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  Apparatus and method for the treatment of infectious disease in keratinized tissueUSPTO Application #: 20070299486Title: Apparatus and method for the treatment of infectious disease in keratinized tissue Abstract: Apparatus and methods for the treatment of keratinized tissue infected with a pathogen are provided. In certain examples, electromagnetic energy, such as microwave energy, may be used in the treatment process to reduce the amount of or eliminate the pathogen from the keratinized tissue. (end of abstract) Agent: Lowrie, Lando & Anastasi - Cambridge, MA, US Inventors: Peter A. Hoenig, B. Stuart Trembly USPTO Applicaton #: 20070299486 - Class: 607088000 (USPTO) Related Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Light Application The Patent Description & Claims data below is from USPTO Patent Application 20070299486. Brief Patent Description - Full Patent Description - Patent Application Claims
PRIORITY APPLICATIONS [0001] This application is a continuation-in-part of U.S. application Ser. No. 10/845,761 filed on May 14, 2004, and is a continuation-in-part of U.S. application Ser. No. 10/845,010, filed on May 13, 2004, each of which claims priority to U.S. provisional application No. 60/471,230, filed May 16, 2003, and the entire disclosure of each of which is hereby incorporated herein by reference for all purposes. FIELD OF THE TECHNOLOGY [0002] Certain examples relate to the field of medicine, particularly the treatment of infectious diseases. More specifically, certain examples relate to treatment of keratinized tissue infected with a pathogen. BACKGROUND [0003] Infectious diseases of keratinized tissues are a difficult problem for medical treatment. Keratins are a class of scleroprotein that serve as the major protein components of hair, wool, nails, the organic matrix of the enamel of teeth, horns, hoofs, and the quills of feathers. These proteins generally contain large quantities of the sulfur-containing amino acids, particularly cysteine. Keratins provide a tough, fibrous matrix for the tissues in which they are found. These proteins are characterized as being extremely water insoluble. Because keratins contain few polar amino acids, there is little or no moisture content in the tissues they form. This presents difficulties for the medical treatment of infected keratinized tissues because medicaments are not easily delivered into this type of tissue. [0004] By way of example, onychomycosis is clinically defined as an infection of the nail plate caused by any fungus, including dermatophytes, non-dermatophytes and yeasts. This disease accounts for up to 50% of all nail disease and affects 2% to 18% or more of the world's population. There are four clinical types of onychomycosis: (1) distal subungual onychomycosis, (2) proximal subungual onychomycosis, (3) white superficial onychomycosis, and (4) candidal onychomycosis. The target sites for the treatment of onychomycosis reside in the nail plate, nail bed and nail matrix. Characteristically, infected nails coexist with normal-appearing nails. [0005] The most common form of treatment for onychomycosis is the oral administration of terbinafine (Novartis International AG, Basel, Switzerland) or itraconazole (Janssen Pharmaceutical Products, L.P., Titusville, N.J.). These drugs dominate the current market for the treatment of onychomycosis. [0006] However, there is a need for the development of other forms of treatment. Hay, R J (British Journal of Dermatology 145(S60):3-11, 2001) teaches that these drugs have a clinical failure rate of approximately 25-40%. In addition, both drugs carry label precautions about potential organ toxicity and interactions with common prescription and non-prescription drugs. The Physicians Desk Reference (2003) teaches that rare cases of hepatic failure (including death) have been reported following oral treatment with Terbinafine and Itraconazole. Rare cases of serious cardiovascular events, including death, also have been associated with Itraconazole (Id.). Treatment times are long (several months) and costly. Hay, 2001 teaches that 5-10% of the nail surface still remains abnormal even with a full cure (defined by negative re-culturing). Mandell et al (Principles and Practice of Infectious Diseases, Fifth edition, Chapter 257 by Hay R. J., p. 2765, 2000) teach that the relapse rate is 40%. Treatment options using topical agents are usually of little benefit, and chemical or surgical removal of the infected nail(s) are not adequate therapies, since these treatments can lead to nail bed shrinkage and dorsal dislocation of the nail bed. [0007] Thus, there remains a need in the art to develop improved methods for the treatment of keratinized tissue infected with a pathogen. SUMMARY [0008] Certain aspects and examples described herein provide an apparatus and methods for the medical treatment of keratinized tissue infected with a pathogen. The methods according to the invention enable an efficacious, localized, speedy, and non-invasive medical treatment with little or no side effects. [0009] In a first aspect, a method of treating keratinized tissue infected with a pathogen is provided. In certain examples, the method comprises exposing the keratinized tissue to an effective amount of electromagnetic energy having a wavelength greater than about 0.0004 mm, e.g., microwave energy or millimeter wave energy, sufficient to kill the pathogen infecting the keratinized tissue. In a particularly preferred embodiment, the keratinized tissue is human keratinized tissue, e.g., nail tissue, infected with a pathogen. In one specific embodiment, the nail tissue is human nail tissue. In certain embodiments, the electromagnetic energy is microwave energy, e.g., microwaves having frequencies of about 15 MHz to about 30 GHz, or millimeter wave energy. [0010] In a second aspect, an applicator for the delivery of electromagnetic energy to keratinized tissue infected with a pathogen is disclosed. In certain examples, the applicator comprises one or more conductors configured to deliver energy to the anatomical site. In certain embodiments, a pair of conductors has a coaxial cable geometry. In one embodiment, the outer conductor of a coaxial cable has been removed for part of its circumference to expose tissue in proximity to the applicator to electromagnetic energy. In another embodiment, the inner conductor of the coaxial cable geometry is connected to a disk at its terminal end to form an end-loaded monopole that transfers energy efficiently to tissue in proximity to the applicator. In some embodiments, the applicator further comprises a cable, e.g., coaxial cable, and an electromagnetic energy source. BRIEF DESCRIPTION OF THE DRAWINGS [0011] Certain illustrative examples and embodiments are described below with reference to the accompanying figure in which: [0012] FIG. 1 is an exploded view of one example of an applicator, in accordance with certain examples of aspects of the invention; [0013] FIG. 2 is a perspective view of the assembled applicator of FIG. 1, in accordance with certain examples of aspects of the invention; [0014] FIG. 3 is a perspective view of an alternative embodiment of the applicator of FIG. 1, in accordance with certain examples of aspects of the invention; [0015] FIG. 4 is a schematic view of an embodiment comprising an applicator, cable, and electromagnetic energy source, in accordance with certain examples of aspects of the invention; and [0016] FIG. 5 is a schematic view of an embodiment that includes a radiometry sensor to measure temperature in treated tissue, in accordance with certain examples of aspects of the invention. [0017] It will be recognized by the person of ordinary skill in the art, given the benefit of this disclosure, that the figures are not necessarily to scale and that certain features of the figures may have been enlarged, distorted or emphasized to facilitate a better understanding of the illustrative aspects and examples described in more detail below. DETAILED DESCRIPTION [0018] Certain examples disclosed herein provide significant advances in the treatment of keratinized tissues not heretofore recognized by practitioners. For example, it was a surprising discovery that the high water content of fungi, bacteria, and parasites relative to keratinized tissue renders the fungi, bacteria, and parasites sensitive to electromagnetic energy, particularly microwave energy. Such application of energy can result in "superheating" and explosion of the bacterial, fungal, or parasitic cells. Certain examples of the methods described herein do not rely on an electrical conduction current flowing through tissue between two or more metallic conductors in direct contact with tissue (resistive heating). Instead, examples of the methods described herein use an electric field of electromagnetic energy, e.g., microwave energy, to penetrate into tissue. The rapidly-oscillating field in tissue causes polar molecules, such as water in fungal, bacterial, or parasite cells, to rotate in place, thereby producing local frictional heating. Without wishing to be bound by any particular scientific theory or this example, the pathogens are destroyed when the heating process has sufficient magnitude and duration. The penetrating electric field permits transmission of energy through tissue of low water content, which can effectively be an electrical insulator. In this way, a penetrating electric field of electromagnetic energy applied, for example, at the surface of the nail plate, which has low water content, can sterilize a pathogen below the surface of the nail plate. In contrast, a conduction current, e.g., a radio frequency current, applied to the nail plate would have little or no heating effect on a pathogen below the nail plate. Continue reading... Full patent description for Apparatus and method for the treatment of infectious disease in keratinized tissue Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Apparatus and method for the treatment of infectious disease in keratinized tissue patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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