Set depth nail notcher with patch system and method for...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into body by contact with wound...

Reexamination Certificate

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C604S293000, C604S304000, C604S500000, C606S172000, C132S075400

Reexamination Certificate

active

06572580

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a system including a nail notcher for cutting a notch in a nail plate and a patch to assist in holding anti-fungal medication in place. The present invention also relates to a method for applying topical anti-fungal composition to fungus underneath a nail by applying the composition through the notch cut by the nail notcher of the present invention and placing a patch over the notch to assist in holding the anti-fungal medication in place.
2. Background Discussion
A human's nail has a nail plate, which is a hard outer surface of dead cells, and a nail bed below the nail plate. The nail plate is non-porous, whereas the nail bed is porous. There is soft flesh beneath the nail bed. The nail plate and the nail bed are relatively insensitive to pain. The underlying flesh is sensitive to pain. The nail plate, nail bed, and, in severe cases, the flesh below the nail bed can be infected by a wide variety of common fungi. Such fungi are responsible for nail infections, medically known as onychomycosis. Examples of onychomycosis are caused by fungi, such as trichophyton mentagrophytes, candida albicans or trichophyton rubrum. Other terms for onychomycosis are ringworm of nails or tinea unguium.
It is difficult to treat such infections. Although the infections are highly localized, they are located in a part of the body which is difficult to reach. U.S. Pat. No. 5,573,786 discloses application of the composition for treating fungal diseases of the skin and mucus membrane with a small, pointy wooden stick or thin plastic porous plastic stick, or brush for treating large areas. Its Example 11 discloses onychomycosis treatment of a fingernail. However, the Example emphasizes that its preparation is suitable for treating superficial onychomycotic infections. In the case of infection of the nail bed, however, therapy must be carried out together with an oral antimycotic. U.S. Pat. No. 5,573,786 is incorporated herein by reference.
U.S. Pat. No. 5,696,105 discloses drilling holes in nails to apply anti-fungal medication, as an attempt to improve topical administration of medication. U.S. Pat. No. 5,696,105 also discloses other local measures to treat nail fungus include mechanical ablation of affected nail areas, or nail removal. U.S. Pat. No. 5,696,105 is incorporated herein by reference. U.S. Pat. No. 5,696,105 also discloses application of anti-fungal medication with a brush or an applicator tipped bottle.
Rather than directly applying topical anti-fungal medication, systemic treatments are also employed. However, such systemic treatments spread medication throughout the patient's body. Thus, the medicine is not concentrated in the infected area and may cause side-effects.
It would be desirable to provide a medication for treating nail fungus, particularly toenail fungus, which easily can be directly applied to the nail to result in effective, painless and bloodless treatment.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a system including a set depth nail notcher for cutting a notch in a fingernail or toenail plate.
It is another object of the invention to provide a method for applying topical anti-fungal medication to an infected nail area through a notch cut in the nail plate by the set depth nail notcher of the present invention and placing the patch impregnated with or otherwise containing anti-fungal medication over the notch.
In its apparatus respects, the present invention relates to a system including a set depth nail notcher for cutting a notch of predetermined depth in a fingernail or a toenail plate and a patch for holding anti-fungal medication in place and delivering the medication to the notch and underlying tissue. The nail notcher comprises a handle having a smooth flat surface and a longitudinal cutting edge protruding from the smooth flat surface. The longitudinal cutting edge protrudes from the smooth flat surface to a height equal to the predetermined depth of the notch. If desired, the set depth nail notcher may provide a smooth convex surface rather than a smooth flat surface for a cutting edge to protrude therefrom. The patch is an adhesive patch including a portion for being impregnated with or otherwise contain anti-fungal medication and a flexible adhesive portion bordering the portion for being impregnated. Any pad which is capable of holding the mediation is suitable for the portion for being impregnated. Typically the pad is supple and the adhesive portion is flexible such that the patch will conform to the shape of the toe, finger and/or nail to which it is applied.
The patch serves to protect the open notch from contamination as well as prevent loss of the medication. Thus, it is easy for the patient to apply the medication to the notch and by virtue of the patch, maintain a normal daily routine while the medication is in the notch and underlying tissue. This easily permits extended treatment times. The patch may be particularly effective for time release formulations of anti-fungal medication.
In its method respects, the present invention involves a method for treating fingernail or toenail fungus comprising employing the above-described nail notcher to cut a notch to a predetermined depth in a fingernail or a toenail infected with fungus. Then a topical anti-fungal medication is applied to the nail bed of the finger or toe through the notch cut by the above-described nail notcher. As many as two or three notches may be employed on each nail. The medication may be put on/into the patch before the patch is put on the notch, or the medication may be put on/into the notch before the patch is put on the notch.
The method treats the infected nail to create a sterile antiseptic area proximal to the cuticle of the infected nail. Then the infected area grows distally away from the cuticle and is eventually trimmed off. The sterile area typically extend into the nail bed and may extend into the underlying flesh.


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