FR3140538A1 - Protective device - Google Patents

Abstract

Protection device (1), comprising at least one protection means (2), said protection means (2) comprising at least one active. Figure to be published with the abstract: Fig. 1

Description

Protective device

The present invention belongs to the technical field of medical devices. More precisely, it belongs to the technical field of medical devices comprising active ingredients.

In the context of this description, an interval described by the expression “between […] and […]” includes the limits. For example, the interval “between 1 and 2” includes the two values “1” and “2” as well as all values being both strictly greater than 1 and strictly less than 2.

In the context of this description, the term “approximately” preceding a numerical value means that the value can be modified by plus or minus 10%. In the particular case of a digital value being an interval limit, the term "approximately" means that the lower limit can be reduced by 10% or the upper limit can be increased by 10%. It is also possible to delete the term “approximately” preceding a numerical value.

The foot can be affected by many pathologies.

Hallux valgus, otherwise known as a “bunion” on the foot, is an outward deviation of the big toe. It is favored by several factors (heredity, age, wearing high-heeled shoes, etc.) and is often painful when the deformation becomes significant. In practice, the protruding deformed area rubs into the shoe and calluses develop. Ultimately, this friction can create inflammation of the covering of the metatarsophalangeal joint, this inflammation is called “bursitis”. The deformation tends to gradually worsen, the bursitis grows and the foot then becomes completely deformed, due to the correction that the patient practices in favor of support on the other toes. Calluses appear on the sole of the foot and corns on the side toes. In France, hallux valgus is extremely common, and affects 30% of the population aged over 65 and 2% of children under 15. Surgical treatment can be considered, the latter is very invasive and very painful.

Partridge's eyes are hyperkeratoses which appear in areas of the foot subject to excessive friction which may be due to abnormal support when walking. They consist of a core that is very sensitive to pressure. Their occurrence can be reduced by foot care, wearing comfortable and well-fitting shoes, wearing comfortable socks, orthopedic insoles, etc.

Other conditions should also be noted, such as calluses, damaged nails, ingrown nails, corns, metatarsalgia, Morton's neuroma, sesamoiditis, calcaneus, Achilles tendinitis, plantar warts, scars, areas prone to excessive plantar support, deformation of the midfoot or toes, claw toe, hammer toe, plantar aponeurosis, heel pain, etc.

These pathologies have the common point of causing skin or nail lesions on areas, also called “lesional areas” of the skin or nails.

These lesional areas are very difficult to treat over time, because the cause of these lesions (rubbing in a static or dynamic position, shoes, compression of the foot, etc.) is often present continuously.

Certain pathologies such as obesity also worsen the condition of these lesional areas.

There is a need for care regarding these lesional areas.

Paradoxically, in the prior art, many orthotic devices are used.

For example, to correct hallux valgus, it may be appropriate to use an orthosis with strong mechanical correction. These orthoses do not protect or treat the skin lesion area located on the side of the foot; on the contrary, in practice they aggravate friction, and therefore lesions.

In the context of this application, the term “lesional zone” means an area subject to plantar conditions, whether these are actually present or not. Protection of an injured area can therefore be preventive or curative.

Such an orthosis is presented in application US20190133803 in the name of FURUKAWA TECHNO MATERIAL. Its aim is to correct hallux valgus through strong mechanical stress. This type of solution perfectly illustrates the practice of correcting hallux valgus, even if it means aggravating friction and the condition of the corresponding skin lesion area.

Furthermore, sticky layers based on silicone and comprising active ingredients as well as compatibilizing agents are disclosed in patent FR2879931 in the name of BRUNET.

Finally, in application FR3103699 in the name of THUASNE, a corrective orthosis comprising active ingredients is disclosed. This device, like that disclosed in the aforementioned application US20190133803, creates significant friction and thus worsens the condition of the corresponding lesional areas.

Surprisingly, it has been demonstrated by the applicant that the use, within a protection device 1, of at least one means of protection 2 loaded with active ingredient(s) makes it possible to treat lesions very effectively. skin or nails specific to the foot P, and/or to prevent the occurrence of such lesions, through a physical protection action associated with the delivery of specific active ingredients.

The dual action of mechanical and pharmacological/cosmetic protection is crucial, and allows the patient to benefit from a very high degree of comfort. This dual action seems to be potentiated by the fact that the mechanical protection allows relative confinement of the active ingredient(s), which are therefore fully effective on the lesion area.

This is all the more surprising since it has also been demonstrated that despite the absence of mechanical restraint due to the protection device 1, the active ingredients are actually delivered to the lesion area, which is very surprising. The actives may also be released to an increased extent during certain foot movements causing increased pressure. Thus, the protection device 1 releases the at least one active ingredient continuously, at a variable intensity depending on the mechanical interactions with the surrounding lesion area. This is particularly advantageous, because the at least one active ingredient is released in large quantities when friction likely to affect the lesion area is particularly present.

The invention thus relates to a protection device 1, comprising at least one protection means 2, said protection means 2 comprising at least one active.

In one embodiment, said device 1 is a device for protecting a lesional area. In one embodiment, said device 1 is a device for protecting an injured area of the foot P.

The use, by a patient, of a protective device 1 according to the invention will provide him with maximized comfort, in particular due to an absence of mechanical restraint, as well as relief from his skin and/or nail lesions due in particular protection at the level of skin and/or nail lesions, while allowing him to wear shoes as he wishes. Furthermore, in one embodiment, the device 1 has a shape matching an area of the foot which includes at least one lesion area.

In one embodiment, in particular when the shape of the protective device 1 depends on the foot (right or left) on which it will be placed, said protective device 1 can be turned over and is thus applicable to use on the right or left foot. LEFT. This embodiment corresponds in particular to the embodiments presented in Figures 2, 3, 4 and 5.

In addition, the reduced size of the protective device 1 according to the invention allows its insertion into all types of shoes.

Finally, the protection device 1 makes it possible, via the protection means 2, to protect all painful, inflamed lesional areas subject to friction, pressure, friction or pressure which may be linked to an external material such as a shoe, seams, or related to deformity of the fingers, toes, foot or hand.

In the context of this description, “protection” refers to the treatment of a lesional area or the prevention of the appearance of such a lesional area. The lesional areas more specifically targeted are those due to skin and/or nail lesions.

In one embodiment, the protection therefore consists of treatment of at least one skin and/or nail lesion area, and/or prevention of the formation of at least one skin and/or nail lesion area.

In one embodiment, the protection consists of treatment of skin and/or nail lesions, or in preventing the occurrence of skin and/or nail lesions.

In a preferred embodiment, the lesional area concerned is located on the foot P. Indeed, the foot P is an area naturally very affected by skin and/or nail lesions.

In one embodiment, the protection device 1 is capable of being placed on an area of the foot P. In one embodiment, the protection device 1 is a foot device P.

In one embodiment, the protection device 1 has a shape corresponding to a zone of the foot P. In one embodiment, the protection device 1 has a shape corresponding to a zone of the foot P including at least a part of at least one toe.

In one embodiment, the protective device 1 does not include any adhesive. In one embodiment, the protective device 1 does not include any adhesive on its external part. In one embodiment, the protective device 1 does not include any adhesive intended to be brought into contact with the skin and/or the nail.

In one embodiment, the protection device 1 is capable of placing at least one means of protection 2 on an injured area of the foot P.

In one embodiment, the lesion zone is chosen from the group consisting of the dorsal zone of the secondus (use of a device as presented in ), from the lateral edge of M1 (use of a device as presented in ), of the metatarsal paddle (use of a device as presented in ), of the metatarsophalangeal joint (use of a device as presented in ), the sesamoid (use of a device as presented in ), of the interphalangeal joint (use of a device as presented in ), the pulp of the hallux = big toe (use of a device as presented in ), the pulp of the secondus (use of a device as presented in ), the pulp of the tertius (use of a device as presented in ), the pulp of the quartus (use of a device as presented in ), quintus pulp (use of a device as presented in ) and the nail (use of a device as presented in ).

In one embodiment, the lesion area is chosen from the group consisting of the dorsal area of the secondus, the lateral edge of M1, the metatarsal paddle, the metatarsophalangeal joint, the sesamoid, the interphalangeal joint, of the pulp of the hallux, of the pulp of the secondus, of the pulp of the tertius, of the pulp of the quartus, of the pulp of quintus and of the nail.

In one embodiment, the lesional area is chosen from the group consisting of the dorsal area of the secondus, the pulp of the hallux, the pulp of the secondus, the pulp of the tertius, the pulp of the quartus, the quintus pulp and nail.

In one embodiment, the lesion area is chosen from the group consisting of the lateral edge of M1, the metatarsal paddle, the metatarsophalangeal joint, the sesamoid and the interphalangeal joint.

In one embodiment, the means of protection 1 has a shape chosen from the group consisting of comfort insoles, sleeves (see ), sleeves closed at one end or “caps” (see ), protective cushions for the metatarsal paddle (see ), mitts to protect the side edge of M1 (see ) and the metatarsophalangeal joint.

In one embodiment, the protection device 1 is a comfort insole comprising at least one protection means 2.

In one embodiment, the protection device 1 is a comfort insole comprising at least one protection means 2 located on a support zone, preferably chosen from the group consisting of the heel support zone, the metatarsal support area and the support area of the big toe.

In one embodiment, the protection device 1 is a comfort insole made up of said protection means 2.

When the protective device 1 is a comfort insole, it may comprise an upper layer of protection secured to said means of protection. Preferably, this upper protective layer is made of textile, preferably the textile comprises polyester. This embodiment is preferred, because the textile makes it possible to reduce the wear of the protective device 1 being a comfort insole.

In one embodiment, the protection means 1 has a shape chosen from the group consisting of sleeves and sleeves closed at one end.

In one embodiment, the protective device 1 is a sleeve of a zone of the foot P chosen from the group consisting of the hallux, the secundus, the tertius, the quartus of the quintus and the metatarsus. Such embodiments are presented in .

When the protective device 1 is intended to be placed on a toe, its shape will be chosen from the group of sleeves (as presented in ) and sleeves closed at one end (as presented in ), the latter can also be called “caps”. Sleeves closed at one end will be preferred, as they allow total coverage of the toe.

In one embodiment, the protection device 1 comprises, in addition to the at least one protection means 2, a holding means 3. The purpose of this holding means 3 is to arrange the protection means(s) at the level of the areas of skin and/or nail lesions.

In one embodiment, said holding means 3 is permeable to gases and air, it can for example comprise woven or non-woven textile. Indeed, it may be advisable not to confine certain lesion areas too much, and the textile is breathable.

In one embodiment, said holding means 3 has an elasticity of 36 newtons in the chain direction of between approximately 10% and approximately 30%, preferably between approximately 10% and approximately 20%, preferably between approximately 15%. and about 20%.

In one embodiment, said holding means 3 has an elasticity of 36 newtons in the weft direction of between approximately 100% and approximately 250%, preferably between approximately 130% and approximately 210%, preferably between approximately 150%. and approximately 200%, preferably between approximately 160% and approximately 180%.

In one embodiment, said textile holding means 3 comprises polyamide and elastane.

In one embodiment, said textile holding means 3 comprises polyamide and elastane, in respective proportions of 30-60% and 40-70% by mass, relative to the total mass of said textile.

In one embodiment, said textile holding means 3 comprises polyamide and elastane, in respective proportions of 35-55% and 45-65% by mass, relative to the total mass of said textile.

In one embodiment, said textile holding means 3 comprises polyamide and elastane, in respective proportions of 40-50% and 50-60% by mass, relative to the total mass of said textile.

In one embodiment, the textile used comprises approximately 45% polyamide and approximately 55% elastane by mass, relative to the total mass of said textile, and has an elasticity at 36 newtons in the weft direction of between approximately 160% and approximately 180% as well as an elasticity at 36 newtons in the chain direction of between approximately 15% and approximately 20%.

In one embodiment, said textile is specifically designed to allow perspiration and the active ingredients of the means of protection 2 to pass through.

In one embodiment, said textile is made of polyester. This textile is both flexible and resistant.

In one embodiment, the protective device 1 has the shape of a sleeve, and said protective device comprises a holding means 3, preferably textile, corresponding to the outer layer, as well as a protective means 2 corresponding to the inner layer. In this embodiment, the protection means 2 is in direct contact with the skin. In this embodiment, the thickness of the protection device, including the holding means 3 and the protection means 2, is between approximately 2 mm and approximately 6 mm, preferably between approximately 3 mm and approximately 5 mm, preferably between approximately 3.5 mm and approximately 4.5 mm. Such an embodiment is presented in .

In one embodiment, the protection device 1 consists of the protection means 2. Such an embodiment is presented in .

In one embodiment, the protection device 1 has the shape of a sleeve closed at one end, and said protection device 1 consists of said protection means 2. Such an embodiment is presented in .

In one embodiment, the protection device 1 is made of a single material.

In one embodiment, the protection means 2 has a thickness of between approximately 0.1 mm and approximately 10 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.3 mm and approximately 6 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.5 mm and approximately 5 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.7 mm and approximately 5 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.7 mm and approximately 4 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.7 mm and approximately 3 mm.

In one embodiment, the thickness of said protection means 2 is between approximately 0.7 mm and approximately 2 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 0.5 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 0.7 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 0.8 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 0.9 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 1 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 1.5 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 2 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 2.5 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 3 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 3.5 mm.

In one embodiment, the thickness of said protection means 2 is greater than approximately 4 mm.

In one embodiment, in areas not provided with protection means, the thickness of the protection device 1, which corresponds to the thickness of the holding means 3, is between approximately 0.01 mm and approximately 1 mm , preferably between approximately 0.1 mm and approximately 0.5 mm.

In one embodiment, said means of protection 2 comprising at least one active ingredient is in the form of a membrane, preferably in the form of a gel membrane.

In one embodiment, said protection means 2 is detachable, because placed in a pocket of the holding means 3 of the protection device 1. This is advantageous because the protection means can, in this case, be washed with water cold and with soap. In one embodiment, the protection means 2 is secured to the holding means 3. In one embodiment, the protection means 2 is included within the holding means 3. In one embodiment, the protection means 2 is included within the holding means 3 and is secured to said holding means 3.

In one embodiment, said protection means 2 is washable separately.

In one embodiment, said protection means 2 is linked to the holding means 3. It may for example be a holding means 3 in the form of a closed pocket, preferably made of textile, and comprising said means of protection 2.

It should be noted that in the context of these embodiments, the active ingredients diffuse through the holding means 3, preferably through the textile of the holding means 3.

In one embodiment, said device comprises a single protection means 2.

In one embodiment, said device comprises several means of protection.

In one embodiment, the area of the protection means(s) 2 is between approximately 10% and approximately 100% of the total area of said protection device 1.

In one embodiment, the protection means 2 is configured so that in operation, it comprises at least one portion covering and/or surrounding, totally or at least partially, in particular at least approximately 50%, more particularly at least approximately 80%, or even approximately 100% of the area of a lesion zone.

In one embodiment, the area of the protection means(s) 2 is between approximately 25 square centimeters and approximately 100 square centimeters.

In one embodiment, the area of the protection means(s) 2 is between approximately 50 square centimeters and approximately 75 square centimeters.

In one embodiment, the area of the protection means 2 is less than approximately 100 square centimeters.

In one embodiment, the area of the protection means 2 is less than approximately 70 square centimeters.

In one embodiment, the area of the protection device 1 is between approximately 50 square centimeters and approximately 200 square centimeters.

In one embodiment, the area of the protection device 1 is between approximately 100 square centimeters and approximately 150 square centimeters.

In one embodiment, the area of the protection device 1 is less than approximately 200 square centimeters.

In one embodiment, the area of the protection device 1 is less than approximately 100 square centimeters.

In one embodiment, the protection device 1 comprises a protection means 2. In one embodiment, the protection device 1 comprises two protection means 2. In one embodiment, the protection device 1 comprises three means protection 2. In one embodiment, the protection device 1 comprises four protection means 2.

In one embodiment, said protection means 2 is a polymer matrix.

In one embodiment, said protection means 2 consists of a silicone elastomer and said active ingredient(s).

In one embodiment, the polymer matrix comprises at least one silicone polymer as well as said active ingredient(s). It may also consist of such compounds.

If the polymerization can be carried out at room temperature, heat will preferably be used to accelerate the reactions and optimize the mechanical performance.

Preferably, the silicone polymer matrix is based on a silicone elastomer or several mixed silicone elastomers.

Preferably, the polymer matrix is composed of several components A and B.

Preferably, component A comprises at least one polyorganosiloxane, preferably of the polydimethylsiloxane type, comprising one or more alkenyl terminus unit(s), more preferably one or more alkenyl terminus unit(s). al) (to) vinyl(s).

Preferably, component B comprises at least one polyorganosiloxane, preferably of the polydimethylsiloxane type, comprising one or more hydrogenosilane terminal unit(s).

In one embodiment, the polymeric matrix does not include an agent for solubilizing the at least one active ingredient. This is advantageous because it limits the number of compounds present in the matrix, and it also simplifies the process of preparing said protective means 2.

The protective device 1 according to the invention is distinguished in particular from orthoses by the fact:

- that it is elastic; and or

- that it does not cause mechanical restraint; and or

- that it is not corrector; and or

- that it is non-compressive; and or

- that it does not include any rigid insert.

As a reminder, an orthosis is defined as being a device configured to supplement or correct a deficient function, particularly joint and/or muscular, and/or compensate for limitations or even increase the physiological performance of an organ or limb which has lost its function temporarily or permanently. Orthotics always have a real action of transmitting forces to particular areas of the body;

- that it comprises a holding means 3 solely intended to place the at least one means of protection in front of a lesional area.

The protective device 1 according to the invention is not an orthosis.

The protection device does not exhibit any significant mechanical action. However, very surprisingly, it was demonstrated that the active ingredients present within the protection means 2 were effectively transmitted to the skin, including through the holding means 3 when it is present between the skin and the means of protection 2, without the need for mechanical restraint. The actives may also be released to an increased extent during certain foot movements causing increased pressure. Thus, the protection device 1 is active continuously, at a variable intensity depending on the mechanical interactions with the surrounding lesion area.

In one embodiment, the at least one active ingredient is intended to be diffused towards the lesion area concerned.

In one embodiment, the at least one asset is included in the mass of the protection means 2.

In one embodiment, the at least one active ingredient is capable of diffusion from the protection means 2. For example, when the protection means 2 consists of a reticulated matrix, this matrix forms a static phase, whereas the At least one active ingredient forms a mobile phase, gradually diffusing towards the patient's skin.

In one embodiment, the protection means 2 comprises a static phase as well as a mobile phase. In one embodiment, the protection means 2 comprises a static phase as well as a mobile phase, and the at least one active is included in the mobile phase.

In one embodiment, the at least one active ingredient can be included in a liquid formulation at room temperature (20°C), said formulation being disposable within said means of protection 2.

In one embodiment, the at least one active ingredient is hydrophilic.

In one embodiment, the at least one active ingredient is lipophilic. This embodiment is preferred, because the lipophilic active ingredients have better compatibility with the skin and with the material of the protective means 2.

In one embodiment, said protection means 2 comprises an active.

In one embodiment, said protection means 2 comprises two assets.

In one embodiment, said protection means 2 comprises three assets. This embodiment is preferred, because the use of several active ingredients is advantageous, and allows the patient to benefit from a wide spectrum of properties.

In one embodiment, the at least one active ingredient is chosen from the group consisting of antifungals (amphotericin, itraconazole, fluconazole, etc.), anti-inflammatories (ibuprofen, aspirin, diclofenac, etc.), soothing agents, analgesics. , nourishers, emollients, refreshers, softeners, purifiers, fortifiers and repairers.

In one embodiment, the at least one active ingredient is chosen from the group consisting of antifungals, anti-inflammatories, soothing agents, analgesics, nourishing agents, emollients, refreshing agents, softeners, purifiers, fortifiers, healing, growth activators, purifying, keratolizing, restructuring, protective and repairing.

In one embodiment, said at least one active ingredient is chosen from the group consisting of honey extracts and polyphenols.

In one embodiment, said honey extract is propolis, preferably black propolis, preferably Cévennes propolis. This active ingredient is very advantageous in the context of the present invention, in particular because of its antioxidant activity.

In one embodiment, said at least one active device 1 is chosen from the group consisting of antifungal, antibacterial, antiviral, repairing, purifying, nourishing, regenerating active ingredients such as tea tree, lemon, aloe vera, geranium, arnica, St. John's wort, evening primrose, castor oil, or any other medicinal plant with these properties.

In one embodiment, at least one active ingredient is a cosmetic active ingredient.

In one embodiment, at least one active ingredient is a pharmaceutical active ingredient.

In one embodiment, said at least one active ingredient is chosen from the group consisting of medicinal plant extracts, vegetable oils, plant extracts and essential oils.

In one embodiment, the at least one active ingredient is chosen from the group consisting of essential oils, vegetable oils, or mixtures of the latter.

In one embodiment, the at least one active ingredient is chosen from the group consisting of plant extracts.

In one embodiment, the at least one active ingredient is chosen from the group consisting of plant extracts chosen from the group consisting of the genera Arnica , Aloe and Melaleuca .

In one embodiment, said means of protection 2 comprises three active ingredients, one of which comes from the Arnica genus, one comes from the Aloe genus and one comes from the Melaleuca genus.

In one embodiment, the at least one active ingredient is chosen from the group consisting of plant extracts chosen from the group consisting of the species Arnica montana , Aloe barbadensis and Melaleuca alternifolia .

In one embodiment, said means of protection 2 comprises three active ingredients, one of which comes from Arnica montana , one comes from Aloe barbadensis and one comes from Melaleuca alternifolia .

In one embodiment, the at least one active ingredient is chosen from the group consisting of active ingredients having for INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

In one embodiment, said means of protection 2 comprises the active ingredients having the INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

In one embodiment, the at least one means of protection 2 comprises at least one active ingredient chosen from the group consisting of active ingredients having INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

In one embodiment, the at least one means of protection 2 comprises at least two active ingredients chosen from the group consisting of active ingredients having for INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

In one embodiment, the at least one means of protection 2 comprises the three active ingredients having for INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

In one embodiment, the asset(s) is/are encapsulated.

In one embodiment, the active ingredient(s) is/are included in a liposome.

In one embodiment, the active ingredient(s) each have a mass concentration (m/m) of between approximately 0.5% and approximately 2% by mass, relative to the total mass of said means of protection 2.

In one embodiment, the active ingredient(s) each have a mass concentration (m/m) of between approximately 0.5% and approximately 1.5% by mass, relative to the total mass of said means of protection 2 .

In one embodiment, the at least one means of protection 2 comprises the three active ingredients having for INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT each having a mass concentration (m/m) between approximately 0, 5% and approximately 2% by mass, relative to the total mass of said means of protection 2.

In one embodiment, the at least one means of protection 2 comprises the three active ingredients having for INCI MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT each having a mass concentration (m/m) between approximately 0, 5% and approximately 1.5% by mass, relative to the total mass of said means of protection 2.

In one embodiment, said device is in the shape of a sleeve. This device is suitable for placement on a toe. In this particular embodiment, the protection device 1 is located on the internal face, facing the skin, while the holding means 3 is located on the external face of the device 1. Indeed, given that the entire surface of the toe potentially corresponds to an area of injury, it is appropriate for the means of protection 2 to completely cover the toe. Such an embodiment is presented in .

In one embodiment, the protection device 1 has a protection means 2 located at the lateral edge of M1, that is to say the lesion zone corresponding to the hallux valgus, as well as a holding means 3. Such an embodiment is presented in .

In one embodiment, the protective device 1 has a part in the form of a protective cushion for the metatarsal paddle 2, as well as a band as part of the holding means 3. This protective cushion for the metatarsal paddle is adapted to the palm of the foot P, and said strip is in contact with the upper part of the foot P and is able to support the cushion. Such an embodiment is presented in .

In one embodiment, the protection device 1 has a protection means 2 intended to be placed at the level of the metatarsophalangeal joint, as well as a holding means 3. Such an embodiment is presented in .

In one embodiment, said device is in the form of a cap. This device is suitable for placement on a toe, preferably the big toe, also called “hallux”. In this particular embodiment, it is advantageous to provide that the protection device 1 consists of said protection means 2. Indeed, given that the entire surface of the toe is an area to be protected from skin and nail lesions, it is appropriate for the means of protection 2 to completely cover the toe. Such an embodiment is presented in .

The invention also relates to a method of manufacturing a protection device 1 according to the invention, comprising the following steps:

Step A: obtaining the holding means 3 if a holding means is provided;

Step A’: preparation of a means of protection 2;

- mix at least one silicone polymer with the at least one active ingredient to form a mixture;

- mold the mixture and crosslink said at least one silicone polymer

Step B: associate the protection means 2 with the holding means 3 when a holding means 3 is provided.

Steps A and A’ can be performed in any order or simultaneously.

Preferably, during the crosslinking step, the mixture is heated to a temperature above approximately 60°C. This allows optimization of mechanical properties.

Preferably, the silicone polymer is selected from silicones that can be polymerized at room temperature, preferably chosen from silicone elastomers that can be vulcanized at room temperature (also called “RTV”).

The invention also relates to uses of the protection device 1 according to the invention.

The invention relates to the use of a protective device 1 according to the invention in the treatment or prevention of skin and/or nail lesions, preferably of the foot P.

The invention relates to the use of a protective device 1 according to the invention in the treatment or prevention of skin and/or nail lesions during a period of between 6 and 20 weeks, preferably between 6 and 12 weeks. At least one asset is released throughout this period.

In one embodiment, the lesion zone is a skin lesion zone.

In one embodiment, the lesion zone is a nail lesion zone.

In one embodiment, the lesional area is chosen from the group consisting of areas of friction due to hallux valgus, corns, calluses, partridge's eyes and damaged nails.

In one embodiment, the lesional area is chosen from the group consisting of areas of friction due to hallux valgus, corns, calluses, redness, calluses and bird's-eyes.

In one embodiment, the lesional area is chosen from the group consisting of calluses, damaged nails, ingrown nails, corns, metatarsalgia, Morton's neuroma, sesamoiditis, calcaneal tendonitis, Achilles tendinitis, plantar warts, scars, areas prone to excessive plantar support, deformation of the midfoot or toes, toe claw, hammer toe, plantar aponeurosis, heel pain, etc.

In one embodiment, the lesional area is a damaged nail.

In one embodiment, the lesion area is chosen from the group consisting of the dorsal area of the secondus, the lateral edge of M1, the metatarsal paddle, the metatarsophalangeal joint, the sesamoid, the interphalangeal joint, of the pulp of the hallux, of the pulp of the secondus, of the pulp of the tertius, of the pulp of the quartus, of the pulp of quintus and of the nail.

The invention relates to the use of a protective device 1 according to the invention to relieve pain.

The invention relates to the use of a protective device 1 according to the invention to relieve inflammation.

The invention concerns the use of a protective device 1 according to the invention to soothe, nourish, protect against dehydration, purify, eliminate viruses, bacteria and/or fungi.

The invention relates to the use of a protective device 1 according to the invention to prevent calluses, eliminate calluses, soften, care for, treat, repair, relieve.

The invention also relates to a protection device 1 according to the invention intended to be used in all the uses mentioned within the present description, taken individually or in combination.

In all Figures 1, 2, 3, 4 and 5, the patient's foot P is shown.

There represents several protective devices 1 according to the invention, presented in the form of sleeves. The protective device 1 is located facing the skin, while the holding means 3 is located on the external part of the device. These devices are particularly suitable for lesional areas corresponding to corns, calluses, redness, calluses and partridge's eyes. This device is not compressive, and is not an orthosis.

There represents a protection device 1 for the lesion zone corresponding to hallux valgus, as well as a holding means 3. The protection means 2 is in the form of a gel membrane comprising at least one active ingredient. The holding means 3 holds the gel membrane facing the area of the foot P presenting lesions linked to hallux valgus. This device is not compressive, and is not an orthosis.

There represents a protective device 1 according to the invention, in the form of a banded metatarsal cushion (see ). The protection means 2 is in the form of a gel membrane comprising at least one active ingredient. The holding means 3 is in the form of a pocket containing the protective means 2 and a strip visible on the right, holding the gel membrane facing the metatarsal of the foot P. This device is not compressive , and is not an orthosis.

There represents a protective device 1 according to the invention, in the form of a mitt for protecting the metatarsal. A means of protection 2 is present, in the form of a gel membrane comprising at least one active ingredient. The holding means 3 holds the protective means 2 facing both the area of the foot P presenting lesions linked to hallux valgus and the palm of the foot P. This device is not compressive.

There represents a protection device 1 according to the invention, in this embodiment, said protection device 1 is constituted by the protection means 2 comprising at least one active, in the form of a cap covering the patient's big toe. This device is not compressive, and is not an orthosis.

There represents a scale presenting the different lesion grades corresponding to dorsal area 02.

Swiss patent application CH000697/2022 filed on June 8, 2022 and whose title is “Composition for cutaneous or nail application, with restorative purposes, the aim of which is to protect and relieve the injured area of the foot or hand. This composition can be molded to form an orthosis or impregnated directly onto a fabric orthosis” is incorporated into this description.

Examples

Example 1 - clinical study

1.1 Presentation

20 patients with lesions were recruited, these lesions affecting different areas of the foot P, and several types of protection device 1 were used:

- dorsal area of the secondus (use of a device as presented in ) ;

- lateral edge of M1 (use of a device as presented in ) ;

- metatarsal paddle (use of a device as presented in ) ;

- metatarsophalangeal joint (use of a device as presented in ) ;

- sesamoid (use of a device as presented in ) ;

- interphalangeal joint (use of a device as presented in ) ;

- pulp of the hallux = big toe (use of a device as presented in ) ;

- secondus pulp (use of a device as presented in ) ;

- tertius pulp (use of a device as presented in ) ;

- pulp of the quartus (use of a device as presented in ) ;

- quintus pulp (use of a device as presented in ).

All the protection devices used present means of protection comprising three active ingredients with the following INCI: MELALEUCA ALTERNIFOLIA LEAF OIL, ARNICA MONTANA FLOWER EXTRACT and ALOE BARBADENSIS EXTRACT.

When a holding means 3 is present, the textile used comprises 45% polyamide and 55% elastane by mass, relative to the total mass of said textile, and this textile has an elasticity of 36 newtons in the weft direction included. between 160% and 180% as well as an elasticity of 36 newtons in the chain direction of between 15% and 20%.

When a device as presented in is used, the thickness of the protection device, including the holding means 3 and the protection means 2, is between 3.5 mm and 4.5 mm.

For all devices other than the one presented in , the thickness of the protection means 2 is systematically greater than 0.7 mm.

For skin lesions, visual scales are used to assign a grade to the lesion, from grade 0 to grade 5:

- grade 0: no pain when walking, no redness, smooth and supple skin;

- grade 1: no pain when walking, no redness, hard skin, calluses;

- grade 2: slight pain when walking, slight redness, hard skin, calluses;

- grade 3: pain when walking, slight pain on palpation, redness, callus;

- grade 4: pain when walking, pain on palpation, redness, corns;

- grade 5: acute pain when walking, acute pain on palpation, intense redness, corns.

The visual scale corresponding to the dorsal zone 02 is given for information purposes only. .

Protective devices 1 were worn for 28 days, and the lesions were evaluated on D0 and D28.

On D28, the following statements were submitted to patients (with 2 possible responses: “disagree” and “agree”, with the possibility of nuance in percentage, for example, a user can be 10% in agreement and 90% disagree, or 100% agree, or 100% disagree):

- The results are visible quickly (from 24 hours);

- The product did not create any inflammation, eczema, erythema or redness;

- The product is easy and quick to use;

- The product is comfortable, it suits the shape of my foot P and my fit;

- The product does not stain;

- The product seems effective;

- The product will be reused by the user.

At the same time, still on D28, the following statements were submitted to the podiatrists (with 2 possible responses: “disagree” and “agree”, with the possibility of nuance in percentage, for example, podiatrist can be at 10% agree and 90% disagree, or 100% agree, or 100% disagree):

- The area concerned seems to be more protected;

- The device relieves pain immediately;

- The device cushions shocks and limits friction;

- The device distributes pressure and absorbs micro-shocks;

- The device provides optimal comfort;

- Arnica has a soothing and softening cosmetic action on the lesion area;

- The device prevents and softens calluses;

- Arnica and aloe vera have a beneficial action;

- The device has a mechanical action that relieves pain instantly;

- The skin appears smoother, more nourished;

- In diabetic patients, the device fits the diabetic foot and does not injure it.

1.2 Results

At D28, user responses were as follows:

All right Disagree The results are visible quickly (from 24 hours) 97% 3% The product did not create any inflammation, eczema, erythema or redness for me. 100% 0% The product is easy and quick to use 100% 0% The product is comfortable, it suits the shape of my foot and my fit 99% 1% The product does not stain 100% 0% The product seems effective 95% 5% Intended future use of the product 93% 7%

On D28, the answers provided by the podiatrists were as follows:

All right Disagree The area concerned seems to be more protected 100% 0% The device relieves pain immediately 97% 3% The device cushions shocks and limits friction 98% 2% The device distributes pressure and absorbs micro-shocks 95% 5% The device provides optimal comfort 96% 4% Arnica has a soothing and softening cosmetic action on the lesion area. 93% 7% The device prevents and softens calluses 94% 6% Arnica and aloe vera have a beneficial action 90% 10% The device has a mechanical action that relieves pain instantly 97% 3% The skin appears smoother, more nourished 90% 10% In diabetic patients, the device fits the diabetic foot and does not injure it 100% 0% Favorable evolution of the visual pain scale in the area concerned 97% 3%

The use of devices according to the invention has therefore enabled an evolution of grade in almost all situations.

In addition, the answers to the questions asked to the patient as well as to the podiatrist perfectly illustrate the effectiveness of the devices according to the invention.

Example 2 - transfer of assets

During the clinical study, it was observed that the active ingredients were naturally delivered to the surface of the skin. This transfer was studied for layers of silicone elastomer gel with a thickness of 3.5 mm.

Two embodiments have been planned:

- in a first embodiment, at T = 0, a force of 3.8 newtons per square centimeter is applied to the gel layer containing the three active ingredients mentioned in example 1, the gel layer is brought into contact with a blotting paper, and the diameter of the stain which becomes visible on the blotting paper is measured at T = 12 hours, T = 14 hours, T = 96 hours and T = 168 hours;

- in a second embodiment, in addition to the conditions identical to the first embodiment, a polyester textile is placed between the gel layer and the blotting paper.

T = 12 p.m. T = 2 p.m. T = 96 hours T = 168 hours First embodiment: Silicone elastomer gel (thickness 3.5 mm) 4.3cm 5.2cm 7.8cm 9.3cm Second embodiment: Silicone elastomer gel (thickness 3.5 mm) + textile 1cm 1.3cm 1.8cm 2.5cm

Concerning the first embodiment, this experiment illustrates that the three active ingredients present within the gel layer are actually released by the gel over several days.

Regarding the second embodiment, even more surprisingly, the three active ingredients present within the gel layer are also released by the gel and diffuse through the polyester textile for several days.

Claims (8)

Protection device (1), comprising at least one protection means (2), said protection means (2) comprising at least one active. Protective device (1) according to claim 1, characterized in that it has a shape chosen from the group consisting of sleeves, sleeves closed at one end, cushions for protecting the metatarsal paddle, mittens for protecting the edge lateral of M1 and the metatarsophalangeal joint. Protective device (1) according to any one of the preceding claims, characterized in that it comprises, in addition to at least one protection means (2), a holding means (3). Protective device (1) according to any one of the preceding claims, characterized in that the at least one means of protection (2) has a thickness of between 0.1 mm and 10 mm. Protective device (1) according to any one of the preceding claims, characterized in that the area of the protection means(s) (2) is between approximately 10% and approximately 100% of the total area of said protection device (1). Protective device (1) according to any one of the preceding claims, characterized in that said at least one protective means (2) consists of a silicone elastomer and said active ingredient(s). Protective device (1) according to any one of the preceding claims, characterized in that the at least one active ingredient is chosen from the group consisting of plant extracts chosen from the group consisting of the genera Arnica , Aloe and Melaleuca . Protective device (1) according to any one of the preceding claims, intended to be used in the treatment or prevention of skin and/or nail lesions.