Method and device for treating nail fungus

Abstract

A method for treating nail fungus includes providing a treatment element having a flexible elongate body. The elongate body has a first end and a second end opposite the first end. The first end and the second end define a length therebetween. An outer surface is defined along the length between the first end and the second end. The method further includes advancing at least a portion of the length of the treatment element to a target treatment site under a user's nail. The target treatment site is an area under the nail where fungal debris has accumulated. The method further includes applying a treatment agent to the target treatment site while simultaneously removing at least a portion of the fungal debris accumulation. The treatment element is then withdrawn from under the nail, thereby removing at least a portion of the released fungal debris.

Description

[Technical Field]

[0001] The present invention relates to the field of nail fungus treatment, and more particularly to an apparatus for treating nail fungus and methods of use thereof. [Background technology]

[0002] Toenail fungus is widespread on many walking surfaces and other surfaces where the toenail may be exposed. Onychomycosis (also known as onychomycosis) is a fungal infection of the nail that occurs frequently due to the widespread presence of toenail fungi. Onychomycosis can manifest as a foul odor, discoloration, and thickening of the nail (hyperkeratosis or hyperkeratosis, or onychomycosis), and may eventually lead to brittle nails and onycholysis (detachment of the nail from the nail bed). Onycholysis can occur when the fungus penetrates under the toenail, feeding and metabolizing the toenail and depositing subungual keratin (keratin) underneath the nail. When subungual keratin accumulates under the nail, it lifts the nail and separates it from the nail bed. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] US Patent Application Publication No. 2016 / 0135657 Summary of the Invention [Problem to be solved by the invention]

[0004] Various treatments for toenail fungus involve applying topical creams or ointments to the top or outer edge of the nail, but these do not adequately penetrate the fungus or the subungual keratin deposits underneath the nail.

[0005] Subungual keratin deposits can also be excavated from beneath the nail with a pick-type instrument. Pick-type instruments are only axially cleanable, in that they can only clean the small area of ​​the nail that the sharp tip of the pick touches. Thus, the axial cleaning motion requires multiple passes of the pick-type instrument before the entire width of the underside of the nail can be cleaned. Additionally, axial insertion of the pick can displace or compress subungual keratin debris toward the back of the nail, making debris removal more difficult. [Means for solving the problem]

[0006] SUMMARY OF THE INVENTION Embodiments of the present invention provide novel and unobvious methods and devices for treating nail fungus that address deficiencies in the art for treating nail fungus. According to one or more embodiments, a method for treating nail fungus includes providing a treatment element having a flexible elongated body. The elongated body has a first end and a second end opposite the first end. The first end and the second end define a length therebetween. An outer surface is defined along the length between the first end and the second end. The method further includes advancing at least a portion of the length of the treatment element to a target treatment site under a user's nail. The target treatment site is an area under the nail where fungal debris has accumulated. The method further includes applying a therapeutic agent to the target treatment site while simultaneously removing at least a portion of the fungal debris. The treatment element is then retracted from under the nail and at least a portion of the dislodgeing fungal debris buildup is extracted.

[0007] In one embodiment, at least one of planar and lateral movement is applied to the treatment element when dislodging at least a portion of the fungal debris deposit and applying the treatment agent. In another embodiment, at least a portion of the exterior surface is coated with a therapeutic agent.

[0008] In another embodiment, the elongate body is saturated (permeated) with the therapeutic agent. In another embodiment, the claw is positioned between the first and second ends of the elongate body when the treatment element is advanced toward the target treatment site.

[0009] In another embodiment, the treatment element has a contoured profile and the treatment element has a plurality of protrusions defined along its length. In another embodiment, the treating element is one of a string, a thread, a filament, a bundle of filaments, a wire, a cable, and a thin tape. The treating element has flexibility such that the elongate body can be contoured and manipulated to achieve a desired shape to follow the contours of the target site under the nail.

[0010] In another embodiment, the first end and the second end of the elongate body are each configured to be wrapped around a user's finger before and during movement of the treatment element under the nail. In another embodiment, the first end and the second end of the elongate body are each coupled to a handle of a treatment device sized and configured to be held by a user.

[0011] In another embodiment, the therapeutic element is formed from at least one material selected from the group consisting of nylon, Teflon, polypropylene, silk, polyester, or any material, or any combination thereof.

[0012] In another aspect, the elongate body is formed from a plurality of filaments wound together in a bundle. According to one or more additional embodiments, a nail fungus treatment device includes a treatment element having a flexible elongate body defining a length and having an outer surface. The outer surface is coated with a treatment agent. The elongate body is sized and configured to be received under a user's nail and advanced toward a target treatment site, which is an area under the nail where fungal debris has accumulated.

[0013] In one embodiment, the treatment element is configured to dislodge and extract at least a portion of the fungal debris deposit through at least one of planar and lateral movement of the elongate body outward toward the distal end of the nail, while simultaneously applying a therapeutic agent to the target treatment site when in contact with the target treatment site.

[0014] In another embodiment, the therapeutic element is saturated with the therapeutic agent. In another aspect, the elongate body is contoured and has a plurality of protrusions defined along its length.

[0015] In another embodiment, the therapeutic element is one of a string, a thread, a filament, a bundle of filaments, a wire, a cable, and a thin tape. In another embodiment, the elongate body includes a first end and a second end opposite the first end, each configured to wrap around a user's finger before and during movement of the treatment element under the nail.

[0016] In another aspect, the elongate body has a first end and a second end opposite the first end, each end being coupled to a handle of a treatment device sized and configured to be held by a user.

[0017] In another embodiment, the therapeutic element is formed from at least one material selected from the group consisting of nylon, Teflon, polypropylene, silk, polyester, or any material, or any combination thereof.

[0018] According to one or more embodiments, a nail fungus treatment device includes a treatment element having a flexible elongate body. The flexible elongate body has a first end and a second end opposite the first end. The first end and the second end define a length therebetween. The flexible elongate body further has an outer surface defined along the length between the first end and the second end. The outer surface is either coated or saturated with an antifungal agent. The treatment element is sized and configured to be received under a user's nail and advance toward a target treatment site, the target treatment site being an area under the nail where fungal debris has accumulated. The treatment element is sized and configured to allow advancement toward the target treatment site, dislodging and removing at least a portion of the accumulated fungal debris through at least one of planar and lateral movement of the flexible elongate body toward the distal end of the nail, and applying a therapeutic agent to the target treatment site upon physical contact with the target treatment site.

[0019] Additional aspects of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. Aspects of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

[0020] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. The embodiments illustrated herein are presently preferred, however, it will be understood that the invention is not limited to the precise arrangements and equipment shown. [Brief explanation of the drawings]

[0021] [Figure 1] 1 illustrates the treatment of a target nail with a flexible treatment element in accordance with the principles of the present invention. [Figure 2] 2 illustrates the flexible therapeutic element of FIG. 1 constructed in accordance with the principles of the present invention. [Figure 3] 1-2 illustrate a flexible treatment element defining a plurality of protrusions in accordance with the principles of the present invention. [Figure 4A] 1-3 illustrate the positioning of the treatment element of FIGS. 1-3 prior to advancement under a patient's target nail in accordance with the principles of the present invention. [Figure 4B] 1-4A as advanced to a target treatment site beneath a target nail in accordance with the principles of the present invention. [Figure 4C] 1-4C illustrate the lateral movement of the treatment element of FIGS. 1-4B when positioned at a target treatment site to remove fungal debris in accordance with the principles of the present invention. [Figure 4D] 1-4C illustrate the lateral movement of the treatment element of FIGS. 1-4B when positioned at a target treatment site to remove fungal debris in accordance with the principles of the present invention. [Figure 4E] 1-4D illustrate the removal of fungal debris from the target treatment site as the treatment element of FIGS. 1-4D is withdrawn from under the target nail in accordance with the principles of the present invention. [Figure 5] In accordance with the principles of the present invention, the therapeutic element of FIGS. 1-4E illustrates an exemplary embodiment in which it is affixed to the distal end of a handle. [Figure 6] 1 shows a flowchart of a process for treating nail fungus using the treatment elements of FIGS. 1-5 in accordance with the principles of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0022] Embodiments of the present invention provide methods and apparatus for treating nail fungus. Referring now to the drawing figures, in which like reference designators refer to like elements, FIG. 1 shows an exemplary apparatus suitable for treating nail fungus. In one or more embodiments, the apparatus includes a treatment element, generally designated "10," having a flexible elongated body 12. The flexibility of the elongated body 12 allows the treatment element 10 to have a free-form body that is free to distort and stretch to achieve various positions. The treatment element 10 can also be freely manipulated by a user to assume a desired shape or other positioning, particularly to substantially conform to the contour of the user's underlying nail. This contour may vary from user to user and may change during the treatment process as debris is removed. The elongated body 12 has a first end 14 and a second end 16 opposite the first end 14, defining a length therebetween. An outer surface 18 is defined along the length between the first end 14 and the second end 16. The elongate body 12 of the treatment element 10 may have a contoured profile and a circular or substantially circular cross-section that is smaller than its length. The treatment element 10 may be a flexible string, thread, filament, a bundle of wound filaments, a wire, a cable, or a thin tape sized and configured to be received under the free edge 20 and nail plate 22 of a user's, subject's, or patient's toenail or fingernail, and coated or saturated with an antifungal agent. By way of non-limiting example, the treatment element 10 may be formed from at least one of nylon, Teflon, polypropylene, silk, polyester, or any combination thereof.

[0023] As used herein, it should be understood that "string" may be used to generally refer to a flexible, manipulable thread, filament, bundle of filaments, wire, cable, or thin tape that is sized and configured to be received under the user's free edge 20 and nail plate 22. A flexible elongate body may be considered a thin or elongate object having a relatively small cross-section relative to the length of the elongate body, for example, on the order of 50 mils to 100 mils (about 1.27 mm to about 2.54 mm) in diameter.

[0024] As shown in FIG. 2, the treatment element 10 may be coated or saturated (impregnated) with a treatment agent—e.g., an antifungal agent—suitable for treating keratin deposits (i.e., fungal debris) under the nail and reducing or eliminating (reducing) their growth and spread. The antifungal agent may be, for example, terbinafine, ketoconazole, clotrimazole, zinc undecylenate, undecylenic acid, or any other agent used to treat nail infections, or any antifungal agent, or any combination thereof. Furthermore, in some embodiments, the treatment element 10 may have an undulating profile and a uniform shape or diameter along the length of the elongate body 12. However, in other embodiments, such as shown in FIG. 3, the treatment element 10 may have a helical or braided configuration with increasing and decreasing diameter along the length of the elongate body 12. In some such configurations, the elongate body 12 may define protrusions along its length configured to facilitate scraping of subungual keratin deposits from under the nail upon contact with the target treatment area.

[0025] 4A-4E, use of the treatment element 10 during a treatment procedure is illustrated. As shown, the first end 14 and the second end 16 of the elongated body 12 can be held by a user. For example, the first end 14 can be grasped by the user's left hand, and the second end 16 can be grasped by the user's right hand. As shown in FIG. 4A, the treatment element 10 is then extended beneath the free edge 20 and nail plate 22 of the nail (toenail or fingernail) and advanced toward the target treatment site within the nail bed. As described herein, the target treatment site is the subungual keratin deposit area beneath the nail plate 22. The treatment element 10 is advanced from the distal end of the free edge 20 toward the back of the nail plate or the proximal end of the nail edge terminating at the nail plate 22 (FIG. 4B), while moving without scraping (scraping or scraping) the subungual keratin deposit to avoid further compressing and forcing debris under the nail plate 22. Upward pressure is then applied to the subungual keratin deposit through the treatment element 10, and the treatment element is then withdrawn from the back of the nail toward the free edge 20, simultaneously scraping the subungual keratin deposit and applying the antifungal agent. The treatment element 10 can also be moved back and forth under the nail, as shown in FIGS. 4C-4D, to further remove the subungual keratin deposit and apply the antifungal agent. Once the treatment element 10 has scraped the desired amount of subungual keratin, the treatment element 10 may then be withdrawn and removed from under the user's nail (FIG. 4E).

[0026] The outward movement of the treatment element 10 allows for a planar cleaning (cleaning) motion across the underside of the nail, as opposed to an axial cleaning motion. Thus, the treatment element 10 can extend across the entire width of the nail (side to side), or across at least a greater portion of the width of the nail than an axial cleaning (straight-line cleaning) motion would allow. The treatment element 10 can be moved outward in a planar cleaning motion substantially perpendicular to the sides of the nail, extending across the entire width of the nail (side to side). Additionally, although not shown, a user can extend the treatment element 10 less than the entire width of the nail to allow for a planar cleaning motion across the underside of the nail at a different angle to further remove subungual keratin deposits and apply antifungal medication. The string-like device can be wrapped around an end user's finger or attached to a handle or frame (as shown in FIG. 5 ) so that the end user can hold the frame between their fingers. The contoured profile is enabled to provide projections that allow the string-like implement to scrape subungual keratin deposits from under the nail.

[0027] According to one or more embodiments, the treatment agent of the treatment element 10 can also be applied topically to the upper or outer surface of the user's nail plate 22. For example, rather than maneuvering the treatment element 10 under the user's nail plate 22, the treatment element 10 can instead be used or brushed (scraped or lightly traced) against the upper or outer surface of the nail plate 22, while applying the treatment agent directly to the upper or outer surface of the nail plate 22. This allows the user to more effectively treat or inhibit the growth of nail fungus by applying the treatment agent to both the upper or outer surface of the nail plate 22, as well as the underside of the nail plate 22. As a non-limiting example, when applied topically to the nail plate 22, the treatment element 10 can be a flexible "string"-like device.

[0028] 5, the treatment element 10 is attached, affixed, or otherwise coupled to a distal end 24 of a handle 26 that may be held between the fingers of an end user to assist the user in reaching the target nail for treatment and / or advancing the treatment element 10 in a planar cleaning motion under the nail. However, it should be understood that in some embodiments, the treatment element 10 is not coupled to the handle 26 and therefore may be wrapped around the end user's finger to extend the string-like device in a planar cleaning motion under the nail.

[0029] Referring now to FIG. 6, a flowchart illustrating a method for treating nail fungus is shown. The method includes providing a treatment element 10 (whether physically held by a user's hand, wrapped around a user's finger, or coupled to the distal end 24 of a handle 26) (block S600) and advancing at least a portion of the length of the treatment element to a target treatment site under the nail of a user, subject, or patient (block S602). The target treatment site is the subungual keratin deposit area under the nail. The treatment element 10 then applies force to the fungal debris in a planar and / or lateral motion to scrape and / or peel the fungal debris from the nail bed (block S604). As the treatment element 10 contacts the fungal debris, the antifungal agent applied to or saturated in the treatment element 10 is simultaneously applied to the target treatment area (including the nail bed) and reduces or eliminates subungual keratin deposits (Block S606). Once the desired amount of fungal debris has been removed, the fungal debris is then removed from under the nail by withdrawing the treatment element 10 outward beyond the free edge 20 of the nail plate 22 (Block S608).

[0030] Although specific embodiments of the present invention have been disclosed, those skilled in the art will recognize that changes can be made to the specific embodiments without departing from the spirit and scope of the invention. Accordingly, the scope of the present invention is not limited to the specific embodiments. Furthermore, the appended claims are intended to cover all such applications, modifications, and embodiments within the scope of the present invention.

[0031] Finally, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Furthermore, as used herein, it will be understood that the terms "comprises" and / or "comprising" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0032] Corresponding structure, material, acts, and equivalents of all means or step-plus-function elements in the following claims are intended to include any structure, material, or acts for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or to limit the invention to the form disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments have been chosen and described to best explain the principles and practical applications of the invention and to enable those skilled in the art to understand the invention in various embodiments with various modifications suited to the particular uses contemplated.

[0033] Having thus described the invention of this application in detail and with reference to embodiments thereof, it will be apparent that modifications and variations are possible without departing from the scope of the invention as defined in the appended claims below.

Claims

1. 1. A method of treating nail fungus, said method comprising: providing a treatment element, the treatment element comprising a flexible elongate body, the elongate body being capable of being distorted and manipulated to achieve a desired shape under the nail, the elongate body comprising: a first end and a second end opposite the first end, the first end and the second end defining a length therebetween; an outer surface defined along the length between the first end and the second end; and presenting a therapeutic agent on the outer surface; advancing at least a portion of the length of the treatment element to a target treatment site under the user's nail, the target treatment site being an area under the nail where fungal debris has accumulated; removing at least a portion of the fungal debris deposit while simultaneously applying the therapeutic agent to the target treatment site; and withdrawing the treatment element from under the nail and removing at least a portion of the detached fungal debris deposit; The method comprises:

2. applying at least one of planar and lateral movements to the treatment element while removing at least a portion of the fungal debris deposit and applying the treatment agent; The method of claim 1.

3. At least a portion of the exterior surface is coated with the therapeutic agent. The method of claim 1.

4. the elongate body being saturated with the therapeutic agent; The method of claim 1.

5. When the treatment element is advanced toward the target treatment site, the claw is disposed between the first end and the second end of the elongate body. The method of claim 1.

6. the elongate body has an undulating shape; the elongate body having a plurality of protrusions defined along its length; The method of claim 1.

7. the elongate body is one of a string, a thread, a filament, a bundle of filaments, a wire, a cable, and a thin tape; The method of claim 1.

8. the first end and the second end of the elongate body are each configured to wrap around a user's finger before and during movement of the treatment element under the nail; The method of claim 1.

9. the first end and the second end of the elongate body are each coupled to a handle of a treatment device sized and configured to be held by a user; The method of claim 1.

10. the therapeutic element is formed from at least one material selected from the group consisting of nylon, Teflon, polypropylene, silk, polyester, or any material, or any combination thereof; The method of claim 1.

11. the elongate body being formed from a plurality of filaments wound together in a bundle; The method of claim 1.

12. A device as a nail fungus treatment device, The device includes a treatment element having a flexible elongate body; the elongate body defining a length and having an outer surface, a therapeutic agent presented on the outer surface, the elongate body having flexibility that allows the elongate body to be distorted and manipulated to achieve a desired shape; the elongated body is sized and configured to be received under a user's nail and advanced toward a target treatment area, the target treatment area being an area under the nail where fungal debris has accumulated; Equipment.

13. the treatment element is configured to simultaneously dislodge and remove at least a portion of the fungal debris deposit and apply the treatment agent to the target treatment area upon contact with the target treatment area by at least one of planar and lateral movement of the elongate body outward toward the distal end of the nail; 13. The device of claim 12.

14. the therapeutic element is saturated with the therapeutic agent; 13. The device of claim 12.

15. the elongate body is laterally contoured and the elongate body has a plurality of protrusions along its length; 13. The device of claim 12.

16. the therapeutic element is one of a string, a thread, a filament, a bundle of filaments, a wire, a cable, and a thin tape; 13. The device of claim 12.

17. The elongate body has a first end and a second end opposite the first end, the first end and the second end of the elongate body are each configured to wrap around a user's finger before and during movement of the treatment element under the nail; 13. The device of claim 12.

18. the elongate body having a first end and an opposite second end; each of the first end and the second end being coupled to a handle of a treatment device sized and configured to be held by a user; 13. The device of claim 12.

19. The therapeutic element is formed from at least one material selected from the group consisting of nylon, Teflon, polypropylene, silk, polyester, or any material, or combination thereof; 13. The device of claim 12.

20. A device for treating nail fungus, the device comprising a treatment element having a flexible elongate body, the elongate body has a first end and a second end opposite the first end, the first end and the second end defining a length therebetween; the elongate body having an exterior surface defined along the length between the first end and the second end, the exterior surface presenting an antifungal agent; The therapeutic element is being received under a user's nail and advanced toward a target treatment site, the target treatment site being an area under the nail where fungal debris has accumulated; loosening and removing at least a portion of the fungal debris deposit through at least one of planar and lateral movement of the flexible elongate body toward the distal end of the nail; applying a therapeutic agent to the target treatment site upon physical contact with the target treatment site; and having a size and configuration that allows Equipment.

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