present invention, the insole may comprise one or more layer which may be permanently joined or attached to each other. Optional sublayers may include surface and bottom layers. The insole may optionally comprise insets of different density, in particular of a lesser density (e.g. at the heel, lateral arch, and ball of the foot). The insole may be configured with a permanently attached upper surface.

In embodiments of the invention, the insole may be formed from any elastic or viscoelastic material of suitable elasticity, viscoelasticity and density to support and/or cushion the foot as described herein. Elastic or viscoelastic materials of suitable density will be apparent to a person of ordinary skill in the art. Illustrative examples include, without limitation, high density thermoplastic materials, low density thermoplastic materials, high density polyethylene (HDPE), Plastazote® (a mouldable, foamed polyethylene of closed cell construction, available in low, medium and high density), latex foam (a cellular rubber of open cell construction), Dynafoam® (a polyvinyl chloride foam compound), Spenco® (a neoprene sponge product with nitrogen-induced closed cells which is covered with a multistretch nylon fabric on one side), Molo® (a combination of latex, jets, leather, cork and other products which are incorporated into a rubbery sheet), PPT® (an open cell, porous, firm foam material), Polyurethane foam, PORON® (a PU foam), EVA foam (a firm closed cell foam with a soft feel), Polyethylene foam, cross-linked polyethylene foam (XLPE), polyolefin foam, TROCELLEN foam (a polyolefin foam), or KYDEX®. Most materials can be laminated or cemented to other materials, as will be apparent to a person of ordinary skill in the art.

In embodiments of the invention, the insole may have a covering on top of the elastic or viscoelastic material, to provide compatibility with prolonged wear, to remove or prevent bacteria and odor, or assist in easy removal thereof. Typically the cover will be thin and of a material suitable to promote a comfortable temperature for preventing excessive wear of the cover even during prolonged wear. The covering may be of any suitable material, e.g. a textile covering of e.g. cotton, wool, synthetic, or combinations thereof, optionally impregnated or threaded with anti-bacterial, anti-fungal or/or anti-odor agents (e.g. chemicals or silver thread), as will be apparent to a person of ordinary skill.

In embodiments of the invention, the insole material may have a density from about 2 lbs/ft³to about 25 lbs/ft³. The base may have a higher density than the inset, for example, the base layer may be e.g. 12 lbs/ft³, and the inset may have a density from 4-8 lbs/ft³, e.g. 6 lbs/ft³, or the base may have a density of 24 lbs/ft³, and the inset may have a density of, e.g., 8-16 lbs/ft³, e.g. 12 lbs/ft³.

To form the insole, the base and optional insets may be formed by injection molding as a single piece, injection molding from multiple pieces later joined, by 3D printing, and/or by various manufacturing and assembly methods including cutting (e.g., die cutting, stamping, etc.), casting, molding, heat bonding of multiple materials, etc., or by combinations thereof.

The insoles may be adapted to fit all shoe sizes and manufactured accordingly, e.g. in US shoe sizes 1-16, and its features may be adapted accordingly, as will be apparent to a person of ordinary skill in the art.

For example, in embodiments, the dimensions between reference points of some of the features of the invention as indicated by reference points A-F shown in FIG. 27 are indicated in mm in the table below. In the table, “L” designates a low orthotic arch, “M” designates a medium, and “H” designates a high orthotic arch.

Size
Arch
A-B
A-C
A-D
A-E
A-F

Pattern Code
US
height
(mm)
(mm)
(mm)
(mm)
(mm)

Women

W6.5 M
6.5
M
117
113
117
79
77

W6.5H

H
102
110
—
72
75

W7.5L
7.5
L
114
113
120
70
66

W7.5M

M
113
116
—
77
77

W7.5H

H
110
112
—
70
72

W8.5L
8.5
L
110
120
125
68
70

W8.5M

M
120
123
—
82
78

W8.5H

H
115
117
—
72
75

W9.5L
9.5
L
114
125
132
66
67

W9.5M

M
125
130
—
80
77

W9.5H

H
118
125
—
73
76

W10L
10
L
117
130
135
68
68

W10M

M
128
132
—
80
79

W10H

H
121
130
—
73
76

W10.5L/M8L
10.5
L
121
132
137
68
69

W10.5M/M8M

M
128
136
—
78
78

W10.5H/M8H

H
126
133
—
72
75

W11L/M8.5L
11
L
123
135
142
70
70

W11M/M8.5M

M
132
138
—
82
82

W11H/M8.5H

H
133
135
—
72
76

Men

M9L
9
L
112
123
133
71
70

M9M

M
124
128
—
82
82

M9H

H
120
123
—
74
77

M10L
10
L
119
130
140
70
70

M10M

M
130
134
—
82
80

M10H

H
125
130
—
74
76

M11L
11
L
126
135
145
73
70

M11M

M
135
135
—
83
80

M11H

H
130
130
—
75
77

M12L
12
L
133
141
147
73
72

M12M

M
142
145
—
87
82

M12H

H
137
140
—
80
78

For example, in embodiments, the dimensions between reference points of some of the features of the invention as indicated by reference points G and H shown in FIG. 27 are indicated in mm in the table below. In the table, “G” to “H” designates the length at the longest point.

Pattern
Size
Arch
Length at longest

Code
(US)
height
point (mm)

Women

W6.5M
6.5
M
240

W6.5H

H
240

W7.5L
7.5
L
248

W7.5M

M
248

W7.5H

H
248

W8.5L
8.5
L
257

W8.5M

M
257

W8.5H

H
257

W9.5L
9.5
L
270

W9.5M

M
270

W9.5H

H
270

W10L
10
L
272

W10M

M
272

W10H

H
272

W10.5L/M8L
10.5
L
280

W10.5M/M8M

M
280

W10.5H/M8H

H
280

W11L/M8.5L
11
L
284

W11M/M8.5M

M
284

W11H/M8.5H

H
284

Men

M9L
9
L
285

M9M

M
285

M5H

H
285

M10L
10
L
295

M10M

M
295

M10H

H
295

M11L
11
L
305

M11M

M
305

M11H

H
305

M12L
12
L
308

M12M

M
308

M12H

H
308

In another embodiment, type 1 and type 2 insoles may have a basic material thickness or height from heel end to toe end of about ¼″ (about 6.35 mm) or more, for example about 7 mm or more, for example about 7 mm, with elevated areas such as the arch and heel having an increased height, as described herein-above.

In another embodiment, provided are insoles of type 2B, which may have one or more features as described for the insoles herein above, and in particular for type 2 insoles, and wherein the basic material thickness of the insoles is less than described for types 1 and 2, i.e. less than about ¼″ (about 6.35 mm). In particular, the thickness from heel end to toe end of the insoles may be from about ⅛″ to about ¼″ (about 3.175 mm to about 6.35 mm), with elevated areas such as the arch and heel having an increased height, as described herein-above. The embodiment may be configured with type 2 dimensions including e.g. the three arch profiles, and length as described herein.

In embodiments, types 1, 2, but in particular type 2B insoles, may be made from a material of the polyolefin family, including, without limitation, polypropylene. Alternatively or additionally, the material may be graphite, or a material comprising graphite, for a lighter and thinner insole. For example, the insole thickness of graphite insoles may be from about 1/16″ to about ⅛″. These materials can be adjusted in their flexibility as desired, from very flexible to relatively rigid, as will be apparent to a person of ordinary skill in the art. In addition, cushioning materials, for example, without limitation, neoprene and open- and closed-cell foams may be used on all or part of the surface (e.g. heel, ball of foot) to provide added comfort, in particular in combination with a harder insole material such as plastic or graphite. Such cushioning materials may include, e.g., materials from the polyethylene foam family. Closed-cell foams are preferred for use in total-contact, pressure-reducing orthotics. Example materials include ethyl-vinyl cetates (EVAs), crepes, neoprenes, silicones, polyurethane foam, or combinations thereof, to provide long-lasting, reliable comfort. Optionally, these cushioning materials or covers, in particular, foam covers, may be topped with fast-drying polyester fabric with a silver ion, anti-microbial treatment to prevent unwanted odors and provide a durable and low-friction surface that prevents hot spots and blisters. Optionally, depending on the type of insole, the shoe may be built around the insole.

In embodiments, types 1, 2, but in particular type 2B insoles, may comprise a molded polypropylene arch support as foundation and to provide a sufficiently strong, sufficiently rigid but at the same time sufficiently flexible or spring-like to provide support but still flex during walking, thus matching the needs of the feet.

DETAILED DESCRIPTION OF THE DRAWINGS

Turning to FIG. 1, a schematic view of the inner side of a left insole for in-shoe placement after manufacture with beveled circumferential edge (1) is shown, according to an embodiment of the invention. The illustration shows an insole US size 9 men's, low arch, which may replace existing insoles in shoes or boots, e.g. steel toe capped boots. Arrows indicate the thickness or height at the heel end, the length of the insole, and the length from heel to the forefoot area, and the height of the arch at the maximum of its profile curve.

In FIG. 2, a schematic view of the inner side of a left insole for use as a combined insole/shoe shank/midsole unit is shown, according to an embodiment of the invention. The combined unit may be used in the manufacture of shoes, in particular in sandals. The illustration shows a combined unit US size 8, women's, high arch. Arrows indicate the thickness or height at the heel end and at the toe end, the length of the insole, and the length from heel to the forefoot area, and the height of the arch at the maximum of its profile curve.

In FIG. 3, a schematic perspective view of a left insole is shown, according to an embodiment of the invention. The illustration shows the neutral/flat forefoot area (2) at the front end, the plantar fascial groove (3) at the inner side, and the heel cup (4) at the back end. The illustration shows the cushioned area of a less dense material at the ball of the foot (6) and at the center of the heel areas (5), and an elevated area of the heel for accommodating the equinus foot.

In FIG. 4, a schematic perspective view of a right insole is shown, according to an embodiment of the invention. The illustration shows the area where the forefoot varus correction is applied across the forefoot (2), including a cushioned area of lesser density at the ball of the foot (6), a cushioned area of a less dense material at the center of the heel area (5), the plantar fascial groove (3) near the inner side, the, and an elevated area of the heel for accommodating the equinus foot.

In FIG. 5, a schematic side view of a low arch profile is shown, according to an embodiment of the invention. The illustration shows a low arch that the inner side and arch area of embodiments of the present invention are configured to align with. The arrows indicate (from left to right) the toe end, the maximum/highest point of the curve of the arch profile, and the back of the heel.

In FIG. 6, a schematic side view of the profile for a medium arch is shown, according to an embodiment of the invention. The illustration shows a medium arch that the inner side and arch area of embodiments of the present invention are configured to align with. The arrows indicate (from left to right) the toe end, the maximum/highest point of the curve of the arch profile, and the back of the heel.

In FIG. 7, a schematic view of the profile for a high arch is shown, according to an embodiment of the invention. The illustration shows a high arch that the inner side and arch area of embodiments of the present invention are configured to align with. The arrows indicate (from left to right) the toe end, the maximum/highest point of the curve of the arch profile, and the back of the heel.

In FIG. 8 a schematic front view of the right insole and metatarsal heads (toe bones). The illustration shows 0° rearfoot and an angle of forefoot correction (angle emphasized for illustration, in the insoles the angle for the forefoot is, e.g., about 2° to about 4°, while the rearfoot will have an angle of 0°, i.e. no rearfoot correction). The forefoot with its metatarsal heads is thus inverted in relation to the heel (as opposed to forefoot and heel being on parallel neutral planes), and supported by the forefoot varus correction.

In FIG. 9, a schematic front view of the left foot is shown, according to an embodiment of the invention. The illustration shows 0° rearfoot and 0° forefoot correction, so that rearfoot/heel and forefoot/ball of the foot are on parallel neutral planes.

In FIG. 10A, a schematic bottom view of the right foot is shown, according to an embodiment of the invention. In this illustration, distinct areas of the foot are shown, including the forefoot (2), the ball of the foot (metatarsal heads) (6), the arch in which the plantar fascial groove (3) will be located, and the heel (4).

In FIG. 10B, a schematic inner side view of the right foot resting on an insole is shown, according to the invention. The circle in the illustration indicates the area where the forefoot correction will be applied to the metatarsal heads, lifting them at the inner side of the insole to achieve the varus correction.

In FIG. 11, a schematic side view of the left foot from the inner side is shown. This illustration shows the areas of the forefoot (2)/ball of the foot (6), arch and location for plantar fascial groove (3), and heel (4).

In FIG. 12A and FIG. 12B, top, i.e. dorsal, and side, i.e. lateral views of an insole according to an embodiment of the invention are shown. In FIG. 12A, top, i.e. dorsal, view of the left insole with forefoot area and heel area are shown. Forefoot (2), plantar fascial groove (3), heel (4) and heel cushion (5) are indicated. In FIG. 12B, side, i.e. lateral, views of FIG. 12A, showing the inner, i.e. medial, side (higher top end for the arch) and the outer, i.e. lateral, side (lower top end) are shown, with illustrative example dimensions indicated. Arrows (from left to right) indicate the thickness/height of the toe end, the length of the insole, the maximum of the arch profile curve, and the thickness/height of the lowest point of the heel cup.

In FIG. 13, a perspective view of the left and right insoles is shown, according to an embodiment of the invention.

In FIG. 14, a top view of the left and right insoles of FIG. 13 is shown, according to an embodiment of the invention.

In FIG. 15, a side view of the left and right insoles of FIG. 13 from their inner sides is shown, according to an embodiment of the invention.

In FIG. 16, a side view of the left and right insoles of FIG. 13 from their outer sides is shown, according to an embodiment of the invention.

In FIG. 17, a front view of the left and right insoles of FIG. 13 is shown, according to an embodiment of the invention.

In FIG. 18, a back view of the left and right insoles of FIG. 13 is shown, according to an embodiment of the invention.

In FIG. 19, a schematic view of a left insole of the invention shows the location of the reference points A-H that are used to indicate dimensions, in tables herein-above. Point A is located towards the middle of the heel cup, at the lowest point of the heel. The curve between points B and C designates the end of orthotic correction. The line between points G and H corresponds to the full length of the insole, i.e. from the middle of its front end to the middle of its back end. The lines between reference points are straight lines between the points on a flattened/2D insole (rather than orthotic curve measurements), i.e. they do not take into account the 3D topography of the insole.

In FIG. 20 a schematic perspective view of a right and a left insole with plantar fascial groove (3) is shown, according to an embodiment of the invention.

In FIG. 21 a schematic top view of a right and a left insole of FIG. 20 with plantar fascial groove (3) is shown, according to an embodiment of the invention.

In FIG. 22, an inner side view of the left and right insole of FIG. 20 is shown, according to an embodiment of the invention. The upper illustration shows a left insole of type 2, the lower illustration shows a right insole of type 1, that is thinner and has a beveled circumference. The right or left insole of type 1 or 2, respectively, are the corresponding mirror image of the illustration shown.

In FIG. 23, an outer side view of the left (type 2) and right (type 1) insoles of FIG. 22 with plantar fascial groove (3) is shown, according to an embodiment of the invention. The right or left insole of type 1 or 2, respectively, are the corresponding mirror image of the illustration shown.

In FIG. 24, a front view of the right (type 1, beveled) and left (type 2) insoles of FIG. 22 with plantar fascial groove (3) is shown, according to an embodiment of the invention. The right or left insole of type 1 or 2, respectively, are the corresponding mirror image of the illustration shown.

In FIG. 25, a back view of the right (type 1, beveled) and left (type 2) insoles of FIG. 22 with plantar fascial groove (3) is shown, according to an embodiment of the invention. The right or left insole of type 1 or 2, respectively, are the corresponding mirror image of the illustration shown.

It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from this detailed description. The invention is capable of myriad modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature rather than restrictive.

ORTHOPEDIC INSOLES

Information

Publication Number

Date Filed

Date Published

Inventors

CPC

International Classifications

Abstract

Description

Claims