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Phototherapeutical method and system for the treatment of inflammatory and hyperproliferative disorders of the nasal mucosa

USPTO Application #: 20060111760
Title: Phototherapeutical method and system for the treatment of inflammatory and hyperproliferative disorders of the nasal mucosa
Abstract: A phototherapeutical apparatus is described, including a light source, generating high intensity visible light, in some embodiments in combination with ultraviolet light, an optical guidance system, and a patient interface. The patient interface can be insertable at least partially into a nasal cavity and is operable to apply the generated light to a tissue surface of the nasal cavity. Applying the apparatus includes providing the phototherapeutical apparatus, preparing for the application of the apparatus, inserting the patient interface into the nasal cavity, and applying the generated light by the patient interface to a tissue surface of the nasal cavity, wherein the tissue of the nasal cavity has an inflammatory or a hyperproliferative disease. The inflammatory diseases include rhinitis, sinusitis, and rhinosinusitis. A photodynamical therapy is also described, applying photosensitizing substances before the treatment with light. The phototherapeutical method is also effective for the prevention of inflammatory or hyperproliferative diseases. (end of abstract)



Agent: Macpherson Kwok Chen & Heid LLP - San Jose, CA, US
Inventors: Lajos Kemeny, Zsolt Bor, Gabor Szabo, Ferenc Ignacz, Bela Racz, Attila Dobozy
USPTO Applicaton #: 20060111760 - Class: 607088000 (USPTO)

Related Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Light Application

Phototherapeutical method and system for the treatment of inflammatory and hyperproliferative disorders of the nasal mucosa description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060111760, Phototherapeutical method and system for the treatment of inflammatory and hyperproliferative disorders of the nasal mucosa.

Brief Patent Description - Full Patent Description - Patent Application Claims
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CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation of U.S. application Ser. No. 10/440,690, filed May 19, 2003, which is incorporated by reference herein. The present Application is also a continuation-in-part of U.S. application Ser. No. 10/410,690, filed Apr. 9, 2003, which is a continuation of International Application No. PCT/HU01/00102, filed Oct. 24, 2001, which claims priority from Hungarian Application No. P 0103279, filed Aug. 10, 2001, all of which are also incorporated by reference herein.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to the treatment and prevention of inflammatory and hyperproliferative diseases of body cavities, more particularly to the treatment and prevention of diseases of the nasal cavity by phototherapeutical methods.

[0004] 2. Description of the Related Art

[0005] The treatment and prevention of inflammatory diseases of the nasal mucous membrane and paranasal sinuses is an unsolved problem. These diseases include allergic rhinitis, commonly referred to as hay fever, vasomotor rhinitis, non-allergic eosinophilic rhinitis, chronic sinusitis, which is the inflammation of the paranasal sinuses, and nasal polyps.

[0006] Rhinitis is an inflammatory disorder of the nasal mucous membrane, which is characterized by nasal itch, sneeze, nose running, nasal blockage, and rarely by loss of smelling. The inflammation of the nasal mucous membrane is frequently associated with the inflammation of the paranasal sinuses (rhinosinusitis, chronic sinusitis). As a consequence of the frequent and persistent inflammation of the mucous membrane hyperproliferative lesions, or so-called polyps develop on the mucous membrane.

[0007] One characteristic disease is the allergic rhinitis, commonly referred to as hay fever. The allergic rhinitis is the most frequent allergic disease affecting 10-20% of the population. The number of patients with allergic rhinitis, especially in the well developed industrial countries increased very rapidly in the last few years. Because of the high number of patients the direct and indirect costs of this disease are great.

[0008] Although hay fever is not a very severe disease, its unpleasant symptoms worsen the quality of life considerably. Hay fever is frequently associated with allergic conjunctivitis and sometimes with general symptoms. The symptoms last only for a few months in some patients (seasonal rhinitis), while in others they last the whole year (perennial rhinitis).

[0009] The symptoms of the allergic diseases develop as follows. An allergen enters the body and induces the production of a specific IgE, which binds to specific receptors on the surface of mast cells. After subsequent exposure the allergen crosslinks the IgE receptors, resulting in mediator release from the mast cells. These mediators are responsible for the development of the symptoms in patient.

[0010] As a result of this activation histamine and other preformed mediators are released from the mast cells. In the mast cells new inflammatory mediators are produced attracting further inflammatory cells into the mucous membrane (Howarth P H, Salagean M, Dokic D: Allergic rhinitis: not purely a histamine-related disease. Allergy 55: 7-16, 2000).

[0011] At present there is no treatment for rhinitis, which would result in a complete elimination of the symptoms. The increased number of inflammatory cells in the nasal mucous membrane release mediators, which are responsible for the clinical symptoms. Often antihistamines are used locally or systemically for the blocking of the released mediators. Sodium cromoglycate is available for the inhibition of the release of mediators. Finally, corticosteroids are used locally or systemically for the blocking of the synthesis of new mediators. In special cases a desensitizing therapy might be used. The pathogenesis of the development of the clinical symptoms is already well known. However, the presently available drugs often do not eliminate the symptoms. Therefore, every new method for the treatment of this disease has a great medical significance.

[0012] A further characteristic disease is vasomotor rhinitis. Vasomotor rhinitis is an inflammatory disorder of the nasal mucous membrane with unknown origin. The clinical symptoms are largely similar to that of allergic rhinitis: permanent nasal blockage, nasal itch, sneeze, nose running, and rarely loss of smelling. Mastocyte-activating mediators cause the symptoms. These are released from the nerve endings of the nasal mucous membrane upon irritation.

[0013] A further characteristic disease is the nonallergic eosinophilic rhinitis. This disease is characterized by the high number of eosinophils in the nasal secretions and by the lack of an allergic origin. The disease is frequently associated with the development of nasal polyps, the hyperproliferative condition of the nasal mucous membrane. The clinical symptoms are the same as in allergic rhinitis.

[0014] Additional diseases are rhinosinusitis and sinusitis. The inflammation of the paranasal sinuses is frequently associated with the inflammatory condition of the nasal mucous membrane (nasosinusitis). The isolated inflammation of the paranasal sinuses is also a frequent disease (sinusitis). This disease has often an allergic origin, although its exact cause remains unknown. There is no well-tested treatment, thus usually the same therapy is used as for rhinitis.

[0015] Ultraviolet light has been used for more than twenty years for the treatment of allergic and auto-immune skin diseases. In various treatments and procedures ultravioletB light (280 nm-320 nm) and ultraviolet-A light (320 nm-400 nm) is used typically. The ultraviolet light inhibits the antigen-induced cellular immune response and is able to induce tolerance (Streilein J W, Bergstresser P R: Genetic basis of ultraviolet-B on contact hypersensitivity. Immunogenetics 27: 252-258, 1988).

[0016] The ultraviolet light suppresses the immune reaction by inhibiting the antigen presentation and by inducing T-cell apoptosis. Irradiation of the skin with ultraviolet-B light or ultraviolet-A light on an area previously photosensitized by psoralen is known to inhibit the immunological processes in the skin. For the treatment of skin diseases there are a number of phototherapeutical devices available.

[0017] These phototherapeutical devices include ultraviolet light sources. These light sources might be classified based on, for example, their operational principle, output energy or power, mode of operation (impulse or continuous), and whether they are emitting monochromatic or multiwavelength light.

[0018] In early treatments broad band ultraviolet B (BB-UVB) light sources were used. In recent years more efficient narrow band ultraviolet B (NB-UVB) light sources became popular (Degitz K, Messer G, Plewig G, Rocken M: Schmalspektrum-UVB 311 nm versus Breitspektrum-UVB. Neue Entwicklungen in der Phototherapie. Hautarzt 49: 795-806, 1998).

[0019] Our previous investigations of psoriatic patients indicated that the 308 nm xenon chloride excimer laser is more effective for phototherapeutical treatments than the NBUVB light sources (Bonis B, Kemeny L, Dobozy A, Bor Zs, Szabo G, Ignacz F: 308 nm UVB excimer laser for psoriasis. Lancet 35: 1522, 1997; Kemeny L, Bonis B, Dobozy A, Bor Z, Szabo G, Ignacz F: 308-nm excimer laser therapy for psoriasis. Arch Dermatol. 137: 95-96, 2001).

[0020] Phototherapeutical treatments improved significantly with the appearance of ultraviolet light delivering optical systems. Such an ultraviolet light delivering phototherapeutical system with fiber optic is used in the Saalmann Cup instrument, in which the concentrated ultraviolet light is coupled into a fiber optic cable. Therefore, it is suitable for the treatment of smaller lesions of the skin or mucous membrane (Taube K M, Fiedler H: Hochkonzentrierte UV Bestrahlung kleiner Hautbezirke mit einem neuen Punktstrahler. Grundlagen und klinische Ergebnisse. Deutsche Dermatologe, 10: 1453, 1992).

[0021] However, the Saalmann Cup can not be introduced into smaller body cavities because of its large contact area and because of the thickness of the used fiber optic cable. This device can be used in body cavities where the distal end of the fiber optic cable and the area to be treated can be visually controlled, such as the oral cavity. For this reason, this device is unsuitable for the treatment of body areas, which cannot be visually controlled, such as the nasal and paranasal mucous membrane, the gastrointestinal, and the urogenital mucous membrane.

[0022] Although ultraviolet light has been used for the treatment of hyperproliferative and inflammatory skin diseases for many years, it has not been used for the treatment of common, immunologically mediated disorders of the nasal mucous membrane. In the U.S. Patent Application by Lajos Kemeny, Zsolt Bor, Gabor Szabo, Ferenc Ignacz, Bela Racz, and Attila Dobozy, entitled: "Phototherapeutical Apparatus and Method for the Treatment and Prevention of Diseases of Body Cavities", filed Apr. 9.sup.th 2003, hereby incorporated by reference in its entirety, a phototherapeutical apparatus and method was described for the treatment of inflammatory and hyperproliferative disorders of the nasal mucosa and paranasal sinuses, such as allergic and non-allergic rhinitis, vasomotor fhinitis, allergic rhinosinusitis, and nasal polips. This method utilized ultraviolet light. Ultraviolet light was reported to be effective for the treatment of different forms of rhinitis, including hay fever. Also, ultraviolet light suppressed the development of nasal polips.

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