| Apparatus and method for the treatment of infectious disease in keratinized tissue -> Monitor Keywords |
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Apparatus and method for the treatment of infectious disease in keratinized tissueRelated Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Thermal Applicators, Electromagnetic Radiation (e.g., Infrared), Microwave Or Rf (high Frequency), With Temperature SensingApparatus and method for the treatment of infectious disease in keratinized tissue description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070219607, Apparatus and method for the treatment of infectious disease in keratinized tissue. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application No. 60/471,230, filed May 16, 2003, which is incorporated by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to the field of medicine, particularly the treatment of infectious diseases. More specifically, the invention relates to treatment of keratinized tissue infected with fungi and/or bacteria. [0004] 2. Summary of the Related Art [0005] 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. [0006] By way of example, onychomycosis is clinically defined as an infection of the nail plate caused by any fungus, including dermatophytes, nondermatophytes 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. [0007] Microwave irradiation is an efficient means of sterilization. For example, U.S. Pat. No. 4,092,800 teaches the sterilization of soil with microwave irradiation. Baker K. F. et al. (Phytopathology 59(2):193-197 (1969)) teach the sterilization of garbage with microwave irradiation. Lagunas-Solar M. C. et al. teach the sterilization of food with microwave irradiation (Food and Agriculture Applications of Pulsed Power Technologies as Alternatives to Methyl Bromide, presented at the 1994 Annual International Research Conference on Methyl Bromide Alternatives and Emissions Reductions. Nov. 13-16 (1994) Kissimme, Fla., and Tanaka Y. et al. (Yonaga Acta medica 41:83-88 (1998)) teach the sterilization of towels with microwave irradiation. [0008] Lantis J. C. et al. (Surg. Endosc. 12:170-176 (1998)) teach that microwave energy has been used in medicine for many clinical applications since the development of reliable magnetrons in the 1960's. Microwave energy therapy has been used for the treatment of malignant and benign neoplasia. It is being explored as a modality to improve the healing of infected wounds. It is being studied as a therapy for the treatment of duodenal ulcer disease, benign prostatic hypertrophy and for heart disease. Microwave energy is also being used to warm diasylate fluid for continuous ambulatory peritoneal dialysis and as a way to sterilize docking connectors. Ferreira, A. V. B. and Glass, N. L. (Fungal Genetics Newsletter No. 43:25-26 (1996)) and Jones, C. L. et al. (4.sup.th Pacific Rim Biotechnology Conference, Melbourne, Australia, Feb. (1995)) teach that microwave energy has proven to be useful in DNA extraction protocols from different eukaryotes. In addition, U.S. Pat. No. 4,881,543 teaches that microwave energy therapy can be used to correct myopia in the human eye. [0009] The most common form of treatment for onychomycosis is the oral administration of Terbinafine (Novartis International AG, Basel, Switzerland) or Itraconazole (Janssen Pharmaceutica Products, L.P., Titusville, N.J.). These drugs dominate the current market for the treatment of onychomycosis, estimated by Datamonitor at $1.4 billion in the year 2000. [0010] 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, R. J. (supra) 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., page 2765) teach that remission rates are above 60%. 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. [0011] Thus, there remains a need in the art to develop improved methods for the treatment of infected tissues containing high amounts of keratin. BRIEF SUMMARY OF THE INVENTION [0012] The invention provides an apparatus and methods for the medical treatment of keratinized tissue infected with a pathogen. The methods according to the invention enable an efficient, non-invasive medical treatment with little or no side effects. The inventors have surprisingly discovered that the high water content of fungi and bacteria relative to keratinized tissue makes them sensitive to electromagnetic energy, particularly microwave energy. This results in "superheating" and explosion of the bacterial and/or fungal cells. There may also be additional, therapeutically beneficial, non-thermal effects of electromagnetic energy, e.g., microwave energy, on bacteria and/or fungi. [0013] In a first aspect, the invention provides a method for treating keratinized tissue infected with a pathogen. The method comprises exposing the tissue to electromagnetic energy thereby killing the pathogen infecting the keratinized tissue. In some embodiments, the pathogen is a fungus. In some embodiments the pathogen is a bacterium. [0014] In certain embodiments, the electromagnetic energy is microwave energy. In some embodiments, the electromagnetic energy is infrared energy or millimeter waves. In certain embodiments, the microwave energy has a wave frequency from about 10 MHz to about 30 GHz. [0015] In some embodiments, the infected keratinized tissue is nail tissue, the corneum stratum of epidermis, hair tissue, hoof tissue, horny tissue, or teeth. In certain embodiments, the infected keratinized tissue is from a mammal, such as for example, human, bovine, or equine tissue. In particularly preferred embodiment, the keratinized tissue is human keratinized tissue infected with a pathogen. In one specific embodiment, the nail tissue is human nail tissue. [0016] In some embodiments, the method includes placing an adaptor over or in contact with the tissue to be treated. The function of the adaptor is to smooth over the heating distribution in the treated tissue. Such an adaptor may be comprised of plastic, for example but not limited to, teflon, nylon, delrin, which may be obtained from Small Parts, Inc., Miami Lakes, Fla.; McMaster Carr Company, Dayton, N.J.; or MSC Company, Melville, N.Y. [0017] In a second aspect, the invention provides an applicator for the delivery of electromagnetic energy to keratinized tissue infected with a pathogen. The applicator comprises more than one metallic conductor separated by a distance much less than half a wavelength and a flexible substrate to allow conformance to a curved surface. [0018] In certain embodiments, the applicator further comprises an adhesive to permit adherence to a surface. Such adhesives are well known in the art. In some embodiments, the metallic conductors and substrate are sufficiently thin to permit trimming to an arbitrary shape in a plane with an instrument such as shears. [0019] In certain embodiments, the applicator has from about 2 to about 40 metallic conductors. In some embodiments, the metallic conductors of the applicator have a length from about 5 to about 40 mm and a width of about 0.25 mm to about 2 mm. In some embodiments, the applicator has an interdigitated geometry. In certain of these embodiments, the metallic conductors are spaced about 0.25 mm to about 2 mm. In some embodiments, the applicator has 2 conductors having a spacing of about 0.25 mm to 2 mm which meander in the plane defined by the surface of the tissue to be heated. In some embodiments, the applicator has a single conductor having the shape of a horn of diameter about 2 mm to 40 mm. [0020] In some embodiments of the second aspect, one or more conductors have spiral geometry. In some embodiments, pairs of conductors have dipole geometry. In some embodiments, each conductor of the applicator has waveguide geometry. In some embodiments, one or more conductors have meandering geometry. In certain embodiments, a pair or pairs of conductors have transmission line geometry. [0021] In some embodiments, the applicator further comprises a cable, e.g., a coaxial cable. In some embodiments, the applicator further comprises a cable, e.g., coaxial cable, and an electromagnetic energy source. In certain embodiments, the electromagnetic energy source is selected from the group consisting of a magnetron and solid state oscillator. In some embodiments, the applicator comprises a waveguide instead of a cable. Continue reading about Apparatus and method for the treatment of infectious disease in keratinized tissue... 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