WO2006100358A1

WO2006100358A1 - Protection module for a region of the foot

Info

Publication number: WO2006100358A1
Application number: PCT/FR2006/000291
Authority: WO
Inventors: Jean-Claude Millet
Original assignee: Millet Innovation
Priority date: 2005-03-24
Filing date: 2006-02-09
Publication date: 2006-09-28
Also published as: FR2883458A1; FR2883458B1

Abstract

The present invention concerns a module for protecting a region of the foot, comprising a polymer gel pad (1) designed to cover a region of the foot to be protected and a polymer gel retaining element (2) configured to be supported on the toes in a concave space of the region of the toes. The invention provides the advantage of an efficient support for the protective module without any risk of injuries, even for the fragile skins of persons suffering form diabetes.

Description

MODULE FOR PROTECTING A FOOT AREA

The present invention relates to a module for protecting a zone of the foot, and in particular for keeping a foot protection module on the foot. Foot protection modules, also called "protection interfaces", are commonly used products. It is for example 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 name Epithelium 26 ^® .

The foot has a shock absorbing layer called the foot pad, able to support up to eight times the weight of the body. The plantar pad helps to distribute the mechanical "load" imposed by the weight of the body. However, many patients suffer from heating, callus or pain due to unavoidable wear, with age, natural plantar. Thus, such protection modules can relieve pain and protect all painful areas of the foot affected by hyperpressions (calluses, corns, partridge eyes, hallux valgus) or suffering from skin injuries (irritation, cracks, plantar warts. ..). 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.

However, maintaining one or more protection modules on one or more specific areas of the foot is problematic. This maintenance must indeed be permanent, whatever the type of exercise (walking, run) performed by the person and the duration of this exercise. This maintenance must also be effective regardless of the type of foot, supinator (support of the foot on the inner side of the plant), axial or pronator (support of the foot on the outside of the plant). Indeed, it has been observed that if the protection is fixed on a plantar area of the foot only by a very adhesive part, it tends to slide on one side or the other of the foot, according to the physiology of the foot, after a few hours of walking. The maintenance of such protection must still resist sweating of the foot even if it is excessive, which precludes the use of an adhesive deposited on one side of the protection module. Moreover, such a use limits the duration and the number of uses of the protection.

To maintain such a protection, elastic fabric holding means is used. However, such holding means generally have seams that are likely to create irritation or injury. Such plantar protection can not meet the needs of people for whom it is essential to avoid the formation of any lesions likely to become infected.

The present invention solves this problem by exploiting the sinuous shapes of the toe region to maintain a protective module. For this purpose, it provides to associate with the protection module a holding element made of a flexible material and shaped so as to cooperate with a toe region to ensure the maintenance of the protection module.

More particularly, the invention provides a module for protecting a zone of the foot, comprising a pad made of a flexible material, shaped to cover an area to be protected from the foot. According to the invention, the protection module comprises a holding element in a flexible material disposed on the pad and shaped so as to be held in a region of the toes to maintain the pad facing the area to be protected.

According to one embodiment of the invention, the pad is shaped to cover one of the following parts of the foot:

- a front part of the sole of the foot,

- a front part of the sole of the foot and the hallux valgus, - a front part of the top of the foot and toes,

- a front part of the top of the foot and toes and the hallux valgus.

According to one embodiment of the invention, the holding element is shaped so as to engage in an interdigital space.

According to one embodiment of the invention, the pad comprises a region shaped to at least partially cover the hallux valgus of the foot and a portion of the top of the big toe, and has an edge which is fixed on one end of the element. keeping.

According to one embodiment of the invention, the holding element has a curved semi-cylindrical shape.

According to one embodiment of the invention, the holding element is shaped so as to occupy substantially all the sub-diaphyseal space, to maintain the pad facing a front part of the sole of the foot.

According to one embodiment of the invention, the holding element contains at least one active ingredient belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

According to one embodiment of the invention, the pad contains less an active ingredient belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

According to one embodiment of the invention, the holding element and the pad are made of a material comprising a polymer gel whose viscoelastic properties are close to natural human tissues.

According to one embodiment of the invention, the holding element and the pad are made of a material comprising silicone gel whose viscoelastic properties are close to natural human tissues.

The invention also relates to a method of manufacturing a protection module of a foot zone, the protection module comprising steps of manufacturing a pad made of a flexible material, shaped to cover an area to be protected from the foot. According to the invention, the method further comprises the steps of: - manufacturing a holding element made of a flexible material, the holding element being shaped so as to cooperate with a region of the toes to hold the pad next to the zone to be protected from the foot, and - assembly of the holding element and the pad.

According to one embodiment of the invention, the pad is manufactured by inserting a polymer gel preparation to be polymerized in a first mold and at least partial polymerization of the preparation in the mold.

According to one embodiment of the invention, the holding element is manufactured simultaneously with the pad by means of a single mold, the step of assembling the holding member and the pad being implicit in the manufacture of two pieces. According to one embodiment of the invention, the holding element is manufactured by inserting a polymer gel preparation to be polymerized in a second mold and at least partial polymerization of the gel in the mold.

According to one embodiment of the invention, the assembly of the holding element and the pad comprises a step of contacting the holding member and the pad and a step of finalizing the polymerization of the element. and / or the pad leaving the holding member in contact with the pad.

According to one embodiment of the invention, the first mold is shaped so as to have an open face which corresponds to a flat face of the pad.

According to one embodiment of the invention, the second manufacturing mold is shaped so as to have an open face which corresponds to a flat lateral face of the holding element.

- a front part of the sole of the foot, - a front part of the sole of the foot and the hallux valgus,

- a front part of the top of the foot and toes,

- a front part of the top of the foot and toes and the hallux valgus. According to one embodiment of the invention, the holding element is shaped to engage in an interdigital space.

According to one embodiment of the invention, the pad region which is provided to at least partially cover the hallux valgus of the foot in addition to a portion of the big toe and has an edge which is fixed on one end of the holding member.

According to one embodiment of the invention, in which the holding element has a semi-cylindrical curved shape.

According to one embodiment of the invention, the holding element is shaped to occupy substantially all the sub-diaphyseal space, to maintain the pad facing a front portion of the sole of the foot.

According to one embodiment of the invention, the method further comprises a step of insertion into the holding element of at least one active principle belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

According to one embodiment of the invention, the method further comprises a step of insertion into the pad of at least one active ingredient belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

According to one embodiment of the invention, the holding element and the pad are made of a material comprising a silicone gel whose viscoelastic properties are close to natural human tissues.

These and other objects, features, and advantages of the present invention will be discussed in more detail in the following description of a foot zone protection module according to the invention, made to nonlimiting title in relation to the attached figures among which:

FIG. 1 is a perspective view from above of a module for protecting a plantar area, according to the invention,

FIG. 2 is a view from below of the forefoot provided with the protection shown in FIG. 1;

FIG. 3 is a perspective view from above of a variant according to the invention of the protection module shown in FIG. 1;

FIGS. 4 to 6 are views, respectively of profile, from below and from above of the forefoot provided with the protection shown in FIG. 3;

FIG. 7 is a perspective view from below of a protection module of a top zone of the forefoot, according to the invention,

FIG. 8 is a view from above of the forefoot provided with the protection shown in FIG. 7,

FIGS. 9 and 10 are views, respectively in profile and from above of the forefoot provided with a variant of the protection shown in FIG. 7,

FIG. 11 is a perspective view from above of another variant according to the invention of the protection module of a plantar zone, shown in FIG. 1; FIG. 12 is a view from below of the front of the foot with the protection shown in Figure 11.

As illustrated in FIGS. 1 and 2, the protection module according to the invention comprises a thin part 1 or pad, and a holding element 2. The pad has a substantially flat shape chosen so as to cover the area of the foot to be protected. . This pad is made of a polymer or silicone gel chosen so that its properties are similar to those of the human tissues of the foot. This is for example EPITHELIUM 26 ^® mentioned above or an equivalent material. The thickness of the pad 1 is typically between 1.5 and 2.5 mm.

The holding member 2 of the pad 1 has a substantially semi-cylindrical curved shape, with a flat lateral face 2a and a curved face 2b. It is fixed as in the example of Figures 1 and 2, in a suitable location on one face of the pad 1. The holding member is also made of a polymer gel, for example in the same material as the pad 1.

As illustrated in Figure 2, the protection module is placed in front of the sole of the foot, the holding member 2 to occupy the interdigital space between the big toe and the adjacent toe. The arched shape of the holding element prevents it from easily disengaging from the interdigital space. The foot protection module is thus effectively maintained on the front of the sole in the manner of a flip-flop, without risk of causing injury. It should be noted that the holding element also provides the separation function of the big toe and the adjacent finger.

The pad 1 and the holding member 2 are advantageously manufactured separately by molding into molds of suitable shapes of a non-crosslinked silicone gel. The holding element 2 can thus be manufactured using an open mold into which a polymer gel is inserted to be crosslinked. The flat face 2a of the holding element advantageously corresponds to the open face of the mold used in its manufacture. The holding member 2 is then heated and placed on the pad 1 as it begins to polymerize (or crosslink). This gives an object formed of a single piece.

The protection module according to the invention can also be obtained by other methods of manufacturing. Thus, the pad can be made by cutting into a sheet of silicone gel. The assembly of these two parts can also be obtained by contacting these two parts in the not completely polymerized state and simultaneous polymerization of the two parts. The protection module can also be obtained by molding a single piece including the holding element.

According to an advantageous embodiment of the invention, the holding element 2, and possibly the pad 1, are doped with an active ingredient such as an antibacterial and / or antimycotic product, in order to limit the risk of mycosis formation and to avoid the generation of bad odors resulting in particular from the occlusivity of the silicone.

In the embodiment illustrated in FIGS. 3 to 6, the pad 3 comprises an additional lateral portion 4 of substantially the same thickness, which is intended to cover the hallux valgus and if necessary a part of the upper face of the big toe. This provides protection both from the front of the sole of the foot and from the hallux valgus.

In an advantageous form, this additional part 4 is bent on the big toe so that its outer edge reaches the top of the separator 2 where it is glued to the latter. This forms a kind of ring around the big toe which reinforces the holding in place of the protection module. In this case, the pad 3 may have a variable thickness. This thickness can thus be 1.5 to 2.5 mm in the plantar zone and decrease in going to the top of the big toe. It can end above the big toe by a thickness ranging from 1 to 1.5 mm so that the extra thickness does not come to increase the pressure of the shoe on the hallux, for lack of space.

In an alternative embodiment of the invention illustrated in FIGS. 7 and 8, the protection module is designed to protect the toe of the toes, in particular because of the presence of dorsal corns. As in the embodiments previously described, the protection module shown in these figures comprises a pad 5 and a holding element 6 shaped to occupy the interdigital space between the big toe and the adjacent toe. The shape of the pad is chosen to cover the area of the foot to be protected. Its thickness can be reduced to a value between 1 and 1.5 mm because the supports are less important than under the foot. In addition, it is not necessary to add a thickness that can generate additional pressures exerted by the shoe.

In the variant embodiment illustrated in FIGS. 9 and 10, the pad 7 comprises an additional lateral portion 8 of substantially the same thickness, which is intended to cover the hallux valgus. This provides protection from both the toes and hallux valgus.

In the variant embodiment illustrated in FIGS. 11 and 12, the protection module comprises a pad 10 for protecting the front of the sole of the foot, which is held by a bar 11 intended to engage in the sub-diaphyseal space that extends transversely under the foot between the front end of the plantar area and the birth of the toes. It turns out that in some forms of feet, this area must be filled to mitigate the "hammer" position of the toes. The bar 11 thus ensures both the straightening of the toes and the holding back and forth of the pad 10. The protection module illustrated in FIGS. 11 and 12 is advantageously manufactured by separately molding the pad 10 and the bar 11, from a polymer gel to be crosslinked and assembling these two pieces at the moment when one or the other of these two parts begins to polymerize, or when these two parts simultaneously begin to polymerize.

In general, the protection module according to the invention has a flexibility that allows it to marry the natural shape of the area to be protected, without asperities likely to hurt the skin of the foot, even if it is very sensitive as is the case with diabetics.

It is also possible to prevent the formation of mycoses and bad odors by incorporating an antibacterial and / or antimycotic product into the bar. One can also prevent or mitigate joint pain in the toes by impregnating the bar of an anti-inflammatory product, for example of natural origin such as essential oil of chamomile.

It will be clear to one skilled in the art that the protection module according to the present invention is capable of various other embodiments and applications, in particular depending on the zone or zones of the foot to be protected and depending on the region. toes that it is desired to cooperate with the bearing holding member. Also possible are various embodiments or formulations of the material or materials used to produce the protection module according to the invention as well as the active substances that can be incorporated therein.

Claims

1. module for protecting a zone of the foot, comprising a pad (1, 3, 5, 7, 10) made of a flexible material, shaped to cover an area to be protected from the foot, characterized in that it comprises an element holding (2, 6, 11) a flexible material disposed on the pad and shaped so as to be maintained in a region of the toes to maintain the pad facing the area to be protected.

2. Protection module according to claim 1, wherein the pad (1, 3, 5, 7, 10) is shaped to cover one of the following parts of the foot:

- a front part of the top of the foot and toes,

- a front part of the top of the foot and toes and the hallux valgus.

3. Protection module according to claim 2, wherein the holding element (2, 6) is shaped to engage in an interdigital space.

4. Protection module according to claim 3, wherein the pad (3) comprises a region (4) shaped to at least partially cover the hallux valgus of the foot and a portion of the top of the big toe, and has an edge which is fixed on one end of the holding element (2).

5. Protection module according to claim 3 or 4, wherein the holding member has a curved semi-cylindrical shape.

6. Protection module according to claim 1, wherein the holding element (11) is shaped so as to occupy substantially all the sub-diaphyseal space, to maintain the pad facing a front portion of the plant of the foot.

7. Protection module according to one of claims 1 to 6, wherein the holding element (2, 6, 11) contains at least one active ingredient belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

8. Protection module according to one of claims 1 to 7, wherein the pad (1, 3, 5, 7, 10) contains less active ingredient belonging to the group comprising antibacterial, antimycotic and anti-inflammatory products.

9. Protection module according to one of claims 1 to 8, wherein the holding member (2, 6, 11) and the pad (1, 3, 5, 7, 10) are of a material comprising a gel polymer whose viscoelastic properties are close to natural human tissues.

10. Protection module according to one of claims 1 to 9, wherein the holding element

(2, 6, 11) and the pad (1, 3, 5, 7, 10) are made of a material comprising silicone gel whose viscoelastic properties are close to natural human tissues. 11. A method of manufacturing a protection module of a foot zone, the protection module comprising steps of manufacturing a pad (1, 3, 5, 7, 10) of a flexible material, shaped to cover an area to be protected from the foot, characterized in that it further comprises steps of:

- manufacture of a holding element (2, 6,

11) of a flexible material, the holding member being shaped to cooperate with a region of the toes to maintain the pad facing the area to be protected from the foot, and

- assembly of the holding element and the pad.

The method of claim 11, wherein the pad (1,3,5,7,10) is manufactured by inserting a polymer gel preparation to be polymerized into a first mold and at least partially polymerizing the preparation in the mold.

13. The method of claim 12, wherein the holding member (2, 6, 11) is manufactured simultaneously with the pad by means of a single mold, the step of assembling the holding member. and bearing being implicit in the manufacture of both parts.

The method of claim 12, wherein the holding member (2,6,11) is manufactured by inserting a polymer gel preparation to be polymerized in a second mold and at least partially polymerizing the gel in the mold.

The method of claim 14, wherein the assembling of the holding member (2, 6, 11) and the pad (1, 3, 5, 7, 10) includes a step of setting contacting the holding member and the pad and a step of finalizing the polymerization of the holding member and / or the pad leaving the holding member in contact with the pad.

16. Method according to one of claims 12 to 15, wherein the first mold is shaped so as to have an open face which corresponds to a flat face of the pad (1, 3, 5, 7, 10).

17. Method according to one of claims 14 to 16, wherein the second manufacturing mold is shaped so as to have an open face which corresponds to a flat lateral face of the holding element (2, 6, 11).

18. Method according to one of claims 12 to 17, wherein the pad (1, 3, 5, 7, 10) is shaped to cover one of the following parts of the foot: - a front part of the sole of the foot ,

- a front part of the sole of the foot and the hallux valgus,

- a front part of the top of the foot and toes,

- a front part of the top of the foot and toes and the hallux valgus.

The method of claim 18, wherein the holding member (2, 6) is shaped to engage in an interdigital space.

20. The method of claim 19, wherein the region (4) of the pad (3) which is intended to at least partially cover the hallux valgus of the foot further covers a portion of the big toe and has a edge which is fixed on one end of the holding member (2).

21. Method according to one of claims 11 to 20, wherein the holding element (2, 6) has a curved semi-cylindrical shape.

22. Method according to one of claims 11 to 17, wherein the holding member (11) is shaped to occupy substantially all the sub-diaphyseal space, to maintain the pad (10) facing a front portion of the sole of the foot.

23. Method according to one of claims 11 to 22, further comprising a step of insertion in the holding element (2, 6, 11) of at least one active principle belonging to the group comprising antimicrobial, antimycotic products. and anti-inflammatories.

24. Method according to one of claims 11 to 23, further comprising a step of insertion into the pad (1, 3, 5, 7, 10) of at least one active ingredient belonging to the group comprising antibacterial products, antimycotic and anti-inflammatory.

25. Method according to one of claims 11 to 24, wherein the holding element (2, 6, 11) and the pad (1, 3, 5, 7, 10) are made of a material comprising a polymer gel whose viscoelastic properties are close to natural human tissues.

26. Method according to one of claims 11 to 25, wherein the holding element (2, 6, 11) and the pad (1, 3, 5, I ₁ 10) are made of a material comprising a silicone gel whose viscoelastic properties are close to natural human tissues.