Orthotic insole

Abstract

An orthotic insole comprising a plurality of independent, tapered, flexible rib elements 2 extending longitudinally along the medial longitudinal arch region 3 of the insole and made of a thermoplasti

Description

FIELD The present invention relates to an orthotic insole. More specifically it relates to an orthotic insole comprising a plurality of independent, tapered, flexible gill elements under the inner medial longitudinal arch region of the foot. The invention further relates to methods of manufacture and the use in treating structural foot problems. BACKGROUND Plantar Fasciitis and associated heel pain is an extremely common condition in the UK with approximately 1 in 10 people experiencing symptoms at some point in their lives. The condition especially affects people around 40 to 60 years old with a prevalence in general and older populations of 4-7% (Hill et al. Prevalence and correlates of foot pain in a population-based study: the North West Adelaide health study. J Foot Ankle Res 2008;1:1-7). A study in 2010 found 12.1% of all musculoskeletal foot and ankle conditions reported in the UK in 2006 were related to heel pain, with 7.5% specifying plantar fasciitis (Menz et al, Characteristics of primary care consultations for musculoskeletal foot and ankle problems in the UK. Rheumatology. 2010;49(7):1391-8). A UK study in 2019 found the prevalence of plantar heel pain in people 50 years and older was 9.6% and the prevalence of disabling plantar heel pain was 7.9%. In the USA, it has been estimated that management of plantar heel pain accounts for 1 million physician visits per year, with the associated annual economic burden calculated at US$284 million (Plantar heel pain in middle-aged and older adults: population prevalence, associations with health status and lifestyle factors, and frequency of healthcare use, Thomas et al, BMC Musculoskelet Disord v.20; 2019). There are many conditions including but not limited to: plantar fasciitis, high arches (pes cavus), flat feet (pes planus), bunions, 1st toe pain, sesamoiditis, tibialis posterior dysfunction, Achillies tendonitis, ankle pain, shin splints, anterior knee pain, hip pain and back pain, that are referred to health services. Often the root causes of these conditions can be due to structural foot problems for example high arches, pes planus (flat feet), and fallen arches causing supination (when weight rolls onto the outer edges of your feet) or overpronation (where the foot rolls inward when it hits the ground). The gait cycle describes the cyclic pattern of movement that occurs while walking. It consists of two main phases: stance phase and swing phase. In stance phase the joints of the foot and ankle perform combinations of dimensional motions as the force of the body is applied. Once the load of the body is received through the heel, force travels in a forward direction through the foot and ankle complex where pressure and load is managed via the locking characteristics of the 33 joints, 26 bones, and hundreds of muscles, tendons, and ligaments. This results in a plantar surface of the foot that is constantly changing during each phase of stance. Orthotic insoles are medical devices that are worn inside the shoe to correct foot problems and relieve pain. To effectively treat common foot conditions, an orthotic insole must be manufactured with design features based on support to the medial longitudinal arch. Current insole designs employ hull or bridge shaped support structures, and which rely on the stiffness and strength of materials to provide the required support, strength and longevity. This can lead problems because these devices can be stiff and uncomfortable, reducing patient compliance and effectiveness. The specification describes a novel orthotic insole that provides medial longitudinal arch support through a plurality of independent, tapered, flexible gill elements. These gill elements store kinetic energy produced by the loading of body weight through the foot during stance phase. The load from the foot is met with a counter force from the insole which is dependent upon the physical parameters of each gill element. The design allows the insole to provide variable continual support across its entire surface, responding to the changing movements and forces of the foot's plantar surface above. The gill elements are independent of one another, and bend or load under pressure according to the forces being applied down through the insole. Each gill element, due to its height, angle, depth, width, thickness and shape will bend and return a corresponding force in the opposing direction. The design delivers a massaging effect to the foot during stance phase. The ribs / struts can be positioned or aligned into different patterns suited to treat conditions related to structural foot problems such as plantar fasciitis, high arches (pes cavus), flat feet (pes planus), bunions, 1st toe pain, sesamoiditis, tibialis posterior dysfunction, Achillies tendonitis, ankle pain, shin splints, anterior knee pain, hip pain and back pain. The insoles comprise thermoplastic elastomer which is flexible, soft to the touch, light, grippy, nonslip, abrasion resistant, highly elastic, and chemical resistant. SUMMARY The specification describes an orthotic insole comprising a thermoplastic elastomer wherein the insole comprises a plurality of independent, tapered, flexible gill elements, extending longitudinally along the inner medial longitudinal arch region of the insole. The specification also describes in part an orthotic insole for use in therapy. DETAILED DESCRIPTION OF THE INVENTION Many embodiments of the invention are detailed throughout the specification and will be apparent to a reader skilled in the art. The invention is not to be interpreted as being limited to any of the recited embodiments. "A" means "at least one". In any embodiment where "a" is used to denote a given material or element, "a" may mean one. "Comprising" means that a given material or element may contain other materials or elements. In any embodiment where "comprising" is mentioned the given material or element may be formed of at least 10% w / w, at least 20% w / w, at least 30% w / w, or at least 40% w / w of the material or element. In any embodiment where "comprising" is mentioned, "comprising" may also mean "consisting of" (or "consists of") or "consisting essentially of" (or "consists essentially of") a given material or element. "Consisting of" or "consists of" means that a given material or element is formed entirely of the material or element. In any embodiment where "consisting of" or "consists of" is mentioned the given material or element may be formed of 100% w / w of the material or element. "Consisting essentially of" or "consists essentially of" means that a given material or element consists almost entirely of that material or element. In any embodiment where "consisting essentially of" or "consists essentially of" is mentioned the given material or element may be formed of at least 50% w / w, at least 60% w / w, at least 70% w / w, at least 80% w / w, at least 90% w / w, at least 95% w / w or at least 99% w / w of the material or element. In any embodiment where "is" or "may be" is used to define a material or element, "is" or "may be" may mean the material or element "consists of" or "consists essentially of" the material or element. In any embodiment where "about" is mentioned, "about" may mean + / - 0% (i.e. no variance), + / - 5%, + / -10%, + / -15%, or + / 20% of the stated number or range. Claims are embodiments. orthotic insole The present invention describes an insole, which may be an orthotic insole or "orthotic". Orthotics or insoles are special shoe inserts. In one embodiment the orthotic insole as described herein is a removable orthotic insole, particularly it is removably receivable in an article of footwear. In one embodiment the orthotic insole as described herein is devoid of means for securing the insole in an article of footwear, i.e. it is removable and replaceable. In one embodiment the orthotic insole as described herein is a fixed orthotic insole. In one embodiment the orthotic insole as described herein is full length, Sulcus length or % length. A full length insole is one that extends past the end of the toes, typically from the heel section to beyond the end of the toes. An insole of Sulcus length ends just distal to the toes, typically from the heel section to just distal to the toes. A % length insole ends proximal to the metatarsal heads, typically from the heel section to proximal to the metatarsal heads. In one embodiment the orthotic insole as described herein is full length. In one embodiment the orthotic insole as described herein is Sulcus length. In one embodiment the orthotic insole as described herein is % length. In one embodiment the orthotic insole as described herein has a foot-like outline. plurality of independent, tapered, flexible gill elements The present invention describes an insole comprising a plurality of independent, tapered, flexible gill elements. The gill elements are attached to the insole at the top and extend downwards so that the bottom of the gill element is in contact with the shoe. In one embodiment, the gill elements are arranged in a row extending longitudinally along the inner medial longitudinal arch region of the insole. In one embodiment, the gill elements are arranged in one or more rows extending longitudinally along the inner medial longitudinal arch region of the insole. The gill elements are "independent". Each gill element is attached to the main body of the insole, but not otherwise to each other. Furthermore, there is sufficient distance between each independent gill element to enable them to flex independently of each other. In one embodiment there is at least a 1mm gap between the gill elements. In one embodiment there is at least a 1.5mm gap between the gill elements. In one embodiment there is at least a 2mm gap between the gill elements. In one embodiment there is at least a 2.5mm gap between the gill elements. In one embodiment, the gills are arranged in block patterns for example as waves, semi-circles, semi-triangles, and / or tyre tread patterns. In one embodiment, the gills are arranged in waves patterns. In one embodiment, the gills are arranged in semi-circle patterns. In one embodiment, the gills are arranged in semi-triangle patterns. In one embodiment, the gills are arranged in tyre tread patterns. In one embodiment a plurality is at least two. In one embodiment a plurality is at least three. In one embodiment a plurality is at least four. In one embodiment a plurality is at least five. In one embodiment a plurality is at least six. In one embodiment a plurality is at least seven. In one embodiment a plurality is at least 10. In one embodiment a plurality is at least 14. In one embodiment a plurality is at least 20. In one embodiment, the gill elements are not all identical to each other and vary by height, and / or width and / or thickness. In one embodiment, the gill elements are not all identical to each other and vary by height. In one embodiment, the gill elements are not all identical to each other and vary by width. In one embodiment, the gill elements are not all identical to each other and vary by thickness. In one embodiment at least 5% of the surface area of the underside of the insole comprises gill elements. In one embodiment at least 10% of the surface area of the underside of the insole comprises gill elements. In one embodiment at least 30% of the surface area of the underside of the insole comprises gill elements. In one embodiment at least 50% of the surface area of the underside of the insole comprises gill elements. In one embodiment 100% of the surface area of the underside of the insole comprises gill elements. The gill elements are "tapered". In one embodiment the gills are tapered, reducing in height as they extend medially from the centre to the inner edge of the insole. In one embodiment the gills are tapered, reducing in height as they extend medially from the centre to the inner and external edges of the insole. In one embodiment, each gill element is tapered, reducing in height as it extends medially from the centre to the edge of the insole. In one embodiment, each gill element is tapered, reducing by at least 0.5% in height as it extends medially from the centre to the edge of the insole. In one embodiment, each gill element is tapered, reducing by at least 1% in height as it extends medially from the centre to the edge of the insole. In one embodiment, each gill element is tapered, reducing by at least 3% in height as it extends medially from the centre to the edge of the insole. In one embodiment, each gill element is tapered, reducing by at least 5% in height as it extends medially from the centre to the edge of the insole. In one embodiment, the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 3:5. This means that the maximum height of the gill element makes up at least 3 / 5s of the height of the whole insole at that point. In one embodiment all the gill elements have the same maximum height. In one embodiment all the gill elements do not have the same maximum height. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 2:3. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 7:10. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 3:4. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 4:5. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 17:20. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 9:10. In one embodiment the ratio of the maximum height of at least one gill element to the overall height of the insole is at least 19:20. In one embodiment the maximum height of at least one gill element is at least 1.5 cm. In one embodiment the maximum height of at least one gill element is at least 2 cm. In one embodiment the maximum height of at least one gill element is at least 2.5 cm. In one embodiment the maximum height of at least one gill element is at least 3 cm. In one embodiment the maximum height of at least one gill element is at least 3.5 cm. In one embodiment the maximum height of at least one gill element is at least 4 cm. In one embodiment the maximum height of at least one gill element is at least 4.5 cm. In one embodiment the maximum height of at least one gill element is at least 5 cm. In one embodiment the maximum height of at least one gill element is 1.5 - 5 cm. In one embodiment the minimum thickness of at least one gill element is at least 0.4mm. In one embodiment the minimum thickness of at least one gill element is at least 0.5mm. In one embodiment the minimum thickness of at least one gill element is at least 0.6mm. In one embodiment the maximum thickness of at least one gill element is at least 0.8mm. In one embodiment the maximum thickness of at least one gill element is at least 1mm. In one embodiment the maximum thickness of at least one gill element is at least 1.2mm. The gill elements are "flexible" - they deform laterally during use. A compressive load causes a bowing or buckling effect along its axis. extending longitudinally along the inner medial longitudinal arch region of the insole The plurality of gill elements extend longitudinally along the inner medial longitudinal arch region of the insole e.g. there is a row of gill elements along the centre region of the inner edge of the insole, under at least a section of the medial longitudinal arch region of the wearer's foot. The plurality of gill elements does not necessarily extend longitudinally along the whole of the inner medial longitudinal arch region, i.e. from the end of the heel to the beginning of the toe, but it can. In one the plurality of gill elements extends along a section of the inner medial longitudinal arch region of the insole. In one the plurality of gill elements extends along the whole of the inner medial longitudinal arch region of the insole. In one embodiment, the plurality of gill elements also extend medially from the medial longitudinal arch region of the insole to the lateral longitudinal arch region of the insole such that there are gill elements, extending crossways under the wearer's foot. two or more regions of different hardness In one embodiment, the orthotic insole may comprise two or more regions of different hardness, particularly of thermoplastic elastomer, i.e. the first region(s) has a different hardness from the second region(s), for example, providing a harder region and a softer region. Regions of different hardness allows a balance to be struck between support and cushioning to achieve a desired amount of offloading to specific regions of the foot. Typically, they may comprise a main body of higher Shore A hardness which also functions as the main supporting structural element, and may be provided with an increased height in the arch area to provide support for the arch of the foot. One or more regions of lower Shore A hardness provides cushioning and offloading properties. A durometer may be used for measuring Shore A Hardness in accordance with standard procedures. For example, the test material is placed on a flat surface at 25 °C and the durometer pressed against the material. After indentation had occurred, a final reading may be taken. Typically the test is repeated 3 times and an average value adopted. In one embodiment the Shore A values described herein are measured at 25°C. In one embodiment the Shore A hardness difference between one region and another region is at least 5A. In one embodiment the Shore A hardness difference between one region and another region is at least 10A. In one embodiment the Shore A hardness difference between one region and another region is at least 20A. In one embodiment a region refers to a region comprising the main body of the insole. In one embodiment a region refers to the region under the heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes. In one embodiment a region refers to a region comprising the main body of the insole, and at least one other region under the heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes wherein the difference between the region of lower Shore A hardness and higher Shore A hardness is at least 20A. In one embodiment a region refers to the region under the heel. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the heel. In one embodiment a region refers to the region under the plantar fascia insertion point. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the plantar fascia insertion point. In one embodiment a region refers to the region under the base of 5th metatarsal. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the base of 5th metatarsal. In one embodiment a region refers to the region under the medial arch. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the medial arch. In one embodiment a region refers to the region under the 1st to 5th metatarsals. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the 1st to 5th metatarsals. In one embodiment a region refers to the region under the toes. In one embodiment the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole under the toes. In one embodiment a region refers to a region comprising the main body of the insole, and at least one other region comprising 2-5% w / w of the insole. In one embodiment a region refers to 2-5% w / w of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole comprises 2-5% w / w of the insole. In one embodiment one or more regions of lower Shore A hardness, when compared to at least one other region of the insole comprises 2-50% w / w of the insole. In one embodiment the insole as described herein has regions of two different hardness. In one embodiment the insole as described herein has regions of three different hardness. In one embodiment the insole as described herein has regions of four different hardness. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region of Shore A hardness 20-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-60A and one region of Shore A hardness 25-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region of Shore A hardness 20-35A wherein the difference between these two regions is at least 10A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-60A and one region of Shore A hardness 20-35A wherein the difference between these two regions is at least 10A. In one embodiment one region of the insole as described herein is of Shore A hardness 36-70A. In one embodiment one region of the insole as described herein is of Shore A hardness 36-60A. In one embodiment one region of the insole as described herein is of Shore A hardness 36-50A. In one embodiment one region of the insole as described herein is of Shore A hardness 40A. In one embodiment 50-98% w / w of the insole as described herein is formed from a region of Shore A hardness 36-70A. In one embodiment 50-98% w / w of the insole as described herein is formed from a region of Shore A hardness 36-60A. In one embodiment 50-98% w / w of the insole as described herein is formed from a region of Shore A hardness 36-50A. In one embodiment 50-98% w / w of the insole as described herein is formed from a region of Shore A hardness 40A. In one embodiment the main body of the insole is formed from a region of Shore A hardness 36-70A. In one embodiment the main body of the insole is formed from a region of Shore A hardness 36-60A. In one embodiment the main body of the insole is formed from a region of Shore A hardness 36-40A. In one embodiment the main body of the insole is formed from a region of Shore A hardness 40A. In one embodiment the structural integrity of the insole is provided by a region of higher Shore A hardness, when compared to at least one other region of the insole. In one embodiment 2-50% w / w of the insole as described is formed from a region of Shore A hardness 20-35A. In one embodiment 2-50% w / w of the insole as described is formed from a region of Shore A hardness 25-35A. In one embodiment 2-50% w / w of the insole as described is formed from a region of Shore A hardness 30A. In one embodiment the insole as described herein has regions of lower Shore A hardness, when compared to at least one other region of the insole, under the heel, the arch, the metatarsal heads and / or the toes. In one embodiment the insole as described herein has a region of Shore A hardness 20-35A under the heel, the arch, the metatarsal heads and / or the toes. In one embodiment the insole as described herein has a region of Shore A hardness 25-35A under the heel. In one embodiment the insole as described herein has a region of Shore A hardness 20-35A under the arch. In one embodiment the insole as described herein has a region of Shore A hardness 20-35A under the metatarsal heads. In one embodiment the insole as described herein has a region of Shore A hardness 20-35A under the toes. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region of Shore A hardness 20-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-60A and one region of Shore A hardness 20-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-50A and one region of Shore A hardness 25-35A wherein the difference between the two regions is at least 10A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-45A and one region of Shore A hardness 25-35A wherein the difference between the two regions is at least 10A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region of Shore A hardness 25-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-45A and one region of Shore A hardness 25-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 40A and one region of Shore A hardness 30A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 20-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-60A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 25-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 20-35A wherein the difference between these two regions is at least 10A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-760A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 25-35A wherein the difference between these two regions is at least 10A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-70A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 20-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 36-60A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 25-35A. In one embodiment, the orthotic insole comprises two or more regions of different hardness of thermoplastic elastomer comprising one region of Shore A hardness 40A and one region under the heel, the arch, the metatarsal heads and / or the toes of Shore A hardness 30A. In one embodiment the two or more regions of different hardness of thermoplastic elastomer comprise the same thermoplastic elastomer. In one embodiment the two or more regions of different hardness of thermoplastic elastomer comprise different thermoplastic elastomers. In one embodiment where there are regions of different hardness, each region of different hardness penetrates 20-100% of the entire height of the insole. The term height as used in connection with the insole, refers to the overall height of the insole, from the underside which would typically be in contact with the shoe, to the upper side, which would typically be in contact with the wearer's foot or sock, or a top cover if one is provided. Penetration % refers to the extent to which the region extends from the underside to the upper side. In one embodiment each region of different hardness penetrates 100% of the entire height of the insole. In one embodiment each region of different hardness penetrates about 100% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 95% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 90% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 85% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 80% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 75% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 70% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 65% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 60% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 55% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 50% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 45% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 40% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 35% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 30% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 25% of the entire height of the insole. In one embodiment each region of different hardness penetrates at least 20% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates 100% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates about 100% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 95% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 90% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 85% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 80% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 75% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 70% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 65% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 60% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 55% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 50% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 45% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 40% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 35% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 30% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 25% of the entire height of the insole. In one embodiment a region of higher Shore A hardness, when compared to at least one other region of the insole, penetrates at least 20% of the entire height of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates 100% of the entire height of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates about 100% of the entire height of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 95% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 90% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 85% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 80% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 75% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 70% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 65% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 60% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 55% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 50% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 45% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 40% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 35% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 30% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 25% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment a region of lower Shore A hardness, when compared to at least one other region of the insole, penetrates at least 20% of the entire height of the insole, particularly extending from the underside of the insole and finishing below the upper surface of the insole. In one embodiment, where the insole comprises two or more regions of different hardness, one region may be produced with "outriggers". Outriggers are designed to lock that region into place physically and increase surface area between the two regions of different hardness, creating a mechanical lock making the one undetachable from another. Typically, an outrigger is a rectangular piece attached longways to the outside wall of one region extending out laterally by up to 4mm. At the end of each extension is a 45deg lip. The lip increases the surface area and mechanical locking effect to the main body component of the insole. Generally, the outrigger from the section of the insole of one region of hardness, sits within the second region of different hardness and is not visible externally. thermoplastic elastomer (TPE) The insole as described herein may be manufactured from thermoplastic elastomer. TPE has unique properties which make it an idea material for use in orthopaedic insole technology: it has the capability of retaining strength when manufactured with a degree of thickness; it can be malleable and shock absorbing when slim and hollow; and it can be resistant to friction and shear forces while still being soft to the touch. TPE also has the added benefit of being an ideal material for use in high-volume injection moulding and extrusion: TPE's require little to no compounding and no reinforcing agents, stabilizers, or cure systems and as a result, there is virtually no variation between batches; TPE requires less processing and shorter fabrication times than other materials, which can significantly lower final costs; and it is highly processable as a melt at elevated temperatures. Finally, articles manufactured from TPE's can be manufactured from one elastomer or from two or more different elastomers which may be bonded, particularly chemically bonded, during the injection moulding process resulting in a stable insole with regions of different properties, e.g. hardness. Thermoplastic elastomers, also known as thermoplastic rubbers, are a class of copolymers or a physical mix of polymers (usually a plastic and a rubber) that consist of materials with both thermoplastic and elastomeric properties. According to the IUPAC definition, a thermoplastic elastomer is an elastomer comprising a thermoreversible network. In order to qualify as a thermoplastic elastomer, a material must have these three essential characteristics: • The ability to be stretched to moderate elongations and, upon the removal of stress, return to something close to its original shape • Processable as a melt at elevated temperature • Absence of significant creep There are several generic classes of commercial TPEs: 1. Styrenic block copolymers, TPS (TPE-s) 2. Thermoplastic polyolefinelastomers, TPO (TPE-o) 3. Thermoplastic vulcanizates, TPV (TPE-v or TPV) 4. Thermoplastic polyurethanes, TPU (TPU) 5. Thermoplastic copolyester, TPC (TPE-E) 6. Thermoplastic polyamides, TPA (TPE-A) 7. Not classified thermoplastic elastomers, TPZ Examples of TPE materials that come from block copolymers group include Cawiton®, Meliflex®, Thermolast K®, Thermolast M®, Arnitel®, Hytrel®, Dryflex®, Mediprene®, Kraton®, Pibiflex®, Sofprene®, and Laprene®. Examples of TPE materials that come from styrenic block copolymers (TPE-s) are Cawiton®, Thermolast K®, Thermolast M®, Sofprene®, Dryflex®, Laprene® and Tuftec®. Examples of TPE materials that come from thermoplastic olefin elastomers (TPO) include For-Tec E® or Engage®. Examples of TPE materials that come from TPV materials include Sariink®, Santoprene®, Termoton®, Solprene®, Thermolast V®, Vegaprene®, and Forprene a®. Examples of TPE materials that come from thermoplastic polyurethanes (TPU) include Laripur®, Desmopan® or Elastollan®. In one embodiment, the thermoplastic elastomer is a styrenic block copolymer. In one embodiment, the thermoplastic elastomer is Thermolast K®. In one embodiment, the thermoplastic elastomer is a thermoplastic polyolefinelastomer. In one embodiment, the thermoplastic elastomer is a thermoplastic vulcanizate. In one embodiment, the thermoplastic elastomer is a thermoplastic polyurethane. In one embodiment, the thermoplastic elastomer is a thermoplastic copolyester. In one embodiment, the thermoplastic elastomer is a thermoplastic polyamide. In one embodiment, the thermoplastic elastomer is a not classified thermoplastic elastomers, TPZ. manufacture The insoles may be manufactured as one single piece which avoids the disadvantages of having inserts, add-ons, layers and separate sections. Furthermore, the insoles comprise thermoplastic elastomer which, when compared to other materials used for insoles, is faster to process via injection moulding, reducing cycle times and moulding costs. In one embodiment manufacture comprises injection moulding, over-moulding, extrusion, 3D printing, blow moulding, melt calendaring, thermoforming, and / or heat welding. In one embodiment manufacture comprises injection moulding. In one embodiment manufacture comprises two-shot injection moulding. In one embodiment manufacture comprises three-shot injection moulding. In one embodiment manufacture comprises over-moulding. In one embodiment manufacture comprises extrusion. In one embodiment manufacture comprises 3D printing. In one embodiment manufacture comprises blow moulding. In one embodiment manufacture comprises melt calendaring. In one embodiment manufacture comprises thermoforming. In one embodiment manufacture comprises heat welding. Where the insoles comprise two or more regions of thermoplastic elastomer of different Shore A hardness, the different regions may be chemically bonded together. In order to achieve this, the insoles may be manufactured whilst hot. Chemical bonds form between the two or more different regions (which are adjacent to each other) as they cool, resulting in a seamless join between the two or more regions of different hardness that are not easily physically separated - they would need to be cut apart to separate them. Two-shot injection moulding and overmoulding, for example, take advantage of the chemical bonds that form between the materials as the product cools, resulting in a physically stable product with seamless joins between the two regions. During 2-shot injection moulding, for example, the substrate will still be warm during the second shot, which can actually increase the strength of these bonds. Where an insole is manufactured from two different thermoplastic elastomers, the two materials must be compatible in order for chemical bonds to form — if contact causes a chemical reaction, however mild, the two materials cannot be used together. top cover The insole does not require a top cover, although one may be added, making the insole slim while retaining its durability to shear forces. In one embodiment, the insole described herein may comprise a top cover. A top cover may aid in moisture wicking and absorption. In one embodiment, the insole described herein does not comprise a top cover. Insoles without a top cover, particularly one manufactured from a different material to the insole, may last longer. In one embodiment, the insole described herein may comprise a top cover comprising a thermoplastic elastomer. In one embodiment, the insole described herein may comprise a top cover manufactured from a different material to the insole. In one embodiment, the insole described herein may comprise a top cover comprising a synthetic or natural material securely glued to the top surface. In one embodiment, the insole described herein may comprise a top cover comprising alcantra, silana, yampi, eva, coolmax, orthabrelle, calf-tech, leather-tech, neoprene, cambrelle, rubber and vinyl, leather, chamois leather, perforated leathers, suede or sheepskin securely glued to the top surface. In one embodiment, the insole described herein may comprise a top cover comprising a thermoplastic elastomer that is chemically bonded, to the insole during manufacture, for example in an injection moulding process. differing height of the insole In one embodiment, the height of rear section of the insole is greater around the heel. Where the height of the insole is greater around the heel it acts so as to cup or cradle the heel. In one embodiment, the height of the rear section of the insole is greater around the sides of the heel than at the back of the heel. Here the cup or cradle around the heel appears to be cut away at the back. This reduces material at the back of the heel to stop the insole pushing the foot further forward in the shoe. This creates a better fitting on the foot and better more comfortable fitting in the shoe. In one embodiment the region under the heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes is shorter when compared to at least one other region of the insole. In one embodiment the region under the heel is shorter when compared to at least one other region of the insole. In one embodiment the region under the plantar fascia insertion point is shorter when compared to at least one other region of the insole. In one embodiment the region under the base of 5th metatarsal is shorter when compared to at least one other region of the insole. In one embodiment the region under the medial arch is shorter when compared to at least one other region of the insole. In one embodiment the region under the 1st to 5th metatarsals is shorter when compared to at least one other region of the insole. In one embodiment the region under the toes is shorter when compared to at least one other region of the insole. In one embodiment, the height of the insole is greater at the rear (ankle end) of the insole than at the front (toes end) of the insole. This raises the heel of the foot in comparison to the toes and may release tension out of the Achilles tendon and plantar fascia tendon, to help reduce pain and symptoms. In one embodiment, the height of the insole is 4-5mm greater at the rear of the insole than at the front of the insole. In one embodiment, the height of the insole is 4.5 mm greater at the rear of the insole than at the front of the insole. In one embodiment, the height of the insole is about 4.5 mm greater at the rear of the insole than at the front of the insole. cored out In one embodiment, the portion of the underside of the insole that is not covered by gill elements may be cored out, described herein below as the 'residual underside'. Cored out refers to a technique where material has been, or appears to have been (typically this would have occurred during manufacture by using less material), removed from the insole, particularly from the underside, leaving distinct walls and ribs. This has the advantage of reducing wall height; saving weight, materials and therefore cost; and providing the insole with a shock absorbing feel, while retaining its strength. Coring out can be done in block patterns, slashes, holes or a tyre tread block pattern. In one embodiment, the residual underside of the insole described herein may be cored out in block patterns, slashes, holes and / or a tyre tread block pattern. In one embodiment, the residual underside of the insole described herein may be cored out in block patterns. In one embodiment, the residual underside of the insole described herein may be cored out in slashes. In one embodiment, the residual underside of the insole described herein may be cored out in holes. In one embodiment, the residual underside of the insole described herein may be cored out in a tyre tread block pattern. In one embodiment, the residual underside of the insole described herein may be cored out in block patterns, slashes, holes and / or a tyre tread block pattern wherein 3-5mm of the height of the insole has been removed from the patterns, slashes and / or holes. In one embodiment, the residual underside of the insole described herein may be cored out in block patterns, slashes, holes and / or a tyre tread block pattern wherein 4mm of the height of the insole has been removed from the patterns, slashes and / or holes. In one embodiment, the residual underside of the insole described herein may be cored out in block patterns, slashes, holes and / or a tyre tread block pattern wherein about 4mm of the height of the insole has been removed from the patterns, slashes and / or holes. uses In one embodiment there is provided an insole as described herein for use in therapy. In one embodiment there is provided an insole as described herein for use in the treatment of structural foot problems. In one embodiment there is provided an insole as described herein for use in the treatment of plantar fasciitis, high arches (pes cavus), flat feet (pes planus), bunions, 1st toe pain, sesamoiditis, tibialis posterior dysfunction, Achillies tendonitis, ankle pain, shin splints, anterior knee pain, hip pain and back pain. In one embodiment there is provided an insole as described herein for use in the treatment of flat feet. In one embodiment there is provided an insole as described herein for use in the treatment of over pronation. In one embodiment there is provided an insole as described herein for use in the treatment of heel spurs. In one embodiment there is provided an insole as described herein for use in the treatment of plantar fasciitis. In one embodiment there is provided an insole as described herein for use in the treatment of sesamoiditis. In one embodiment there is provided an insole as described herein for use in the treatment of Achilles tendonitis. methods of treatment In one embodiment there is provided an insole as defined herein for use in a method of treatment of the human or animal body by therapy. In one embodiment there is provided a method of treating structural foot problems in a warmblooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment, wearing means wearing the insole in a shoe. In one embodiment there is provided a method of treating plantar fasciitis, high arches (pes cavus), flat feet (pes planus), bunions, 1st toe pain, sesamoiditis, tibialis posterior dysfunction, Achillies tendonitis, ankle pain, shin splints, anterior knee pain, hip pain and back pain in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating flat feet in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating over pronation in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating heel spurs in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating plantar fasciitis in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating sesamoiditis in a warm-blooded animal, such as man, which comprises wearing an insole as defined herein. In one embodiment there is provided a method of treating Achilles tendonitis in a warmblooded animal, such as man, which comprises wearing an insole as defined herein. DESCRIPTION OF THE FIGURES Figure 1 depicts a side profile of an orthotic insole (1) for the right foot comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region (3) of the insole. Figure 2 depicts the underside of an orthotic insole (1) for the right foot viewed from underside comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region (3) of the insole. Figure 3 depicts the underside of an orthotic insole (1) for the right foot comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region of the insole, wherein the insole comprises a region of different hardness (4) to the main body of the insole, under the heel. The region of different hardness under the heel comprises outriggers (5) which project into, and are contained within, the main body of the insole. Figure 4 depicts the front section the underside of an orthotic insole for the right foot showing the tapering of the gill elements (2). The gill elements reduce in height as they extend medially from the centre (6) to the inner edge (7) of the insole with a gap (11) between each of the gill elements. The height of a gill element is shown by (8), the width by (9), and the thickness by (10). Figure 5 depicts the underside of an orthotic insole (1) for the right foot, labelled "R" (13), comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region of the insole, wherein the insole comprises a region of different hardness (4) to the main body of the insole, under the heel, which has been cored out in a circle pattern. A section of the main body has been cored out in a tyre tread pattern (12) a region depicting the sizing (14) is present, together with the manufacturer's branding (15). Figure 6 is a photograph of the underside of an orthotic insole (1) for the left foot, comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region of the insole, wherein the insole comprises a region of different hardness (4) to the main body of the insole, under the heel, which has been cored out in a circle pattern. A section of the main body has been cored out in a tyre tread pattern (12). Figure 7 is a photograph of the underside of an orthotic insole (1) looking from the outside edge for the left foot, labelled "L" (16), comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region of the insole, wherein the insole comprises a region of different hardness (4) to the main body of the insole, under the heel, which has been cored out in a circle pattern. A section of the main body has been cored out in a tyre tread pattern (12) a region depicting the sizing (14) is present, together with the manufacturer's branding (15). Figure 8 is a photograph of the underside of an orthotic insole (1) looking from the inside edge for the left foot, labelled "L" (16), comprising a plurality of independent, tapered, flexible gill elements (2), extending longitudinally along the inner medial longitudinal arch region of the insole, wherein the insole comprises a region of different hardness (4) to the main body of the insole, under the heel, which has been cored out in a circle pattern. A section of the main body has been cored out in a tyre tread pattern (12) a region depicting the sizing (14) is present, together with the manufacturer's branding (15). processes A process to manufacture an insole of according to the present invention may be as follows: The process to manufacture a pair of our insoles starts with a CAD file. The insoles are designed on a CAD program, then a mould flow analysis is done to validate the insoles can be made without any issues. After the mould flow the CAD files are sent to have the injection tooling produced. A CNC milling machine mills cavities in the injection tools in the shape of the insoles. The tools required to produce the insoles in this manner are 2 shot over-mould tools. The heel sections are produced first in one tool. These are then hand loaded into a larger injection tool, where the main body is over-moulded around the heel section. This can be done visa-versa with the insole main body manufactured first and the heel moulded into position. The insoles can also be manufactured via a rotating 2 shot injection tool. With this tool, no hand loading in required. The first component (heel or body section) is moulded during the first shot, the tool opens and rotates, then closes again around the component and moulds the second component around the first to produce a complete product. An over-mould or rotating tool can produce a 3rd shot if required. This could create a top cover to the insole of the same material in any Shore A hardness that is required. In the rotating tool this can be done with a second feed system during the second shot. In the over-moulding process this can be done by hand-loading the insole into a separate tool to have this third top cover shot. During the injection moulding process, the TPE materials used are chemically bonded to one another. This creates an extremely robust and long lasting insole. The insoles described herein may also be prepared by 3D printing, e.g. by FDM printing or SLS printing. Fused deposition modelling (with the trademarked acronym FDM), or called filament freeform fabrication, is a 3D printing process that uses a continuous filament of a thermoplastic material. Filament is fed from a large spool through a moving, heated printer extruder head, and is deposited on the growing work. The print head is moved under computer control to define the printed shape. Usually the head moves in two dimensions to deposit one horizontal plane, or layer, at a time; the work or the print head is then moved vertically by a small amount to begin a new layer. Selective laser sintering (SLS) is a 3d printing process that uses high-powered lasers to sinter, or bind, finely powdered material together into a solid structure. In this process, a printer lays down an even layer of powder and then precisely sinters that layer, repeating the deposition and sintering process until the part is complete. The shape of the object is created by aiming a laser at the powder bed in specific points in space, guided by a digitally produced CAD (computer-aided design) file.

Claims

What is claimed is:

1. An orthotic insole comprising a thermoplastic elastomer wherein the insole comprises a plurality of independent, tapered, flexible gill elements, extending longitudinally along the inner medial longitudinal arch region of the insole.

2. An orthotic insole as claimed in claim 1 consisting of thermoplastic elastomer.

3. An orthotic insole as claimed in any one of the preceding claims wherein the maximumheight of at least one gill element is at least 1.5 cm.

4. An orthotic insole as claimed in any one of the preceding claims wherein at least 5% of the surface area of the underside of the insole comprises gill elements.

5. An orthotic insole as claimed in any one of the preceding claims comprising two or more regions of different hardness.

6. An orthotic insole as claimed in any one of the preceding claims wherein the insole comprises a region of lower Shore A hardness, when compared to at least one other region of the insole, under the heel, plantar fascia insertion point, base of 5th metatarsal, medial arch, 1st to 5th metatarsals and / or toes.

7. An orthotic insole as claimed in any one of the preceding claims wherein the insolecomprises a region of Shore A hardness 36-45A.

8. An orthotic insole as claimed in any one of the preceding claims wherein the insole comprises a region of Shore A hardness 20-35A.

9. An orthotic insole as claimed in any one of claims 5-8 wherein the Shore A hardness difference between one region and another region is at least 10A.

10. An orthotic insole as claimed in any one of the preceding claims wherein the thermoplastic elastomer comprises:

1. Styrenic block copolymers, TPS (TPE-s);2. Thermoplastic polyolefinelastomers, TPO (TPE-o);3. Thermoplastic vulcanizates, TPV (TPE-v or TPV);4. Thermoplastic polyurethanes, TPU (TPU);5. Thermoplastic copolyester, TPC (TPE-E);6. Thermoplastic polyamides, TPA (TPE-A); and / or7. Not classified thermoplastic elastomers, TPZ.

11. An orthotic insole as claimed in any one of the preceding claims wherein the thermoplastic elastomer is a styrenic block copolymer.

12. An orthotic insole as claimed in any one of the preceding claims wherein the thermoplastic elastomer is Thermolast K®.

13. An orthotic insole as claimed in any one of the preceding claims wherein the residual underside of the insole is cored out.

14. An orthotic insole as claimed in any one of the preceding claims for use in therapy.

15. The use as claimed in claim 19 in the treatment of structural foot problems.

16. The use as claimed in claim 19 in the treatment of plantar fasciitis, high arches (pescavus), flat feet (pes planus), bunions, 1st toe pain, sesamoiditis, tibialis posterior dysfunction, Achillies tendonitis, ankle pain, shin splints, anterior knee pain, hip pain and back pain.s

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