WO2008051918A2

WO2008051918A2 - Methods, devices and kits for phototherapy and photodynamic therapy treatment of body cavities

Info

Publication number: WO2008051918A2
Application number: PCT/US2007/082112
Authority: WO
Inventors: Jonathan Lockhart Podmore; James R. Flom; Peter Louis Johnson; John E. Crowe; Norbert H. Leclerc
Original assignee: Allux Medical, Inc.
Priority date: 2006-10-23
Filing date: 2007-10-22
Publication date: 2008-05-02
Also published as: GB0720738D0; WO2008051918A3; GB2443318A

Abstract

The invention relates to devices and methods for delivering radiation to regions of a sinus cavity, which includes the emission and propagation of energy in the form of rays or waves, including light, into a nasal cavity. Phototherapeutic apparatuses of the invention are adapted to treat a body cavity and comprise, for example, a light source, and an insertion member, having a distal end, optically coupleable to the light source and configured to be at least partially inserted into the body cavity to deliver light onto a target tissue.

Description

METHODS, DEVICES, AND KITS FOR PHOTOTHERAPY AND PHOTODYNAMIC THERAPY TREATMENT OF BODY CAVITIES

CROSS-REFERENCE

10001] This application claims the benefit of U.S. Provisional Application No. 60/862,563, filed October 23. 2006. and Application No. 60/868,237 filed December 1. 2006. which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

[0002] Field of the Invention. The invention relates to devices, methods, and kits for delivering radiation to regions of a nasal or sinus cavity, which includes the emission and propagation of energy in the form of rays or waves, including light.

[0003] Background of the Invention. The therapeutic use of light has been shown to be effective in the treatment of various medical conditions. For example, whole body exposure to ultraviolet ("UV") light has been used for medical applications, such as the treatment of psoriasis. Ultraviolet lasers and lamps have also been designed to illuminate more localized regions of the skin for treatment of lesions and marks. {0004] Infection of a patient takes many forms. Typically, acute bacterial infections are rather easily controlled using standard antibiotic therapies. Chronic infections, on the other hand, are often very difficult to control for several reasons: (1) the antimicrobial flora of chronically infected regions of the body often develop resistance to standard antibiotics due to multiple attempts to treat the flora with antimicrobial therapy; and (2) the microbes often form biofilms to protect themselves against the protective mechanisms of the patient. Biofilms in the sinus cavity have been shown to be resistant to antibiotic treatments and present a significant health problem.

[0005] Atopy refers to an inherited propensity to respond imunologically to many common, naturally occurring inhaled and ingested allergens with the continual production of IgE antibodies. Allergic rhinitis and asthma are the most common clinical manifestations of atopic disease affecting approximately 50 million people in the United States alone. There is a great deal of overlap among patients with atopic disease. For example, patients with atopic asthma have a greater likelihood of developing allergic rhinitis and dermatitis, and vice versa. Indeed, the pathophysiology for atopic diseases is generally the same whether or not the affected organ is the skin, the nose, the lungs, or the gastrointestinal tract.

[0006] Contact with an allergic particle (for example, pollen, cat dander, or food particle) reacts with an associated antibody on the mast cell, which leads to prompt mediator release and clinical symptoms. The IgE antibody response is perpetuated by T cells (antigen specific memory cells or other regulatory cells), which also have specificity for the allergens.

[0007] Kemeny, et al., in Intranasal Irradiation with the Xenon Chloride Ultraviolet B Laser Improves Allergic Rhinitis, 75 Journal of Photochemistry and Photobiology B: Biology 137-144 (2004) and Koreck, et al., in Rhinophototherapy: A New Therapeutic Tool for the Management of Allergic Rhinitis, Journal of Allergy and Clinical Immunology (March 2005), describe a treatment for allergic rhinitis using the same theory espoused for the efficacy of ultraviolet light in atopic dermatitis. Their placebo-controlled study showed the efficacy of ultraviolet therapy to treat allergic, or atopic, rhinitis over the course of an allergy season.

[0008] Nasal polyps can be round, smooth, soft, semi-translucent, pale or yellow. Polyps can occur as a single polyp or can be clustered together. Typically, the nasal polyp is a structure attached to the sinus mucosa by, for example, a relatively narrow stalk or pedicle. Nasal polyps typically occur in patients with both allergic rhinitis and vasomotor rhinitis. The nasal polyps typically contain mast cells, eosinophils and mononuclear cells in large numbers and cause nasal obstruction, loss of smell and taste and mouth breathing. In some instances, polyps can cause sneezing. Currently, the mechanism for formation of the nasal polyp is not well known. Medication is the most common treatment for nasal polyps. Medications typically include fluticasone (Flonase®), triamcinolone (Nasacort®), budesonide (Rhinocort®), flunisolide (Nasarel®), or mometasone (Nasonex®). These medications are typically prescribed to reduce or relieve inflammation and increase nasal airflow. Additionally, these medications may help shrink polyps. Side effects can include nosebleeds, headaches or sore throat. Other medications that may be prescribed for nasal polyps include oral corticosteroids, alone or in combination with a nasal spray, medications to control allergies or infections, or antifungal medications. [0009] Devices are used to treat nasal polyps often when medications have not been effective. A polypectomy can be performed to remove small or isolated polyps. The polypectomy may employ a small mechanical suction device, or microdebrider, to cut and extract the soft tissue. Another option is endoscopic sinus surgery, In endoscopic surgery, an endoscope is used in conjunction other instruments to open part of one or more sinus cavities and remove any polyps that are present. With either intervention, polyps often return. [0010] A variety of devices are known for delivering light therapy. For example, U.S. Patent 1,616,722 to Vernon for Kromayer Light Attachment; U.S. Patent 1,800,277 to Boerstler for Method for Producing Therapeutic Rays; U.S. Patent 2,227,422 to Boerstler for Applicator for Use in Treatment with Therapeutic Rays; U.S. Patent 4,998,930 to Lundahl for Intracavity Laser Phototherapy Method; U.S. Patent 5,146,917 to Wagnieres for Fiberoptic Apparatus for the Photodynamic Treatment of Tumors; U.S. Patent 5,292,346 to Ceravolo for Bactericidal Therapeutic Throat Gun; U.S. Patent 5,683,436 to Mendes for Treatment of Rhinitis by Biostimulative Illumination; U.S. Patent 6,663,659 to McDaniel for Method and Apparatus for the Photomodulation of Cells; and U.S. Patent 6,890,346 to Ganz for Apparatus and Method for Debilitating or Killing Microorganisms within the Body. Additionally, U.S. Patent Publ. 2002/0029071 to Whitehurst for Therapeutic Light Source and Method; U.S. Patent Publ. 2004/0030368 to Kemeny for Phototherapeutical Method and System for the Treatment of Inflammatory and Hyperproliferative Disorders of the Nasal Mucosa; and U.S. Patent Publ. 2005/0107853 to Krespi for Control of Rhinosinusitus-Related, and Other Microorganisms in the Sino-Nasal Tract.

[0011] A variety of devices are known for delivering light and/or radiation. For example, PCT Publication WO 03/013653 to Kemeny et al. for Phototherapeutical Apparatus (see also, U.S. Patent Pub. US 2004/0030368 to Kemeny et al. for Phototherapeutical Method and System for the Treatment of Inflammatory and Hyperproliferative Disorders of the Nasal Mucosa); WO 2005/000389 to Fiset for Skin Tanning and Light Therapy Incorporating Light Emitting Diodes {see also, U.S. Patent Pub. 2004/0232339 to Lanoue for Hyperspectral Imaging Workstation Having Visible/Near-Infrared and Ultraviolet Image Sensors); U.S. Patent 6,290,713 to Russell for Flexible Illuminators for Phototherapy; and U.S. Patent Pub. 2004/0176824 to Weckworth for Method and Apparatus for the Repigmentation of Human Skin.

SUMMARY OF THE INVENTION [0012] An aspect of the invention is directed to a phototherapeutic apparatus for treating a body cavity. The phototherapeutic device comprises: a light source; an insertion member, having a distal end with a first configuration and a second configuration, optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto a target tissue, wherein the second configuration of the distal end is conformable to a tissue surface within the body cavity without inflation. The insertion member can at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic. Additionally, the insertion member can be detachable from the light source, thus allowing replacement. Furthermore, one or more sheaths can be provided that cover at least a portion of the insertion member. Typically, the sheath is removable and replaceable. Additionally, the apparatus can comprise an optical guidance system which transmits light from the light source to the insertion member, including an optical guidance system that is detachable from the insertion member. In some instance, the insertion member comprises optical fibers. Depending upon the configuration of the device, the apparatus can further comprise a delivery device, such a syringe or a pump. The delivery device can be configured to deliver therapeutic material, such as saline or antibiotics, to the target tissue surface. The target tissue is typically located within the nasal cavity, a sinus cavity, or an ear canal. A timer can also be provided to control the duration of light delivered from the distal end of the device. Additionally, a controller can be provided for controlling an amount of light delivered from the distal end of the device. Typically, the light source is an ultraviolet light source. In some instances, a connector can be provided to connect a distal end of the apparatus to a proximal end of the apparatus.

[0013] Another aspect of the invention includes an apparatus for treating a body cavity comprising: a light source; and an insertion member having a proximal end and a distal end, optically coupleable to the light source, and configured to be at least partially inserted into the body cavity to selectively deliver light to a target tissue, wherein the insertion member comprises an optical pathway which passes through an angle at the distal end of the insertion member. The insertion member can at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic. Additionally, the insertion member can be detachable from the light source, thus allowing replacement. Furthermore, one or more sheaths can be provided that cover at least a portion of the insertion member. Typically, the sheath is removable and replaceable. Additionally, the apparatus can comprise an optical guidance system which transmits light from the light source to the insertion member, including an optical guidance system that is detachable from the insertion member. In some instance, the insertion member comprises optical fibers. Depending upon the configuration of the device, the apparatus can further comprise a delivery device, such a syringe or a pump. The target tissue is typically located within the nasal cavity, a sinus cavity, or an ear canal. A timer can also be provided to control the duration of light delivered from the distal end of the device. Additionally, a controller can be provided for controlling an amount of light delivered from the distal end of the device. Typically, the light source is an ultraviolet light source. In some instances, a connector can be provided to connect a distal end of the apparatus to a proximal end of the apparatus. The angle through which the optical pathway passes can be between about 30 and 120 degrees. Furthermore, the pathway can be bent in a radius of between about 0.1 mm and 2.0 mm. A flexible distal neck may also be provided, such as a flexible distal neck on the insertion member. In some cases a spacer is engaged to control the distance between the distal end of the device and the target tissue. A focusing element can also be provided for altering the size of the light beam emanating from the distal end of the device onto the target tissue. The apparatus can further comprise a tissue deformable distal tip. Additionally, a sensor can be provided to sense a variety of parameters that would be useful in the operation of the device. [0014] In yet another aspect of the invention, a phototherapeutic apparatus for treating a body cavity comprising: a light source; and an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light to target tissue, wherein the distal end of the insertion member reflects light from the light source at an angle greater than 0 degrees from a longitudinal axis of the distal end of the insertion member. The insertion member can at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic. Additionally, the insertion member can be detachable from the light source, thus allowing replacement. Furthermore, one or more sheaths can be provided that cover at least a portion of the insertion member. Typically, the sheath is removable and replaceable. Additionally, _ _. _ t e apparatus can compπse an optica gui ance system w ic transmits ig t om t e light source to the insertion member, including an optical guidance system that is detachable from the insertion member. In some instance, the reflection is cased by one or more internal reflections, reflectors, mirrors and light diffusers. For example, one or more mirrors can be provided that is at an angle relative to the longitudinal axis of the distal end of the insertion member. The mirror, or mirrors, can each also have multiple positions and multiple surfaces. Multiple surfaces of the mirror can create a near uniform pattern of light emitted from the distal end of the insertion member. Light diffusers can also be comprises of particles, such as light reflection particles, which can be dispersed uniformly or non-uniformly in the distal end of the insertion member. Light diffusers could also be one or more of glass, fluid, plastic, metal, rubber and elastomer. Typically, plastic is any suitable plastic including PTFE. Depending upon the configuration of the device, the apparatus can further comprise a delivery device, such a syringe or a pump. The delivery device can be configured to deliver therapeutic material, such as saline or antibiotics, to the target tissue surface. The target tissue is typically located within the nasal cavity, a sinus cavity, or an ear canal. A timer can also be provided to control the duration of light delivered from the distal end of the device. Additionally, a controller can be provided for controlling an amount of light delivered from the distal end of the device. Typically, the light source is an ultraviolet light source. A flexible distal neck may also be provided, such as a flexible distal neck on the insertion member. In some cases a spacer is engaged to control the distance between the distal end of the device and the target tissue. A focusing element can also be provided for altering the size of the light beam emanating from the distal end of the device onto the target tissue. The apparatus can further comprise a tissue deformable distal tip. Additionally, a sensor can be provided to sense a variety of parameters that would be useful in the operation of the device.

[0015] In still another embodiment, a phototherapeutic apparatus for treating a body cavity is provided comprising: a light source; an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity, wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area. The insertion member can at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic. Additionally, the insertion member can be detachable from the light source, thus allowing replacement. Furthermore, one or more sheaths can be provided that cover at least a portion of the insertion member. Typically, the sheath is removable and replaceable. Additionally, the apparatus can comprise an optical guidance system which transmits light from the light source to the insertion member, including an optical guidance system that is detachable from the insertion member. In some instance, the insertion member comprises one or more optical fibers. A flexible distal neck may also be provided, such as a flexible distal neck on the insertion member. The target tissue is typically located within the nasal cavity, a sinus cavity, or an ear canal. A timer can also be provided to control the duration of light delivered from the distal end of the device. Additionally, a controller can be provided for controlling an amount of light delivered from the distal end of the device. Typically, the light source is an ultraviolet light source. In some cases a spacer is engaged to control the distance between the distal end of the device and the target tissue. A focusing element can also be provided for altering the size of the light beam emanating from the distal end of the device onto the target tissue. The apparatus can further comprise a tissue deformable distal tip. Additionally, a sensor can be provided to sense a variety of parameters that would be useful in the operation of the device. In some instances, a connector can be provided to connect a distal end of the apparatus to a proximal end of the apparatus. [0016] Methods of using the devices disclosed herein, and modifications of the devices disclosed herein are also contemplated. In one instance, a method for treating a body cavity comprises: providing a phototherapeutical device comprising a light source, an insertion member, having a distal end with a first configuration and a second configuration, optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto a target tissue, wherein the second configuration of the distal end conformable to a tissue surface within the body cavity, without inflation; and applying phototherapeutical light from the device to a target tissue within the body cavity. The method can further comprise one or more of generating light, applying a therapeutic solution to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light, deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp, detaching the insertion member from the light source, applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue, controlling the distance between the device and the target tissue with a spacer, emitting a plurality of non-parallel light beams from the distal end of the device on the target tissue, controlling the duration of light delivered from the device, controlling the amount of light delivered, and delivering ultraviolet light.

[0017] In another aspect, a method for treating a nasal or sinus cavity comprises: providing a phototherapeutical device comprising a light source, and an insertion member having a proximal end and a distal end, optically coupleable to the light source, and configured to be at least partially inserted into the body cavity to selectively deliver light to a target tissue, wherein the insertion member comprises an optical pathway which passes through an angle at the distal end of the insertion member; and applying phototherapeutical light from the device to a target tissue within the nasal or sinus cavity. The method can further comprise one or more of generating light, applying a therapeutic solution to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light, deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp, detaching the insertion member from the light source, applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue, controlling the distance between the device and the target tissue with a spacer, emitting a plurality of non-parallel light beams from the distal end of the device on the target tissue, controlling the duration of light delivered from the device, controlling the amount of light delivered, and delivering ultraviolet light. [0018] Still another aspect includes a method for treating a nasal or sinus cavity comprising: providing a phototherapeutical device comprising a light source, and an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light to target tissue, wherein the distal end of the insertion member reflects light from the light source at an angle greater than 0 degrees from a longitudinal axis of the distal end of the insertion member; and applying phototherapeutical light from the device to a target tissue within the nasal or sinus cavity. The method can further comprise one or more of generating light, applying a therapeutic solution to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light, deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp, detaching the insertion member from the light source, applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue, controlling the distance between the device and the target tissue with a spacer, emitting a plurality of non-parallel light beams from the distal end of the device on the target tissue, controlling the duration of light delivered from the device, controlling the amount of light delivered, and delivering ultraviolet light. [0019] Yet another aspect includes a method for treating a body cavity comprising: providing a phototherapeutical device comprising a light source, an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity, wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area; and applying phototherapeutical light from the device to a target tissue within the body cavity. The method can further comprise one or more of generating light, applying a therapeutic solution o e arge issue wi in e nasa or sinus cavi y pπor o app ying p o ot erapeu ica iignt, αerorming a nasa polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp, detaching the insertion member from the light source, applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue, controlling the distance between the device and the target tissue with a spacer, emitting a plurality of non-parallel light beams from the distal end of the device on the target tissue, controlling the duration of light delivered from the device, controlling the amount of light delivered, and delivering ultraviolet light.

[0020] A phototherapeutic kit is also contemplated for treating a body cavity comprising: a light source; body comprising a handle and a connector; and one or more removable insertion members adapted to engage the connector of the body and optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto target tissue wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area. The kit can also comprise other items such as one or more therapeutic solutions or compounds to facilitate delivery of phototherapy and one or more sheaths configured to fit over the insertion member.

INCORPORATION BY REFERENCE

[0021] All publications, patents and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS [0022] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [0023] FlGS. 1A-B are a physiological view of the nasal passage illustrating the anatomy nasal polyps within the nasal cavity;

[0024] FlG. 2 is a physiological view of the ear illustrating the anatomy of the outer, middle, and inner ears; [0025] FlG.3 depicts an overview of a device and feedback method for controlling photo-radiation; [0026] FlGS.4A-G depict a distal configuration of a photo-radiation therapy device, a handheld photo -radiation therapy device, a photo-radiation therapy device configured to connect to an external light source, a hand-held photo-radiation therapy device with a removable distal end, a photo-radiation therapy device with a sheath, a photo- radiation device adapted and configured to deliver a photo-dynamic substance to the delivery site, and a photo- radiation therapy device having a thumbwheel;

[0027] FlGS.5A-R illustrate a variety of configurations for a distal end of a photo-radiation therapy device; [0028] FlGS.6A-B illustrate the construction of a hand-piece of a photo-radiation therapy device; [0029] FlGS.7A-B illustrate a proximal end of a photo-radiation device adapted and configured to deliver light for phototherapy, a camera, and a therapeutic solution;

[0030] FlG. 8A illustrates a distal end of a photo-radiation therapy delivery device adapted to control the distance of the distal tip of the device from a target surface; FlGS.8B-C illustrate a distal end of a photo-radiation therapy device wherein the device emits a plurality of non-parallel light beams on a target tissue; and [0031] FIGS. 9A-B are method steps for treating a target tissue. ETAILED DESCRIPTION OF THE INVENTION

[0032] Turning now to FlGS. IA-B, a saggital section of the skull and face of a human is depicted with the anatomy of the nasal cavity illustrated. The nasal cavity is a cavity that relates to the nose and is a type of sinus cavity, which more generally refers to anatomical cavities, channels, recesses, hollows or reservoirs. When the nasal cavity 10 is accessed through the anterior nares 12, the nasal vestibule (anterior vestibule) 14 is the first portion of the nasal cavity encountered. The limen nasi (vestibular limen) 16 is a ridge of skin, tissue, and mucosa that marks the transition between the squamous epithelium and the respiratory epithelium. The lateral wall 20 of the nasal cavity 10 is a complex structure containing three bony turbinates 22, 24, 26 with overlying mucosa consisting of stratified pseudocolumnar respiratory epithelia as well as muscles (e.g. the nasalis muscle). [0033] When conducting a speculum exam, a physician encounters (in order of appearance): the squamous epithelium of the nasal vestibule, the limen nasi, the transition to respiratory epithelium, and the inferior turbinate 22. The middle and superior turbinates 24, 26 are encountered further back in the nasal cavity. Nasal polyps 25 typically form in a sinus cavity and grow into the nasal cavity, often in clusters. The hypothesis of the mechanism of action in polyps is based on an atopic dermatitis model. Allergens present to allergen presenting cells (Langer hans) and increase TH2 type cytokines, such as IL-3, and IL-4. This stimulates the production of local IgE. In the chronic phase, there are two main triggers: scratching and microbial colonization, including staph and strep. Staph super- antigens, in particular, stimulate T lymphocytes, which then shifts the immune response from TH2 to TH 1 type. There is also an increase in IL-5 in this phase, which is a key cytokine in the increase of tissue migration and lifespan of eosinophils. In chronic phase both peripheral blood eosinophils and local eosinophils are elevated due to increased resistance to apoptosis and increased lifespan. For nasal polyps there is an increase in eosinophils due to decreased apoptosis, similar to that observed in atopic dermatitis. T lymphocytes secrete IL-5 and IL-4 which increase local IgE production. In the chronic process, epithelial damage and superantigens further encourage eosinophil proliferation. {0034] It is expected that phototherapy in polyps will break the inflammatory cycle by eliminating key cells like eosinophils and/or T cells. Polyps should be reduced in size or eliminated as a result of treatment, thereby avoiding the need for surgical intervention, delaying the need for surgical intervention or delaying the reoccurrence of the polyps. However, as will be appreciated by those skilled in the art, additional mechanisms or other mechanisms may be occur or be involved in the therapeutic effectiveness of the device without departing from the scope of the invention. [0035] FlG. 2 illustrates the anatomy of the ear in a human. Entering the ear from the outside through the auditory canal 30 provides access to the ear drum, also known as the tympanic membrane 32. The section of the ear before the tympanic membrane is often referred to as the outer ear. The middle ear 40, an air-filled cavity behind tympanic membrane, includes the three ear bones (ossicles): the incus (anvil) 42, malleus (hammer) 44, and stapes (stirrup) 46. The three bones are arranged so that movement of the tympanic membrane causes successive movement of the malleus, then the incus, and then the stapes. When the stapes footplate pushes on the oval window, it causes movement of fluid within the cochlea 48.

[0036] In humans and other animal subjects, the middle ear is typically filled with air that is not in direct contact with the atmosphere outside the body. The Eustachian tube 34 connects from the chamber of the middle ear to the back of the pharynx. The middle ear, also referred to as the tympanic cavity, is a hollow mucosa-lined cavity in the skull that is ventilated through the nose, similar to a paranasal sinus. Otitis media is an inflammation of the middle ear which can occur as a result of an infection. t er o y cavit es w t n t e scope o t s nvent on nc u e, ut are not limited to, a mouth cavity, a throat, an esophagus, a stomach, a small intestine, a large intestine, a gastrointestinal tract, a rectum, a trachea, a urogenital tract, a portio, and a uterus. The phototherapeutical devices, methods and kits included herein can be used to treat, for example, inflammatory diseases and infectious diseases of these body cavities. [0038] Turning now to an overview of the devices, methods and kits, FlG. 3 illustrates a system comprising a sensor 302, a controller 304, a photo-radiation source 318, optics 316 and a delivery source 306. The sensor 302 collects information about the site to be treated by the delivery source 306 and confers the information to the controller 304. In the embodiment illustrated in FlG. 3, the controller 304 is a central processing unit. However, as will be appreciated by those skilled in the art, other controller systems can be used without departing from the scope of the invention. After the sensor information has been processed, the controller 304 controls the delivery of photo- radiation from the delivery source 306 either directly 310 or indirectly 320, 330. An example of an indirect path 320 of control of the delivery source 306 includes controlling a photo-radiation source 318 that sends photo-radiation directly to the delivery source 306 to modulate, or condition, therapy delivery at the target site. Another example of indirect control 330 of delivery source therapy modulation is through control of a photo-radiation source 318 and optics 316 that send modulated photo-radiation to the delivery source 306 for therapy.

[0039] The delivery source can be an insertion member configured for insertion into the body cavity. In some embodiments of this invention, the delivery source 306 can be a photo-radiation source, such as a light source, adapted for delivering therapeutic photo-radiation to a target site. The photo-radiation delivered by photo-radiation source 318 and/or delivery source 306 varies depending upon the desired optical properties, such as spectrum, fluence and illumination pattern, and the desired clinical results. The photo-radiation can be coherent or noncoherent light. The photo-radiation may be any of a variety of monochromatic and multi -wavelength light emitting devices. Examples of monochromatic light emitting devices that are incorporated into the invention include, but are not limited to, a xenon chloride laser, a xenon fluoride laser, a nitrogen laser, a solid state laser, a laser diode, or a combination thereof. Examples of multi- wavelength light emitting devices that are incorporated into the invention include, but are not limited to, an incandescent bulb, a dye laser, a gas discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode (LED), or a combination thereof. Light includes a variety of electromagnetic radiation, including electromagnetic radiation capable of inducing a visual sensation, such as those radiation having wavelengths between 380 nm and 780 nm. Additionally, light includes the ultraviolet wavelengths of UVC (100-280 nm), UVB (280-320 nm), and UVA (320-400 nm), the visible wavelengths (between 400-800 nm) and the infrared wavelengths (greater than 700 nm).

[0040] The photo-radiation source 318 and/or delivery source 306 is generally adapted and configured to emit photo-radiation with at least some wavelengths in the ultraviolet spectrum, including the portions of the ultraviolet spectrum known to those of skill in the art as the UVA (or UV-A), UVA₁, UVA₂, the UVB (or UV-B) and the UVC (or UV-C) portions. The photo-radiation source can emit photo-radiation in the visible spectrum (e.g., visible light) in combination with ultraviolet light or by itself. Alternatively, the photo-radiation source can emit photo-radiation within the infrared spectrum, in combination with white light and/or ultraviolet light, or by itself. It is generally understood that these spectra have the following definitions; 100-280 nm for UVC, 280-320 nm for UVB, 320-400 nm for UVA, 400-800 nm for visible, and 800-11,000 nm for infrared. [0041] Optical guidance systems can also be used to pass or communicate therapeutic radiation from the photo- radiation source to the delivery source of the device. For example, photo-radiation can be emitted from, for example, a distal end of the device from which the photo-radiation is applied to a target tissue site in a subject. Alternatively, the photo-radiation can be emitted from a photo-radiation source positioned on the distal end of the evice om w ic e p o o-ra ia ion is app ie o a targe tissue in a su ject. ptics 31b can be placed between t e photo-radiation source 318 and delivery source 306 to direct the therapeutic radiation. Examples of optics 316 incorporated into the device include, but are not limited to, optical fibers, liquid light guides, dichroic mirrors, lenses, filters, apertures, shutter devices, difϊiisers, mirrors, digital micromirror devices, LCD's, scanning mirrors, or combinations thereof.

[0042] The sensor 302 can be adapted and configured to interpret reflected photo-radiation from the target surface or site. For example, when the sensor 302 is a photo-detector it can measure the intensity of the reflected radiation from the target surface. The intensity of the reflected radiation is a result of the distance to the target tissue, the angle of the target surface relative to radiation beam, and the reflective qualities of the tissue surface. For each of these influences, there is a relationship between the intensity of the reflected radiation and the amount of therapeutic radiation that will be absorbed into the target tissue. The sensor 302 can also detect the spectrum of the reflected therapeutic photo-radiation. Differences between the spectrum of the radiation source and reflected radiation are detected and used to control treatment parameters. Thus, process reflected light can be used to determine the size of the target tissue area or to regulate treatment time or intensity. [0043] Instead of, or in addition to, measuring reflected radiation, the sensor 302 can measure other properties of the target tissue such as temperature. The target tissue may, for example, have a different temperature than non- target tissue. For example, a nasal polyp that is less vascularized than surrounding nasal mucosa might have a lower temperature than the surrounding tissue area. Conversely, a target tissue that is inflamed or is highly vascularized might have a higher temperature than the surrounding tissue area. This information can be used to determine the shape and position of the target tissue. Additionally, it may also determine the type of tissue and/or whether the tissue is appropriate for treatment. A temperature sensor can be used to measure an increase or decrease in temperature of target tissue as it is being treated or in relation to surrounding tissue. Measuring a temperature change in the target tissue, or a temperature change relative to surrounding tissue, can be assessed to determine if a sufficient amount of radiation has been delivered to the target tissue. [0044] Suitable sensors include, but are not limited to image sensors, such as charge-coupled devices (CCDs) and CMOS sensors; photodetectors, such as photodiodes, photocells, and phototransistors; infrared sensors; reflectometers, capacitive sensors; acoustic detectors; microwave antennaes; acoustic sensors; temperature sensors; or a combination thereof, as well as any other suitable electronic device that can be adapted and configured to sense a target parameter. [0045] Information from a sensor 302 can be used to obtain a measurement of distance. The sensor may provide the intensity of the reflected radiation, or simply provide the response time from the sensor radiation source to the sensor via reflection off the target surface. The distance measurement can be computed using a CPU that is, or is not, part of the controller that controls the delivery source. A single radiation source can provide both the sensing radiation and therapeutic radiation; alternatively, the sensing radiation source can be a second radiation source. For example, the photo-radiation source 318 can have multiple wavelengths, including both therapeutic radiation and sensing radiation. Alternatively, a second radiation source could communicate with the delivery source 306 and provide the sensing radiation. In yet another alternative, the delivery source 306 provides the sensing radiation. As will be appreciated by those skilled in the art, other sensing radiation configurations can be used without departing from the scope of the invention. [0046] A variety of configurations for the sensor 302 can be used without departing from the scope of the invention such that the sensor comprises one or more components. For example, the sensor 302 can be configured to include a laser source and an imaging camera. This combination would be adapted to use a method of triangulation e ermine e is anc e arge issue su ace. e imaging camera can e an imaging αevice sucn as a or CMOS sensor. The imaging camera can be integrated with the phototherapeutic device or can be a separate device used in conjunction with the phototherapeutic device, such as an endoscope. A laser shines on the target tissue and exploits a camera to look for the location of the laser dot. Depending on how far away the laser strikes a surface, the laser dot appears at different places in the camera's field of view. This technique is called triangulation because the laser dot, the camera and the laser emitter form a triangle from which can be calculated the distance to the treatment surface. The information is processed, for example, by a controller, such as a CPU, and is used to dictate treatment parameters such as treatment time, therapeutic photo-radiation intensity or illumination pattern. [0047] The sensor 302 can also be a combination that comprises a photo-radiation source and an imaging camera which, together, are adapted and configured to determine the contour of a target surface using a method called structured photo-radiation. For example, the photo-radiation source could project a pattern of photo-radiation on the target tissue surface, and assess the deformation of the pattern on the surface with an imaging camera in a structured photo-radiation method. The pattern, such as a line, is projected onto the tissue surface using a photo-radiation source such as a sweeping laser. A camera, offset slightly from the pattern projector, looks at the shape of the line and uses a technique similar to triangulation to calculate the distance of every point on the line. In the case of a single-line pattern, the line is swept across the field of view to gather distance information one strip at a time. When this is coupled with a photo-radiation source 318 that combination is capable of controlling the application of photo- radiation in a variable two dimensional profile, such as a scanning mirror, digital micromirror device, LCD, or LED matrix, and the therapeutic photo-radiation can be applied in a manner to achieve controlled or controllable dose distribution to the target surface, such as uniform dose distribution.

[0048] The controller 304 of the therapy device 300 can be adapted and configured to control at least one of the control parameters of a device. The controller 304 can control or change, for example, the quantity {e.g., total energy) and intensity {e.g., power) and spectrum (e.g. wavelengths) and illumination pattern of photo-radiation emitted by the photo-radiation source 318, or combinations thereof over time. For example, in one embodiment, the controller 304 determines and/or controls the power from a power supply. The controller 304 can also be configured to control photo-radiation regulating optics such as an aperture which dictates fluence. The controller 304 can also be configured to control the illumination pattern. For example, by turning one or more photo-radiation sources powered on and powered off, the illumination pattern can be controlled. The controller 304 can further control the illumination pattern by moving (actively or passively) or otherwise altering optics such as a mirror, a filter or a lens. The controller 304 can further control the time of treatment by, for example, applying power to the photo-radiation source or opening and closing of a shutter device or controlling other optics. The controller 304 can also apply current to the photo-radiation sources at a desired frequency or duty cycle.

[0049] All of the control parameters for delivering therapy to a site with the device 300 of the invention can be adjusted based upon feedback of the sensor. Delivered photo-radiation radiation, or dose, can be defined in units of millijoules per squared centimeter. Treatments could range, for example, from about 10 mJ cm^'2 to about 4,000 mJ cm^"2 of ultraviolet light to nasal mucosa for the treatment of various inflammatory diseases such as sinusitis, nasal polyps and allergic rhinitis. Alternatively, treatment of infectious conditions may require more germicidal wavelengths, between about 250nm and 280nm, and may require from about 10 mJ cm^"2 and about 200 mJ cm^"2. Photodynamic therapy may require wavelengths between 400 nm and 700 nm and doses of about between 10 J cm^"2 and 750 J cm^"2. As will be appreciated by those skilled in the art, the treatment ranges would vary depending upon the therapeutic application and the tissue to be treated. o o-ra ia ion source an or e ivery source can e con igure o proαuce rmuupie raαia ion wavelengths, consisting of both therapeutic wavelength(s) and the wavelength(s) used to detect the reflective qualities of the target tissue. A second radiation source can also be provided which produces radiation at a different wavelength(s) than the therapeutic radiation source. In some instances, the sensor 302 can be configured to measure reflected radiation of this spectrum by being tuned or calibrated to this spectrum, or alternatively, receive only these wavelength(s) through optics such as filters, or alternatively, be timed such both radiation sources are not active at the same time, or alternatively, have separate optics than the therapeutic radiation. The second radiation source can be monochromatic or multi- wavelength. For example, the second radiation source can be a laser, a laser diode, an incandescent bulb, a gas discharge lamp, an arc lamp, a fluorescent lamp, and a light emitting diode, or a combination thereof. The second radiation source can communicate with the delivery source 306, or can be incorporated into the delivery source 306. Alternatively, the second radiation source is a separate device such as an endoscope.

[0051] In some embodiments, the device can be programmed by a user to deliver therapy for a set time or intensity based on the user's evaluation of the tissue to be treated. [0052] FlGS. 4A-C are examples of devices 400 for controlling delivery of photo-radiation to a tissue site. The device has a distal end 416 adapted for insertion into a body cavity and a proximal end 414 adapted to be engaged by a user. Photo-radiation is delivered from a device body 412. The device 400 can be configured to access a target tissue or desired treatment site through intracavity, interstitial, minimally-invasive, or non-invasive techniques known to those skilled in the art. The shaft, or insertion member, 408 or body 412 of the device 400 can enclose a variety of components, including one or more optical fibers, a liquid lightguide, a reflecting tube, and wires for driving a photo-radiation source or transmitting a signal from a sensor at the distal tip 422 of the device 400, to name a few. The shaft 408 and distal tip 422 of the device 400 can also be incorporated with a handle 428 which is positioned proximally 414. The handle 428 allows the user to comfortably position the device 400 and deliver therapy by hand. The handle can be low profile to improve handling. A photo-radiation source is generally positioned proximally in or near the handle 428 or shaft 408. In addition, control components of the device 400 may be incorporated into the handle 428, limiting the size and equipment that is required to power and run the device 400. The body 412 of the therapy device 400 in combination with the photo-radiation source 440 can be adapted and configured to be held in hand for an extended period of time (e.g. , a therapeutic time) without undue effort or discomfort to the user (e.g., healthcare practitioner delivering therapy to a patient, or patient delivering therapy to him or herself), due to the lightweight, portable design of the device 400. Photo-radiation is delivered from the distal end 416 of the device, or along a distal length of the device 400. The photo-radiation source can be positioned within the device, e.g., within the handle or the shaft, or can be external to the device as shown in FlG. 4c. The distal end of the device is adapted and configured to enable delivery of photo-radiation into tight spaces within a sinus or cavity. The height and width of the distal end can be lmm to 15mm, but is preferably 2mm to 5mm. The cross- section shape can be round, oval, rectangular or other suitable shape. The insertion member 408 is optically coupleable to the light source and configured to be at least partially inserted into the body cavity to deliver or selectively delivery light onto a target tissue. The insertion member can comprise an optical pathway which passes through an angle at the distal end of the insertion member. The optical pathway utilizes light transmissive materials such as glass, light transmissive liquid and light transmissive plastic. Certain materials could be used for UV light transmission including, but not limited to, quartz, fused silica, silicone rubber, liquid, PMMA, acrylic, magnesium fluoride, sapphire, calcium fluoride, specialty "i-line" glasses (e.g. manufactured by Schott) and certain cured optical cements. Furthermore, the distal end of the insertion member can reflect light from the light source at an angle grea er an egrees rom a ongi u ina axis o e is a en o e inser ion mem er, t uπnermore, tne ista en of the insertion member could conform to the target tissue surface. In any of these embodiments, the distal end could additionally comprise optics, such as a lens, to further direct the light. The optical pathway can comprise one or more UV transmissive optical fibers such as quartz or fused silica. These fibers have diameters which range from 2um to l,000um. They can be bundled together to form a densely packed grouping which then can collectively transmit the therapeutic light.

[0053] In FlG.4D, the shaft 408 is detachable from the handle 428 while remaining optically coupleable, if required. This configuration allows a user to change shafts having differing distal tip configurations during a procedure for a patient. Additionally, the detachable shafts allow the handle mechanism to be re-used from procedure to procedure. The shaft attachment can be a mechanical snap, press-fit, or other mechanism. The shaft can be keyed to the handle to ensure angular orientation. The shaft can have a hub at its proximal end which docks into the handle. The hub can be a molded plastic component. As shown in FlG.4E, sheaths 415 can be provided to cover the shaft 408. The sheaths can be formed of any suitable material known in the art. The sheaths can form a barrier between the shaft and the tissue of a patient, thus providing additional protection from infection and contamination. Additionally, the sheaths can be formed of a material that is transmissive to the therapeutic light, including glass, plastic and elastomer. Materials suitable to transmit ultraviolet light include PMMA, acrylic, silicone rubber, and plastics fabricated in thin films. The sheath may be molded, cast, or extruded. It may comprise a single fabricated part or an assembly of multiple parts. The sheath may also enhance the delivery of light from the distal end of the device. For example, the distal end of the sheath may comprise an optical element such as a lens, mirror, reflector, light scatterer or diffuser. The sheath may engage the shaft or handle with a mechanical means such as a press fit, snap fit, lock feature, thread, or other mechanism. Other functions of the sheath will be apparent to those skilled in the art.

[0054] Turning now to FlG. 4F, a system 401 is depicted wherein the device 400 is coupled with a delivery system 430 for delivery of photo-dynamic or light sensitive agent, or therapeutic material. As illustrated, a syringe is provided which is adapted to be positioned adjacent the shaft 408 of the device 400. Other delivery systems could also be employed without departing from the scope of the invention. For example, a pump could be adapted and configured to engage the device to deliver therapeutic material. Upon manual, automatic, or semi-automatic actuation of an actuation element 431 the delivery system delivers a photo-dynamic, therapeutic or antibacterial substance which overlaps at least a portion of the tissue to be treated by the device. In an alternative embodiment, the delivery system 430, shown in FlG.4F as adjacent and external the shaft 408 of the device 400 can be positioned within the shaft of the device with an actuation element 431 in the handle of the device. Suitable substances would be known to those skilled in the art and include, but are not limited to, saline solution, photosensitizers, and photodynamic agents such as porphyrin precursor, 5-aminolevulinate, methyl 5-aminolevulinate, metabolite of a porphyrin precursors, and synthetic porphyrin precursor. [0055] In FlG.4G a fiber optic assembly 460 is illustrated having a reflector 461 which reflects light at a distal end 416. The hand piece or handle 428 can be provided with a mechanism, such as a thumbwheel 421 to alter the angular orientation of a reflector. Thus, the hand piece assembly enables control of the therapeutic photo-radiation into the body cavity by rotating the reflector to change the direction at which the photo-radiation is delivered into the body cavity. The reflector can be formed from any suitable material including, but not limited to, a mirror, such as polished metal or plated glass, or a diffusing or scattering material. The angle is greater than 0 degrees from the longitudinal axis of the distal end of the insertion member, and could be as great as 90 degrees. The reflector could be planar or have a surface which alters the geometry or shape of the light beam. s scusse above, t e t p can e an ntegra part o t e s a suc t at the shaft and toe tip are one piece, or the tip can be secured to the shaft such that the tip and the shaft act in a unified manner during use. The tip 422 orientation can be controlled by, for example, a thumbwheel 421. Additionally, the tip 422 at the distal end of the device could comprise both the photo-radiation delivery source and a sensing optics 402. As would be appreciated by those skilled in the art, other configurations of the photo-radiation delivery source 418 and sensing optics 402 are possible. The photo-radiation source could comprise, for example, an LED, an array of LEDs, fiber optics, or another small, compact photo -radiation source. A sensor 402 could be positioned on the distal end of the tip to sense parameters such as photo-reflectance. [0057] Alternatively, optics could transmit reflected radiation to a sensor 402 which could be located in a handle or in a separate enclosure. The network of fiber optics 460 can be adapted and configured to act as both a sensor and a delivery source for photo-radiation. For example, a photo-radiation source located away from the distal tip of the device can be provided that communicates photo-radiation through the fiber optics to the delivery tip. Also, reflected photo-radiation is received by the fiber optics and travels to a sensor located away from the distal tip. In an alternative embodiment, a single fiber may be used for the transmission optics. In this embodiment, the fiber could be attached to an endoscope to provide the physician with visual guidance for the treatment.

[0058] The insertion member, which can include the tip 422 of the device 400, or the tip in combination with some or all of the shaft 408 of the device, can be configured so that it is flexible and its shape and orientation with respect to the handle is adjustable. The insertion member can be rigid, flexible, semi-flexible, conforming or steerable. [0059] FlGS. 5A-R illustrate a variety of configurations for a distal end 516 of a photo -radiation therapy device. The distal end is optically coupleable to the light source and is configured to be at least partially inserted into a body cavity, including the nasal or sinus cavity. The phototherapeutic apparatus or device is adapted and configured to selectively deliver light to a target tissue within the cavity such that the distal end of the device delivers a diverging beam of targeted light, conformable to the tissue being treated without inflation, can deliver light at an angle to the longitudinal axis of the insertion member, has a deformable distal tip adapted to engage the target tissue, an articulating neck member, or a combination thereof. The distal ends can be in the form of a paddle to provide a blunt, rounded, atraumatic end that is adapted and configured to be inserted between, for example, a polyp and a nasal cavity wall. Where the paddle tip can be inserted between the polyp and the cavity wall, more surfaces of the polyp can be illuminated. [0060] The distal tip can emit a diverging beam of light which is parallel with the longitudinal axis of the distal end of the insertion member. The emitted light targets the tissue area to be treated. In one embodiment, the target tissue area is "painted" with the targeted light to ensure the intended area is sufficiently treated (e.g., by moving the light back-and-forth across the tissue surface). In another embodiment, target tissue areas are treated incrementally. It may be beneficial for the treatment apparatus to have a focus, or zoom, function to allow the user to match the targeted tissue area to the emitted light beam spot. This can be achieved, for example, with optics at the distal tip. Optics can include a focusing lens.

[0061] The distal tips 530, 532, 534 in FlGS.5A-C illustrate configurations that deviate an angle α from a long axis x of the device. For purposes of illustration three angles α are depicted: 40° (FlG.5A), 90 ° (FiG.5B) and 120 ° (FiG. 5c). Other angles could be employed without departing from the scope of the invention. Typically, the angle configuration will be a function of the location of the target tissue and the physiological orientation of the target tissue to be treated compared to the surrounding tissue. FlG. 5D is configured to provide a distal tip 536 that can surround a three dimensional tissue structure on a plurality of sides. For example, as a polyp extends from a tissue surface the distal tip 536 can surround the polyp within a hood 523 that defines a tissue receiving cavity 524. As the . _ tissue is positione wit in t e cavity p oto-ra iation t erapy can e e ivere to t e tissue while protecting surrounding tissue from receiving phototherapy. In another embodiment, the hood 523 can be formed from a material that allows visible light to pass through but does not allow ultraviolet light to pass through. Suitable material includes, but is not limited to, polycarbonate, acrylic, ABS, PET, and elastomers. The shield 523 can be cup shaped, cup shaped with a soft foam pad, or a flat shield shape. Additionally, the hood can, in some cases, conform around a portion of a polyp.

[0062] Due to anatomical constraints in small body cavities, it may be desirable for the optical therapy device to apply therapy while in close proximity or in contact with the target tissue surface. Additionally, it may be desirable to treat a surface which is at an angle relative to the main axis of the insertion member. For example, a nasal polyp can span the width of the nasal cavity. To treat the sides of the polyp, it may be desirable to insert the emitting portion of the therapy device between the polyp and nasal cavity wall. This surface would otherwise not be treatable with a forward directed light beam. FlGS. 5E-F illustrate distal ends 538, 540 of a photo-radiation therapy device having an insertion member comprised of a bundle of fibers which undergo a bend and are also configured to create a specific light-emitting pattern. The bend could be 1 to 180 degrees, but more preferably is 30 to 120 degrees. Other angles could, however, be employed without departing from the scope of the invention. The fibers could be bonded into their final configuration using an epoxy material, a common process in the optics industry. As shown in FlG. 5F, the fibers form a line of emitted light. This insertion member could, for example, be placed in contact with or in close proximity to the lateral side of a nasal polyp to expose that surface to therapeutic light. If the polyp is in contact with the opposing nasal cavity wall, the insertion member could dissect the plane between the two tissue surfaces. The edges of the insertion member would be blunt and smooth in order to avoid damage to the tissue it would contact. In order to cover a surface area, the tip could be moved over the surface in a manner consistent with the desired dose application. For example, to treat the side of a nasal polyp, the distal end of the insertion member could be placed at the posterior edge of the targeted surface, then be moved in an anterior direction until the target tissue is treated. Although one configuration of fibers is shown, alternative arrangements can be envisioned. For example, the fiber ends could form a linear pattern that is parallel to the axis of the distal end of the insertion member, a rectangular pattern, a circular pattern, or an oval pattern. Other configurations can be envisioned by those skilled in the art.

[0063] Fibers could be made out of UV transmissive material such as quartz or fused silica or UV transmissive plastic. Smaller diameter fibers can be bent in smaller radii; this can be beneficial to redirect light in a short distance. When the fibers undergo a bend at the distal end of the insertion member, for example, a small bend radius will minimize the impact to the size of the insertion member. For example, a 2um fiber can be formed into a bend of about 30um. Small bend radii are beneficial when the body cavity, such as a nasal cavity, is small and thus requires small treatment instruments. The bend radius can be in the range of about 30um to about 2.0cm, but is more preferably in the range of about 0.5mm to 5mm. Optical fibers are typically constructed of a core material surrounded by a cladding material. Numerical aperture is defined as the angle at which the fiber will accept or emit light, and is a result of the core and cladding materials. A larger numerical aperture will accept light entering the fiber at a larger angle; subsequently, the same light will depart the fiber at a greater angle. The emitted light, then, will have a diverging angle that is dependant on the angle of the accepted light and the fiber's numerical aperture. When the insertion member distal end is not in contact with the target tissue, the projected light will create a larger target area to treat larger surfaces.

[0064] FlG.5G illustrates a distal end 542 of a device having an articulating neck 544. The articulating neck 544 enables optimal positioning of the distal end. Thus, for example, the device can be advanced into a sinus cavity and e is a en can e en o a ow e is a ip wi ig emi ing capa i i y o eliver inerapy to tne oac si e of a three dimensional tissue structure. The neck could have a steering mechanism that is controlled by the user. Alternatively, the neck could be malleable, enabling the user to form the desired shape or angle of the tip. As will be appreciated by those skilled in the art, the articulating neck feature of FlG. 5G can be incorporated into other distal tip designs disclosed herein, or contemplated as a result of this disclosure, without departing from the scope of the invention. FlG.5H illustrates a device tip 546 is a tissue deformable tip adapted and configured to compress a three dimensional tissue structure within two surfaces 547, 547' by shortening a spacer between their surfaces. Thus, the distal end of the insertion member has a first configuration and a second configuration wherein the second configuration is achieved when the distal end of the insertion member is flattening tissue to be treated. Flattening the target tissue between two surfaces can enable the device to deliver light therapy more evenly to the target tissue.

The distal end can be formed as a pair of fingers, or jaws. In another design, the distal end forms a pair of paddles, or as a pair of loops. Other shapes of the distal end can be envisioned. The distal end can be configured to deliver therapeutic light to the target tissue. A second instrument can also be introduced to deliver the therapeutic light. In some instances, the distal end of the device can be disconnected from the device and left in place. The paddles can also operate such that they conform partially to the tissue surface without distortion of the tissue.

[0065] FlG. 5l is adapted to provide a distal end 550 having a looped end 552 which is adapted and configured to surround the tissue to be treated. The looped end can be configured such that it surrounds the tissue with or without space between the loop and the tissue, or can be configured to decrease the circumference of the loop to compress tissue within the loop. The loop can be configured such that it is conformable to an exterior dimension of a polyp. [0066] FlG.5J illustrated a distal tip 554 which is adapted to potentially curve around a three-dimensional target tissue and to deliver light from apertures 556 along its length thereby providing a tissue conforming light delivery apparatus. Thus, the distal end of the insertion member has a first configuration and a second configuration wherein the second configuration is achieved when the distal end of the insertion member is conforming to the shape of the tissue to be treated. [0067] FlG.5K provides a distal end 558 comprising a plurality of light delivery fibers 560 which, when advanced to a target tissue, conform around the tissue to be treated. Thus, the distal end of the insertion member has a first configuration and a second configuration wherein the second configuration is achieved when the distal end of the insertion member is conforming to the shape of the tissue to be treated. Each fiber strand can be configured to emit light. When in contact with a target area, the device can potentially illuminate a larger area due to the flexibility of the fibers and the ability of the fibers to contact a larger surface area. For example, on an irregularly shaped surface, the fibers can still provide reasonably uniform illumination. The fibers could be various light transmitting materials including, but not limited to, quartz, fused silica, acrylic, and silicone rubber. Additionally, the fibers could further comprise optics. FlG. 5L illustrates a light delivery band 562. Since nasal polyps often appear in clumps, a light delivery band or ribbon can optimally deliver a light to their contoured surface. For example, a flexible ribbon made from a suitable material, such as semi- flexible metal or a plastic or an elastomer, is placed along the floor of the nasal cavity to conform to the treatment surface and emits therapeutic light upward toward the polyp tissue. The ribbon can be malleable to enable the user to optimize the shape to that of the target tissue. The ribbon could comprise a multitude of optical fibers that emit therapeutic light. In another embodiment, the ribbon material is capable of transmitting the light. Such materials include those that have been mentioned elsewhere in this invention including, but not limited to, silicone rubber and light transmissive plastic.

[0068] FlG. 5M illustrates a light delivery tip 564 wherein the tip of the device comprises optics which reflect light at an angle to the longitudinal axis of the distal end of the insertion member. In the embodiment shown, the light a r w ang e su a e a s s a en . e aiigieu sur atc tαu cause reflection by the use of internal reflection, a mirror or a light diffuser. Total internal reflection will occur if angle of incidence of the light is less than the critical angle of the two materials, one material being the reflector 565 and the other material being the material immediately adjacent to the angled surface. In another embodiment, the angled surface is a mirror. The mirror could, for example, be a reflective coating, such as a metal, applied to the angled surface. In yet another embodiment, the angled surface is a light diffuser. The light diffuser can be , for example, plastic such as PTFE, polytetrafiuoroethylene (Teflon®). The angled surface can be at different angles, but preferably is between 30 and 90 degrees from the longitudinal axis of the distal end of the insertion member. The reflector 565 can engage the shaft 508 of the insertion member by adhesive, a mechanical press or snap fit, thread, or locking mechanism. It can be permanently attached or be detachable. When it is detachable, the user could, for example, have multiple reflectors 565 available to select for treating a body cavity.

{0069] FlG.5N illustrates an alternative embodiment where the distal end 566 of the insertion member has particles 567 which reflect, scatter or diffuse the therapeutic light. These particles could, for example, be solid particles such as PTFE, glass, quartz, plastic, elastomer, titanium, stainless steel or aluminum; alternatively, the particles could be a gas, such as air, or a fluid, such as saline. Other materials can be envisioned by those skilled in the art. These elements can be embedded into a light transmitting material such as silicone rubber, quartz, fused silica or light transmitting plastic or elastomer. The size, shape, density and location of the particles will determine the pattern of distributed light. For example, there may be fewer particles at the proximal end of the light emitting portion than the distal end. Since light intensity is greatest at the proximal end, varying the density of particles in this way will enable a more even distribution of therapeutic light onto the tissue surface. In another example, it may be desirable to place more particles away from the light emitting surface in order to allow light to pass more distally and create a more desirable distribution of emitted light.

[0070] In one embodiment, light emits from only one side of the distal end. The opposite side could have a light- blocking or mirrored surface to ensure light does not escape from that side. In another embodiment, light emits from two sides. In yet another embodiment, light emits from a combination of sides and edges.

[0071] FlG. 5θ illustrates an alternative distal tip 568 which uses fibers to bend light at an angle. In this embodiment, the end of the fiber has been cleaved at an angle. Light passing to the end of the fiber will reflect off the cleaved angle. A group of fibers could be cut to different lengths so that light emitted from each fiber spreads out over an area to achieve the desired light distribution. The efficiency of reflecting light off a cleaved fiber end depends on the fiber material, the material contacting the fiber cleave, and the angle of the cleave. Total internal reflection will occur if angle of incidence of the light is less than the critical angle based on the two materials. This may be desirable as it is a more efficient use of the light. Although the cleaved fibers are all shown in the figure to emit light from one surface, the cleaved fibers can face different directions. In this embodiment, the distal end could emit light from more than one surface. A continuous pattern around a circumference would result in light being emitted circumferentially.

[0072] In yet another embodiment of the present invention, light is emitted from the side of a fiber as shown in the distal tip 570 depicted in FlG. 5P. One or more fibers can weave around a distal, or light emitting, portion of an insertion member. A single fiber can be used, or multiple fibers can be used. Those configurations result in a thin profile of the distal end which is suited to treat narrow spaces in body cavities. The fiber cladding can be at least partially removed from the fiber, thus allowing light to escape. A non-clad material could replace the cladding to protect the fiber or act to direct the light. Additionally, the fiber could be etched or cut in the light emitting portion to further direct the emitted light. The cladding could be removed from just one side of the fiber or could be _ . removed from all sides or the iiber. In the later scenario, a reflective backing matenal could be placed on one side of the distal end to direct the light only in one direction.

[0073] FlGS.5Q-R illustrate a distal end 572, 574 of an insertion member having a reflecting mirror which redirects the therapeutic light at an angle to the axis of the insertion member. A stepped or staggered mirror surface could be utilized to spread the light beam over a large surface relative to the area of the cross-section of the incoming light beam within the insertion member. A portion of the beam can be reflected at different points along the reflecting surface depending on that portion of the beam which comes into contact with the reflecting surface. The light emitting portion of the distal end could be, for example, a UV transmissive material such as quartz, fused silica, silicone rubber, light transmissive liquid, or UV transmissive plastic. The reflecting surface could be bordered by air which would cause light to reflect assuming the angle does not exceed the critical angle for internal reflection. Alternatively, as shown in FlG. 5R, the reflecting surface could have a reflective coating such as, for example, a deposited metal such as aluminum. Although a stepped surface is presented, alternative surface contours can be imagined by those skilled in the art. For example, parabolic or other geometric contours could be utilized to control the direction, shape and/or distribution of the emitted therapeutic light. Although the presented embodiments show light emitted from one side of the distal end, alternative embodiments can be imagined where light is emitted on two or more sides, or circumferentially. Furthermore, the emitting surface could comprise optics such as a lens or a light diffuser. Additional embodiments as those described above can be envisioned and are within the scope of this invention. For example, the distal tip of the insertion member could be configured to pierce a nasal polyp thereby illuminating the inside of the polyp. The inside of most nasal polyps consists of a stroma which contains inflammatory cells. These inflammatory cells have been shown to be susceptible to ultraviolet light.

Directing light from the inside of the polyp may potentially optimize the treatment by potentially treating more cells. The piercing fiber could be of a fixed length or could be adjustable. A plurality of fibers could be deployed to maximize the volume of tissue treated simultaneously. [0074] FIGS.6A-B illustrate the construction of a hand-piece 628 of a photo-radiation therapy device. The handle 628 has a size and shape adapted to improve handling and maneuverability during use. Low profile fmger grasps can be provided along the length of the handle as well. An outer jacket of 304 or 316 hypotubing can be provided. The proximal end 614 can have a coupling bushing 630. A fiber bundle (not shown) can be provided within the hypotubing 632 to communicate light from a light source to the distal end 616. The fiber bundle can have an outer diameter of, for example, 1.8 mm. The handle component can be formed from any suitable plastic or metal material, including ABS, polycarbonate, and aluminum. The length of the handle typically ranges from 3.5 to 6 inches in length with a diameter of 0.5 to 2 inches. Although, as will be appreciated by those skilled in the art, the diameter at any given place along the length of the handle can vary in order to improve handling by the user. The overall length of device will vary depending upon the location of the target tissue to be treated, but could be greater than 6 inches, and in many cases greater than 9 inches. A connector 632 can also be provided that is adapted and configured to enable the hand piece 628 to optically connect to an external light source, if desired.

[0075] FlGS. 7A-B illustrate a proximal end 714 of a photo-radiation device 700 adapted and configured to deliver light for phototherapy from a light source 702, a camera 704 , and a photodynamic solution 706. An endoscopic approach to treatment of a sinus cavity provides an added benefit of visualization at the distal end of the device. In this embodiment, a phototherapy light cable could be a flexible endoscope with UV transmissive core, such as a quartz or fused silica fiber or fibers, or a liquid light guide. In some instances, the endoscopic device could have a beveled end (e.g., 15°, 30 °, etc.) to provide better visualization. In most cases, the endoscope would be flexible and steerable and the phototherapy light cable would also be flexible. In some instances, the light cable is adapted to a vance eyon t e end o t e en oscope or optima positioning re ative to, or example, a polyp, in an alternative configuration, the light cable could be mounted along the outside of the endoscope. Additionally, a vacuum 710 can be provided to provide suction to the therapy device site. In yet another embodiment, the light source provides both visible light for imaging and therapeutic light. [0076J FlG- 8A illustrates a distal end 814 of a photo-radiation therapy delivery device adapted to control the distance of the distal tip of the device from a target surface. A spacer 870 extends from the distal end of the device to guide the placement of the tip of the device relative to the target tissue. Diverging light has a decreasing intensity at further distances from the tip, so in some treatment scenarios it is important to maintain a specified distance from the tip to the target tissue in order to ensure the tissue receives the proper dose of therapeutic light. As illustrated in the figure, the length of the spacer 870 determines the distance from the polyp 25 to the distal end of the apparatus tip 814. The spacers can be removable and replaceable in order to allow the user to adjust the distance the distal tip is from the tissue. Alternatively, the spacer length can be adjustable, either manually or automatically. Although a circular tip is as shown, other tip shapes can be envisioned including a fiber or rod, a finger shape, a loop shape or other shapes suitable for this application. [0077] FlGS.8B-C illustrate a distal end 814 of a photo-radiation therapy device wherein the device projects a plurality of non-parallel beams of light 872, 872' on a target tissue. A variety of configurations can be used to project the light onto the target tissue to be treated. When the beams are separated on the tissue, the device is either too far or too near the target tissue. When the beams overlap and form a single beam on the target tissue then the distal end of the device is the desired distance from the tissue. The distance determining light beams can be separate from the photo-radiation delivery device and can be non-therapeutic. The insertion member may have separate optical pathways for these light beams. Additionally, other shapes can be used to achieve the objective, or colored lights that form a single desired color when positioned an optimal distance from the target tissue. [0078] FlGS.9A-B are method steps for treating a target tissue. The method includes performing an initial examination 900 to make an initial assessment of symptoms and also, optionally, to determine the size and extent of a target area for treatment. Thereafter, a therapy device is introduced 902. The therapy device can, as described above, be adapted and configured to assess the size of the target tissue for treatment 904. Once the size and/or nature of the treatment tissue is determined, a treatment time, light intensity or treatment dose (treatment parameter) is set 906 and the target tissue is treated 908. The target tissue can be treated for even exposure, or locationally customized exposure based on physiological features of the polyp at a particular location. This process can be repeated 910 as many times as necessary to achieve desired treatment effect. In one embodiment, the light beam is moved over the target surface. In another embodiment, sections of the targeted tissue area are treated incrementally. Turning to FlG.9B, the method includes introducing a therapy device 902 and thereafter delivering a therapeutic solution 920 and delivering light therapy 922, which can be performed sequentially in any order, or concurrently. As a result of this process, the effectiveness of the treatment is increased 924. As will be appreciated by those skilled in the art, the use of ultraviolet radiation can be used as an adjunctive therapy to reduce bioburden and improve wound status. An increase in concentration of sodium chloride concentration impacts the sensitivity of methicillin-resistant Staphylococcus. Thus the combination of saline and UV light can be used to reduce bioburden in sinus cavities of a patient with sinusitis. Alternatively, photodynamic therapy can be effective in treating inflammatory diseases. A photosensitizer is applied to or in the target tissue prior to exposing the tissue to targeted light. The treatment modality has been used in dermatology for treatment of psoriasis using psoralen combined with UVA.

Photodynamic therapy has also been shown to be effective in treating malignancies using, for example, methyl 5- aminolevulinate in combination with blue or red light. XAMPLE

[0079] Phototherapy was delivered for 3-5 minutes, three times per week, in patients with allergic rhinitis. Sneezing, itching, rhinorrhea, and congestion were evaluated each week by a blinded observer and daily by the patient in a diary. Twenty-five patients were enrolled; twenty-four were control patients. An in vitro correlation of nasal lavage pre and post treatment was performed to evaluate local immune response. The total nasal score improve over the placebo (P<.004). Additionally, sneezing, rhinorrhea, itching and congestion improved. Nasal lavages decreased eosinophil count, IL-5, and ECP (eosinophil cationic protein). Furthermore, there was an induction of T cell and eosinophil apoptosis (in intro studies). EXAMPLE 2 [0080] Polyps to be treated are identified endoscopically. A total of three polyps will be taken from each patient for histological analysis. Twenty-four hours (+/- 4 hours) prior to the nasal polypectomy, UV phototherapy treatment will be delivered to the first polyp, at the time of the polypectomy surgery, a control polyp (second polyp) that was not exposed to phototherapy will be removed. Immediately after the second polyp is removed, a third polyp will be exposed to a phototherapy dose and then removed. The polyps will be fixed for histological study immediately. Histopathology results indicate significant apoptosis in the polyp which was treated twenty- fours hours prior to surgical removal.

[0081] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

WHAT IS CLAIMED IS:

1. A phototherapeutic apparatus for treating a body cavity comprising: a light source; an insertion member, having a distal end with a first configuration and a second configuration, optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto a target tissue, wherein the second configuration of the distal end is conformable to a tissue surface within the body cavity without inflation. 2. The phototherapeutic apparatus of claim 1 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic.

3. The phototherapeutic apparatus of claim 1 wherein the insertion member is detachable from the light source.

4. The phototherapeutic apparatus of claim 1 further comprising a sheath covering at least a portion of the insertion member.

5. The phototherapeutic apparatus of claim 4 wherein the sheath is removable.

6. The phototherapeutic apparatus of claim 1 further comprising an optical guidance system which transmits light from the light source to the insertion member.

7. The phototherapeutic apparatus of claim 6 wherein the optical guidance system is detachable from the insertion member.

8. The phototherapeutic apparatus of claim 1 wherein the insertion member comprises optical fibers.

9. The phototherapeutic apparatus of claim 1 further comprising a delivery device.

10. The phototherapeutic apparatus of claim 9 wherein the delivery device is a syringe adapted to deliver therapeutic material to the target tissue surface. 11. The phototherapeutic apparatus of claim 1 wherein the target tissue is located within the nasal or sinus cavity.

12. The phototherapeutic apparatus of claim 1 wherein the target tissue is located within the ear canal.

13. The phototherapeutic apparatus of claim 1 further comprising a timer for controlling the duration of light delivered from the distal end of the device. 14. The phototherapeutic apparatus of claim 1 further comprising a controller for controlling an amount of light delivered from the distal end of the device.

15. The phototherapeutic apparatus of claim 1 wherein the light source is an ultraviolet light source.

16. The phototherapeutic apparatus of claim 1 further comprising a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus. 17. A phototherapeutic apparatus for treating a body cavity comprising: a light source; and an insertion member having a proximal end and a distal end, optically coupleable to the light source, and configured to be at least partially inserted into the body cavity to selectively deliver light to a target tissue, wherein the insertion member comprises an optical pathway which passes through an angle at the distal end of the insertion member.

. ne pno o erapeu ic appara us o c aim w erein e op ica pa way comprises one o quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic.

19. The phototherapeutic apparatus of claim 17 wherein the insertion member comprises optical fibers. 20. The phototherapeutic apparatus of claim 17 wherein the insertion member is detachable from the light source.

21. The phototherapeutic apparatus of claim 17 further comprising a sheath covering at least a portion of the insertion member.

22. The phototherapeutic apparatus of claim 21 wherein the sheath is removable. 23. The phototherapeutic apparatus of claim 17 further comprising an optical guidance system which transmits light from the light source to the insertion member.

24. The phototherapeutic apparatus of claim 23 wherein the optical guidance system is detachable from the insertion member.

25. The phototherapeutic apparatus of claim 17 wherein the angle is between about 30 and 120 degrees.

26. The phototherapeutic apparatus of claim 17 wherein the optical pathway is bent in a radius of between about 0.1 mm and 2.0 cm.

27. The phototherapeutic apparatus of claim 17 further comprising a flexible distal neck.

28. The phototherapeutic apparatus of claim 17 further comprising a delivery device. 29. The phototherapeutic apparatus of claim 28 wherein the delivery device is a syringe adapted to deliver therapeutic material to the target tissue surface.

30. The phototherapeutic apparatus of claim 17 wherein the target tissue is located within the nasal or sinus cavity.

31. The phototherapeutic apparatus of claim 17 wherein the target tissue is located within the ear canal.

32. The phototherapeutic apparatus of claim 17 wherein the distal end of the insertion member engages a spacer to control the distance between the end of the distal end and the target tissue.

33. The phototherapeutic apparatus of claim 17 further comprising a focusing element for altering the size of the light beam emanating from the distal end of the device onto the target tissue. 34. The phototherapeutic apparatus of claim 17 further comprising a timer for controlling the duration of light delivered from the distal end of the device.

35. The phototherapeutic apparatus of claim 17 further comprising a controller for controlling an amount of light delivered from the distal end of the device.

36. The phototherapeutic apparatus of claim 17 wherein the light source is an ultraviolet light source. 37. The phototherapeutic apparatus of claim 17 further comprising a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus.

38. The phototherapeutic apparatus of claim 17 further comprising a tissue defoπnable distal tip.

39. The phototherapeutic apparatus of claim 17 further comprising a sensor.

40. A phototherapeutic apparatus for treating a body cavity comprising: a light source; and an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light to target tissue, w erein e is a en o e inser ion mem er re ec s ig om e ig source a an angle greater man υ egrees from a longitudinal axis of the distal end of the insertion member.

41. The phototherapeutic apparatus of claim 40 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic. 42. The phototherapeutic apparatus of claim 40 wherein the insertion member is detachable from the light source.

43. The phototherapeutic apparatus of claim 40 further comprising a sheath covering at least a portion of the insertion member.

44. The phototherapeutic apparatus of claim 43 wherein the sheath is removable. 45. The phototherapeutic apparatus of claim 40 further comprising an optical guidance system which transmits light from the light source to the insertion member.

46. The phototherapeutic apparatus of claim 45 wherein the optical guidance system is detachable from the insertion member.

47. The phototherapeutic apparatus of claim 40 wherein the reflection is caused by one or more internal reflections, reflectors, mirrors and light diffusers.

48. The phototherapeutic apparatus of claim 47 wherein the mirror is at an angle relative to the longitudinal axis of the distal end of the insertion member.

49. The phototherapeutic apparatus of claim 47 wherein the mirror has multiple positions.

50. The phototherapeutic apparatus of claim 47 wherein the mirror has multiple surfaces. 51. The phototherapeutic apparatus of claim 50 wherein the multiple surfaces of the mirror create a near uniform pattern of light emitted from the distal end of the insertion member.

52. The phototherapeutic apparatus of claim 47 wherein the light diffuser comprises particles.

53. The phototherapeutic apparatus of claim 47 wherein the light diffuser comprises one or more of glass, fluid, plastic, metal, rubber and elastomer. 54. The phototherapeutic apparatus of claim 53 wherein the particles are dispersed uniformly or non- uniformly in the distal end of the insertion member.

55. The phototherapeutic apparatus of claim 53 wherein the plastic is PTFE.

56. The phototherapeutic apparatus of claim 40 further comprising a flexible distal neck.

57. The phototherapeutic apparatus of claim 40 further comprising a delivery device. 58. The phototherapeutic apparatus of claim 57 wherein the delivery device is a syringe adapted to deliver therapeutic material to the target tissue surface.

59. The phototherapeutic apparatus of claim 40 wherein the target tissue is located within the nasal or sinus cavity.

60. The phototherapeutic apparatus of claim 40 wherein the target tissue is located within the ear canal.

61. The phototherapeutic apparatus of claim 40 wherein the distal end of the insertion member engages a spacer to control the distance between the end of the distal end and the target tissue.

62. The phototherapeutic apparatus of claim 40 further comprising a focusing element for altering the size of the light beam emanating from the distal end of the device onto the target tissue. 63. The phototherapeutic apparatus of claim 40 further comprising a timer for controlling the duration of light delivered from the distal end of the device.

. no g a co uυnci υi Lu muniiig an amount of light delivered from the distal end of the device.

65. The phototherapeutic apparatus of claim 40 wherein the light source is an ultraviolet light source.

66. The phototherapeutic apparatus of claim 40 further comprising a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus.

67. A phototherapeutic apparatus for treating a body cavity comprising: a light source; an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity, wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area.

68. The phototherapeutic apparatus of claim 67 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid, and light transmissive plastic.

69. The phototherapeutic apparatus of claim 67 wherein the insertion member is detachable from the light source. 70. The phototherapeutic apparatus of claim 67 further comprising a sheath covering at least a portion of the insertion member.

71. The phototherapeutic apparatus of claim 70 wherein the sheath is removable.

72. The phototherapeutic apparatus of claim 67 further comprising an optical guidance system which transmits light from the light source to the insertion member. 73. The phototherapeutic apparatus of claim 72 wherein the optical guidance system is detachable from the insertion member.

74. The phototherapeutic apparatus of claim 67 wherein the insertion member comprises optical fibers.

75. The phototherapeutic apparatus of claim 67 further comprising a flexible distal neck. 76. The phototherapeutic apparatus of claim 67 wherein the target tissue is located within the nasal or sinus cavity.

77. The phototherapeutic apparatus of claim 67 wherein the target tissue is located within the ear canal.

78. The phototherapeutic apparatus of claim 67 wherein the distal end of the insertion member engages a spacer to control the distance between the end of the distal end and the target tissue.

79. The phototherapeutic apparatus of claim 67 further comprising a focusing element for altering the size of the light beam emanating from the distal end of the device onto the target tissue.

80. The phototherapeutic apparatus of claim 67 further comprising a timer for controlling the duration of light delivered from the distal end of the device. 81. The phototherapeutic apparatus of claim 67 further comprising a controller for controlling an amount of light delivered from the distal end of the device.

82. The phototherapeutic apparatus of claim 67 wherein the light source is an ultraviolet light source.

83. The phototherapeutic apparatus of claim 67 further comprising a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus. 84. The phototherapeutic apparatus of claim 67 further comprising a sensor.

85. A method for treating a body cavity comprising: oviαi ig u , an i υi liiciii ci, uαving a distal end with a first configuration and a second configuration, optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto a target tissue, wherein the second configuration of the distal end conformable to a tissue surface within the body cavity, without inflation; and applying phototherapeutical light from the device to a target tissue within the body cavity.

86. The method according to claim 85 wherein the apparatus further comprises an optical guidance system which transmits light from the light source to the insertion member.

87. The method according to claim 85 wherein the light source generates light. 88. The method according to claim 85 further comprising the step of applying a therapeutic solution or compound to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light.

89. The method according to claim 85 wherein the target tissue is within a sinus or nasal cavity.

90. The method according to claim 85 wherein the target tissue is a nasal polyp.

91. The method of claim 85 further comprising the step of deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp.

92. The method of claim 85 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid and light transmissive plastic.

93. The method of claim 85 wherein the insertion member is detachable from the light source.

94. The method of claim 85 further comprising applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue.

95. The method of claim 85 wherein the phototherapeutical device further comprises an optical guidance system which transmits light from the light source to the insertion member.

96. The method of claim 95 wherein the optical guidance system is detachable from the insertion member. 97. The method of claim 85 wherein the insertion member of the phototherapeutical device comprises optical fibers.

98. The method of claim 85 wherein the phototherapeutic apparatus further comprises a delivery device adapted to deliver therapeutic material to the target tissue surface.

99. The method according to claim 85 wherein the target tissue is located within the ear canal. 100. The method according to claim 85 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a spacer.

101. The method according to claim 85 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a emitting a plurality of non-parallel light beams from the distal end of the device onto the target tissue. 102. The method according to claim 85 further comprising controlling the duration of light delivered from the distal end of the device.

103. The method according to claim 85 further comprising controlling an amount of light delivered from the distal end of the device.

104. The method according to claim 85 wherein the light source is an ultraviolet light source. 105. The method according to claim 85 wherein the phototherapeutical device further comprises a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus. 106. A method for treating a nasal or sinus cavity comprising: ui , u an iuaci uuu iucui r av ng a proximal end and a distal end, optically coupleable to the light source, and configured to be at least partially inserted into the body cavity to selectively deliver light to a target tissue, wherein the insertion member comprises an optical pathway which passes through an angle at the distal end of the insertion member; and applying phototherapeutical light from the device to a target tissue within the nasal or sinus cavity.

107. The method according to claim 106 wherein the apparatus further comprises an optical guidance system which transmits light from the light source to the insertion member.

108. The method of claim 107 wherein the optical guidance system is detachable from the insertion member.

109. The method according to claim 106 wherein the light source generates light.

110. The method according to claim 106 further comprising the step of applying a therapeutic solution or compound to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light.

111. The method according to claim 106 wherein the target tissue is within a sinus or nasal cavity. 112. The method according to claim 106 wherein the target tissue is a nasal polyp.

113. The method of claim 106 further comprising the step of deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp.

114. The method of claim 106 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid and light transmissive plastic. 115. The method of claim 106 wherein the insertion member is detachable from the light source.

116. The method of claim 106 further comprising applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue.

117. The phototherapeutic apparatus of claim 106 wherein the angle is between about 30 and 120 degrees. 118. The phototherapeutic apparatus of claim 106 wherein the optical pathway is bent in a radius of between about 0.1 mm and 2.0 cm.

119. The method of claim 106 wherein the wherein the insertion member of the phototherapeutical device comprises optical fibers.

120. The method of claim 106 wherein the phototherapeutic apparatus further comprises a delivery device adapted to deliver therapeutic material to the target tissue surface.

121. The method according to claim 106 wherein the target tissue is located within the ear canal.

122. The method according to claim 106 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a spacer.

123. The method according to claim 106 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a focusing element which focuses light emanating from the distal end of the device onto the target tissue.

124. The method according to claim 106 further comprising controlling the duration of light delivered from the distal end of the device.

125. The method according to claim 106 further comprising controlling an amount of light delivered from the distal end of the device.

126. The method according to claim 106 wherein the light source is an ultraviolet light source.

. ne me ca c vi iw m i wi piises a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus. 128. A method for treating a nasal or sinus cavity comprising: providing a phototherapeutical device comprising a light source, and an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light to target tissue, wherein the distal end of the insertion member reflects light from the light source at an angle greater than 0 degrees from a longitudinal axis of the distal end of the insertion member; and applying phototherapeutical light from the device to a target tissue within the nasal or sinus cavity. 129. The method according to claim 128 wherein the apparatus further comprises an optical guidance system which transmits light from the light source to the insertion member.

130. The method according to claim 128 wherein the light source generates light.

131. The method according to claim 128 further comprising the step of applying a therapeutic solution or compound to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light. 132. The method according to claim 128 wherein the target tissue is within a sinus or nasal cavity.

133. The method according to claim 128 wherein the target tissue is a nasal polyp.

134. The method of claim 128 further comprising the step of deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp.

135. The method of claim 128 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid and light transmissive plastic.

136. The method of claim 128 wherein the insertion member is detachable from the light source.

137. The method of claim 128 further comprising applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue.

138. The method of claim 128 wherein the phototherapeutical device further comprises an optical guidance system which transmits light from the light source to the insertion member.

139. The method of claim 138 wherein the optical guidance system is detachable from the insertion member.

140. The phototherapeutic apparatus of claim 128 wherein the reflection is caused by one or more internal reflections, reflectors, mirrors and light diffusers. 141. The method of claim 128 wherein the wherein the insertion member of the phototherapeutical device comprises optical fibers.

142. The method of claim 128 wherein the phototherapeutic apparatus further comprises a delivery device adapted to deliver therapeutic material to the target tissue surface.

143. The method according to claim 128 wherein the target tissue is located within the ear canal. 144. The method according to claim 128 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a spacer.

145. The method according to claim 128 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a focusing element which focuses light emanating from the distal end of the device onto the target tissue. 146. The method according to claim 128 further comprising controlling the duration of light delivered from the distal end of the device.

. e met o accor ing o c aim ur er comprising con ro ing an amount or ugni αeπvere from the distal end of the device.

148. The method according to claim 128 wherein the light source is an ultraviolet light source.

149. The method according to claim 128 wherein the phototherapeutical device further comprises a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus.

150. A method for treating a body cavity comprising: providing a phototherapeutical device comprising a light source, an insertion member optically coupleable to the light source and configured to be at least partially inserted into the body cavity, wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area; and applying phototherapeutical light from the device to a target tissue within the body cavity.

151. The method according to claim 150 wherein the apparatus further comprises an optical guidance system which transmits light from the light source to the insertion member.

152. The method according to claim 150 wherein the light source generates light.

153. The method according to claim 150 further comprising the step of applying a therapeutic solution or compound to the target tissue within the nasal or sinus cavity prior to applying phototherapeutical light.

154. The method according to claim 150 wherein the target tissue is within a sinus or nasal cavity.

155. The method according to claim 150 wherein the target tissue is a nasal polyp.

156. The method of claim 150 further comprising the step of deforming a nasal polyp within the nasal or sinus cavity prior to applying phototherapeutical light to the nasal polyp. 157. The method of claim 150 wherein the insertion member at least partially comprises one of quartz, fused silica, silicone rubber, light transmissive liquid and light transmissive plastic.

158. The method of claim 150 wherein the insertion member is detachable from the light source.

159. The method of claim 150 further comprising applying a sheath to cover at least a portion of the insertion member prior to applying phototherapeutical light from the device to a target tissue. 160. The method of claim 150 wherein the phototherapeutical device further comprises an optical guidance system which transmits light from the light source to the insertion member.

161. The method of claim 160 wherein the optical guidance system is detachable from the insertion member.

162. The method of claim 150 wherein the wherein the insertion member of the phototherapeutical device comprises optical fibers.

163. The method of claim 150 wherein the phototherapeutic apparatus further comprises a delivery device adapted to deliver therapeutic material to the target tissue surface.

164. The method according to claim 150 wherein the target tissue is located within the ear canal.

165. The method according to claim 150 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a spacer.

166. The method according to claim 150 wherein a distance between the end of the distal end of the phototherapeutical device and the target tissue is controlled by a focusing element which focuses light emanating from the distal end of the device onto the target tissue.

167. The method according to claim 150 further comprising controlling the duration of light delivered from the distal end of the device.

168. The method according to claim 150 further comprising controlling an amount of light delivered from the distal end of the device.

. iravioiex ngni source.

170. The method according to claim 150 wherein the phototherapeutical apparatus further comprises a connector adapted and configured to connect a distal end of the apparatus to a proximal end of the apparatus.

171. The method according to claim 150 wherein the phototherapeutical apparatus further comprises a sensor.

172. A phototherapeutic kit for treating a body cavity comprising: a light source; body comprising a handle and a connector; and one or more removable insertion members adapted to engage the connector of the body and optically coupleable to the light source and configured to be at least partially inserted into the body cavity to selectively deliver light onto target tissue wherein the insertion member emits a diverging beam of light which is targeted onto a target tissue area.

173. The phototherapeutical kit of claim 172 further comprising one or more therapeutic solutions or compounds to facilitate delivery of phototherapy. 174. The phototherapeutical kit of claim 172 further comprising one or more sheaths configured to fit over the insertion member.