Method, apparatus, and kit for onychomycosis treatment

Abstract

Methods, apparatus, and kits for onychomycosis treatment are presented. In one embodiment, a kit for treatment includes an anti-fungal agent, in a composition, and an electrically powered patch. Exemplary embodiments of the patch include a first electrode, a power source having a first and second terminal, a second electrode coupled to the second terminal of the power source, and a base member supporting the first electrode, the second electrode, and the power source. Embodiments include those where the first and second electrode and power source are printed on the base member. Anti-fungal agents may be unionized while the composition includes an ionizing agent. Home use may be practiced, as embodiments include those in which the voltage or current of the power source cannot be adjusted by a user. Exemplary methods include the selection of a nail or diseased area to which treatment is desired and administering the kit as described.

1 - 54 . (canceled) 
   
   
       55 . A device for the treatment of onychomycosis comprising:
 at least one active electrode for facilitating delivery of an anti-fungal agent into an onychomycosis infected region of at least one digit, by application of an electrical current to the region;   at least one counter electrode facilitating closing of electrical circuit with the at least one active electrode;   at least one power source for providing a current and voltage, connected through a conductive media to the active and counter electrodes; and   at least one base member supporting the at least one active electrode, the at least one counter electrode, and the at least one power source,   wherein the device has a first flat position and a second curved position conforming to the curvature of the digit, and   wherein the at least one active electrode is adapted to be disposed on the onychomycosis infected region of the at least one digit and the at least one counter electrode is adapted to be disposed on a non-infected region of the at least one digit in both the first position and the second position.   
   
   
       56 . The device of  claim 55 , further comprising a composition, wherein the composition comprises at least one anti-fungal agent. 
   
   
       57 . The device of  claim 56 , wherein the at least one anti-fungal agent comprises terbinafine. 
   
   
       58 . The device of  claim 56 , wherein the composition further comprises a conductive interfacing material. 
   
   
       59 . The device of  claim 56  wherein the composition comprises at least one pharmaceutically acceptable excipient that cause enhancement of an electrical current into and through human nail and/or skin. 
   
   
       60 . The device of  claim 56 , wherein the composition comprises at least one anti-fungal agent, a water miscible solvent and a gelling agent. 
   
   
       61 . The device of  claim 56 , wherein the composition is at least one of a cream, ointment, lotion, gel, and hydrogel. 
   
   
       62 . The device of  claim 56  wherein the device promotes delivery of the anti-fungal agent by at least one of iontophoresis, electrotransportation, electroosmosis, and electroporation. 
   
   
       63 . The device of  claim 55 , wherein the at least one power source is a thin and flexible power source. 
   
   
       64 . The device of  claim 55 , further comprising electronics to control the current. 
   
   
       65 . The device of  claim 56 , wherein the counter electrode is adapted to be disposed on a non-infected region of the at least one digit that is on the opposite side of the at least one digit from the infected region. 
   
   
       66 . The device of  claim 56 , wherein the at least one active electrode and the at least one counter electrode lie in a first plane in the first position and lie in a second plane in the second position, and the first plane and the second plane are substantially co-planar. 
   
   
       67 . The device of  claim 56 , wherein the base member comprises left and right lateral portions and a midline portion and wherein the left and right lateral portions are adapted to be curvilinearly folded on the at least one digit. 
   
   
       68 . The device of  claim 55 , wherein the at least one active electrode is an anode. 
   
   
       69 . The device of  claim 55 , wherein the number of the at least one active electrode and the number of the at least one counter electrode is unequal. 
   
   
       70 . A kit for treatment of at least one fungal infected nail comprising: an anti-fungal agent, in a composition; and a device according to the device of  claim 55 . 
   
   
       71 . The device of  claim 55  wherein the at least one active electrode and the at least one counter electrode are spaced within about 5 mm to about 10 mm of each other in both the first position and the second position. 
   
   
       72 . The device of  claim 55 , wherein the counter electrode is adapted not to be disposed on an infected region of the at least one digit. 
   
   
       73 . The device of  claim 55 , wherein the at least one active electrode and the at least one counter electrode are on the same side of the at least one digit when in both the first position and the second position. 
   
   
       74 . A device for the treatment of onychomycosis comprising:
 at least one active electrode for facilitating delivery of an anti-fungal agent into an onychomycosis infected region of at least one digit, by application of an electrical current to the region;   at least one counter electrode facilitating closing of electrical circuit with the at least one active electrode;   at least one power source for providing a current and voltage, connected through a conductive media to the active and counter electrodes; and   at least one base member supporting the at least one active electrode, the at least one counter electrode, and the at least one power source,   wherein the at least one active electrode is adapted to be disposed on the onychomycosis infected region of the at least one digit, wherein the at least one anti-fungal agent is a terbinafine compound in a formulation, wherein the formulation is electrically conductive and comprises the terbinafine compound solubilized in water, terbinafine cations and a gelling agent.   
   
   
       75 . A device for the treatment of onychomycosis comprising at least one flexible wearable patch conformable to the contour of at least a non-nail portion of at least one digit and at least part of the nail portion of the at least one digit, the flexible wearable patch comprising:
 at least one active electrode for facilitating delivery of an anti-fungal agent into a region of the at least part of the nail portion of the at least one digit infected with onychomycosis, by application of an electrical current to the region;   at least one counter electrode facilitating closing of electrical circuit with the at least one active electrode;   a composition disposed on the at least one active electrode;   at least one power source for providing a current and voltage, connected through a conductive media to the active and counter electrodes; and   a base member supporting the at least one active electrode, the at least one counter electrode, and the at least one power source, wherein the base member is in a folded configuration on the digit, so that the at least one active electrode is adapted to be disposed on the region of the digit infected with onychomycosis and wherein the at least one counter electrode is adapted to be disposed on a non-infected region of the digit.   
   
   
       76 . A device for the treatment of onychomycosis comprising:
 at least one active electrode for facilitating delivery of an anti-fungal agent into an onychomycosis infected region of at least one digit, by application of an electrical current to the region;   at least one counter electrode facilitating closing of electrical circuit with the at least one active electrode;   at least one power source for providing a current and voltage, connected through a conductive media to the active and counter electrodes; and   at least one base member comprising a midline portion, a left lateral portion and a right lateral portion, wherein the at least one base member supports the at least one active electrode, the at least one counter electrode, and the at least one power source,   wherein the at least one active electrode is supported on the midline portion, and   wherein the at least one active electrode is adapted to be disposed on the onychomycosis infected region of the at least one digit, the at least one counter electrode is adapted to be disposed on a non-infected region of the at least one digit, and the left lateral portion and the right lateral portion are adapted to wrap around the at least one digit.   
   
   
       77 . The device of  claim 76 , wherein the at least one counter electrode are supported on the midline portion of the at least one base member.