Device for protecting the medial tarsal ball

Abstract

The present invention relates to a device for protecting the medial tarsal ball of the foot, comprising a pad (1) comprising a viscoelastic material and adapted to be held on the skin in the plantar region and to cover all metatarsal heads and metatarsophalangeal joints of the foot, and an elastic strap (2) attached to the lateral edges (24, 25) of the pad and including a transverse portion (21) and a longitudinal portion (22) forming a brace adapted to pass between the big toe and an adjacent toe, the longitudinal portion (22) having a distal edge (28) secured to the distal edge (16) of the pad; the transverse portion has a distal edge (23) that, together with the pad and the lateral edge (26) of the longitudinal portion, defines an opening for the second to fifth toes to pass therethrough, the distal edge and the lateral edge of the transverse portion have straight portions that, in an unstretched flat state, form an angle (α) of 75 to 100 degrees between them, the lateral edge (26) has a length (L2) that is 40 to 60% of the length (L1) of the distal edge (23) of the transverse portion (21), and the length of the distal edge of the transverse portion is 55 to 65% of the length of the transverse portion; and an elastic strap (2).

Description

[Technical field]

[0001] The present invention relates to a foot protection device, particularly for distributing pressure on the front of the foot. [Background technology]

[0002] The foot has a protective layer called the "medial tarsal ball," which can withstand up to eight times the body weight. The medial tarsal ball distributes the mechanical loads applied to the metatarsals by the body weight. However, many people suffer from overheating, calluses, or pain associated with the inevitable wear of the natural medial tarsal ball with age, which no longer effectively fulfills its role of load distribution. As a person ages, the medial tarsal ball tends to become thinner and harder. The foot may also suffer from skin disorders (inflammation, cracks, plantar warts, etc.).

[0003] To reduce or prevent these pains and / or disorders, it is known to place pads of selected viscoelastic material under the metatarsal heads and / or under the metatarsophalangeal joints to distribute the load, in particular to avoid the formation of localized hyperkeratosis, commonly called calluses. To create such pads, it is also known to use polymer gel-based inserts, such as silicone gels or hydrogels, to provide a replacement function for the medial tarsal ball. Such inserts, which are a few square centimeters in size, can thus be made, for example, from a PDMS (polydimethylsiloxane) silicone gel composition sold by the applicant under the name Epithelium 26®. French Patent Application Publication No. 2 712 487 discloses a silicone gel with properties similar to those of the medial tarsal ball, used essentially for the prevention of overpressure lesions occurring on or under the foot. Summary of the Invention [Problem to be solved by the invention]

[0004] The invention more particularly aims to protect the medial tarsal ball in the region of the metatarsal head and to compensate for the deterioration of that area by distributing the pressure caused by the body's weight over the entire metatarsal head. However, the presence of a pad under the metatarsal head can disrupt the user's posture and balance when walking. In fact, balance in standing results from the permanent integration of data coming from three receptor systems: the visual system, the proprioceptive system and the vestibular system.

[0005] The visual system (position relative to the environment) and the vestibular system (detection of rotational and linear acceleration of the head in space by organs in the ear) should not be affected by the presence of pads under the feet. This is not the case for the proprioceptive system, since the perception of the ground by cutaneous and deep mechanoreceptors is attenuated by the intervention of the pads. However, awareness of the signals from these senses results in muscle responses aimed at eliminating the conscious or unconscious feeling of imbalance. These muscle responses can be the cause of lesions that can be temporary, such as spasms, or more long-term, such as tendonitis, in the overall kinematics of the body.

[0006] The applicant has developed and commercialized a pad that fits elderly people whose medial tarsal ball has worn (become thin and hard). The pad creates an extra thickness under the foot of more than 3 mm for a viscoelastic material thickness of 2.2 mm. The pad functions to compensate for the wear of the medial tarsal ball. However, the way in which the pad is held on the foot, the bulkiness, and the comfort associated with wearing the pad in the shoe should obviously be improved. [Means for solving the problem]

[0007] It is therefore desirable to provide a pad with pressure dispersion features associated with the retention means that allows the pad to be comfortably held in place on the foot without causing postural instability to the user. It is therefore also desirable that the pad and retention means are not too bulky so that they can fit into the footwear being worn without causing discomfort. It may also be desirable that the pad does not cause injury, particularly to the toes, or skin reactions. It may also be desirable that both the pad and retention means are usable for several months and are easily manufacturable.

[0008] An embodiment relates to a device for protecting the medial tarsal ball of the foot, the device including: a pad comprising a viscoelastic material and configured to be retained on the skin of the plantar region and cover all metatarsal heads and metatarsophalangeal joints of the foot; and an elastic strap attached to a lateral edge of the pad and including a transverse portion and a longitudinal portion forming a brace configured to pass between the first toe and an adjacent toe, the longitudinal portion having a distal edge secured to a distal edge of the pad, the transverse portion having a distal edge that, together with the pad and the lateral edge of the longitudinal portion, defines an opening for passage of the second toe through the fifth toe, the distal and lateral edges of the transverse portion having straight portions that form an angle of 75-100° therebetween in an unstretched flat state, the lateral edge having a length that is 40-60% of the length of the distal edge of the transverse portion, and the length of the distal edge of the transverse portion is 55-65% of the length of the transverse portion.

[0009] According to one embodiment, the distal edge of the longitudinal portion is attached to the distal edge of the pad after being rotated by an angle of 80-100° in the plane of the pad.

[0010] According to one embodiment, before fastening the longitudinal portion to the pad, the distal edge of the longitudinal portion and the distal edge of the pad form an angle of 70-90° with respect to each other.

[0011] According to one embodiment, the longitudinal portion has a width at its distal end of 1.5 cm ±20%.

[0012] According to one embodiment, the pad includes an outer piece of fabric joined with an inner piece of fabric to form a pocket in which the insert is received.

[0013] According to one embodiment, the outer fabric piece has a thickness of 0.5 to 0.8 mm and the inner fabric piece has a thickness of 0.1 to 0.5 mm.

[0014] According to one embodiment, the insert is glued to the outer fabric piece.

[0015] According to one embodiment, the insert has a planar base and a stud formed on an upper side of the planar base.

[0016] According to one embodiment, the flat base has a thickness of 1.4-2 mm and the studs extend to a height above the flat base of 1.3-1.7 mm and have a total volume per unit area equal (within ±10%) to the total volume per unit area of ​​a flat layer having 1 / 3 the height.

[0017] According to one embodiment, the studs have a spherical cap shape with a diameter of 4mm ± 0.2mm and are spaced from each other by 5mm intervals (within ± 0.2mm) in the 0°, 60° and 120° directions.

[0018] According to one embodiment, the viscoelastic material is based on a polydimethylsiloxane silicone gel composition.

[0019] Non-limiting examples of embodiments of the invention will now be described with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0020] [Figure 1] 1 shows a schematic top view of a protection device for protecting the medial tarsal ball in the region of the metatarsal heads. [Diagram 2] 2 is a cross-sectional view of the protection device taken along plane AA' shown in FIG. 1; [Diagram 3] FIG. 1 is a top view of the protection device when attaching the straps over the foot, prior to attaching the brace. [Figure 4] FIG. 13 is a top view of the protective device while attaching the straps after the brace has been attached. [Diagram 5] 1 shows a schematic representation of a foot fitted with a protective device; [Figure 6] FIG. 1 is a top view of a pad housed within a brace. [Figure 7] 8 is a cross-sectional view of the pad of FIG. 7 taken along the plane CC' shown in FIG. 6; [Figure 8] 7 shows a curve illustrating the crushability of the wafer of FIG. 6. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 1 and 2 show a foot protection device according to one embodiment. The protection device comprises a pad 1 and an elastic strap 2 having a transverse portion 21 attached to the pad 1 along two opposite lateral edges 24, 25 of the pad 1. The assembly of the pad 1 and the strap 2 thus forms a sleeve having two opposite openings 31-32, 33 adapted to slightly tighten the front part of the foot. The strap 2 is further attached to the pad 1 by a brace 22 which is integral with the strap 2 and is attached to the distal longitudinal edge 16 of the pad. The brace 22 thus defines two distal openings 31, 32, the opening 31 being provided for the passage of the first toe and the opening 32 being provided for the passage of the other toe. The lateral and distal attachment of the strap 2 to the pad 1 is performed, for example, by stitching.

[0022] According to one embodiment, the strap 2 is made of an elastic fabric, for example a fabric that is not prone to run, and has a thickness of 0.5 to 1 mm, for example about 0.6 mm.

[0023] According to one embodiment, the opening 32 is defined on the strap 2 side by two edges with straight sections, namely a transverse edge 23 with length L1 formed by the transverse section 21 and a longitudinal edge 26 with length L2 formed by the brace 22. The edges 23, 26 are connected to each other by a curved edge in the region 40 of the strap 2. The edge 23 extends along the axis SS' and the edge 26 extends along the axis BB', which makes an angle α with the axis SS'. According to one embodiment, the angle α is between 75 and 100°, the ratio L2 / L1 is between 40 and 60%, preferably between 45 and 55%, and the curved edge has a radius of curvature of less than 1 cm.

[0024] The pad 1 includes an insert 11 made of a viscoelastic material configured to provide a pressure distribution function (FIG. 2). According to one embodiment, the insert 11 is accommodated in a pocket formed by an outer piece of fabric 12 joined with an inner piece of fabric 13. The shape and dimensions of the pocket can be exactly matched to the shape and dimensions of the insert 11. The insert 11 can be glued over its entire surface to one of the two pieces of fabric 12, 13, for example the outer piece of fabric 12. The outer piece of fabric 12 and the inner piece of fabric 13 are elastic and can have a thickness of 0.5-0.8 mm, for example a thickness of the order of 0.6 mm. According to one embodiment, the inner piece of fabric 13 has a smaller thickness, for example a thickness of 0.1-0.5 mm, for example a thickness of the order of 0.2 mm. The pieces of fabric 12, 13 can be joined to each other along the periphery of the insert 11, for example by a stitch.

[0025] According to one embodiment, the insert 11 is made of a viscoelastic polymer gel, for example a silicone gel. Thus, the insert 11 may for example be made of PDMS (polydimethylsiloxane) having a Shore 00 hardness of 10-40 (equivalent to a Shore A hardness of 05), preferably a Shore 00 hardness of 17.

[0026] The insert 11 may have a thickness of 1.7 to 3.5 mm, for example about 1.8 mm. In this way, the total thickness of the protection device under the foot may be at least 2.5 mm. Under these conditions of thickness and hardness of the insert 11 and the thickness of its fabric covering (12, 13), the insert 11 can ensure effective protection of the medial tarsal ball without interfering with the postural stability of the user, while at the same time minimizing the space it occupies in the footwear.

[0027] 3 and 4 show the shape of the strap 2, which in 3 is in a flat shape and in 4 is sewn to the pad 1. In 3, the strap 2 is laid flat on the pad 1 and then attached to the pad 1 without stretching (FIG. 4) such that at this position along the side edges 24, 25 of the pad 1, the length of the strap 2 at rest after attachment between the side edges 24, 25 substantially corresponds (within 10%) to the width of the pad 1 between these side edges. In this position, the side edge 26 of the brace 22 extends in a direction UU' at an angle γ with the direction SS' of the edge 23 of the transverse portion 21 on the opening 32 side. The brace 22 has a distal portion 27 that extends substantially in the direction of the transverse portion 21 of the strap 2. The distal portion 27 of the brace 22 extends in a direction VV' at an angle δ with the direction UU', so that the direction VV' forms an angle γ-δ with the direction SS'. In the example shown in FIG. 3, the angle γ is in the range of 60° to 85°, and the angle γ-δ is in the range of 0° to 20°.

[0028] As shown in Figures 3 and 4, the distal portion 27 of the brace 22 is fixed flat and unstretched to the distal edge 16 of the pad 1 by a fixing line 28 (Figure 3) that extends substantially perpendicular (within ±10°) to the distal portion 27 (direction VV') and extends from the intersection of the outer edge 26 of the brace 22 and the distal edge 16 of the pad 1 at rest. The brace 22 is fixed to the distal edge 16 of the pad 1 by rotating the brace 22 in the plane of the pad 1 to increase the angle γ between the axis SS'' and the axis UU' to angle α so that the axis UU' coincides with the axis BB' (Figure 1) and rotating the attachment line 28 on the brace 22 about the intersection between the side edge 26 of the brace and the distal edge 16 of the pad 1 to coincide with the distal edge 16 of the pad 1. In this way, the brace 22 is fixed to the pad 1 to form a cambered curve, keeping the opening 31 open, the size of which depends on the magnitude of these two rotations. Under these conditions, the outer edge 26 of the brace 22 extends, at the opening side 32, along an axis BB' that forms an angle α with the axis SS'. Considering that the distal edge 16 of the brace 22 at the attachment location is substantially parallel to the axis SS', the rotation angle of the attachment line 28 is substantially equal to 90°-(γ-δ), i.e. 70° to 90°.

[0029] As shown in FIG. 5, which shows the protection device worn on the foot, the shape and dimensions of the pad 1 (and thus the insert 11) are intended to cover the entire metatarsal heads and metatarsophalangeal joints of the foot and, if necessary, a part of the lateral edge of one or both of the feet. The pad 1 is intended to be worn on the foot so that its distal edge 16 substantially coincides with a line passing through the base of the toes in the case of an Egyptian foot. The edge 23 of the opening 32 belonging to the transverse portion 21 of the strap 2 extends along the axis OO', while the edge 26 of the opening 32 belonging to the brace 22 extends along the axis PP'. The edge 26 of the brace 22 on the opening 32 side passes through the commissure area 41 between the first and second toes. In addition, the cambered curve surrounds the first toe.

[0030] When the support device is rotated around the foot (around the XX' axis) and accurately positioned, the PP' axis is substantially parallel (within ±10° depending on the foot morphology) to the XX' longitudinal axis of the foot, which passes through the center of the heel and the center of the end of the second toe. Furthermore, when the support device is accurately positioned along the axis XX' of the foot, the axis PP' forms an angle β of 100-120° with the axis OO', depending on the foot morphology. In the example shown in FIG. 5, the angle β is approximately 110°.

[0031] When these conditions for proper positioning of the brace on the foot are met, the shape and placement of strap 22 described above avoids tensioning between the lateral area of ​​the foot on the side of the little toe (attachment line 25) and the commissure area 41 between the first and second toes. It has been found that these tensions tend to induce forward migration of the device and create an uncomfortable shearing action on the commissure between the first and second toes. Elimination of these tensions therefore helps to minimize the risk of displacement of the brace during use, and therefore mispositioning, and improves the comfort of the brace around the first toe.

[0032] Additionally, the curvature of the brace 22 around the big toe allows the fabric to be attached to the medial edge of the first metatarsophalangeal joint without placing significant tension on the commissure area with the second toe 41. This arrangement also helps improve the comfort of the support device around the big toe.

[0033] The properties of strap 22 further impart significant stretching capability to the portion of the strap corresponding to the passage over the commissure between the first and second toes, as compared to a strap without curvature and with a shorter or no length L2, resulting in the user feeling the presence of strap 22 less, thereby allowing for extended use of the brace without discomfort to the user, thus increasing the daily use time of the brace.

[0034] According to one embodiment, the brace 22 has a relatively large width (approximately 1.5 cm (20% plus or minus)) along the seam 28. This large width, made possible by the formation of the cambered curve, further reduces the risk of shearing that may be caused by the strap 22 at the commissure between the first and second toes (region 41).

[0035] 6 and 7 show an insert 11 according to an embodiment. The upper surface (foot side) of the insert 11 has a flat base 15 of thickness e on which the studs 14 are distributed. In the example of Figs. 6 and 7, the studs 14 have the shape of spherical caps S of diameter d1 and are regularly distributed on the base 15 of the insert 11. The studs 14 protrude above the base 15 of the insert 11 by a height h and are spaced apart from each other by a distance d2 along the three directions 0°, 60° and 120°. According to an embodiment, the thickness e is selected to be 1.7 mm (±0.3 mm), the height h is selected to be 1.5 mm (±0.2 mm), the diameter d1 of the sphere is selected to be 4 mm (±0.2 mm) and the distance d2 between the studs 14 is selected to be 5 mm (±0.2 mm). Under these conditions, the volume of material above the flat base 15 of thickness e is approximately one third compared to a layer of constant thickness with height h. That is, this volume corresponds to the volume of a layer of constant thickness equal to approximately 1 / 3 (±10%) of the height h.

[0036] FIG. 8 shows curves C1, C2 of applied force F (N) versus crush depth T (mm) for different inserts. Curve C1 is the curve obtained using insert 11 (FIG. 6) and curve C2 is the curve obtained using a flat insert 11 with approximately the same volume of material per unit area as insert 11. FIG. 8 further shows the initial thickness e1 (=2.9 ​​mm) of insert 11 and the initial thickness e2 (=2 mm) of the other insert. Curves C1 and C2 each show three stages: a first stage called "contact" where the crushing of the pad offers little resistance (pad thickness decreases rapidly as a function of the crushing force), a second intermediate stage that begins when the crushing of the insert reaches about 1 mm for insert 11 and 0.6 for the other insert when the crushing force is a few Newtons to about 20 N for curves C1 and C2, and a third stage known as the "stiffening" stage where the crushing of the insert increases substantially linearly and more rapidly along the crushing force axis. During the stiffening stage, which starts with a force of about 200 N for a crush depth of about 1.9 mm for curve C1 and a force of about 100 N for a crush depth of about 0.95 mm for curve C2, curves C1 and C2 have approximately the same slope, which can be explained by the fact that during this stage the insert 11 behaves substantially like a flat plate.

[0037] Compared to curve C2, the intermediate phase of curve C1 is longer and ends with a further compression of about 0.95 mm. This is because the studs 14, after contacting each other, collapse until the spaces between them are filled, and the compliance of the flat base 15 of the insert 11 decreases. During this intermediate phase, the collapse of the insert 11 is not proportional to the force applied to it. This intermediate phase gives the pad 1 a lasting, soothing comfort when the foot starts to compress the pad against the ground. When the force reaches 500 N during the stiffening phase, the insert 11 has a thickness of about 0.48 mm and the other insert has a thickness of about 0.33 mm. The stiffening phase does not affect postural stability and prevents excessive local growth of the callous layer (keratinization) thanks to the pressure distribution provided by the pad.

[0038] Comparing insert 11 to a flat insert of the same pressure dispersion capacity and thickness, if base 15 of insert 11 has a thickness of 1.5 mm and height h of studs 14 of 1.4 mm, then the flat insert must have a thickness of 2 mm thicker than thickness e of base 15 of insert 11. The studs 14 will collapse more easily in response to a load than the base of the flat insert, causing the compression stage of the studs 14 to occur before the compression stage of the flat base 15, resulting in a similar compression response as a flat insert of substantially similar final thickness (0.48 mm for insert 11 and 0.33 mm for the other insert) given the average weight of an adult (500N).

[0039] It is noted that the studs 14 penetrate slightly into the soft tissue of the medial tarsal ball, further reducing the thickness felt under the foot compared to a flat insert. As a result, the insert 11 has a potentially smaller footprint in the shoe than a flat insert, improving comfort for the user and reducing loss of stability when walking. The penetration of the studs 14 into the soft tissue of the medial tarsal ball further contributes to improving the retention of the pad 1 under the foot.

[0040] It should also be noted that the reduced thickness e of the base 15 of the insert 11, compared to a flat insert with a thickness providing the same pressure dispersion capacity (same volume of material per unit surface), allows the insert 11 to closely follow the anatomical structure of the metatarsal zone, which has a biconvex shape (longitudinally and transversely convex). In fact, the studs 14 do not increase the bending resistance of the insert 11, since they are not connected to each other. It is therefore the thickness e of the flat base 15 that determines the bending strength and therefore the ability of the insert to adapt to the shape of the medial tarsal ball in the region of the metatarsal head.

[0041] Moreover, wearing a pad under the forefoot adds a significant amount of soft material to this area. This changes the orientation of the foot relative to the ground (by raising the forefoot) and the feel of the ground when loaded with body weight during rest and during movement. The feel of the ground as perceived by the user is no longer a direct feel, but delayed in time and may be modified by shear deformation of the pad's bulk. The addition of the pad will upset the user's balance during walking and reduce the ability to adjust posture within the cone of stability, especially when supported on one foot during the forward bending tendency phase. It should be noted that the user's balance can be affected by many external factors such as the nature of the ground (e.g. sand or grass), which can vary in hardness, wind gusts, and the presence of grips on the sole. However, the majority of people who need to wear protection under the metatarsal heads are elderly people who already have poor or reduced stability. Thus, the pad 1 with a flat base 15 adjusted by studs 14 has the advantage, compared to pads with the same pressure distribution characteristics, of being able to minimize the predicted instability during walking movements due to its reduced thickness under load.

[0042] As will be clear to those skilled in the art, the invention is open to various alternatives and applications. In particular, the invention is not limited to inserts with studs. In fact, it is known that the inserts may be flat and such inserts may also perform a pressure dispersion function. The inserts may furthermore be made of a viscoelastic material that allows them to be attached directly to the strap 2 without having to be wrapped in a pocket.

[0043] The insert 11 may have studs of other shapes. The parameters to be considered for the layer containing studs are the height h of the studs, the distance d2 between the studs and the packing factor, i.e. thickness, of this layer (hereinafter referred to as the "equivalent thickness" of the volume of material distributed in the studs per unit area when distributed in the whole layer). According to one embodiment, the height of the studs is 1-2 mm and the packing factor of the layer containing the studs is 20-40%, i.e. the equivalent thickness of the studs is 20-40% of the height of the studs.

[0044] The height h and shape of the studs 14, as well as the distance between the studs 14, are not necessarily uniform throughout the insert 11, but may be locally defined according to the needs, in particular according to the pressure distribution and thickness under load. For example, the pressure exerted on the ground by the heads of the first and second metatarsals may be higher than the pressure exerted by the head of the fifth metatarsal. Thus, the equivalent thickness of the studs 14 may be gradually thinner along a line from the head of the first metatarsal to the head of the fifth metatarsal.

[0045] Furthermore, by adjusting the position of the brace 22 relative to the strap 2 and pad 1, rotation of the brace 22 for fixing to the camber curve and thus to the pad 1 can be omitted without affecting the comfort of the device.

[0046] In some applications, it may be desirable to obtain a better adhesion of the insert to the skin. In this case, all or only a part of the inner cloth piece 13 may be omitted. Similarly, the use of the support device may be combined with wearing a sock. In this connection, a better adhesion of the insert 11 to the sock covering the foot may be desired. Part of the outer cloth piece 12, in particular the central part, may be omitted.

[0047] A piece of fabric may be embedded in the insert 11, which piece of fabric is in particular used to fasten the strap 2 to the insert 11, for example by means of a stitch.

Claims

1. 1. A device for protecting the medial tarsal ball of the foot, the device comprising: a pad (1) comprising a viscoelastic material and adapted to be held on the skin in the plantar region and to cover all metatarsal heads and metatarsophalangeal joints of the foot, said pad (1) including a distal edge (16) and lateral edges (24, 25); an elastic strap (2) attached to the outer edges (24, 25) of the pad (1), the elastic strap (2) comprising a transverse portion (21) and a longitudinal portion (22); Including, The longitudinal portion (22) of the elastic strap (2) has a distal portion (27) and an outer edge (26); The transverse portion (21) of the elastic strap (2) has a distal edge (23); The elastic strap (2) forms a brace configured to pass between the first toe and an adjacent toe of the foot; a distal portion (27) of the longitudinal portion (22) of said elastic strap (2) is secured to the distal edge (16) of said pad (1); a distal edge (23) of the transverse portion (21) of the elastic strap (2) together with the pad (1) and the outer edge (26) of the longitudinal portion (22) of the elastic strap (2) define an opening (32) for the passage of the second to fifth toes; a distal edge (23) of the transverse portion (21) of said elastic strap (2) and an outer edge (26) of the longitudinal portion (22) of said elastic strap (2) having straight portions that form an angle (α) between them of 75 to 100° in an unstretched flat state; the outer edge (26) of the longitudinal portion (22) of the elastic strap (2) has a length (L2) that is 40-60% of the length (L1) of the distal edge (23) of the transverse portion (21) of the elastic strap (2); The length (L1) of the distal edge (23) of the transverse portion (21) of the elastic strap (2) is 55-65% of the length (L1+L3) of the transverse portion (21) of the elastic strap (2), wherein the length (L1+L3) of the transverse portion (21) of the elastic strap (2) is the length of the transverse portion (21) of the elastic strap (2) in the direction of extension of the distal edge (23) of the transverse portion (21) of the elastic strap (2).

2. 2. The device according to claim 1, wherein, prior to fastening the longitudinal portion (22) of the elastic strap (2) to the pad (1), a fastening line (28) fastened to the pad (1) at a distal portion (27) of the longitudinal portion (22) of the elastic strap (2) and a distal edge (16) of the pad (1) form an angle of 70 to 90 degrees with respect to each other.

3. 3. The device according to claim 1, wherein the longitudinal portion (22) of the elastic strap (2) has a width of 1.5 cm ± 20% at a fixing line (28) where the longitudinal portion (22) is fixed to the pad (1) at a distal portion (27) of the longitudinal portion (22).

4. 4. The device according to claim 1, wherein the pad (1) comprises an outer piece of fabric (12) joined to an inner piece of fabric (13) so as to form a pocket in which the insert (11) is received.

5. 5. The device according to claim 4, wherein the outer piece of fabric (12) has a thickness of 0.5 to 0.8 mm and the inner piece of fabric (13) has a thickness of 0.1 to 0.5 mm.

6. 6. The device according to claim 4, wherein the insert (11) is glued to the outer piece of fabric (12).

7. 7. The device according to claim 4, wherein the insert (11) has a planar base (15) and a stud (14) formed on the upper side of the planar base (15).

8. 8. Apparatus according to claim 7, wherein the planar base (15) has a thickness of 1.4 to 2 mm and the studs (14) extend to a height (h) above the planar base (15) of 1.3 to 1.7 mm and have a total volume per unit area equivalent (within ±10%) to the total volume per unit area of ​​a flat layer having ⅓ of said height (h).

9. 9. Apparatus according to claim 7 or 8, wherein the studs (14) have a spherical cap shape with a diameter (d1) of 4 mm ± 0.2 mm and are spaced apart from each other by intervals (d2) of 5 mm (within ± 0.2 mm) in the 0°, 60° and 120° directions.

10. 10. The device according to claim 1, wherein the viscoelastic material is based on a polydimethylsiloxane silicone gel composition.

11. 1. A method of making a device for protecting the medial tarsal ball of the foot, the method comprising: A pad (1) comprising a viscoelastic material and adapted to be held on the skin in the plantar region and to cover all metatarsal heads and metatarsophalangeal joints of the foot, said pad (1) including a distal edge (16) and a lateral edge (24, 25); providing an elastic strap (2) including a transverse portion (21) and a longitudinal portion (22), the longitudinal portion (22) of the elastic strap (2) having a distal portion (27) and an outer edge (26), the transverse portion (21) of the elastic strap (2) having a distal edge (23), the distal edge (23) of the transverse portion (21) of the elastic strap (2) together with the pad (1) and the outer edge (26) of the longitudinal portion (22) of the elastic strap (2) defining an opening (32) for passing the second to fifth toes; attaching the elastic strap (2) to the lateral edges (24, 25) of the pad (1) and fastening a distal portion (27) of the longitudinal portion (22) of the elastic strap (2) to the distal edge (16) of the pad (1), whereby the elastic strap (2) forms a brace configured to pass between the first toe and an adjacent toe of the foot; Including, the outer edge (26) of the longitudinal portion (22) of the elastic strap (2) has a length (L2) that is 40-60% of the length (L1) of the distal edge (23) of the transverse portion (21) of the elastic strap (2); a distal edge (23) of the transverse portion (21) of said elastic strap (2) and an outer edge (26) of the longitudinal portion (22) of said elastic strap (2) having straight portions that, in an unstretched flat state, form an angle between them of 75 to 100°; the length (L1) of the distal edge (23) of the transverse portion (21) of the elastic strap (2) is 55-65% of the length (L1+L3) of the transverse portion (21) of the elastic strap (2), wherein the length (L1+L3) of the transverse portion (21) of the elastic strap (2) is the length of the transverse portion (21) of the elastic strap (2) in the direction of extension of the distal edge (23) of the transverse portion (21) of the elastic strap (2).

12. 12. The method according to claim 11, wherein the distal portion (27) of the longitudinal portion (22) of the elastic strap (2) is attached to the distal edge (16) of the pad (1) after rotating it through an angle of 80-100° in the plane of the pad (1).

13. 12. The method according to claim 11, wherein, prior to fastening the longitudinal portion (22) of the elastic strap (2) to the pad (1), a fastening line (28) at a distal portion (27) of the longitudinal portion (22) of the elastic strap (2) to the pad (1) and a distal edge (16) of the pad (1) form an angle of 70-90° with each other.

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