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Title:
IMPROVED FOOTWEAR WITH MEDICINE EMITTING PROPERTIES
Document Type and Number:
WIPO Patent Application WO/1998/002056
Kind Code:
A2
Abstract:
Improved footwear having medicine emitting properties for the prevention and treatment of foot diseases acquired by contact with external disease carrying agents.

Inventors:
KEOUGH STEVEN J (US)
Application Number:
PCT/US1997/012576
Publication Date:
January 22, 1998
Filing Date:
July 11, 1997
Export Citation:
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Assignee:
KEOUGH STEVEN J (US)
International Classes:
A43B3/00; (IPC1-7): A43B/
Attorney, Agent or Firm:
Thuente, John F. (P.A. 1200 Rand Tower, 527 Marquette Avenue Sout, Minneapolis MN, US)
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Claims:
WHAT IS CLAIMED IS:
1. An improved article of footwear having medicine emitting properties, comprising: an outsole portion; a support member attached to the outsole portion configurable to provide support and attachment to a wearer's foot; and medicinal dispensing means for dispensing a medicine to a wearer's foot when in an environment of high humidity.
2. The article of claim 1, in which the medicine comprises a fungicide, a fungistat or a bactericide.
3. The article of claim 1, in which the medicinal dispensing means comprises a medicine dispensing element which is in removable contact with the article of footwear.
4. The article of claim 1, in which the medicinal dispensing means comprises the support member having both a medicinal formulation portion and a strengthening portion.
5. The article of claim 1, in which the medicinal dispensing means is positioned within the outsole.
6. The article of claim 1 in which the outsole portion comprises a portion of the support member, and the support member comprises a flexible substrate material worn as a sock by the wearer.
7. A sandal, comprising: an outsole; a support member attached to the outsole configurable to provide support and attachment to a wearer's foot; and a medicinal dispensing elements having a medicinal formulation with an active ingredient, the medicinal formulation positioned within the sandal such that the medicinal formulation is exposed to moisture when the sandal is worn in a humid environment, the positioning allowing the moisture to transport the active ingredient from the article of footwear to the foot to deliver an effective dosage of the active ingredient to the foot.
8. A method of manufacturing an improved footwear article, comprising the steps of: providing an outsole portion; providing a support member configured for attachment to the outsole portion and suitable for providing support and attachment to a wearer's foot; and configuring a medicinal dispensing element as part of the footwear relative to the expected location of the wearer's foot so that the medicinal dispensing element may dispense a medicine in an effective dosage for contact with the wearer's foot when the footwear is an environment of high humidity.
9. The method of claim 8, wherein the medicinal dispensing element is replaceable.
10. A medicinal dispensing article for use in contact with a user's foot, the article comprising a medicinal formulation with an active ingredient, the medicinal formulation being situated within the article such that the formulation is exposed to a fluid when the footwear is worn, the fluid transporting the active ingredient from article to the foot, thereby delivering an effective dosage of the active ingredient to the foot.
11. The article of claim 10, in which the article is a sock.
12. The article of claim 10, in which the article is an insole worn on an outsole of an article of footwear.
Description:
IMPROVED FOOTWEAR WITH MEDICINE EMITTING PROPERTIES

Field of the Invention The invention relates to improved footwear, and more particularly to footwear with medicine emitting properties.

Background of the Invention It is common for individuals to wear footwear when using public showers or other similar facilities. For example, individuals at athletic clubs, swimming pools and other such public use facilities, where water is present on the floors of such facilities, normally wear footwear that is known in the United States as shower shoes. Such footwear is designed to keep the user's bare feet off of the floor in order to minimize or prevent the user from becoming infected with various diseases. It is quite common in such facilities for fungal inoculum to be present and to spread to and thereby infect the feet of users who do not have adequate protection. However, even those users who utilize some form of footwear may be subject to infection due to splashing of water near the floor. It is estimated that a sizable percentage of the population of the United States suffers from some form of preventable foot infection daily. Such a percentage is likely experienced in other countries as well. These infections may have a relatively short course, or may result in a persistent, more threatening form.

This invention comprises features designed to overcome such health risks and to encourage more users to wear certain footwear or partial foot coverings designed to reduce the overall rate of spread of such diseases. This invention contemplates a wide array of preventive or therapeutic uses as well.

Brief Description of the Drawings Figure 1 is a top plan view of representative footwear according to the invention.

Figure 2 is a side view of the footwear of Figure 1. Figure 3 is a bottom plan view of the footwear of Figure 1.

Figure 4 is a section view taken along lines 4-4 in Figure 2. Figure 5 is a top plan view of an embodiment of the present invention with a narrow strapped support member.

Figure 6 is a top plan view of another embodiment of the present invention with a support member surrounding a portion of the foot.

Figure 7 is a medial side plan view of another embodiment of the present invention configured as a disposable sock.

Figure 8 is a top plan view of the disposable sock of Figure 7. Figure 9 is a top plan view of a footwear insert embodiment of the invention.

These figures, which are idealized, are not to scale and are intended to be merely illustrative and non-limiting.

Detailed Description of the Invention Figure 1 is a top plan view of a type of partial foot covering, referred to below generally as footwear, designed for use in locations prone to infection or other disease dangerous to humans and transmittable via contact with the human foot. In particular, this footwear is often designed for use in public shower facilities or around swimming pools and similar facilities where the risk of fungal infections and other health risks is high.

Footwear 10 has many possible design configurations, with that shown in Figure 1 as merely an illustrative first embodiment. In this embodiment, an outsole 50 is configured as a basic support for the foot, and preferably is made of material that is nonabsorbent to water and which has some slip-resistant characteristics. One such material is rubber, with numerous other materials being acceptable. Outsole 50 comprises an

upper surface 52 configured for providing a plurality of apertures, which in Figure 1 are denoted as apertures 20, 30 and 40.

Support means, such as support member 60, provides support and attachment of the footwear 10 to a wearer's foot. Preferably, support member 60 is configured for use by the wearer so that the footwear 10 can be easily and rapidly placed on the wearer's foot and removed with little effort. It is recognized, however, that a more elaborate support means is possible and is within the scope of this invention.

Referring to Figure 2 and Figure 3, one embodiment of support member 60 is shown with a protruding portion 70 extending through apertures 20 and 30. The protruding portion extending through aperture 40 is not shown, but may be similar. A simple connection of support member 60 to outsole 50 is via protruding portion 70 extending through the thickness of outsole 50, and with a flexible, disc-shaped terminus 75 of protruding portion 70 resting in a recessed portion 76 of the bottom surface 80 of the outsole 50 being a preferred means of attachment. Regardless of the specific construction of the connecting means between the support member 60 and the outsole 50, and many different means of connection are possible, it is preferable to have a construction suitable to readily remove and replace support member 60 at the will of the user.

An important feature of this invention resides in the construction of support member 60 so that when the support member 60 is in a high moisture, humid, or wet environment, certain protective features are enhanced. In particular, referring to Figure 4, a cross section of a representative support member 60 is shown. In this view, support member 60 comprises a novel construction having strengthening portions 90 and medicinal portions 100. Strengthening portions 90 are manufactured from materials designed to provide strength and support to the wearer's foot and for attachment to the outsole 50. Medicinal portions 100, shown in schematic form in Figure 4, comprise substantially solidly formed amounts of antifungal medicinal formulation, or other disease-resistant medicinal formulations with base

medicines as active ingredients. Examples of such base medicines include fungicides such as clotrimazole, tolnaftate and antibiotics such as penicillin, tetracycline and ampicillin, as well as substances that are fungistatic and thus serve to inhibit the growth and development of fungi, thereby inhibiting infection of the foot by fungal pathogens as are known in the art. Other medicines are clearly contemplated and likely fall within the scope of this invention. The base medicines, either singly or in combination, may be combined with carrier components which may be in more solid form than the medicine and which provide the support and longevity for the medicinal portions over the design life of the support members. These carrier components or other components of the medicinal formulations may also act to solubilize or suspend the active ingredient in water, thereby enabling the active ingredient, which can be insoluble in water, to become either suspended in an emulsion or otherwise become mobilized within the liquid water from the floor of the public shower, swimming pool or other facility. Still other ingredients of the medicinal formulation may be present to retard the activity of the water in solubilizing or suspending the active ingredients, so that only an effective dosage of active ingredient is released within a given time of exposure of the medicinal formulation to water. The general technology of effecting a similar "timed release" formulation is known in the medical arts as well as in the fertilizer industry.

In one type of use, support member 60 is attached to outsole 50. The wearer may then use the footwear 10 by walking into a shower facility. In such use, water from the shower facility contacts the medicinal portions 100, causing release of the antifungal or antibacterial medicine. The antifungal or antibacterial medicine is designed for a controlled release during these conditions so that it is allowed to flow down and around the wearer's foot, and provide protection to the foot at the locations normally susceptible to disease. The most likely of such locations include the areas between and beneath toes, the medial and lateral portions of the foot, and the insole area, although other areas are also contemplated. Various

configurations of support member 60 are possible within the scope of the invention to enhance individual protective and therapeutic needs of the wearer. In similar manner, the medicinal formulation may be part of the support member or part of the outsole, where such exists in the various embodiments.

It is emphasized that the most likely critical event to enable the preventive and therapeutic properties of the present invention is the occurrence of a liquid, such as water, or even perspiration, upon the medicinal formulation and the subsequent exposure of the wearer's foot to the active ingredient then contained within the liquid. This event can occur whether or not the wearer is in a shower or pool area. Indeed, conditions of high moisture or high humidity in the vicinity of the wearer's foot, as when wearing a shoe or boot, would also enable the therapeutic properties of the present invention to become manifest. It is further recognized that certain therapeutic properties of certain embodiments of this invention may aid users in relatively dry conditions. One example includes footwear of the invention useful by persons suffering from diabetes.

Figure 5 is a top plan view of another embodiment of the invention. In this embodiment, the support means comprises support member 160 which is a strap affixed to the outsole 50 by such means as bonding, stitching or riveting as known in the art. The medicinal formulation of the present invention can be either injected, embedded or impregnated into support member 160, outsole 50 or both. Also, apertures within support member 160 may allow release of the medicinal formulation in accordance with this invention. The medicinal formulation could also be formed as a removable and replaceable insert, as illustratively shown and bounded by lines 162. Insert 162 may be held within a pocket or otherwise attached to the inner portion of support member 160 by means of snaps, hook and loop type of fasteners, zippers, or other means.

Figure 6 is a top plan view of another embodiment of the invention. In this embodiment support member 260 and walls 261 surround the periphery of the foot. Support member 260 has resilient means for supporting and retaining the walls 261 at a desired elevation along the periphery of outsole 50. Preferably constructed of pliable materials as may be known in the art, support member 260 is either embedded or impregnated with a medicinal formulation according to the teachings of this invention. Support member 260 and walls 261 are depicted in Figure 6 as having elliptical or other shaped slits 263 to aid in air and water exchange, and for drying, but can be with or without openings. Outsole 50 can also be impregnated or imbedded with medicinal formulations, or it can also be of similar materials to walls 261.

Figures 7 and 8 depict another embodiment of the invention comprising a disposable sock or similar type of flexible foot covering which may cover all or part of the foot or lower leg region. Figure 7 is a side elevation view and Figure 8 is a top plan view. In use the wearer places the foot covering 170 on the wearer's foot in the same manner as any other sock or anklet is donned. The embodiment is optionally worn inside a shoe or boot, in the case or a single-use embodiment, preferably for a single period of time such as a normal work day or work shift, then discarded. The medicinal formulation of the present invention is impregnated in portions of the sock or anklet so as to enable the active ingredient to be transferred or transported to a site on the wearer's foot where the active ingredient either inhibits the onset of foot disease or treats an existing disease. Portions of the sock or anklet where the medicinal formulation of the present invention might be impregnated are the upper toe 172, the lower toe 174, and/or the medial or arch 176. However, any portion of the sock might be impregnated or otherwise have the medicinal formulation present, including the entire portion or several portions thereof. If the medial or arch portion 176 of the sock or anklet is impregnated with the formulation of the present invention, some indication, such as a dye, as to which side of the sock or anklet is treated

might be desirable in order to enable the wearer to quickly discern a left from a right sock or anklet and thus correctly position the medicinal formulation impregnated in this portion adjacent to the wearer's arch. One advantage of this embodiment of the present invention is elimination of the risk of donning a sock containing viable foot disease inoculum, inoculum not eliminated or killed during laundering and which may infect, or reinfect, the wearer's foot during subsequent wear. Another advantage is the administering of more enduring and effective topical dosages of active ingredient or medication to the skin surface for the treatment of foot disease than is now possible with conventional ointments, sprays or powders. Since moisture would be necessary in order for the active ingredient to contact the skin of the wearer's foot and since moisture is usually necessary for infection to occur, the only time the active ingredient would likely be in contact with the wearer's foot would be when infection is likely to occur, therefore the appropriate dosage could be administered when needed by the wearer.

Any material that might be suitable for use as a sock or stocking, such as nylon, cotton, wool, or blends such as cotton-wool, or cotton- synthetic, would also be suitable for impregnation and wear by the user, provided that the substrate material is able to absorb or retain and then release an effective amount of medicinal material. Indeed, the apparel could then be worn and laundered repeatedly as any normal sock, even after the medication has been used. Also, materials, such as paper and plastic products, are suitable that, while lacking the ability to withstand multiple wearings and launderings, would be otherwise suitable for a single use. Generally, the technology for such single-use materials is known due to wide usage of these materials in surgical wear and for protective clothing used when handling restricted use pesticides or other materials, as well as in materials for use in the release of fabric conditioning agents during laundry cycles. While shown to be a sock or anklet for wear next to the wearer's foot and inside a shoe or boot, the invention, especially in the single-use embodiment, can also be a thin

piece of foot apparel worn next to the foot and inside a conventional sock. Another advantage of this embodiment of the present invention is the ease to which it can be manufactured and packaged for either low volume or high volume compact dispensing. A wide array of materials would be suitable for either type of sock or anklet and thus the ease of obtaining materials at favorable prices and that possess favorable attributes in facilitating the impregnation or placement of the medicinal formulation and in aiding its application to the desired site on the wearer's foot would be apparent. Similarly, the single-use embodiments of this invention could be packaged in a wide assortment of sizes in packaging intended to supply the wearer for a given period of time, such as a pre-determined number of hours or days. The single-use embodiments could also be color coded or packaged in distinctive packaging to indicate the particular active ingredient present and the concentration of the active ingredient, thereby enabling the wearer and others to more easily determine the identity of this invention. A perfume agent may also be used with embodiments of this invention, as may be the use of various traction means to minimize the risk of slipping while using such footwear.

Figure 9 is a top plan view of a further embodiment of the invention comprising an insert liner or insole 110. Insert liner 110, here shown with a slot 115 to allow for insertion or placement on the outsole 50 of Figure 1, has embedded or impregnated within its upper surface a medicinal formulation according to this invention to prevent or to treat fungal or bacterial infections of the foot. Insert liner 110 can also be inserted within shoes or boots as an insole and can be made with or without the slotted opening or openings, as shown in Figure 9. Insert liner 110 may also constitute an arch support, thus combining the purposes of arch support for the foot and serving as a therapy to, or prevention of, fungal or bacterial infection. At the completion of each use of the multiple-use embodiments, the wearer can remove moisture from the medicinal portions by simply drying such portions with virtually any means available, such as a towel,

athletic clothing, exposure to ambient air or even a hot air dryer. Once the moisture is removed from the medicinal portions, then the release of active ingredient is stopped and the footwear is reconfigured for further user at a later time. Depending on the frequency and duration of use of each individual wearer or the rate of release of the active ingredient, the support members may be replaced at various times by the wearer. It is also recognized that certain medicines may require limited exposures to the wearer due to allergies or other considerations, as such factors may affect the replacement and /or reuse of articles using this invention. Yet another embodiment of the invention comprises rubber or plastic footwear similar to that known as diver's boots or aqua-socks, but having means for dispensing the medicinal materials described above. This embodiment actually promotes foot perspiration and rapid application of the medicinal materials. However, in this embodiment there is generally no dispersal of body fluids or medicinal materials outside of the footwear.

When properly used, the invention provides articles of footwear or foot covering designed for greatly easing the discomfort of millions of people caused by contagious spread of fungal and other infections, including parasitic infestations. The invention is, therefore, of a nature which greatly improves the public health of the population. Indeed, it is recognized that the invention may even be applicable to footwear of a more general nature designed for users who normally would wear such type of footwear in the normal course of daily wear, as illustrated in some of the embodiments of this invention. For example, regions in which individuals are susceptible to high daily humidity, or plentiful rain, may choose to utilize footwear or components thereof having the innovative features disclosed above in order to reduce the risk of foot infection each day. The invention also clearly discloses a previously unknown method of treatment for a persistent and well known disease. Various methods of manufacturing the improved footwear are also disclosed.

Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention.