FR2904932A1 - Foot zone i.e. heel, protecting device for e.g. neuropathy or arteriopathy victim diabetic persons, has external layer, whose internal face covers adhesive layer suitable to adhere with skin, where adhesive layer has silicone gel - Google Patents

Abstract

The device (1`) has an external layer (11) made of an elastic elastane polymide tissue and provided with an internal face for covering an adhesive layer (12) suitable to adhere with skin, where the adhesive layer has a silicone gel. A lining layer (13) partially covers an external face of the tissue layer (11) and is made of a polyolefin, where the layer (13) has a microporous membrane. An independent claim is also included for a method for manufacturing a foot zone protecting device.

Description

The present invention relates to a device

  device for protecting a zone of the foot, and in particular a device for protecting the heel. The invention also relates to the maintenance on the foot, and in particular on the heel, of such a protective device. The heel area is subject to significant mechanical stress that is manifested by immediate pathologies such as blisters or by pathologies that develop in the longer term, such as hyperkeratosis leading to the formation of cracks. Foot protection devices are commonly used products. It is for example strips of adhesive elastic fabric or platelets of a few square centimeters in silicone gel, for example a silicone gel composition as described in patent FR 2 712 487, or marketed by the applicant under the Epithelium 26, 27, 28 or 29.

  Such protective devices are designed to relieve pain and protect painful areas of the foot affected by hyperpressions or suffering from skin traumas (blisters, irritations, cracks, plantar warts ...).

  These protective devices also aim to prevent the effects resulting from excessive support or friction. During walking, the foot may be subjected to repeated rubbing with the shoe resulting in the formation of blisters. The wearing of shoes open at the back (clappers) leads by the repeated micro shocks to the formation at the edge of the foot of hyperkeratosis which can be severe and in all the cases very unsightly. In some people, such as diabetics suffering from neuropathies or arterial diseases, it is absolutely vital to protect certain areas of the foot to prevent the formation of lesions. Devices based on adhesive elastic fabric are not very effective in preventing the formation of blisters, especially when friction forces or micro shocks are intense and prolonged.

Hydrocolloid products currently marketed for this purpose are not entirely satisfactory, in particular because they do not improve the distribution of the charge. Moreover, maintaining a protection device on one or more specific areas of the foot is problematic. This maintenance must indeed be permanent, regardless of the type of exercise (walking, running) performed by the person and the duration of this exercise. Indeed, it has been observed that if the protective device 20 is fixed on a plantar area of the foot by a very adhesive part, it tends to slide on one side or the other of the foot, depending on the physiology of the foot after a few hours of walking. The maintenance of such a protective device must still withstand sweating of the foot even if it is excessive. The use of a conventional adhesive deposited on one side of the protective device is often unsatisfactory, and limits the duration and the number of possible uses of the protective device.

To maintain such a protective device on the foot, it is also known to use elastic fabric holding means. However, such holding means generally have seams that are likely to create irritation or injury. The use of such a holding means for maintaining a foot protection device can not therefore meet the needs of persons for whom it is absolutely necessary to avoid the formation of wounds that are slow to heal and that can become infected as they are. diabetics or people who have had surgery. The present invention relates to a protective device covering the back of the foot and in particular the edges of the heel, and capable of absorbing most of the mechanical attacks of repeated support and friction. The invention also relates to a device for protecting the foot, and in particular the heel, having a minimum thickness to be able to be worn with a shoe without inducing additional supports caused by the shoe, and without disturbing the posture of the person as well. good in static than in dynamics. The invention also relates to a heel protection device able to remain in place even after several hours of walking, which can be used for several weeks to be able to treat a keratosis, and therefore that is washable. This objective is achieved by providing a device for protecting a zone of the foot comprising an outer fabric layer comprising an inner face 25 covered with an adhesive layer capable of sticking to the skin. According to one embodiment of the invention, the adhesive layer comprises silicone gel. According to one embodiment of the invention, the outer layer comprises an elastic fabric.

According to one embodiment of the invention, the outer layer comprises a polyamide elastane fabric. According to one embodiment of the invention, the inner layer has a thickness of between 0.2 and 2 mm and preferably substantially equal to 1 mm.

According to one embodiment of the invention, the device has a general X, U or T shape. According to one embodiment of the invention, the device comprises a reinforcing layer partially covering an outer face. of the cloth layer. According to one embodiment of the invention, the reinforcing layer comprises a microporous membrane. According to one embodiment of the invention, the reinforcing layer has an outer face with a low coefficient of friction and a rounded contour. According to one embodiment of the invention, the reinforcing layer has a thickness of between 0.5 and 1 mm, and preferably substantially equal to 0.6 mm. According to one embodiment of the invention, the reinforcing layer is made of polyolefin. According to one embodiment of the invention, the outer and inner layers are generally X-shaped with two shaped indentations formed on opposite edges, and the reinforcing layer has an elongate shape having a rounded contour with a central area. and widened end zones, the central zone being disposed between the V-shaped indentations of the outer and inner layers. According to one embodiment of the invention, an active ingredient is introduced into the inner layer. According to one embodiment of the invention, the active ingredient comprises a keratolytic compound and / or preventing the formation of blisters and / or promoting the regeneration of the skin. The invention also relates to a method of manufacturing a foot zone protection device, comprising a step of assembling an outer fabric layer on an adhesive inner layer 2904932 which is capable of adhering to the skin. According to one embodiment of the invention, the inner layer comprises a silicone gel. According to one embodiment of the invention, the assembly of the outer and inner layers is performed by gluing. According to one embodiment of the invention, the outer layer comprises an elastic fabric. According to one embodiment of the invention, the outer layer comprises a polyamide elastane fabric. According to one embodiment of the invention, the inner layer has a thickness of between 0.2 and 2 mm and preferably substantially equal to 1 mm. According to one embodiment of the invention, the method comprises a step of assembling a reinforcing layer on an outer face of the outer layer. According to one embodiment of the invention, the reinforcing layer is assembled on the outer layer by gluing or by ultrasonic welding.

According to one embodiment of the invention, the reinforcing layer comprises a microporous membrane. According to one embodiment of the invention, the reinforcing layer has an outer face with a low coefficient of friction and a rounded contour.

According to one embodiment of the invention, the reinforcing layer has a thickness of between 0.5 and 1 mm, and preferably substantially equal to 0.6 mm. According to one embodiment of the invention, the method comprises steps of cutting the outer and inner layers into a generally X-shaped shape with two V-shaped indentations formed on opposite edges, and cutting of the reinforcing layer. following an elongated rounded contour with a central zone 35 and enlarged end zones, the central zone being disposed between the indentations of the outer and inner layers. According to one embodiment of the invention, the method comprises a step of introducing an active ingredient into the inner layer. According to one embodiment of the invention, the active ingredient comprises a keratolytic compound and / or preventing the formation of blisters and / or promoting the regeneration of the skin.

These and other objects, features, and advantages of the present invention will be set forth in greater detail in the following description of an embodiment of the invention, given as a non-limiting example in connection with the accompanying figures, among which: FIG. 1 is a sectional view of a protection device according to one embodiment of the invention; FIGS. 2A, 2B, 2C show, in front view, various possible forms of the protective device represented on the FIG. FIG. 3 is a sectional view of another embodiment of the protective device according to the invention; FIG. 4 is a view of an external face of the protective device represented in FIG. 3; - Figure 5 shows a foot on which is disposed the protection device according to one embodiment of the invention. Figure 1 shows a device 30 for protecting the heel 1 according to one embodiment of the invention. The device 1 comprises an outer layer 11 of fabric, and an inner layer 12 of an adhesive silicone gel having a certain elasticity. The two layers are joined together preferably by an adhesive.

The outer layer 11 has elasticity both along the axis of the yarns and the weft of the fabric. The inner layer 12 preferably has equivalent resilience in all directions so that the protection device can be adapted without forming folds on the heel by covering the heel edge. The inner layer 12 is preferably made of a silicone gel composition as described in patent FR 2 712 487, or sold by the applicant under the name Epithelium 26, 27, 28 or 29. These are materials which differ from each other by their adhesiveness or their hardness. The more adhesive material, the softer it is. However, the harder the material, the more it is able to distribute the charges. The softer and therefore adhesive it is, the more it absorbs the shear forces resulting from friction of the foot in the shoe. Thanks to its high adhesiveness, it prevents the friction energy from reaching the skin. The inner layer 12 has a thickness of between 0.2 and 2 mm, and preferably substantially equal to 1 mm. The outer layer 11 is preferably made of a polyamide elastane fabric. The materials (fabric, silicone gel) constituting the two layers 11, 12 are washable. It turns out that the washing of the silicone gel does not reduce its adhesiveness. The protection device therefore has the advantage of being reusable. In FIGS. 2A, 2B, 2C, the protection device may have different shapes to protect the bead and in particular to cover the bead edge. Thus, the protection device shown in FIG. 2A has a generally X-shaped shape with two rounded indentations 3, 4 formed on opposite edges, and two V-shaped indentations 5, 6 formed on two other opposite edges. The area between the two notches 5, 6 is intended to cover the edge of the heel. A part of the device having one of the rounded notches 3, 4 is intended to cover the underside of the heel, while another part with the other of the rounded indentations 3, 4 covers the back of the heel along the Achilles' tendon. The yarns of the fabric and the weft are preferably arranged parallel to axes respectively connecting the notches 3 to 4 and 5 to 6. The protection device 1b shown in FIG. 2B has the shape of a T. The part corresponding to FIG. the horizontal leg of the T is intended to cover the edge of the heel, while the portion 15 corresponding to the vertical leg of the T covers the rear zone of the heel along the Achilles tendon. The protective device shown in FIG. 2C has a generally U-shaped shape. The part of the device corresponding to the base of the U is intended to cover the heel ridge and the Achilles heel zone, while the parts corresponding to the branches of the U cover peripheral areas of the underside of the heel. However, in use, the device tends to not remain in place during an extended walk, whatever the sock or shoe used. Although completely washable, the device also has insufficient life when subjected to repeated shear stresses (in the plane of layers 11, 12).

According to one embodiment of the invention, illustrated in FIGS. 3 and 4, the protective device 1 'further comprises a reinforcing layer 13 at least partially covering the external face of the outer layer 11 on which it is fixed. .

The material constituting the layer 13 is preferably chosen to be of small thickness while having a good mechanical strength. The outer surface of the layer 13 is preferably smooth (low coefficient of friction) so that the shear stresses are at least partially absorbed by slipping of the sock on the layer 13. The material constituting the outer layer is also chosen preferably washable.

Advantageously, the material constituting the layer 13 chosen is a microporous polyolefin membrane. Preferably, this material is a microporous polyethylene whose thickness is between 0.5 and 1 mm, preferably substantially equal to 0.6 mm.

As shown in FIG. 4, the layer 13 is fitted on layers 11, 12 having the X-shape shown in FIG. 2A. The layer 13 has an elongated shape with a rounded contour. The layer 13 comprises two end zones 14a, 14b and an enlarged central zone 15. The central zone 15 is disposed between the V-shaped indentations 5, 6, while the end zones 14a, 14b are each arranged in the vicinity of a notch 3, 4. The shape of the layer 13 is chosen so its exposed surface is maximum relative to the surface of the layers 11 and 12, without hindering the possibility of elastic deployment of the layers 11, 12 to allow adjustment of the protective device on the foot without forming folds. The shape of the reinforcing layer 13 is also chosen so as not to present sharp angles likely to cling to the sock during the establishment of the latter. The reinforcing layer 13 is fixed to the fabric layer 11, for example by gluing or ultrasonic welding.

Figure 5 illustrates the placement of the protection device 1 'on the heel. The layers 11, 12 completely cover the underside of the heel, the back heel area along the Achilles heel, and the lateral heel portions on either side of the Achilles tendon. The reinforcing layer 13 protects the heel ridge, a portion of the underside of the heel and the Achilles tendon area. The part of the protective device that partially covers the area of the Achilles tendon may be larger or smaller depending on whether it is desired to protect this zone or not, especially against the formation of ampoules. According to another embodiment of the invention, the absorbent properties of the silicone gel are used to gradually diffuse active principles to the skin. Thus, keratolytic active ingredients, such as methyl salicylate and / or vitamin A, can be introduced into the silicone gel inner layer 12 in suitable proportions. Other active ingredients such as products preventing the formation of blisters or promoting healing and regeneration of the skin can also be inserted into the layer 12. Because of its strong occlusive power (sealing), the protective device is extremely hydrating, which promotes the action of keratolytic active ingredients. The protection device is also extremely effective in preventing the formation of blisters because of its ability to absorb friction and thus to avoid any rubbing motion on the surface of the skin. It is especially effective in inhibiting the mechanism of hyperkeratosis formation and in allowing rapid disappearance of horn produced in excess and thus corresponding crevices. It has been commonly observed that wearing the protective device for two weeks is sufficient to obtain an excellent result. It will be apparent to those skilled in the art that the present invention is susceptible to various embodiments and applications. In particular, the invention is not limited to the protection of the heel. It more generally applies to the protection of an area of the foot, in particular exposed to repeated rubbing with the shoe. The outer layer is not necessarily elastic. Indeed, some areas of the foot have a simple shape that can be covered without resorting to the elasticity of the protective device. 15 10 25

Claims (28)

  1. Device for protecting a zone of the foot comprising an outer fabric layer (11) comprising an inner face covered with an adhesive layer (12) capable of sticking to the skin, characterized in that the adhesive layer (12) includes silicone gel.   2. Device according to claim 1, wherein the outer layer (11) comprises an elastic fabric.   3. Device according to claim 2, wherein the outer layer (11) comprises a polyamide elastane fabric. 15   4. Device according to one of claims 1 to 3, wherein the inner layer (12) has a thickness of between 0.2 and 2 mm and preferably substantially equal to 1 mm. 20   5. Device according to one of claims 1 to 4, having a general shape in X.   6. Device according to one of claims 1 to 4, having a generally U-shaped.   7. Device according to one of claims 1 to 4, having a general shape T.   8. Device according to one of claims 1 to 7, 30 comprising a reinforcing layer (13) partially covering an outer face of the fabric layer (11). 12 2904932 13   9. Device according to claim 8, wherein the reinforcing layer (13) comprises a microporous membrane. 5   10. Device according to claim 8 or 9, wherein the reinforcing layer (13) has an outer face with a low coefficient of friction and a rounded contour.   11. Device according to one of claims 8 to 10, wherein the reinforcing layer (13) has a thickness between 0.5 and 1 mm, and preferably substantially equal to 0.6 mm.   12. Device according to one of claims 8 to 11, wherein the reinforcing layer (13) is polyolefin.   13. Device according to one of claims 8 to 12, wherein the outer and inner layers (11, 12) have a general shape X with two shaped notches (5, 6) formed on opposite edges, and the layer reinforcement (13) has an elongate shape having a rounded contour with a central zone (15) and enlarged end zones (14a, 14b), the central zone (15) being disposed between the V-shaped notches of the layers external and internal.   14. Device according to one of claims 1 to 13, wherein an active ingredient is introduced into the inner layer (12).   15. The device of claim 14, wherein the active ingredient comprises a keratolytic compound and / or preventing the formation of blisters and / or promoting the regeneration of the skin.   16. A method of manufacturing a foot zone protection device, comprising a step of assembling an outer fabric layer (11) on an adhesive inner layer (12) capable of adhering to the skin. characterized in that the inner layer (12) comprises a silicone gel.   17. The method of claim 16, wherein the assembly of the outer and inner layers (11, 12) is performed by gluing.   The method of claim 16 or 17, wherein the outer layer (11) comprises an elastic fabric. 20   The method of claim 18, wherein the outer layer (11) comprises a polyamide elastane fabric.   20. Method according to one of claims 16 to 19, 25 wherein the inner layer (12) has a thickness of between 0.2 and 2 mm and preferably substantially equal to 1 mm.   21. Method according to one of claims 16 to 20, 30 comprising a step of assembling a reinforcing layer (13) on an outer face of the outer layer (11).   22. The method of claim 21, wherein the backing layer (13) is bonded to the outer layer (11) by gluing or ultrasonic welding. 2904932 15   23. The method of claim 21 or 22, wherein the backing layer (13) comprises a microporous membrane.   24. Method according to one of claims 21 to 23, wherein the reinforcing layer (13) has an outer face with a low coefficient of friction and a rounded contour.   25. Method according to one of claims 21 to 24, wherein the reinforcing layer (13) has a thickness between 0.5 and 1 mm, and preferably substantially equal to 0.6 mm. 15   26. A method according to one of claims 21 to 25, comprising steps of cutting the outer and inner layers (11, 12) into a generally X-shaped shape with two V-shaped indentations (5, 6) formed on opposing edges, and cutting the reinforcing layer (13) in a rounded contour of elongated shape with a central zone (15) and enlarged end zones (14a, 14b), the central zone (15) being arranged between the indentations of the outer and inner layers. 25   27. Method according to one of claims 16 to 26, comprising a step of introducing an active ingredient into the inner layer (12).   28. The method of claim 27, wherein the active ingredient comprises a keratolytic compound and / or preventing the formation of blisters and / or promoting the regeneration of the skin. 5 1035