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Title:
DEVICE FOR THE TREATMENT OF ATHLETE'S FOOT
Document Type and Number:
WIPO Patent Application WO/2022/025761
Kind Code:
A1
Abstract:
The invention relates to a device for preventing, treating and/or curing athlete's foot, the device comprising a hollow body and one or two flanges at two ends of the hollow body. The hollow body comprises at least one opening that allows fluid communication between the inner space of the hollow body and an environment outside the device. With a design to fit between the toes of a human or an animal, the device is capable of preventing, treating and/or curing the occurrence of athlete's foot, also known as tinea pedis.

Inventors:
NOLLEN SYLVIA CORNELIA MARIA JOZEF (NL)
KNEEPKENS ERNEST JULIAAN JOZEF MARIE (BE)
TIESNITSCH JOHANNES IJSBRAND (NL)
KORBEE ROLAND ALEXANDER
Application Number:
PCT/NL2021/050467
Publication Date:
February 03, 2022
Filing Date:
July 21, 2021
Export Citation:
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Assignee:
TIESNITSCH BEHEER B V (NL)
KORBEE NOLLEN BEHEER B V (NL)
International Classes:
A61F5/01; A43B7/26
Foreign References:
KR20100108468A2010-10-07
US20080113854A12008-05-15
KR20080078275A2008-08-27
KR101522383B12015-05-20
Attorney, Agent or Firm:
HUBREGTSE, Teunis (NL)
Download PDF:
Claims:
CLAIMS

1. Device (1 ) for the treatment of athlete's foot, the device (1 ) comprising

- a hollow body (2) having a body wall (3) extending from a first end (2a) of the hollow body to a second end (2b) of the hollow body (2), the body wall (3) having a body wall total surface area and defining an inner space (4) of the hollow body (2);

- one or two flanges (5), each of which is present at an end (2a, 2b) of the hollow body (2) and protrudes from the body wall (3); wherein the body wall (3) comprises

- at least one opening (6) that allows fluid communication between the inner space (4) and an environment outside the device (1), the at least one opening (6) defining a body wall open surface area;

- an open surface area fraction which is defined as the body wall open surface area divided by the total body wall surface area.

2. Device (1 ) according to claim 1 , wherein the hollow body (2) is a cylinder, in particular an elliptic cylinder or a round cylinder.

3. Device (1) according to claim 1 or 2, wherein the hollow body (2) comprises a coil, in particular a tube coil, so that the body wall (3) comprises at least one elongated spiraling opening (6).

4. Device (1) according to any one of claims 1-3, wherein the open surface area fraction is in the range of 0.1 -0.8, in particular in the range of 0.2-0.6.

5. Device (1 ) according to claim 4, wherein the material is a rubber or a polysiloxane.

6. Device (1) according to any one of claims 1-5, wherein the number of openings (6) in the body wall (3) is in the range of 6-40 or at least 8.

7. Device (1) according to any one of claims 1-6, having an opening (6) at one or both ends (2a, 2b), which opening (6) allows fluid communication between the inner space (4) and an environment outside the device (1). 8. Device (1) according to any one of claims 1-7, wherein each flange (5) is a cone-shaped flange with a first segment having a first cross-section of a smaller diameter and a second segment having a second cross-section of a larger diameter, wherein in each flange (5)

- the first segment of the cone blends with the body wall (3); and

- the second segment of the cone forms the protrusion; wherein the cone has an angle of up to 60° with the normal to the hollow body (2).

9. Device (1 ) according to any one of claims 1 -8, which device (1 ) is made in one piece from one type of material.

10. Device (1 ) according to any one of claims 1 -9, wherein the device (1 ) is a dumbbell-shaped device.

11. Device (1 ) according to any one of claims 1 -10, wherein the distance between the two ends (2a, 2b) of the hollow body (2) is in the range of 1-5 cm.

12. Device (1 ) according to any one of claims 1-11 , wherein the largest dimension of the one or two flanges (5) is in the range of 1-5 cm.

13. Device (1 ) according to any one of claims 1 -12, wherein the device (1 ) fits in a sphere with a radius of 2-8 cm, in particular 3-5 cm.

14. Device (1 ) according to any one of claims 1 -12, wherein the inner space (4) has a volume in the range of 1-5 cm3.

15. Footwear (10), comprising a device (1) according to any one of claims 1-14.

16. Footwear (10) according to claim 15, wherein the footwear is selected from the group of shoes, socks, slippers, sandals and boots.

17. Use of a device (1) according to any one of claims 1-14 for the treatment of athlete's foot.

Description:
DEVICE FOR THE TREATMENT OF ATHLETE'S FOOT

FIELD OF THE INVENTION

The invention relates to a device for preventing, treating and/or curing athlete's foot and to footwear comprising such a device.

BACKGROUND

Athlete's foot, or tinea pedis, is a contagious skin infection of the foot caused by fungus. It may infect any part of the foot, but it most often starts to grow between the toes to cause itchy white patches. The bottom of the foot close to the toes is also prone to infection, resulting in red, sore and flaky patches on the skin. More severe symptoms are a cracked skin and bleedings. The fungus can ultimately spread to the toenails and cause a fungal nail infection, which is much more difficult to treat than the initial symptoms that are limited to the top layer of the skin. It is therefore important to treat athlete's foot when the symptoms are still mild.

The fungus can be treated with creams, sprays or powders from a pharmacy. There are also appliances that can be worn in footwear, providing physical spacing of the toes combined with cushioning. In addition, some appliances achieve moisture absorption and aeration of the toes. Such appliances may also be effective as a prophylactic measure.

However, known devices for spacing, cushioning and aeration of the toes have proven insufficient in preventing, treating and/or curing athlete's foot, in particular they are not providing sufficient air circulation.

Another issue with many known devices is their wearing comfort, in particular devices that are designed as a single piece to be worn on and between (nearly) all toes. Such devices restrain the toes, which makes them thicker and leads to even more restraint.

SUMMARY OF THE INVENTION

It is therefore an objective of the present invention to provide a device for preventing athlete's foot which is more effective than known devices, in particular a device that provides sufficient air circulation around the toes. It is also an objective to improve the wearing comfort of such a device.

It has now been found that one or more of these objectives can be reached by providing a device with an improved design for preventing athlete's foot.

Accordingly, the present invention relates to a device for preventing athlete's foot, the device comprising

- a hollow body (2) having a body wall (3) extending from a first end (2a) of the hollow body to a second end (2b) of the hollow body (2), the body wall (3) having a body wall total surface area and defining an inner space (4) of the hollow body (2);

- one or two flanges (5), each of which is present at an end (2a, 2b) of the hollow body (2) and protrudes from the body wall (3); wherein the body wall (3) comprises

- at least one opening (6) that allows fluid communication between the inner space (4) and an environment outside the device (1), the at least one opening (6) defining a body wall open surface area;

- an open surface area fraction which is defined as the body wall open surface area divided by the total body wall surface area.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 displays a three-dimensional view of a device according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

A device of the invention is designed to fit between the toes of a human or an animal. Its main component is a hollow body, typically made of a flexible material. The hollow body may in principle have any shape, as long as it is suitable for positioning between the toes. Regardless of the shape of the hollow body, at one or two positions of the hollow body is mounted a flange. These positions are two ends of the hollow body, i.e. a first flange is present at the first end and a second flange is optionally present at the second end of the hollow body. Thus, in the case of two flanges, these are mounted at two opposite positions of the hollow body. When a device of the invention is worn by a person, the one or two flanges themselves are not present between the toes but reside above and below them. In this way, the device of the invention stays better in position during use than known devices.

The hollow body comprises a body wall, or may even consist of a body wall. For example, when the hollow body is a cylinder, then the body wall corresponds to a cylinder wall. At one or both ends of such cylinder is then connected a flange. In the case of two flanges (one on either end), a device of the invention typically has the shape of a dumbbell.

The hollow body may also be of a cylinder-like shape rather than being a perfect cylinder with a round cross-section (a round cylinder). For example, the cylinder may be curved and/or have a variation in thickness. The latter variation may be along its circumference or in the elongated direction between both ends (perpendicular to the circumference).

For example, the cylinder is an elliptic cylinder. By an elliptic cylinder is meant that the (perpendicular) cross-section of the cylinder is an ellipse.

The cross-section of the cylinder may also have another non-circular shape. In such case, the cross-section is preferably any curved convex shape. A shape or object is considered to be convex when it is curved outward (in a convex shape, a line connecting any two points somewhere within the shape should not go outside the shape). A curved shape (as compared to one with corners, e.g. polygon) has the advantage of less irritation when the device is in contact with the skin.

When a hollow body with an elliptic cross-section is placed between two toes, the long dimension of the ellipse is preferably in same the direction as the direction wherein the toes extend from the foot, while the short dimension of the ellipse intersects the two toes. This in principle also applies to any devices with a hollow body of any cross-section that has different cross-sectional diameters.

In a preferred embodiment, the hollow body comprises a coil. Such coils are known as a tube coils or helically wound pipes, which are in fact tubes/pipes formed by bending a long strip or thread in the shape of a spiral. The coil or helix thus formed can be considered as a cylinder having one elongated opening that spirals between the spiraling strip or thread from one end of the cylinder to the other end of the cylinder. In such arrangement, the body wall of the hollow body comprises at least one elongated spiraling opening. In the case of a coil, the hollow body may also have the variations in shape as described above, such as the cylinder-like shapes including the cylinders with circular and non-circular (convex) shapes.

In a device of the invention, the body wall of the hollow body may thus be formed by a strip of material that is bent in the shape of a coil. In the hollow body thus formed, the space between the windings of the coil may be present as the only opening in the device.

The body wall (as well as the one or two flanges thereon) may in principle be made of any material that is suitable for placement between toes, in particular between toes that suffer from athlete’s foot. Preferably, the material is a flexible material, such as a rubber or a polysiloxane. By a flexible material is meant a material that can be bent or folded without permanent deformation and without breaking. It thus reverts to its original shape in the absence of a force previously exerted on the material to deform it. For example, in a device of the invention, the hollow body may be compressed to at least 25% of its diameter without permanent deformation and breaking.

Preferably, a device of the invention is made in one piece from one type of material. For example, when different parts of the device (such as the hollow body and the one or two flanges) are first prepared separately and merged at a later stage, surface irregularities may be formed ( e.g . ridges), which may cause irritation of the skin. A smooth surface of the device is of high importance since the device is in contact with the skin, which skin may be sensitive and vulnerable due to the athlete’s foot condition. Therefore, generally, all edges that are present in a device of the invention are rounded, such as edges of openings and the contours of the one or two flanges.

The hollow body of the device of the invention (and thus also the body wall of the hollow body) comprises one or more holes or openings. An important function of these one or more openings is that they allow fluid communication between the inner space of the hollow body and an environment outside the device. This means that the openings allow a fluid (a gas or a liquid) to pass from the inner space to the environment outside and vice versa. Thus, the openings generate a fluid connection between the inner space and the outside environment. When using a device of the invention, the openings’ main function is to allow the passage of air and to allow the passage of air over the skin of a toe (or other nearby part of the foot) that completely or partly covers an opening.

In the embodiment where the hollow body comprises a coil with one elongated spiraling opening, the presence of only one opening in the device is in principle sufficient to achieve a proper functioning of the device of the invention.

In embodiments wherein the openings are not so elongated, it is however preferred that there are more openings, for example at least 2, at least 3, at least 5, at least 8, at least 10, at least 15, at least 20, at least 25, at least 30, at least 35, at least 40 or at least 50. Usually, the number of openings is in the range of 6-50, in particular in the range of 10-40. Such openings typically have an aspect ratio of at least 0.05. For example, the aspect ratio is at least 0.10, at least 0.15, at least 0.20, at least 0.25, at least 0.30, at least 0.40, at least 0.50, at least 0.60, at least 0.70, at least 0.80, at least 0.90 or at least 0.95.

In case more than two of such openings are present, the openings are evenly spread over the surface of the body wall. Typically, they are arranged in such pattern that with different positionings of the device between the toes, different parts of the skin abut the openings. This allows an averaging of the skin positions that are treated, so that each position of the skin is given a fair share of the positive effects of the device of the invention ( e.g . all positions that come into contact with the device have similar possibilities to benefit from the device of the invention).

An opening in a device of the invention, in particular in the hollow body thereof, is regarded as an equivalent of a surface, and is therefore considered to have two dimensions. Usually, an opening has at least one dimension that is at least 1.0 mm. Preferably, two of its dimensions are at least 1.0 mm. The surface area of an opening is usually in the range of 1-20 mm 2 . In the case the hollow body comprises a coil, the surface area of an opening is usually in the range of 10-800 mm 2 , in particular in the range of 20-200 mm 2 .

The body wall of a device of the invention defines an inner space of the hollow body. The body wall has a body wall total surface area, which is the surface area of the body wall as if it were a continuous wall, i.e. lacking any openings. In other words, the surface area of all openings that may be present in the wall are included when determining the total body wall surface area.

The body wall of a device of the invention comprises one or more openings. The total surface area of these one or more openings together define a so-called body wall open surface area (i.e. the open surface area of the body wall).

From the body wall total surface area and the body wall open surface area, the fraction of the surface area of the body wall that is open (i.e. that is part of an opening) can be calculated. This is a measure for the ‘openness’ of the body wall, and is a dimensionless number between 0 and 1. For the calculation of the fraction, it is preferred to only take into account openings with a surface area of at least 1.0 mm 2 , for example openings with a surface area of at least 2.0 mm 2 , at least 3.0 mm2, or at least 5.0 mm 2 . Openings that fall outside this range may be too small to have a significant beneficial effect.

The open surface area fraction in a device of the invention is usually in the range of 0.10-0.80, in particular in the range of 0.20-0.60, more in particular in the range of 0.30-0.50.

A device of the invention may comprise an opening at one or both ends of the hollow body. This means that such opening is located at that side of the flange that is opposite to the side where the hollow body is connected to the flange. Such opening allows fluid communication between the inner space and an environment outside the device. Such device then comprises at least two openings (because the other opening is present in the body wall), which has the advantage that it improves the air circulation from the inner space to the outside environment and vice versa. This, on its turn, results in a better ventilation of the toes.

In case the hollow body is of a cylindrical shape (round, elliptical or other shape), then such opening(s) result in the cylinder being open on the respective end.

When a device with a cylindrical hollow body comprises only one opening, it is typically present in the body wall as one elongated spiraling opening.

When a device with a cylindrical or cylindrical-like hollow body comprises two or more openings, at least one opening is present in the in the body wall. Other openings are then present either in the body wall or at an end of the cylinder. A device of the invention comprises one or two flanges on either end of the device. The function of the flange(s) is to secure the device between the toes of a user of the device. The one or two flanges themselves is/are not present between the toes but reside above and/or below them. When the device comprises only one flange, one end remains without a flange. The securing of the device between the toes is then not as good as with a flange on either side, but this may still be sufficient, depending on the person using the device, the presence of eventual footwear and the physical activities performed by the person.

A flange protrudes from the body wall, typically in a circumferential manner, i.e. a flange protrudes from the body wall around the entire circumference of the hollow body. A flange may be of a flat shape such as the shape of a disc (a thin circular object). It may also have a conical shape, e.g. it may have the shape of a cone wherein the cone has a first segment with a first cross-section of a first diameter and a second segment with second cross-section of a second diameter, the second cross-section being parallel to the first cross-section, wherein 1) the first diameter is smaller than the second diameter; and 2) the first diameter and the second diameter are measured in the same direction (i.e. they form two parallel lines, each line laying in the respective cross-sectional surface). In case of such conical shape, the first segment of the cone blends with the body wall to become an integrated whole; and wherein the larger diameter section forms the protrusion. Whereas a disc-shaped flange typically aligns with the normal to a cylindrical hollow body, a cone-shaped flange may have an angle of up to 60° with such normal, in particular of up to 45° or up to 30°. A smaller angle provides better securing between the toes than a larger angle.

In an embodiment, the hollow body has a non-circular cross-section and the flange is non-circular. In particular, the hollow body has an elliptic cross-section and the flange is elliptic. In such case, the shortest dimension of the hollow body cross-section is preferably perpendicular to the shortest dimension of the elliptic flange, when viewed along the axis that runs from the first end to the second end of the hollow body. When positioned between the toes, an improved securing is achieved with this configuration, since the longest dimension of the hollow body cross-section runs parallel to the toes and the longest dimension of the flange is perpendicular to the toes. When the hollow body is formed by a coil (as described above), the coil may also form the one or two flanges. This is typically accomplished by providing larger windings of the coil near one or both ends of the coil (and thus one or both ends of the hollow body). In this way, the one or two flanges can be shaped at either end of the hollow body and the whole device may consist of one coil. Thus, a device of the invention may comprise, or may even consist of, a coil, wherein the coil constitutes the hollow body as well as the one or two flanges.

A device of the invention may comprise an active pharmaceutical ingredient such as an antifungal agent, an antibacterial agent and/or an antiviral agent. The device is then typically designed to release such agent from the device, thereby allowing migration of the agent to the infected skin. The device may however contain an active agent (or a combination of active agents) as a non-releasable coating on the surface that comes into contact with infected skin. For example, metallic silver may be present at the surface.

The size of a device of the invention is in fact dictated by the size of the human (or animal) foot, because the device is designed to fit between the toes of a human. Therefore, the distance between the two ends of the hollow body is usually in the range of 1-5 cm, in particular in the range of 2-4 cm. Also, the largest dimension of the one or two flanges is usually in the range of 1-5 cm. The device usually fits in a sphere with a radius in the range of 2-8 cm, in particular of 3-7 cm, more in particular of 4-6 cm. The inner space usually has a volume in the range of 0.5-125 cm 3 , in particular in the range of 1-25 cm 3 , more in particular in the range of 3-15 cm 3 . The diameter of the cross-section of the hollow body is usually in the range of 0.5-5 cm, in particular in the range of 2-4 cm or in the range of 1-3 cm.

A device of the invention is designed to be positioned between the toes of a person. Its application is however not limited to humans; it may also be used by animals. It is then placed between the toes, hoofs, or equivalent body parts.

The benefits of the device can manifest during any activity of the person (or animal) wearing the device. During walking, for example, the device is repeatedly compressed and decompressed. This results in a subsequent decreasing and increasing of the volume of the inner space, so that passage of air occurs through the one or more openings. The displaced air then results in ventilation around the toes, thereby preventing or reducing the occurrence of athlete’s foot.

It is however not necessary to move the feet to experience the beneficial effects of a device of the invention. Also when the wearer of the device is sitting still or is asleep, the device improves the accessibility of air to the infected skin at and/or near the toes. It is preferred that for this use, the device comprises at least two openings, more preferably at least three openings.

In the case of two or more openings, convection of surrounding air through the hollow body (i.e. in its the inner space) may occur wherein the air enters the hollow body via an opening that is different from the opening through which it leaves the hollow body. Especially when the toes are not enclosed by any enclosing object such as a shoe or a sock, the surrounding air has a lower humidity than the air that is initially present in the hollow body. This aids the evaporation of water from a piece of toe skin or foot skin that is abutting ( e.g . at least partly covering) an opening, since such a stream of surrounding air passes over such piece of skin to thereby take up some of the humidity of the respective piece of skin.

Without wishing to be bound to any theory, it is contemplated that any such convection of air may occur naturally due to differences in the temperature inside the hollow body and outside the hollow body. Also movement of the toes, such as movement or displacement of the entire foot may induce convection of air through the hollow body. Both causes of convection are likely to occur when a person is awake {e.g. during employing activities) and having bare feet; or when a person is sleeping, especially when the feet are bare and are not covered by a blanket.

A device of the invention may therefore in particular be used with bare feet, preferably without any toe-enclosing footwear such as shoes, socks, and boots. In practice, this will often be during sleep.

The absence of footwear in general (also including partial toe-enclosure by slippers and sandals) allows more and faster evaporation of sweat and other residual water from the skin than when a foot is enclosed in footwear, which is beneficial because it is common practice to mitigate the fungus by decreasing the humidity of its surroundings. An advantage of a device wherein the hollow body comprises a coil, is that, independent of the positioning between the toes, a significant portion of the opening is not blocked by abutting skin, so that there is always enough ventilation around the toe. Also when there are a plurality of openings, in particular at least eight, which are evenly distributed around the surface of the hollow body, the toes become sufficiently ventilated.

Another advantage of such device is that it has an improved wearing comfort, since it does not restrain the toes.

Yet another advantage of such device is that it can conveniently be prepared in one piece, thereby severely reducing the occurrence of undesired surface irregularities.

The invention further relates to footwear comprising a device as described above. The footwear is for example selected from the group of shoes, socks, slippers, sandals and boots.

The invention further relates to an animal comprising a device as described above. In particular, the device is present between the toes (or the equivalent animal body portions) of the animal.

The invention further relates to a method of treating a human or animal foot suffering from athlete's foot or tinea pedis, comprising placing a device as described above between the toes of the human or animal. The method may also concern a prophylactic treatment, for example to be applied by a person before he or she is entering an area, such as a swimming pool or sanitary facilities, where he or she may get infected.

The invention further relates to the use of a device as described above for the treatment of athlete's foot, or tinea pedis.