Foot orthosis

Abstract

Custom-made foot orthosis (100) for protecting a foot (10) of a user during gaiting, the foot orthosis comprises a layer (110) shaped for encapsulating the whole foot; the layer comprises at least one of the features of: a Thomas bar (130) arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch (131) arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation (132) arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch (133) arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot.

Description

[0001] FOOT ORTHOSIS

[0002] FIELD OF THE INVENTION

[0003] The invention relates to a foot orthosis for protecting a foot of a user during gaiting. The invention further relates to a method for producing the foot orthosis.

[0004] BACKGROUND OF THE INVENTION

[0005] Peripheral neuropathy is caused by damage to nerves located outside of the brain and spinal cord. This condition often causes weakness, numbness, and pain, usually in the hands and feet. Patients having diabetes are an example of patients prone to suffer from peripheral neuropathy in their feet. Peripheral neuropathy in a foot in combination with gaiting typically causes one or more ulcers and one or more deformations of the foot. An attempt to prevent deformation and ulcers is typically made by special shoes or insoles.

[0006] US10595749 (B1) discloses a pair of electronic shoe insoles aiding an individual with peripheral neuropathy in walking without falling, despite the user having little or no sensation in her feet. Each insole uses a number of pressure sensors and provides various forms of biofeedback to the user such as auditory, haptic, and vibratory feedback which corresponds to the position of the user's foot on the ground. Vibration feedback is provided through vibration motors disposed against the soles of the user's feet at selected locations which correspond to locations of pressure sensors. This allows for direct neural stimulation of the sole of the foot at three biomechanically appropriate locations. Auditory and haptic feedback are provided through auxiliary devices that the user wears on appropriate parts of the body. Biofeedback transmitted through these mechanisms would correspond to change in foot position as detected by the pressure sensors. The shoe insoles may provide one or more of these forms of feedback, and other types of feedback may be provided by output devices as well. An embedded microcontroller wirelessly connected to a computer, tablet or phone permits an individual to monitor gait performance and to adjust numerous parameters of this biofeedback mechanism, such as time delays and strength of vibration or audio feedback. The device may also include a driving mode in which small variations of pressure on the gas pedal would be conveyed to the user through haptic and auditory feedback, thereby allowing the user to drive. A disadvantage of the electronic shoe insole is that it fails to provide carefree gaiting to the user as the user is constantly confronted with his / her gaiting. A further disadvantage is that the user should make the adjustments him- / herself while not being a medical practitioner.

[0007] Another example is CN209547980 (U), which discloses a plantar pressure testing system. The plantar pressure testing system comprises an insole, the flexible pressure sensing array is fixed on the upper surface of the insole of the patient; the data acquisition module is used for receiving the plantar contact force information transmitted from the flexible pressure sensing array; the wireless communication module is connected with the data acquisition module and used for transmitting plantar contact force information outwards; the mobile phone terminal is connected with the wireless communication module and used for receiving the plantar contact force information transmitted by the wireless communication module; the server is in communication connection with the mobile phone terminal and is used for storing the plantar contact force information sent by the mobile phone terminal; the computer is in communication connection with the server and is used for calling and processing plantar contact force information; according to the utility model, the problem of foot peripheral neuropathy and even pressure ulcer caused by diabetes mellitus at present is solved, and real-time observation and examination of plantar pressure can be realized, so that the effect of preventing foot problems in advance or preventing deterioration is achieved. A disadvantage of the plantar pressure testing system is that it requires a mobile phone to be in wireless range of the system all the time for the system to be operational. A further disadvantage is that it is a testing system and not discloses use by a patient for preventing one or more ulcers and deformation of the foot.

[0008] US 2013 / 0261525 A1 discloses a sock assembly for correcting a deformed toe of a foot of a person, comprising a sock wearable on an at least a part of the foot, a strap connected to the sock and wearable on an at least a part of the foot and wrappable on an at least a part of the deformed toe as the sock it worn on the foot, consequently applying a corrective force on the deformed toe.

[0009] US 2020 / 0100927 A1 discloses a footwear article that covers the foot and ankle of the wearer. The footwear object protects the wearer’s feet and ankle while improving blood circulation, and supporting the toes, arches, and ankles of the wearer. The footwear object is manufactured of layered fabrics that are knitted and / or woven from both man-made and natural fibers. The footwear object has portions providing compression, padding, and grip to provide support and prevent injury to the wearer’s feet and ankles.

[0010] US 10,456,287 B2 discloses a therapeutic sock formed from a knit sock body formed in a tubular shape and terminating in a closed toe portion, the toe portion being divided into a first compartment configured accommodating a big toe and at least one additional compartment for other toes. At least one of the compartments has a area of increased compression as compared to a compression in other areas of the sock. The area of increased compression can be disposed on the first compartment and extend longitudinally along a medial edge of the first compartment and / or can be disposed on the at least one additional compartment and extend laterally around a circumference of the at least one additional compartment.

[0011] A disadvantage of the disclosures is that these do not protect or not adequately protect the foot during gaiting.

[0012] SUMMARY OF THE INVENTION

[0013] An object of the invention is to overcome one or more of the disadvantages mentioned above.

[0014] According to a first aspect of the invention, a foot orthosis for protecting a foot of a user during gaiting, wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; wherein the plantar surface comprises: a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; wherein the foot orthosis comprises a layer shaped for encapsulating the whole foot; wherein the layer comprises at least one of the features of: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot; and wherein the foot orthosis is custom-made for the user.

[0015] An orthosis is an externally applied device used to influence the structural and functional characteristics of the neuromuscular and skeletal systems, according to International Organization for Standardization. A foot orthosis therefore is an externally applied device used to influence the structural and functional characteristics of the neuromuscular and skeletal parts of the foot. The foot orthosis is especially applied during gating. A foot orthosis may be considered a foot protector.

[0016] A gait is a manner of limb movements made during locomotion, according to Dictionary.com. Human gaits are the various ways in which humans can move, either naturally or as a result of specialized training, according to Proceedings of the Royal Society B: Biological Sciences. A Gait typically involves the use of the foot. The foot is typically the part of the body contacting a surface whereon the gaiting is performed. As the foot is contacting, the foot also typically experiences the highest pressures or impacts during gating. The combination of peripheral neuropathy being typically most severe or starting at the extremities of the limbs cause the feet to be most prone to developing one or more deformations and one or more ulcers.

[0017] The foot comprises a plantar surface, a transversal arch, toes, a ball of the foot, metatarsal bones, metatarsal joints, a medial longitudinal arch, and a calcaneus. The plantar surface is the underside of the foot. During gaiting the larger part of the plantar surface is in contact with the underground at one time or another. The transversal arch runs substantially parallel to the tips of the toes on the underside of the foot. The transversal arch, or anterior transversal arch, is formed by the arrangement and / or position of the distal ends of the metatarsal bones or metatarsi in space. The toes are at the distal end of the foot. The phalanges provide a structure to the toes. The ball of the foot is the padded portion of the sole between the toes and the medial longitudinal arch, underneath the heads or distal ends of the metatarsal bones, according to TheFreeDictionary.com. The medial arch, or the medial longitudinal arch, is higher than the lateral longitudinal arch and the transversal arch. The medial longitudinal arch is made up by the calcaneus, the talus, the navicular, the three cuneiforms (medial, intermediate, and lateral), and the first, second, and third metatarsals, according to Gray, Henry in Arches of the Foot. The calcaneus or heel bone is a bone of the tarsus of the foot which constitutes the heel, according to Wikipedia.

[0018] The plantar surface may be divided up in areas, which might be partly overlapping. The Thomas area is associated with an area bordered by the plantar surface associated with the toes and the plantar surface associated with the transversal arch. In comparison to soles or insoles, this area of the plantar surface is typically not in contact with the sole or insole. The metatarsal area is associated with the plantar surface associated with or positioned relative to the ball of the foot, and / or the metatarsal bones, more specifically the heads of the metatarsal bones. Alternatively, the metatarsal area may be associated with the plantar surface with or positioned relative to the metatarsal articulations or metatarsal joints, more specifically the distal metatarsal joints. The arch area is the plantar surface associated with the medial longitudinal arch. The calcaneus area is the plantar surface associated with the calcaneus.

[0019] The foot orthosis comprises a layer shaped for encapsulating the whole foot. The layer is typically thick enough to attribute to the protection of the foot. The layer may have a thickness at the plantar surface for adapting the pressure distribution also taking into account the mass resting on the foot. The layer may have a different thickness for the dorsal surface and the side surface of the foot as typically the mass resting on the foot is not pressing onto these surfaces. The layer is typically thick enough to attribute to the pressure distribution without providing instability to the foot when gaiting. The instability of a too thick layer may be caused by shearing of / inside the layer. Encapsulating the foot typically comprises snugly fitting around the larger part of the foot. Encapsulating the foot typically comprises encapsulating the foot up to, on, or even over the ankle.

[0020] The layer comprises at least one of the features of: the Thomas bar, the metatarsal patch, the foot arch elevation, and the calcaneus patch.

[0021] The Thomas bar is arranged or positioned to the Thomas area. The Thomas bar is arranged for reducing development of hammer toes. A hammertoe, hammertoe or contracted toe is a deformity of the muscles and ligaments of the proximal interphalangeal joint of the second, third, fourth, or fifth toe, bending it into a shape resembling a hammer. In the early stage, a flexible hammertoe is movable at the joints; a rigid hammertoe joint cannot be moved and usually requires surgery. This according to S. Felson on WebMD. Hammer toes are a deformation of the foot. Further, hammer toes, especially with people suffering from peripheral neuropathy, are a cause of an ulcer. Early stage hammertoe may be corrected by correctly positioning a bar underneath the base of the toes lessening or reducing the hammertoe shape of the toe or toes, or the curve in the contracted toe. The Thomas bar is typically shaped to at least fill the space underneath the toes prone to develop hammertoes. The Thomas bar is thus shaped for adapting the pressure distribution on the foot, in this case the shape of the toes, for reducing development of an ulcer on and / or a deformation of the foot, especially the toes.

[0022] The metatarsal patch is arranged or positioned to the metatarsal area. The metatarsal patch is arranged for smoothing pressure under or impact on the metatarsal joints during rolling off of the foot or more particular to the metatarsal joints impacting on the surrounding foot tissue. During the roll off of the foot, the pressure on the foot is transferred from the calcaneus area to the ball of the foot and the metatarsal joints. The foot may be deformed, typical for foot suffering from peripheral neuropathy, such that the metatarsal joints are pressed forward. The metatarsal joints, more specifically the heads of the metatarsal bones are relatively sharp. The sagging of the medial longitudinal arch combined with the forward motion of the metatarsal joints results in internal tissue damage which may turn in an ulcer and / or a deformation The metatarsal patch allows a redistribution of the pressure build up or impact of the metatarsal joints. The metatarsal patch is thus shaped for adapting the pressure distribution on the foot, in this case the impact on the metatarsal joints, typically close to the ball of the foot, for preventing or reducing development of an ulcer on and / or a deformation of the foot. Furthermore, during walking the stairs, the area associated with the metatarsal joints may be the first part of the foot contacting the stair. Users, such as patients, suffering insensitivity in the foot, such as neuropathy, typically have an issue with the timing of their foot walking the stairs. This issue with timing causes the foot to impact or hit the stair much harder and typically too hard causing ulcers and / or deformation of the foot especially around the metatarsal joints. The metatarsal patch is thus shaped for adapting the pressure distribution on the foot, in this case the impact on the metatarsal joints, for preventing or reducing development of an ulcer on and / or a deformation of the foot.

[0023] The foot arch elevation is arranged or positioned to the arch area. The foot arch elevation is arranged for reducing sagging of the medial longitudinal arch. Users, such as Patients, suffering insensitivity in the foot, such as neuropathy, typically have a reduced blood circulation in the foot. The reduced blood circulation results in reduced muscle-tone. The reduced muscle-tone of these muscles causes the medial longitudinal arch and transversal arch to sag or reduce in height. A decrease in medial longitudinal arch height is defined as pes planus. Pes planus is associated with a diminished physiologic mechanism of the foot supporting the weight of the body, absorbing shocks, adapting to any kind of ground, and the propulsion of the body during gaiting. Pes planus, typical for foot suffering from peripheral neuropathy, is a cause of deformation of the foot. Pes planus in itself may already be considered as a deformation of the foot. Pes planus is a cause of the formation of an ulcer on the foot, specifically under the foot on the plantar surface. Pes Planus further typically causes the metatarsal arch (bones) to sag. The sagging exposes tissue to the heads of the metatarsal bones, which are sharp. These sharp heads in combination with pes planus typically cause tissue around these heads to become inflamed causing in turn one or more ulcers to form from the inside out of the foot. The foot arch support restores elevation or at least improves the transversal and medial longitudinal arch for reducing one or more of the issues associated with pes planus. The foot arch elevation is thus shaped for adapting the pressure distribution on the foot, in this case the pressure distribution due to the foot arch elevation, for preventing or reducing development of an ulcer on and / or a deformation of the foot.

[0024] The calcaneus patch is arranged or positioned under the calcaneus area. The calcaneus patch is arranged for reducing impact on the calcaneus upon heel contact or heel strike of the foot. The calcaneus impacts the ground as the first part of the foot during gaiting. The foot may be deformed, typical for foot suffering from peripheral neuropathy, such that the plantar surface experiences a sudden pressure build up during gaiting in the area associated with the calcaneus area also typed as heel or calcaneus strike. The heel strike of the foot can be a cause of a deformation of the foot. The heel strike can cause an ulcer in the skin associated with the calcaneus area. The calcaneus patch reduces and / or distributes the pressure following from the impact of the heel strike. The reduction and / or distribution prevents or reduces the development of an ulcer and / or a deformation of the foot, especially the heel. The calcaneus patch is thus shaped for adapting the pressure distribution on the foot, in this case the pressure build up due to the calcaneus patch, for preventing or reducing development of an ulcer on and / or a deformation of the foot.

[0025] Thus, at least one feature is shaped for adapting the pressure distribution on the foot for having the technical effect of preventing or reducing development of one or more ulcers on and / or one or more deformations of the foot as explained above.

[0026] According to another aspect of the invention, a method for producing a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; and wherein the method comprises: scanning the foot having a plantar surface; identifying at least one area of the plantar surface associated with a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; modelling the foot orthosis based on the scanning and the identifying; printing the modelled foot orthosis comprising a layer shaped for encapsulating the whole foot wherein the layer comprises at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammertoes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot. The method provides the advantages as mentioned for the foot orthosis.

[0027] According to another aspect of the invention, use of a foot orthosis according to the invention. The use provides the advantages as mentioned for the foot orthosis.

[0028] According to another aspect of the invention, a production, such as machining and / or printing, a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; wherein production comprises: receiving a foot orthosis model based on: scanning the foot having a plantar surface; identifying at least one area of the plantar surface associated with a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; and modelling the foot orthosis based on the scanning and the identifying, wherein the foot orthosis comprises a layer shaped for encapsulating the whole foot; and wherein modelling the foot orthosis comprises modelling the layer comprising at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot; and printing the foot orthosis model. The production provides a foot orthosis providing the advantages as mentioned. Printing may be 3D printing or additive manufacturing.

[0029] According to another aspect of the invention, a foot orthosis model modelling a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot orthosis model is suitable for printing the foot orthosis; wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; wherein the foot orthosis model is based on: scanning the foot having a plantar surface; identifying at least one area of the plantar surface associated with a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; and modelling the foot orthosis based on the scanning and the identifying; wherein the foot orthosis model comprises a layer shaped for encapsulating the whole foot; wherein modelling the foot orthosis comprises modelling the layer comprising at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot. The production provides a foot orthosis providing the advantages as mentioned. In an embodiment, the data structure is in a computer readable format and / or on a computer readable medium providing the model in an advantageous simple transferrable format.

[0030] According to another aspect of the invention, a foot orthosis for protecting a foot of a user, comprising a layer shaped for encapsulating the whole foot; wherein the foot comprises a plantar surface area; wherein the layer comprises silicon or a material with similar properties as silicon, and a plurality of ventilation holes arranged in the layer; wherein the plurality of ventilation holes are arranged to at least a part of the plantar surface area; wherein optionally the plurality of ventilation holes have a diameter in the range of 0.05 mm to 1 mm, preferable in the range of 0.08 mm to 0.5 mm, more preferably about 0.1 mm; and wherein optionally the plurality of ventilation holes are spaced apart in a range of 10 mm to 30 mm, preferably 15 mm to 25 mm, more preferably substantially 20 mm. The ventilation holes may be seen as functioning as a valve. The ventilation holes may temporarily open for advantageously allowing air to pass enabling or facilitating donning or doffing of the foot orthosis. Further, during gaiting, the skin of the foot secrete sweat. This sweat may be transported with the help of the ventilation holes away from the skin. Selecting the ventilation holes in the right range allows for the ventilation holes to function as valves while maintaining adhering characteristics adhering to the skin.

[0031] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0032] In an embodiment, the user is a patient suffering from pressure related issues in the foot, optionally a patient suffering from peripheral neuropathy. These are the types of users prone to develop one or more ulcers in and / or one or more deformations of the foot. These types of users typically therefore benefit the most by using a foot orthosis according to the invention.

[0033] In an embodiment, the layer contains silicon or a material having similar properties as silicon, preferably is substantially made of silicon, more preferably is made of silicon. Silicon typically adheres well to the skin, such as the skin of a foot. Adhering to the skin prevents or at least reduces the chance of the layer to shear, rub, and / or move relative to the skin preventing or reducing friction between the layer and the skin. A skin exposed to friction will develop callus as natural counter measure. The callus may or typically is a start for developing ulcers underneath the callus commonly followed by deformations of the foot, especially by patients suffering from peripheral neuropathy. Using silicon in the layer, preferably making the layer from silicon as dominant material or even completely making the layer of silicon, improves the adhering properties of the layer adhering to the skin of the foot. The adhering properties of preferably silicon thus adapt the pressure distribution on the foot, in this case the callus development, for preventing or reducing development of an ulcer on and / or a deformation of the foot. In a specific embodiment, the layer contains a material having a property of adhering to skin providing the previously mentioned advantages. Further, encapsulating the whole foot provides protection against the shearing forces of the foot against e g. footwear by providing adhesion between the skin and the foot orthosis. Further, the snugly fitting advantageously secures the foot orthosis, more specifically the features, on the exact pressure-distribution points.

[0034] In an embodiment, encapsulating the whole foot comprises snugly fitting around the foot apart from the area associated with the tip of the toes. Snugly fitting the foot orthosis around the foot reduces or even prevents the layer from wrinkling and / or shifting relative to the skin of the foot. As explained above, wrinkling and / or shifting causes the skin of the foot to develop callus typically followed by ulcers on and / or deformations of the foot. Alternatively, especially wrinkles may cause blisters turning into ulcers when not treated properly. Not treating your foot in general, and blisters or pressure points specifically, occurs often unwanted and unintended with a user or patient suffering from peripheral neuropathy. Furthermore, due to the different arches adapting to the pressure placed on the foot, the foot deforms under the influence of this pressure. This deformation is a natural process, and is not mentioned as the unnatural deformation process prevented or reduced by the features. One of the natural deformations is that if pressure is applied on the foot, such as the body weight resting on the foot, the foot lengthens. The lengthening of the foot is accommodated by not snugly fitting the layer to the tip of the toes. At the tip of the toes the layer is providing space for this lengthening such that advantageously no pressure is exerted on the tip of the toes when the foot lengthens. In a further embodiment, a distance between the tip of the toes and the area associated with the tip of the toes is in the range of 0.5 mm to 2 mm, preferably 0.75 mm to 1 .5 mm, more preferably 0.8 mm to 1 .25 mm, most preferably substantially 1 mm. These ranges advantageously provide space for lengthening of the foot under pressure, such as body weight resting on the foot.

[0035] In a preferred embodiment, the layer contains silicon or a material having similar properties as silicon, preferably is substantially made of silicon, more preferably is made of silicon, in combination with encapsulating the whole foot comprises snugly fitting around the foot apart from the area associated with the tip of the toes; and optionally a distance between the tip of the toes and the area associated with the tip of the toes is in the range of 0.5 mm to 2 mm, preferably 0.75 mm to 1 .5 mm, more preferably 0.8 mm to 1 .25 mm, most preferably substantially 1 mm. This preferred embodiment provides the advantage that the combination of these features improve each other’s advantages mentioned above. An advantage overtime may be that callus previously developed on the foot reduces or even dissolves with the use of this foot orthosis.

[0036] In an embodiment, the layer is flexible for allowing donning and / or doffing the foot orthosis. As the foot orthosis is encapsulating the foot, the foot orthosis is typically close-fitting or even snugly fitting, donning and / or doffing is best with a layer having flexibility. A non-functional alternative is to have a lace or zipper in the layer, which typically cause pressure points will all kinds of trouble and disadvantages for the foot.

[0037] In an embodiment, the foot orthosis, specifically the layer, has an outer shape; and the outer shape is suitable for arranging the foot with foot orthosis in footwear, such as off the shelf semi orthopedic shoes or even different pairs of regular shaped shoes. The foot orthosis fitting in footwear provides the advantage of reusing shoes. Furthermore, a larger variation of shoes may advantageously be used over the foot orthosis. Of the shelve semi orthopedic shoes typically provide the advantage of more space inside the shoes for accommodating the foot orthosis inside the shoes.

[0038] In an embodiment, the foot orthosis comprises an outer layer encapsulating the layer, preferably snugly encapsulating the layer, wherein the outer layer provides a lower friction between the foot orthosis and the footwear compared to the friction between the layer and the footwear; and wherein preferably the outer layer is made of a fabric, such as a fabric used for a sock. The outer layer having less friction or adherence to the footwear provides the advantage that the shifting, moving, and / or shearing occurs between the footwear and the outer layer and not between the layer and the skin of the foot. Due to that the shearing, moving and / or shifting does not occur or less occurs between the skin and the layer provides a preventing and / or reducing of the development of an ulcer on and / or a deformation of the foot.

[0039] In an embodiment, at least one feature is integrated with the layer, preferably made of the same material as the layer. This advantageously prevents pressure points on the foot on the edge where the layer transits to the layer with a feature.

[0040] In an embodiment, the feature comprises cavities. Cavities may provide additional cushioning for redistributing pressure. The cavities may be filled with a fluid, such as a liquid for further enhancing the redistribution of pressure.

[0041] In an embodiment, the feature comprises a thickening of the layer. The thickening of the layer provides and / or enhances the redistribution of the pressure. A basic redistribution of the pressure may already be provided with the layer. The thickness of the feature is typically measured additional, on top of or separate from the basic thickness provided by the layer.

[0042] In an embodiment, the Thomas bar has a thickness up to 17 mm, preferably 16 mm, more preferably 15 mm, most preferably 14.5 mm; and the Thomas bar has a thickness of at least 3.0 mm, preferably 4.0 mm, more preferably 4.5 mm, most preferably 5.0 mm. In a preferred combination the Thomas bar is within a range of 5 to 15 mm. The Thomas bar is typically at least filling up the space underneath the toes showing some form of hammertoes. The Thomas may already be used to prevent hammertoe by occupying the space that would become available when hammertoes develop. The Thomas bar in this specific occurrence anticipates the development of hammertoes and already prevents and / or reduces the side-effects of the hammertoes.

[0043] In an embodiment, the metatarsal patch has a thickness up to 7.0 mm, preferably 5.5 mm, more preferably 4.5 mm, most preferably 4 mm; and the metatarsal patch has a thickness of at least 2 mm, preferably 2.5 mm, more preferably 2.75 mm, most preferably 3 mm. In a preferred embodiment, the metatarsal patch is in the range of 3 mm to 4 mm, preferably around 3.5 mm. The metatarsal patch is arranged for softening and / or adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot.

[0044] In an embodiment, the foot arch elevation has a thickness up to 9.0 mm, preferably 8.0 mm, more preferably 7.5 mm, most preferably 7 mm; and the foot arch elevation has a thickness of at least 4.5 mm, preferably 5.5 mm, more preferably 5.75 mm, most preferably 6 mm. In a preferred embodiment, the foot arch elevation is in the range of 6 mm to 7 mm, preferably around 6.5 mm. The foot arch elevation is typically preventing or reducing sagging of the foot, specifically the foot arch or medial longitudinal arch. It is noticed that sagging of the foot arch may influence the amount the tip of the toes are pushed forward potentially causing pressure on the tip of the toes in turn potentially causing an ulcer and / or a deformation of the foot.

[0045] In an embodiment, the calcaneus patch has a thickness up to 7.0 mm, preferably 6.0 mm, more preferably 5.5 mm, most preferably 5 mm; and the calcaneus patch has a thickness of at least 2.5 mm, preferably 2.75 mm, more preferably 2.9 mm, most preferably 3.0 mm. In a preferred embodiment, the calcaneus patch is in the range of 3.0 mm to 5.0 mm, preferably around 4.0 mm. The calcaneus patch redistributed or adapts the impact of the heel strike. The calcaneus patch may be labelled heel patch. Furthermore, the calcaneus patch may redistribute pressure when continuously pressing on the heel when standing still. Although a heel strike is typically providing a much higher peak pressure compared to standing still, standing still for longer periods of time may also require pressure redistribution. In an embodiment, the foot orthosis is custom-made for the user. The foot orthosis is typically requiring a custom shape for aligning the features with the shape of the foot of the user. The positioning of the features is typically such crucial, that a custom shape is advantageously required.

[0046] In an embodiment, encapsulating the whole foot comprises encapsulating the whole foot up to, onto or even over the ankle. In a preferred embodiment, the foot orthosis is encapsulating the foot just under the ankle. The underside ofthe foot or plantar surface ofthe foot typically requires a pressure distribution or a pressure redistribution. The top side ofthe foot typically advantageously requires protection against friction with footwear. Alternatively, the top side ofthe foot may require protection against impacts of objects on the foot, such as bumping into an object while walking, for example a stair or sidewalk. In an embodiment, the ankle may also be encapsulated. Especially the protrusion of the ankle caused and / or positioned at the lateral malleolus may encounter friction with footwear and is advantageously protected by the foot orthosis also encapsulating the ankle.

[0047] In an embodiment, a part ofthe layer apart from a part associated with the plantar surface has a thickness in the range of 0.30 mm to 2.5 mm, preferably 0.40 mm to 2.75 mm, more preferably 0.5 to 1 .5 mm, most preferably 0.75 mm to 1.25 mm. A foot surface consists of:

[0048] 1. plantar surface associated with the plantar side;

[0049] 2. dorsal surface associated with dorsal side;

[0050] 3. medial surface associated with medial side;

[0051] 4. lateral surface associated with lateral side;

[0052] 5. surface associated with the tip ofthe toes; and

[0053] 6. dorsal calcaneus surface associated with the dorsal side ofthe calcaneus. The part ofthe layer apart from a part associated with the plantar surface is typically thinner such that the foot is protected from impacts with other objects than the ground, but these surfaces do not have to be such thick that these surfaces are protected from impacts with the ground or underground.

[0054] In an embodiment, a part ofthe layer associated with the plantar surface and outside the parts of the plantar surface associated with the at least one feature has a thickness up to 9 mm, preferably 7 mm, more preferably 6 mm, most preferably 5.5 mm; and the part of the layer associated with the plantar surface outside the parts of the plantar surface associated with the at least one feature has a thickness of at least 2 mm, preferably 2.5 mm, more preferably 2.75 mm, most preferably 3 mm. In a preferred embodiment, a part ofthe layer associated with the plantar surface and outside the parts ofthe plantar surface associated with the at least one feature has a thickness in the range of 3 mm to 6 mm. The thickness specified for the plantar surface may be considered as a basic thickness. The specified thickness ofthe features is added to the basic thickness of the layer providing thus a thickness typically a layer thickness local to where the feature is positioned adding the basic thickness with the feature thickness.

[0055] In an embodiment, the foot comprises an ulcer and / or a deformation or risk to develop an ulcer and / or a deformation; the layer comprises an ulcer relief arranged to the ulcer and / or the deformation; and the ulcer relief advantageously comprises a thickening of the layer arranged around the ulcer and / or the deformation or area where there is a risk to develop an ulcer and / or a deformation for relieving the pressure on the ulcer and / or the deformation or area where there is a risk to develop an ulcer and / or a deformation for reducing further development or development ofthe ulcer and / or the deformation. In a preferred embodiment, the thickening is up to 3.0 mm, preferably 2.5 mm, more preferably 2.0 mm, most preferably 1 .7 mm. The thickening provides a hole, typically a blind hole, wherein the ulcer or deformation or area where there is a risk to develop an ulcer and / or a deformation is positioned for advantageously relieving or adapting the pressure on the ulcer, deformation, or area. In a further embodiment, the ulcer relief smoothly transitions to a surrounding layer part surrounding the ulcer relief for advantageously preventing ulcer or deformation forming on the edge ofthe ulcer relief.

[0056] In an embodiment, the foot comprises a toe amputation; and the layer comprises a toe replacement arranged to the toe amputation for replacing the amputated toe. Toes typically provide stability to a body comprising the foot while standing up or gaiting. When one or more toes are amputated, this instability may be partly compensated with one or more toe replacements in the foot orthosis. Furthermore, the skin forming the surface in the place where the toe should protrude from the rest ofthe foot is typically sensitive to forming an ulcer or deformation. This part of the skin may therefore be protected from friction with a toe replacement. This toe replacement may snugly fit onto the skin preventing this friction. This toe replacement may also be arranged at a slight distance at some locations for allowing the foot to extend in the same way as described for the tip ofthe toes. The toe replacement may fill the space in footwear advantageously preventing friction or additional friction between the footwear and the foot. In an embodiment, the layer comprises a plurality of ventilation holes distributed over the layer. The ventilation holes are through holes providing a connection between an inner side of the foot orthosis or layer of the foot orthosis and the outer side of the foot orthosis or layer of the foot orthosis. The ventilation holes advantageously allow air in or out when doffing or donning the foot orthosis, respectively. Further, the ventilation holes advantageously may allow sweat to flow from the skin to an outer side of the foot orthosis and / or layer of the foot orthosis.

[0057] In an embodiment, the plurality of ventilation holes have a diameter in the range of 0.05 mm to 1 mm, preferable in the range of 0.08 mm to 0.5 mm, more preferably about 0.1 mm. The ventilation holes may have the specified diameter when donned on the foot. In a further embodiment, these ventilation holes may be closed of sealed when the foot orthosis is not donned on a foot. In a further embodiment, the plurality of ventilation holes are spaced apart in a range of 10 mm to 30 mm, preferably 15 mm to 25 mm, more preferably substantially 20 mm. The ventilation holes may have the specified distance when donned on the foot. In a further embodiment, these ventilation holes may be closer to each other when the foot orthosis is not donned on a foot.

[0058] In an even further embodiment, the ventilation holes are distributed according to a quincunx pattern. Or in an alternative embodiment, the distribution of the ventilation holes is selected such that the ventilation holes advantageously do not form a tear line. If the ventilation holes form or resemble a tear line, the foot orthosis, specifically the layer of the foot orthosis, may be tear when wearing such as during shearing of the layer, or during donning or doffing of the foot orthosis.

[0059] In an embodiment of the method, the layer contains silicon, preferably is substantially made of silicon or a material with similar properties as silicon, more preferably is made of silicon providing the effect and advantageous described previously.

[0060] BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The invention will be apparent from and elucidated further with reference to the embodiments described by way of example in the following description and with reference to the accompanying drawings, in which:

[0062] Figure 1 schematically shows a foot with different areas;

[0063] Figure 2 schematically shows a foot orthosis;

[0064] Figure 3 schematically shows a bottom part of a foot orthosis;

[0065] Figure 4 schematically shows a foot with different features of the foot orthosis;

[0066] Figure 5 schematically shows a foot with an ulcer relief ; and

[0067] Figure 6 schematically shows an embodiment of a computer program product.

[0068] The figures are purely diagrammatic and not drawn to scale. In the figures, elements which correspond to elements already described may have the same reference numerals.

[0069] LIST OF REFERENCE NUMERALS

[0070] DETAILED DESCRIPTION OF THE FIGURES

[0071] The following figures may detail different embodiments. Embodiments can be combined to reach an enhanced or improved technical effect. These combined embodiments may be mentioned explicitly throughout the text, may be hint upon in the text or may be implicit.

[0072] Figure 1 schematically shows a foot 10 with different areas. The foot comprises and shows a plantar surface 20, a transversal arch 21 , toes 22, ball of the foot 23, a medial longitudinal arch 25, a heel 26, and toe tips 28. Further, the foot comprises internally metatarsal bones 24, metatarsal joints 29, and a calcaneus 27. The internal parts of the foot are not show in figure 1. Also, a circumference 40 is shown around or just above the ankle. The metatarsal bones, more specifically the heads of the metatarsal bones, may build the transversal arch.

[0073] The surface of the foot, specifically the plantar surface, comprises several areas. These areas may be selected from the open list of a Thomas area 31 , a metatarsal area 32, an arch area 33, and a calcaneus area 34. The Thomas area is associated with an area bordered by the toes and the transversal arch. The metatarsal area is associated with the metatarsal joints. The arch area is associated with the medial longitudinal arch. The calcaneus area is associated with the calcaneus. Figure 2 schematically shows a foot orthosis 100. The foot orthosis comprises a layer 110. The layer may be forming a shell, preferably a flexible shell around the foot. The layer comprises at least on of the features. The features may be selected from the open list of a Thomas bar 130, a metatarsal patch 131 , a foot arch elevation 132, and a calcaneus patch 133. The list may for example be extended with an ulcer relied which may be associated with an area of the foot, not specifically limited to the plantar surface. The Thomas bar is arranged to the Thomas area for reducing development of hammer toes. The metatarsal patch is arranged to the metatarsal joints for reducing impact on the metatarsal bones upon contact of the ball of the foot and / or the metatarsal joints. The foot arch elevation is arranged to the arch area for reducing sagging of the medial longitudinal arch. The calcaneus patch is arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot.

[0074] The layer is typically flexible for providing the characteristic of pressure distribution. Further, the shape is selected for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot. The foot orthosis, specifically the layer, typically comprises a rim 141 forming an opening 140.

[0075] Figure 3 schematically shows a bottom part 101 of a foot orthosis 100. The bottom part is typically the bottom part of the layer. The features of figure 2 are shown as relief in figure 3. Also, a toe tip space 142 is shown.

[0076] Figure 4 schematically shows a foot with different features of the foot orthosis. The layer of the foot orthosis is shown in transparent grey to show the different features relative to the foot, more specifically plantar surface, and the features of the plantar surface. The identified features are the same features as identified in figure 3 with a different perspective.

[0077] Figure 5 schematically shows a foot with an ulcer relief 143. The ulcer relief is arranged and / or positioned to an ulcer and / or a deformation 41 .

[0078] The user is typically diabetic, has foot necrose, and / or neuropathy. Encapsulating the whole foot is typically from the ankle down. The sagging of the foot arches, such as the medial longitudinal arch and / or the transversal arch, is typically a dynamic process. This dynamic process is next to a process of flexing of the foot during gaiting. The flexing of the foot during gaiting may be one of the contributors of the sagging of one or more of the foot arches. Sagging of one or more of the foot arches may result in reduced blood circulation or blood flow in the foot. The reduced blood circulation in turn may result in reduced stimulation of the nerves in the foot. The reduced stimulation of the nerves in the foot in turn may result in muscles normally pulling on the various bones in the foot to stretch and / or relax such that the one or more foot arches sag or start sagging. Foot arches that sag may cause ulcers in or on, and / or deformations of the foot. The one or more foot arches sagging may also cause forward pressure on the bones in the foot, especially in a distal parts or bones. Especially the distal heads or articular distal heads of the metatarsal bones are sharp. The sharpness of these articular distal heads in combination with the forward pressure may cause ulcers to form from the inside to the outside of the foot, or under the skin. Especially these ulcers forming inside the foot cannot be treated as a typical wound, as wound treatment on the skin is not reaching the ulcer and is thus ineffective.

[0079] An orthopedic shoe may regulate pressure on the foot in some way or the other, but has a disadvantage of not being easily replaceable, donning and doffing is typically difficult, and the manufacturing does take time. Although that the manufacturing does take time seems not significant, in all day practice it is. The foot of a user, especially someone suffering from an ulcer and / or a deformation is constantly changing shape. The current foot orthosis, especially when made from a material suitable for additive manufacturing, may be printed and worn by the user. The method for producing allows to adapt and produce the foot orthosis quickly such that the ulcer and / or the deformation may be prevented and / or healed quicker. The foot orthosis, when wearable in a regular shoe or orthopedic shoe, allows the user, such as a patient, to be quickly back on his or her feet.

[0080] The use of a material such as silicon or a material having comparable characteristics as silicon provides the advantage of a flexible material typically well suited for additive manufacturing. One or more of the characteristics of silicon advantageous for the foot orthosis is its flexibility, ability to be shaped, adhesiveness to the skin, and / or durability. The adhesiveness of the layerto the skin reduces or even prevents friction between the foot orthosis and the foot. The reduced or prevented friction typically stimulates the disappearing of callus on all parts of the foot. And as callus is a cause for an ulcer on the foot, the adhesiveness prevents forming of or reduces ulcers in or on the foot, and / or deformations of the foot.

[0081] Figure 6 schematically shows an embodiment of a computer program product 1000, computer readable medium 1010 and / or non-transitory computer readable storage medium according to the invention comprising computer readable code 1020.

[0082] It will also be clear that the above description and drawings are included to illustrate some embodiments of the invention, and not to limit the scope of protection. Starting from this disclosure, many more embodiments will be evident to a skilled person without departing from the scope of the invention as set forth in the appended claims. These embodiments are within the scope of protection and the essence of this invention and are obvious combinations of prior art techniques and the disclosure of this patent. Devices functionally forming separate devices may be integrated in a single physical device.

[0083] The term “substantially” herein, such as in “substantially all emission" or in “substantially consists", will be understood by the person skilled in the art. The term “substantially" may also include embodiments with “entirely", “completely", “all", etc. Hence, in embodiments the adjective substantially may also be removed. Where applicable, the term “substantially" may also relate to 90% or higher, such as 95% or higher, especially 99% or higher, even more especially 99.5% or higher, including 100%. The term “comprise" also includes embodiments wherein the term “comprises" means “consists of’. The term "functionally" will be understood by, and be clear to, a person skilled in the art. The term “substantially" as well as “functionally" may also include embodiments with “entirely", “completely", “all", etc. Hence, in embodiments the adjective functionally may also be removed. When used, for instance in “functionally parallel", a skilled person will understand that the adjective “functionally" includes the term substantially as explained above. Functionally in particular is to be understood to include a configuration of features that allows these features to function as if the adjective “functionally" was not present. The term “functionally" is intended to cover variations in the feature to which it refers, and which variations are such that in the functional use of the feature, possibly in combination with other features it relates to in the invention, that combination of features is able to operate or function. For instance, if an antenna is functionally coupled or functionally connected to a communication device, received electromagnetic signals that are receives by the antenna can be used by the communication device. The word “functionally" as for instance used in “functionally parallel" is used to cover exactly parallel, but also the embodiments that are covered by the word “substantially" explained above. For instance, “functionally parallel" relates to embodiments that in operation function as if the parts are for instance parallel. This covers embodiments for which it is clear to a skilled person that it operates within its intended field of use as if it were parallel.

[0084] Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein. Thus, these terms are not necessarily intended to indicate temporal or other prioritization of such elements.

[0085] The devices or apparatus herein are amongst others described during operation. As will be clear to the person skilled in the art, the invention is not limited to methods of operation or devices in operation.

[0086] It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. Use of the verb "to comprise" and “to include", and its conjugations does not exclude the presence of elements or steps other than those stated in a claim. Also, the use of introductory phrases such as “at least one" and “one or more" in the claims should not be construed to imply that the introduction of another claim element by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim element to inventions containing only one such element, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an." The article "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

[0087] The invention may be implemented by means of hardware comprising several distinct elements, and by means of a suitably programmed computer. In the device or apparatus claims enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0088] The invention further applies to an apparatus or device comprising one or more of the characterising features described in the description and / or shown in the attached drawings. The invention further pertains to a method or process comprising one or more of the characterising features described in the description and / or shown in the attached drawings.

[0089] It will be appreciated that the invention also applies to computer programs, particularly computer programs on or in a carrier, adapted to put the invention into practice. The program may be in the form of a source code, a code intermediate source and an object code such as in a partially compiled form, or in any other form suitable for use in the implementation of the method according to the invention. It will also be appreciated that such a program may have many different architectural designs. For example, a program code implementing the functionality of the method or system according to the invention may be sub-divided into one or more sub-routines. Many different ways of distributing the functionality among these sub-routines will be apparent to the skilled person. The sub-routines may be stored together in one executable file to form a self-contained program. Such an executable file may comprise computer-executable instructions, for example, processor instructions and / or interpreter instructions (e g. Java interpreter instructions). Alternatively, one or more or all of the sub-routines may be stored in at least one external library file and linked with a main program either statically or dynamically, e g. at run-time. The main program contains at least one call to at least one of the sub-routines. The sub-routines may also comprise function calls to each other. An embodiment relating to a computer program product comprises computer-executable instructions corresponding to each processing stage of at least one of the methods set forth herein. These instructions may be sub-divided into sub-routines and / or stored in one or more files that may be linked statically or dynamically. Another embodiment relating to a computer program product comprises computer- executable instructions corresponding to each means of at least one of the systems and / or products set forth herein. These instructions may be sub-divided into sub-routines and / or stored in one or more files that may be linked statically or dynamically.

[0090] The carrier of a computer program may be any entity or device capable of carrying the program. For example, the carrier may include a data storage, such as a ROM, for example, a CD ROM or a semiconductor ROM, or a magnetic recording medium, for example, a hard disk. Furthermore, the carrier may be a transmissible carrier such as an electric or optical signal, which may be conveyed via electric or optical cable or by radio or other means. When the program is embodied in such a signal, the carrier may be constituted by such a cable or other device or means. Alternatively, the carrier may be an integrated circuit in which the program is embedded, the integrated circuit being adapted to perform, or used in the performance of, the relevant method.

[0091] The various aspects discussed in this patent can be combined in order to provide additional advantages. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage. Furthermore, some of the features can form the basis for one or more divisional applications.

Claims

CLAIMS1. Foot orthosis (100) for protecting a foot (10) of a user during gaiting, wherein the foot comprises a plantar surface (20), a transversal arch (21), toes (22), metatarsal bones (24), metatarsal joints (29), a medial longitudinal arch (25), a heel (26), and a calcaneus (27); wherein the plantar surface comprises:- a Thomas area (31) associated with an area bordered by the toes and the transversal arch;- a metatarsal area (32) associated with the metatarsal joints;- an arch area (33) associated with the medial longitudinal arch; and- a calcaneus area (34) associated with the calcaneus; wherein the foot orthosis comprises a layer (110) shaped for encapsulating the whole foot; wherein the layer comprises at least one of the features of:- a Thomas bar (130) arranged to the Thomas area for reducing development of hammer toes;- a metatarsal patch (131) arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area;- a foot arch elevation (132) arranged to the arch area for reducing sagging of the medial longitudinal arch; and- a calcaneus patch (133) arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot; and wherein the foot orthosis is custom-made for the user.

2. Foot orthosis according to the preceding claim, wherein the user is a patient suffering from pressure related issues in the foot, optionally a patient suffering from peripheral neuropathy; wherein the layer contains silicon or a material having similar properties as silicon, preferably is substantially made of silicon, more preferably is made of silicon; wherein encapsulating the whole foot comprises snugly fitting around the foot apart from the area associated with the tip of the toes, and wherein optionally a distance between the tip of the toes and the area associated with the tip of the toes is in the range of 0.5 mm to 2 mm, preferably 0.75 mm to 1 .5 mm, more preferably 0.8 mm to 1 .25 mm, most preferably substantially 1 mm; and / or wherein the layer is flexible for allowing donning and / or doffing the foot orthosis.

3. Foot orthosis according to any of the preceding claims, wherein the foot orthosis, specifically the layer, has an outer shape; and wherein the outer shape is suitable for arranging the foot with foot orthosis in footwear, such as off the shelf semi orthopedic shoes or even different pairs of regular shaped shoes.

4. Foot orthosis according to the preceding claim, comprising an outer layer encapsulating the layer, preferably snugly encapsulating the layer, wherein the outer layer provides a lower friction between the foot orthosis and the footwear compared to the friction between the layer and the footwear; and wherein preferably the outer layer is made of a fabric, such as a fabric used for a sock.

5. Foot orthosis according to any of the preceding claims, wherein at least one feature is integrated with the layer, preferably made of the same material as the layer.

6. Foot orthosis according to the preceding claim, wherein the feature comprises cavities.

7. Foot orthosis according to any of the preceding claims, wherein the feature comprises a thickening of the layer.

8. Foot orthosis according to any of the preceding claims, wherein the Thomas bar has a thickness up to 17 mm, preferably 16 mm, more preferably 15 mm, most preferably 14.5 mm; and wherein the Thomas bar has a thickness of at least 3.0 mm, preferably 4.0 mm, more preferably 4.5 mm, most preferably 5.0 mm.

9. Foot orthosis according to any of the preceding claims, wherein the metatarsal patch has a thickness up to 7.0 mm, preferably 5.5 mm, more preferably 4.5 mm, most preferably4 mm; and wherein the metatarsal patch has a thickness of at least 2 mm, preferably 2.5 mm, more preferably 2.75 mm, most preferably 3 mm.

10. Foot orthosis according to any of the preceding claims, wherein the foot arch elevation has a thickness up to 9.0 mm, preferably 8.0 mm, more preferably 7.5 mm, most preferably 7 mm; and wherein the foot arch elevation has a thickness of at least 4.5 mm, preferably 5.5 mm, more preferably 5.75 mm, most preferably 6 mm.

11. Foot orthosis according to any of the preceding claims, wherein the calcaneus patch has a thickness up to 7.0 mm, preferably 6.0 mm, more preferably 5.5 mm, most preferably 5 mm; and wherein the calcaneus patch has a thickness of at least 2.5 mm, preferably 2.75 mm, more preferably 2.9 mm, most preferably 3.0 mm.

12. Foot orthosis according to any of the preceding claims, wherein encapsulating the whole foot comprises encapsulating the whole foot up to, onto or even over the ankle; wherein a part of the layer apart from a part associated with the plantar surface has a thickness in the range of 0.30 mm to 2.5 mm, preferably 0.40 mm to 2.75 mm, more preferably 0.5 to 1 .5 mm, most preferably 0.75 mm to 1 .25 mm; and / or wherein a part of the layer associated with the plantar surface and outside the parts of the plantar surface associated with the at least one feature has a thickness up to 9 mm, preferably 7 mm, more preferably 6 mm, most preferably 5.5 mm, and wherein the part of the layer associated with the plantar surface and outside the parts of the plantar surface associated with the at least one feature has a thickness of at least 2 mm, preferably 2.5 mm, more preferably 2.75 mm, most preferably 3 mm.

13. Foot orthosis according to any of the preceding claims, wherein the foot comprises an ulcer and / or a deformation or risk to develop an ulcer and / or a deformation; wherein the layer comprises an ulcer relief arranged to the ulcer and / or the deformation; wherein the ulcer relief comprises a thickening of the layer arranged around the ulcer and / or the deformation for relieving the pressure on the ulcer and / or the deformation for reducing further development of the ulcer and / or the deformation; wherein optionally the thickening is up to 3.0 mm, preferably 2.5 mm, more preferably 2.0 mm, most preferably 1 .7 mm; and wherein preferably the ulcer relief smoothly transitions to a surrounding layer part surrounding the ulcer relief.

14. Foot orthosis according to any of the preceding claims, wherein the foot comprises a toe amputation; and wherein the layer comprises a toe replacement arranged to the toe amputation for replacing the amputated toe.

15. Foot orthosis according to any of the preceding claims, wherein the layer comprises a plurality of ventilation holes distributed over the layer; wherein optionally the plurality of ventilation holes have a diameter in the range of 0.05 mm to 1 mm, preferable in the range of 0.08 mm to 0.5 mm, more preferably about 0.1 mm; and wherein optionally the plurality of ventilation holes are spaced apart in a range of 10 mm to 30 mm, preferably 15 mm to 25 mm, more preferably substantially 20 mm.

16. Foot orthosis according to the preceding claim, wherein the ventilation holes are distributed according to a quincunx pattern.

17. Method for producing a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; and wherein the method comprises:- scanning the foot having a plantar surface;- identifying at least one area of the plantar surface associated with: a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus;- modelling the foot orthosis based on the scanning and the identifying;- printing the modelled foot orthosis comprising a layer shaped for encapsulating the whole foot wherein the layer comprises at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot.

18. Method according to the preceding claim, wherein the layer contains silicon, preferably is substantially made of silicon or a material with similar properties as silicon, more preferably is made of silicon.

19. Use of a foot orthosis according to any of the preceding claims 1-16.

20. Production, such as machining and / or printing, a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; wherein production comprises:- receiving a foot orthosis model based on:- scanning the foot having a plantar surface;- identifying at least one area of the plantar surface associated with: a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal joints; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; and- modelling the foot orthosis based on the scanning and the identifying, wherein the foot orthosis comprises a layer shaped for encapsulating the whole foot; and wherein modelling the foot orthosis comprises modelling the layer comprising at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of the metatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot; and- printing the foot orthosis model.

21. Foot orthosis model modelling a foot orthosis arranged for protecting a foot of a user during gaiting, wherein the foot orthosis model is suitable for printing the foot orthosis; wherein the foot comprises a plantar surface, a transversal arch, toes, metatarsal bones, metatarsal joints, a medial longitudinal arch, a heel, and a calcaneus; wherein the foot orthosis model is based on:- scanning the foot having a plantar surface;- identifying at least one area of the plantar surface associated with: a Thomas area associated with an area bordered by the toes and the transversal arch; a metatarsal area associated with the metatarsal area; an arch area associated with the medial longitudinal arch; and a calcaneus area associated with the calcaneus; and- modelling the foot orthosis based on the scanning and the identifying; wherein the foot orthosis model comprises a layer shaped for encapsulating the whole foot; wherein modelling the foot orthosis comprises modelling the layer comprising at least one of the features: a Thomas bar arranged to the Thomas area for reducing development of hammer toes; a metatarsal patch arranged to the metatarsal area for reducing impact on the metatarsal bones upon contact of themetatarsal area; a foot arch elevation arranged to the arch area for reducing sagging of the medial longitudinal arch; and a calcaneus patch arranged to the calcaneus area for reducing impact on the calcaneus upon heel contact of the foot; and wherein the at least one feature is shaped for adapting the pressure distribution on the foot for preventing and / or reducing development of an ulcer on and / or a deformation of the foot.

22. Foot orthosis model according to the preceding claim, wherein the data structure is in a computer readable format and / or on a computer readable medium.

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