US20060271024A1 - Nasal Cavity Treatment Apparatus - Google Patents

Abstract

An optical therapy device for providing therapeutic light to a person's nasal cavity includes a body and at least one UV light source in or on the body. A distal end of the body is configured to be inserted into the person's nasal cavity. The body can be configured to be hand-held. The optical therapy device is configured such that the UV light source emits a dose of UV light toward tissue in the patient's nasal cavity.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This Application is a Continuation of U.S. patent application Ser. No. 11/152,946, filed Jun. 14, 2005. This Application also claims the priority benefit of U.S. Provisional Application No.60/646,818, filed1/25/05, and U.S. Provisional Application No. 60/661,688, filed Mar. 14, 2005, all of which are incorporated by reference herein in their entireties.
BACKGROUND
• 1. Field of the Invention
• The present invention relates generally to optical therapies and phototherapies for treatment of diseases and physiological disorders, such as, for example, rhinitis.
• 2. Background of Invention
• Phototherapy has been used to treat skin disorders, such as psoriasis and atopic dermatitis. As the understanding of the pathophysiologic mechanisms of disease has become better understood, it has been learned that psoriasis is mediated by an immune reaction orchestrated by activated T-cells specific for an antigen. It has also been learned that the T cells undergo apoptosis (or programmed cell death) in response to ultraviolet light therapy (see, for example, Ozawa et al, 312-Nanometer Ultraviolet B Light (Narrow-Band UVB) Induces Apoptosis of T Cells within Psoriatic Lesions, 189(4) J. Exp. Med. 711-18, which is incorporated by reference herein). Ultraviolet-B (UVB) light, generally in the range of about 280 nm to about 320 nm, has also been shown to induce cytokines such as interleukin 10 (IL10) and tumor necrosis factor alpha (TNF-α) (see, for example, Narrow-Band Ultraviolet B and Broad-Band Ultraviolet A Phototherapy in Adult Atopic Eczema: A Randomized Controlled Trial, 357 Lancet 2012-16 (2001), which is incorporated by reference herein).
• Ultraviolet therapy was also studied in the context of atopic dermatitis and was found to have a beneficial effect (see, for example, Narrow-Band Ultraviolet B and Broad-Band Ultraviolet A Phototherapy in Adult Atopic Eczema: A Randomized Controlled Trial, 357 Lancet 2012-16 (2001) and UVB Phototherapy of Atopic Dermatitis, 119 British Journal of Dermatology 697-705 (1988), both of which are incorporated by reference herein). Similar mechanistic actions of ultraviolet light are invoked in atopic dermatitis as in psoriasis; that is, apoptosis of immune regulatory cells. Additional mechanisms are invoked for atopic dermatitis as well. For example, Guhl, et al., (Bivalent Effect of UV Light on Human Skin Mast Cells—Low-Level Mediator Release at Baseline but Potent Suppression upon Mast Cell Triggering, 124 J. Invest. Dermatol. 453-56 (2005), which is incorporated by reference,) showed that mast cells from skin are sensitive to UVA light having a wavelength in the range of 320 nm to 400 nm, and that these wavelengths (albeit at higher doses) can inhibit the degranulation of mast cells, thereby preventing histamine release.
• More recent work in atopic dermatitis has revealed that light concentrated in the blue range (which is generally light having a wavelength in the range of about 400 nm to about 450 nm) can also improve the symptomatology of atopic dermatitis. See, for example, Krutman, et al., Ultraviolet-Free Phototherapy, 21 Photodermatology, Photoimmunology, and Photomedicine 59-61 (2005), which is incorporated by reference. Krutman, et al. showed that the application 40 J/cm2 of essentially blue light can dramatically improve the symptomatology of atopic dermatitis even when one observes patients further out over time.
SUMMARY OF THE INVENTION
• In one embodiment, an optical therapy device for providing therapeutic light to a person's nasal cavity comprises a body, wherein at least a distal end of the body is configured to be inserted into the person's nasal cavity and wherein said body is further configured to be hand-held; and at least one UV light source positioned in or on said body, wherein said device is configured such that said at least one UV light source emits a dose of UV light toward tissue in said patient's nasal cavity when the distal end of the body is positioned in the nasal cavity.
• The body may further comprise a microcontroller electrically coupled to the at least one UV light source. The at least one UV light source may comprise a solid-state light source, a light emitting diode (LED), at least one of a mercury vapor lamp and a UV enhanced halogen lamp, a UVA light source, a UVB light source, and/or a UVA light source and a UVB light source.
• In one embodiment, the optical therapy device further comprises a light conditioner. The light conditioner may comprise a light scattering medium, a light focusing element, a lens, a light reflecting element, a mirror, a filter, an optical filter and/or a sheath.
• In another embodiment, the optical therapy device body further comprises a body proximal portion and a body distal portion, wherein the at least one UV light source is located at the body distal portion. In yet another embodiment, the optical therapy device body further comprises a body proximal portion and a body distal portion, the body distal portion comprising the distal end of the body, wherein the at least one UV light source is located at the body proximal portion. The body may be elongate and have a length extending from a proximal end of the body to the distal end, and the length may be less than or equal to about 30 cm.
• In another embodiment, the optical therapy device body further comprises a body proximal portion and a body distal portion, the body distal portion comprising the distal end of the body, wherein said optical therapy device further comprises a window, wherein the window is located at or near the body distal portion. The window may be at least partially transmissive of UV light generated by the UV light source.
• The optical therapy device may further comprise a sheath, wherein the sheath is configured to at least partially cover the body. The sheath may be manufactured using a mold. In addition, the sheath may comprise at least one material that is at least partially transmissive of UV light. The at least one material may condition the light.
• In another embodiment, the optical therapy device further comprises a controller, wherein said controller controls a parameter of the dose. The controller may be in or on said body. The parameter may comprise at least one of an on-time and an off-time of the optical therapy device and/or a sequence for activating said at least one UV light source. The controller may record a total number of doses and prevents the emission of the dose after the total number of doses reaches a predetermined level.
• In another embodiment, the optical therapy device further comprises a power supply for powering said at least one UV light source, wherein said power supply is positioned in or on the body. In yet another embodiment, the optical therapy device further comprises a cooling module that dissipates heat generated by said optical therapy device. The cooling module may comprise a heat pipe and/or an active cooling device.
• In another embodiment, the optical therapy device further comprises a visible light source. The visible light source may comprise at least one LED.
• In another embodiment, the at least one UV light source provides a UVA percentage and a UVB percentage of total optical energy delivered by the optical therapy device, and the UVB percentage is less than said UVA percentage. In another embodiment, the at least one UV light source comprises an LED chipset, wherein the LED chipset comprises at least one UVA LED that emits UVA light and at least one UVB LED that emits UVB light.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: a body, wherein at least a portion of the body is configured to be inserted into the nasal cavity; at least one UV light source positioned on or in said body, wherein said at least one UV light source generates light that is emitted toward tissue inside said nasal cavity when the portion of the body is inserted into the nasal cavity; and a light conditioner configured to condition light emitted from the at least one UV light source.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: a body, wherein at least a portion of the body is configured to be inserted into the nasal cavity; at least one UV light source positioned on or in said body, wherein said at least one UV light source generates light that is emitted toward tissue inside said nasal cavity; and a sheath, configured to cover at least a portion of the body.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: a body, comprising a distal portion, wherein at least the distal portion is configured to be inserted into the nasal cavity; and at least one UV light source that generates UV light, said UV light source positioned at said distal portion.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: a body, wherein at least a portion of the body is configured to be inserted into the nasal cavity; and at least one solid-state UV light source positioned in or on said body, wherein said at least one solid-state UV light source is configured to emit light into the nasal cavity when the portion of the body is inserted into the nasal cavity.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: an elongate body, wherein at least a distal end of the elongate body is configured to be inserted into the nasal cavity, wherein the elongate body has a length, extending from a proximal end of the body to the distal end, that is less than or equal to about 30 cm; and at least one UV light source positioned in or on said elongate body, wherein said at least one UV light source is configured to emit light into the nasal cavity when the distal end is inserted into the nasal cavity.
• In yet another embodiment, an optical therapy device for providing therapeutic light to a person's body cavity, comprises: a body, wherein at least a portion of the body is configured to be inserted into the person's body cavity; at least one UV light source positioned in or on said body, wherein said at least one UV light source is configured to emit light into the person's body cavity; and a light conditioner, configured to condition light emitted from the at least one UV light source.
• In another embodiment, an optical therapy device for providing therapeutic light to a person's body cavity, comprises: a body, wherein at least a portion of the body is configured to be inserted into the person's body cavity; at least one UV light source positioned in or on said body, wherein said at least one UV light source is configured to emit light into the person's body cavity; and a sheath, configured to cover at least a portion of the body.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: a body, wherein at least a distal portion of the body is configured to be inserted into the nasal cavity; at least one UV light source located at the distal portion, said optical therapy device being configured to activate said at least one UV light source to generate a therapeutic dose of UV light to tissue in the nasal cavity when the portion of the body is positioned in the nasal cavity.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: an elongate body, wherein at least a distal end of the elongate body is configured to be inserted into the nasal cavity; and a light conditioner configured to condition light emitted from at least one UV light source located in or on the body, wherein the elongate body has a length, from a proximal end of the body to the distal end, that is less than or equal to about 30 cm.
• In another embodiment, an optical therapy device for providing therapeutic light to a nasal cavity, comprises: an elongate body, wherein at least a distal end of the elongate body is configured to be inserted into the nasal cavity; and a sheath, configured to cover at least a portion of the body, wherein the elongate body has a length, from a proximal end of the body to the distal end, that is less than or equal to about 30 cm.
• In yet another embodiment, an optical therapy device for providing therapeutic light to a mammal's nasal cavity, the optical therapy device comprises: inserting means for delivering light to the mammal's nasal cavity, said inserting means comprising an insertion portion that is configured to be wholly inserted into the mammal's nasal cavity; and UV light-emission means, positioned on or in said insertion portion of said inserting means, such that said UV light-emission means generates UV light that is emitted toward tissue in said mammal's nasal cavity when the insertion portion is inserted into the patient's nasal cavity.
• In another embodiment, a method of delivering optical therapy to a patient, comprises: providing an optical therapy device, said optical therapy device comprising: a body that is configured to be hand-held, said body comprising a distal portion, wherein at least the distal portion is configured to be inserted into the patient's nasal cavity; and at least one UV light source positioned in or on said body; inserting the optical therapy device in the patient's nasal cavity; and emitting UV light for a period of time from said UV light source toward tissue inside said patient's nasal cavity. In another embodiment of the method, the at least one UV light source comprises a light emitting diode.
• In another embodiment, a method of delivering optical therapy to a patient, comprises: providing an optical therapy device, said optical therapy device comprising: an elongate body, wherein at least a distal end of the elongate body is configured to be inserted into the person's nasal cavity, and wherein the elongate body has a length, from a proximal end of the body to the distal end, that is less than or equal to about 30 cm; and at least one UV light source located in or on said elongate body; and emitting a dose of UV light from said UV light source toward tissue in said patient's nasal cavity when the distal end of the body is positioned in the nasal cavity. In another embodiment of the method, the at least one UV light source comprises is a light emitting diode.
• In one embodiment, an optical therapy device includes a proximal end, a distal end, a connecting structure, and one or more independently controllable light emitting semiconductor devices at the distal end, wherein at least one independently controllable light emitting semiconductor device emits electromagnetic radiation in the range of between about 200 nm and about 400 nm. The device may be further configured for medical use and/or for research use. In one embodiment, at least one of said one or more of the light emitting semiconductor devices emits electromagnetic radiation in the range of between about 250 nm and about 350 nm. In another embodiment, at least one of said one or more of the light emitting semiconductor elements emits electromagnetic radiation in the range of between about 270 nm and about 320 nm. In another embodiment, at least one of said one or more light emitting semiconductor elements emits electromagnetic radiation between about 300 nm and about 315 nm.
• In another embodiment, the device also includes a controller configured to modulate the spectral characteristics of the device. At least one light emitting semiconductor devices may emit electromagnetic radiation with more than one individually controllable wavelength. The medical use may be an optical therapy. The device may be configured to enter a body cavity. The electromagnetic radiation of the independently controllable semiconductor device may emit directly into a body cavity. The electromagnetic radiation of the at least one independently controllable semiconductor device may emit electromagnetic radiation into a body cavity without an optical guidance system. The connector of the device can include a rigid and/or a flexible material. In one embodiment, the connector includes a catheter, laparoscope, and/or an endoscope.
• In another embodiment of the present invention, an optical therapy device includes a proximal end, a distal end, and a connecting structure between the proximal and distal ends, wherein the distal end includes more than one individually controllable light emitting semiconductor devices. The device may be configured for medical and/or research use, and may further comprise a control system to independently control light emitting semiconductor devices. The device may be configured to apply light therapy to a body surface. The proximal end may be configured to control the orientation of the distal end.
• In one embodiment of the present invention, a method of treating a patient includes providing a device having a proximal end, a distal end, and at least one light-emitting semiconductor device at the distal end, and applying the device to a patient such that the distal end resides within 20 mm of a body surface.
• In one embodiment of the method, the at least one light-emitting semiconductor device emits electromagnetic radiation with a wavelength in the range of between about 200 nm and about 400 nm. In one embodiment, the body surface is the skin. In another embodiment, the body surface is a mucosal surface of an airway. In yet another embodiment, the mucosal surface of the airway is the nasal mucosa. The mucosal surface may be the mucosa of a paranasal sinus. As used herein, “nasal cavity” includes its ordinary meaning and can also include the paranasal sinuses and nearby anatomic structures. Additionally, the body surface may be a tract created by a man-made device, such as an indwelling catheter. The body surface may be the surface of an implanted device, such as the skin. In one embodiment, a synergistic moiety is introduced into the body surface prior to applying said device.
• In one embodiment, a method of treating a patient includes providing a device including a proximal end, a distal end, and at least one semiconductor element at the distal end wherein the at least one semiconductor element or combination of semiconductor elements emit more than one individually controllable wavelength and applying the device to a patient. The method may further include applying the device to the patient to treat or prevent a medical condition. In one embodiment, the medical condition is rhinitis, sinusitis, a disorder of the anterior portion of the eye, a state of infection, an allergic condition, sinusitis, a state of organ rejection, and/or a dermatologic disorder.
• In one embodiment, a method of treating a patient includes providing a device having a photon generator, a supply of power, and a mechanism of attachment to the patient, and attaching the device to a patient. The method may further include applying optical therapy to a patient with said device.
• In another embodiment, a method of treating a patient includes providing a device having photon generator, a supply of power, a mechanism of attachment to the patient, and a system to control the spectral output of the device, and applying optical therapy to the patient. The method may further include programming said controller to deliver a custom spectral output.
• In another embodiment, a method of treating a patient includes providing a device including a semiconductor based photon generator, a supply of power, a mechanism of attachment to the patient, and a system to control the spectral output of the device, and applying optical therapy to the patient.
• In one embodiment, a method of treating a patient includes providing a device having at least one semiconductor-based generator of photons that emits light having a wavelength in the range of between about 200 nm and about 400 nm, and a mechanism of attachment to the patient. The method may further include treating a patient with optical therapy.
• In one embodiment, a system for delivering optical therapy includes an array of individually controllable light emitting semi-conductor devices, a controller, and a handheld probe, wherein the spectral output of the system is programmable with the controller. The controller may be programmable to deliver one or more doses of optical therapy. The controller may be configured to deliver enough power to destroy said light emitting semiconductor devices after a defined number of optical therapy doses. The system may further include an optical guidance system.
• At least one individually controllable semiconductor element may emit electromagnetic radiation having a wavelength in the range of between about 200 nm and about 400 nm. The at least one individually controllable semiconductor device may emit electromagnetic radiation having a wavelength in the range of between about 250 nm and about 350 nm. The system may further include a wireless transmitter in communication with said controller.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a cross-sectional view of an optical therapy device in accordance with one embodiment of the present invention;
• FIG. 1B is a cross-sectional view of the sheath of the optical therapy device ofFIG. 1A;
• FIG. 2 illustrates an optical therapy system in accordance with another embodiment of the present invention;
• FIGS. 3A and 3B illustrate an optical therapy device inserted into a person's nasal cavity;
• FIGS. 4 and 5A are cross-sectional views of optical therapy devices in accordance with embodiments of the present invention;
• FIG. 5B is a cross-sectional view taken alongline5B-5B ofFIG. 5A;
• FIGS. 6A-7A are cross-sectional views of optical therapy device in accordance with additional embodiments of the present invention;
• FIG. 7B is a cross-sectional view taken alongline7B-7B ofFIG. 7A;
• FIG. 8A is a cross-sectional view of an optical therapy device in accordance with other embodiments of the present invention;
• FIG. 8B is a cross-sectional view taken alongline8B-8B ofFIG. 8A;
• FIGS. 9A-9H illustrate optical therapy devices having different tubes in accordance with additional embodiments of the present invention and generally configured to treat the sinuses of a patient;
• FIGS. 91-9J illustrate another optical therapy device in accordance with another embodiment of the present invention;
• FIG. 10A illustrates a light emitting diode (LED) device in accordance with one embodiment of the present invention;
• FIG. 10B is an exploded view of the LED ofFIG. 10A;
• FIG. 10C illustrates a spectroradiometer measurement of the optical output from an LED device, such as the LED ofFIG. 10A, having a peak at about 308 nm;
• FIG. 10D illustrates the output from one embodiment of a set of three white-light emitting LEDs (wLED);
• FIG. 10E illustrates a spectroradiometer measurement of the optical output from a multi-chip LED (mLED);
• FIGS. 11A and 11B are cross-sectional views of an optical therapy device according to additional embodiments of the present invention;
• FIG. 11C is a cross-sectional view taken along line11C-11C ofFIG. 11B;
• FIG. 11D is a cross-sectional view taken along line11D-11D ofFIG. 11B;
• FIG. 12A illustrates another embodiment of an optical therapy device positioned at the end of a flexible medical device;
• FIG. 12B illustrates one embodiment of an indwelling catheter according to another embodiment of the present invention;
• FIG. 12C illustrates one embodiment of an optical therapy device located inside of an at least partially optically-transparent balloon;
• FIGS. 13A-13B illustrates one embodiment of an optical therapy system to treat transplanted organs, such as transplanted kidney;
• FIGS. 14A-14B illustrate another embodiment of an optical therapy device used to treat disorders of the eye;
• FIG. 15A illustrates an optical therapy device delivering optical therapy to a patient's skin;
• FIG. 15B illustrates a wearable optical therapy device in the form of a wrist bracelet;
• FIG. 15C illustrates an optical therapy device delivering optical therapy to a patient's fingernail; and
• FIG. 15D illustrates an optical therapy device in the form of an adhesive bandage.
DETAILED DESCRIPTION OF THE INVENTION
• The Atopic Diseases
• Atopy refers to an inherited propensity to respond immunologically 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. Atopic dermatitis, or eczema, is less common, but nonetheless afflicts an estimated 20 million people in the U.S. There is a great deal of overlap among patients with atopic disease. Patients with atopic asthma have a greater likelihood of developing allergic rhinitis and dermatitis, and vice versa. Indeed, the pathophysiology for all atopic diseases is generally the same whether or not the affected organ is the skin, the nose, the lungs, or the gastrointestinal tract. 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.
• 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), both of which are incorporated by reference, 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.
• Ultraviolet Therapy, Other Skin Disorders, and Other Diseases
• Ultraviolet A-1 therapy (typically performed with light having a wavelength in the range of about 340 nm to about 400 nm) has also been shown to be useful in the treatment of disorders of excess collagen production such as scleroderma. In this disease state, the phototherapy has been shown to induce collagenases within the skin which ultimately leads to softer and more compliant skin (See, for example, UVA-1 Phototherapy, 21 Photodermatology, Photoimmunology, and Photomedicine 103-08 (2003), which is incorporated by reference).
• Collagenases are also present in other organ systems where scarring is a problem as well. For example, the myocardium is endowed with a very active collagenase system which has been shown to affect the scarring process in disease states such as diastolic heart failure and other cardiomyopathies (See, for example, Fibrosis as a Therapeutic Target Post-Myocardial Infarction, 11(4) Curr Pharm Des. 477-87, which is incorporated by reference). Similarly, interstitial bladder disease also results from imbalances in the collagenase system (Peters, et al., Dysregulated Proteolytic Balance as the Basis of Excess Extracellular in Fibrotic Disease, Am. J. Physiol. June, 272 (6 pt 2): R1960-5, which is incorporated by reference).
• Antimicrobial Effects of Ultraviolet Light
• 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; 2) the microbes often form biofilms to protect themselves against the protective mechanisms of the patient; 3) many chronic infections occur around man-made implants which often serve as a nidus for microbes to proliferate as well as form biofilms. Examples of chronic infections include: sinusitis (including chronic bacterial and fungal), vascular access catheter infections, chemotherapy port infections, peritoneal dialysis access catheter infections, vaginal yeast infections, chronic skin ulcerations and wounds, ventriculo-peritoneal shunts, sinus tracts in patients with Crohn's disease, chronic bronchitis and COPD, helicobacter pylori infections of the stomach, aerobic and anaerobic infections of the small intestine and colon, chronic ear infections, skin ulcers (e.g., diabetic skin ulcers), and fungal infections of the nail beds. There is also increasing evidence that atherosclerosis is caused by infections by micro-organisms such as Chlamydia.
• It is well-known that ultraviolet light (typically the longer wavelengths of the UVC region of the spectrum, 250-280 nm) has the ability to sterilize and destroy microbes through multifactorial mechanisms. To destroy viruses and bacteria, a dose of 2.5-50 mJ/cm2 can be utilized; for yeast, a dose of 6.6-35.6 μmJ/cm2 is typically utilized; and for molds, spores, fungi, and algae, a dose of 1-330 mJ/cm2 is typically utilized.
• Lighting Technologies
• Advanced lighting technologies, including solid state devices (e.g., light emitting diodes, electroluminescent inorganic materials, organic diodes, etc.), miniature halogen lamps, miniature mercury vapor and fluorescent lamps, collectively offer the potential for less expensive and more flexible phototherapeutical units. Solid state technology has already revolutionized areas outside medicine and holds a great deal of promise inside the biomedical sciences.
• Light emitting semiconductor devices (e.g., light emitting diodes or LEDs) offer many advantages in the biomedical sciences. For example, they are generally less expensive than traditional light sources in terms of cost per lumen of light; they are generally smaller, even when providing a similar amount of therapeutic power; they generally offer well-defined and precise control over wavelength and power; they generally allow for control of the pattern of illumination by allowing the placement of discrete optical emitters over a complex surface area and by allowing for individual control of each emitter; they also generally allow for easy integration with other microelectronic sensors (e.g., photodiodes) to achieve low cost integrated components; and finally, solid state components generally permit placement of the light source close to the treatment site rather than relying on costly, inefficient, and unstable optical guidance systems and light sources to do so. Solid state technology also promises portability and patient convenience (e.g., better patient compliance) because the lower cost and improved safety profile of the devices will allow for transfer of the therapies from the physician office and hospital to the patient's home.
• Solid state lighting technology has recently advanced to the point where it is useful in the longer wavelength ultraviolet and even more recently in the short ultraviolet wavelengths. For example, S-ET (Columbia, S.C.) manufactures LED dies as well as fully packaged solid state LEDs that emit relatively monochromatic ultraviolet radiation from 240 nm to 365 nm. Similarly, Nichia Corporation (Detroit, Mich.) supplies ultraviolet light emitting diodes which emit relatively monochromatic, non-coherent light in the range 365 nm to 400 nm. White light emitting diodes have been available for a relatively long time and at power densities which rival conventional lighting sources. For example, the LED Light Corporation (Carson City, Nev.) sells high powered white light LEDs with output from 390 nm to 600 nm. Cree Inc. (Durham, N.C.) also produces and sells LED chips in the long wave ultraviolet as well as the blue, amber and red portions of the electromagnetic spectra.
• Although some embodiments of the present invention include solid state light sources, other embodiment include non-solid state technologies, such as low pressure lamps, with or without solid state light sources. The Jelight Corporation (Irvine, Calif.) provides customized low pressure mercury vapor lamps complete with phosphors which emit a relatively narrow spectrum depending on the phosphor used. For example, Jelight's 2021 product emits 5 mW in the 305 nm to 310 nm portion of the electromagnetic spectrum.
• Halogen lighting technology can also be used to generate ultraviolet light, including light having wavelengths in the UVA (e.g., 320-400 nm), UVB (e.g., 280-320 nm), and white light (e.g., 400-700 nm) portions of the spectrum, as well as relatively narrow-band ultraviolet light (for example, when the lamp is provided with an appropriate filter and/or phosphors). For example, Gilway Technical Lamp (Wolburn, Mass.) supplies quartz halogen lamps, which are enhanced for ultraviolet emission by virtue of the quartz (rather than ultraviolet absorbing glass) bulb covering the filament. Such lamps are generally inexpensive, small, generate minimal heat, and may therefore be incorporated with many of the embodiments of the present invention, as disclosed in greater detail below.
• In many embodiments of the present invention, novel methods and devices to treat diseases utilizing optical therapies are disclosed. In addition to novel disease treatments and methods, many embodiments of the present invention are portable, and may be implemented with many of a variety of light sources. In many embodiments, a specific desired illumination pattern and controlling a preferred spectral output may be achieved.
• Anoptical therapy device100 in accordance with one embodiment of the present invention is illustrated inFIG. 1. Theoptical therapy device100 generally includes a body and alight source126. The term “body” is intended to have its ordinary meaning and can mean any structure of any size or configuration. In one embodiment, the body refers to theoptical therapy device100 without thelight source126 and without theexternal power supply110 orpower cords114 connected. The body of the optical therapy device in combination with thelight source126 can be held in one's hand or hands for an extended period of time (e.g., a therapeutic time) without undue effort or discomfort. The body and thelight source126 together can also be held in one's hand or hands and applied to the nasal cavity of a patient without undue effort or discomfort. In one embodiment, where the device is applied to the patient's nasal cavity, the body is not longer than about 30 cm. In another embodiment where the device is applied to the patient's nasal cavity, the body is not longer than about 50 cm. In another embodiment where the device is applied to the patient's nasal cavity, the body is not longer than about 20 cm. The body and thelight source126 should be able to fit into a typically sized briefcase or overnight bag.
• The body and light source in some embodiments do not weigh more than about one pound. In other embodiments, the light source and body do not weigh more than about two pounds. And in still other embodiments, the body and light source do not weigh more than about three pounds. When acord114 is attached, the device andcomputer110 are attached (e.g., the optical therapy system), the body and light source continue to be held in one's hand or hands.Optical therapy device100 can have ahandpiece102 that in one embodiment has a contoured surface for right-handed or left-handed gripping by a user. Thedistal end104 of thehandpiece102 can be coupled to atube106 at the tube'sproximal end108; in one embodiment, thetube106 is adapted to transport light. Theproximal end112 of thehandpiece102 can also be coupled to apower supply110. Apower coupling114 can couple thehandpiece102 to thepower supply110.
• Thetube106 is, in one embodiment generally shaped and sized to be inserted through the nostril of a patient and into the patient's nasal cavity. The nasal cavity is used herein to refer to the region of the nose from the nares to the nasopharynx and includes the paranasal sinuses and the nasal septum. For insertion into the nostril of a patient, the diameter of the distal end of thedevice body116 is generally not larger than about 1 cm. In some embodiments, the diameter of the distal end of thedevice body116 is not larger than about 5 mm. In other embodiments, the diameter of the distal end of thedevice body116 is not larger than about 3 mm. In one embodiment, thetube106 has a tapered shape, and tapers from a large diameter at itsproximal end108 to a smaller diameter (e.g., about 1 cm) at itsdistal end116. The diameter at theproximal end108 can be chosen for the ergonomic comfort of the person holding the device. In some embodiments, the diameter of theproximal end108 is in the range of from about 1 cm to about 5 cm. The proximal end can also be contoured as a hand grip for a right or left-handed user. Thedistal end116 has additional features which can control the illumination pattern. Additional features and embodiments of thetube106 and itsdistal end116 are provided in greater detail below.
• In one embodiment, thetube106 includes atip118 at thedistal end116 of thetube106. Thetip118 of thetube106 is any of a variety of optically transparent or partially transparent structures. The term “optically transparent” is intended to have its ordinary meaning, and to also mean transparent to wavelengths between about 250 nm and about 800 nm. In some cases, optically transparent can refer to more narrow ranges of transparency. For example, “optically transparent to ultraviolet light” can refer to transparency in the range from about 200 nm to 400 nm; “optically transparent to ultraviolet B” can refer to transparency in the range from about 280 nm to about 320 nm.
• In one embodiment, thetip118 includes a window, a diffusing lens, a focusing lens, an optical filter, or a combination of one or more of such tip types or other tip types which allow the spectral output to be conditioned. The terms conditioning, conditioner, and the like refer to their ordinary meaning, as well as a modification of the spectral output or the geometric illumination pattern of the device. In one embodiment, to provide a desired output spectrum, three types of tips are used in series within thetube106. For example, in one embodiment, a lens is used to diffuse (e.g., refract) certain wavelengths while filtering (e.g., transmitting certain wavelengths and absorbing others) certain wavelengths, and serving as a window (e.g., transmitting) certain wavelengths. In another embodiment, the light from thetube106 is transferred throughtip118 through a series of internal reflections. In one embodiment, thetip118 is made at least in part from a different material than that of thetube106. Thetip118 of thetube106 may be shaped or designed to disperse light as it exits the reflectingtube106 and is transmitted to a patient.
• In some embodiments,tube106 can be a reflecting tube and can be manufactured from any of a variety of materials, including plastic, stainless steel, nickel titanium, glass, quartz, aluminum, rubber, lucite, or any other suitable material known to those of skill in the art that may be adapted to be place inside of a patient's body. In some embodiments, the material of the tube is chosen to reflect certain wavelengths and/or absorb others. In some embodiments, the tube is configured to yield near or total internal reflection.
• In one embodiment, the reflectingtube106 is hollow. Theinside wall120 of the reflectingtube106 at least partially reflects light of a selected wavelength. Theinside wall120 may include a reflectinglayer122 applied over its entire surface although in other embodiments theinside wall120 does not include a reflectinglayer122. In one embodiment, thereflective layer122 includes a coating of a reflecting material such as, for example, aluminum, silica carbide, or other suitably reflective material.
• Theproximal end108 of thetube106 is coupled to thedistal end105 of thehandpiece102 by any of a variety ofcouplings124 well known to those of skill in the art. For example, in one embodiment, thecoupling124 includes a press-fit connection, a threaded connection, a weld, a quick-connect, a screw, an adhesive, or any other suitable coupling as is known to those of skill in the art. Coupling124 includes mechanical, optical, and electrical couplings, as well as combinations thereof.
• In one embodiment, thecoupling124 is releasable so that thetube106 may be decoupled or removed from thehandpiece102.Such coupling124 may also be made from a disposable material. In another embodiment, the reflectingtube106 is permanently attached to thehandpiece102. In such case, thecoupling124 is a permanent connection.
• In one embodiment, thehandpiece102 of the body includes alight source126. The light source may be any of a variety of high, low, or medium pressure light emitting devices such as for example, a bulb, an emitter, a light emitting diode (LED), a xenon lamp, a quartz halogen lamp, a standard halogen lamp, a tungsten filament lamp, or a double bore capillary. tube, such as a mercury vapor lamp with or without a phosphor coating. The particular light source selected will vary depending upon the desired optical spectrum and the desired clinical results, as will be described in greater detail below. Although thelight source126 ofFIG. 1 is shown in thehandpiece102, thelight source126 can be placed anywhere on, in, or along theoptical therapy device100. In some of the embodiments discussed below, multiple light sources are placed within theoptical therapy device100, some of which may reside in thehandpiece102 and some of which may reside on or in thetube106, and some of which may reside on or in thetip118.
• In one embodiment, thelight source126 includes a phosphor-coated, low pressure mercury vapor lamp. In a related embodiment, the phosphor is placed distal to the mercury vapor lamp; for example, the phosphor is coated onto the reflectingtube106 or is incorporated into thetip118.Optical emitter128 illustrates the light emitting portion of thelight source126. In one embodiment,optical emitter128 is a filament. Such filaments may be used whenlight source126 is an incandescent or halogen lamp. Whenlight source126 is a mercury vapor lamp,optical emitter128 can be an inner capillary tube where the mercury plasma emits photons.Leads132 extending from thelight source126, electrically couple thelight source126 with acontrol circuit134. In one embodiment, thecontrol circuit134 is in electrical communication with acontroller136 and withpower supply110 via thepower coupling114.
• In some embodiments, it is desired to control variables or control parameters associated with the output of theoptical therapy device100. Examples of such variables include power, timing, frequency, duty cycle, spectral output, and illumination pattern. In one embodiment, thecontrol circuit134 controls the delivery of power from thepower supply110 to thelight source126 according to the activation or status of thecontroller136. For example, in one embodiment, thecontrol circuit134 includes a relay, or a transistor, and thecontroller136 includes a button, or a switch. When the button or switch of thecontroller136 is pressed or activated, power from thepower supply110 is able to flow through thecontrol circuit134 to thelight source126.
• The variables can be controlled in response to, for example, at least one photoreflectance parameter, which, for example, may be measured or obtained at thedistal end116 of thetherapy device100. Other variables or control parameters include a desired dosage, or a previous dosage. In some embodiments, the patient or treating physician can adjust the treatment time based on the prior history with theoptical therapy device100. In some embodiments, controller mechanisms, which can be integral to theoptical therapy device100, allow for control over dosage and illumination. In other embodiments, the controller tracks the total dose delivered to a patient over a period of time (e.g., days to months to years) and can prohibit the device from delivering additional doses after the preset dosage is achieved.
• Although thecontrol circuit134 is illustrated within thehandpiece102 of theoptical therapy device100, in another embodiment, thecontrol circuit134 is located within thepower supply110. In such embodiments, thecontroller136 communicates with thecontrol circuit134 through thepower coupling114. Control data, commands, or other information may be provided between thepower supply110 and thehandpiece102 as desired. In one embodiment,control circuit134 stores information and data, and can be coupled with another computer or computing device.
• In one embodiment, power from thepower supply110 flows to thecontrol circuit134 of thehandpiece102 through apower coupling114. Thepower coupling114 maybe any of a variety of devices known to those of skill in the art suitable for providing electrical communication between two components. For example, in one embodiment, thepower coupling114 includes a wire, a radio frequency (RF) link, or a cable.
• Thelight source126 is generally adapted to emit light 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. In another embodiment of the current invention,light source126 emits light in the visible spectrum in combination with ultraviolet light or by itself. Finally, in yet another embodiment, thelight source126 emits light within the infrared spectrum, in combination with white light and/or ultraviolet light, or by itself.Light source126 may be adapted to emit light in more than one spectrum simultaneously (with various phosphors, for example) or a multiplicity of light sources may be provided to generate more than one spectrum simultaneously. For example, in one embodiment, thelight source126 emits light in the UVA, UVB, and visible spectra. Light emission at these spectra can be characterized as broad- or narrow-band emission. In one embodiment, narrow-band is over a bandgap of about 10-20 nm and broad-band is over a band gap of about 20-50 nm.
• In other embodiments, the spectrum is continuous. Continuous (or substantially continuous) emission is intended to have its ordinary meaning, and also to refer to generally smooth uniform optical output from about 320-400 nm for UVA, 280-320 nm for UVB, and below about 280 nm for UVC. In other embodiments, thelight source126 emits light in any two of the foregoing spectra and/or spectra portions. In addition, in some embodiments, some portions of the spectra are smooth and others are continuous.
• For example, in one embodiment, thelight source126 emits light having a narrow-band wavelength of approximately 308 nm within the UVB portion of the UV spectrum. In another embodiment, thelight source126 emits light having a wavelength below approximately 300 nm. In other embodiments, thelight source126 emits light having a wavelength between about 254 nm and about 313 nm.
• In one embodiment, theoptical therapy device100 includes more than onelight source126, where eachlight source126 has an output centered at a different wavelength. Eachlight source126 can have an output that can be characterized as broad-band, narrow-band, or substantially single band. Alllight sources126 can be the same characterization, or may have one or more different characterizations. For example, in one embodiment, theoptical therapy device100 includes three light sources126: one that emits light in the UVA region of the UV spectrum, one that emits light in the UVB region of the UV spectrum, and one that emits light in the visible region of the optical spectrum.
• The light sources may each emit light at a different energy or optical power level, or at the same level. Theoptical therapy device100 may be configured to provide light from threelight sources126, each having a different relative output energy and/or relative energy density level (e.g., fluence). For example, in one embodiment, the optical energy emitted from thelight source126 that provides light in the UVA region of the UV spectrum is about 10%, 20%, 25%, 35%, between about 15% and about 35%, or at least about 20% of the optical energy and/or fluence provided by theoptical therapy device100. In one embodiment, the optical energy emitted from thelight source126 that provides light in the UVB region of the UV spectrum is about 1%, 3%, 5%, 8%, 10%, between about 1% and about 11%, or at least about 2% of the optical energy and/or fluence provided by theoptical therapy device100. In one embodiment, the optical energy emitted from thelight source126 that provides light in the visible region of the optical spectrum is about 50%, 60%, 75%, 85%, between about 60% and about 90%, or at least about 65% of the optical energy and/or fluence provided by theoptical therapy device100.
• In one embodiment, theoptical therapy device100 includes a UVAlight source126, aUVB light source126, and a visiblelight source126, where the UVAlight source126 provides about 25%, the UVB light source provides about 5%, and the visible light source provides about 70% of the optical energy and/or fluence provided by theoptical therapy device100. For example, in one embodiment, theoptical therapy device100 provides a dose to the surface it is illuminating (e.g., the nasal mucosa) of about 2 J/cm2, where the UVAlight source126 provides about 0.5 J/cm2, theUVB light source126 provides about 0.1 J/cm2, and the visiblelight source126 provides about 1.4 J/cm2. In another embodiment, theoptical therapy device100 provides a dose of about 4 J/cm2, where the UVAlight source126 provides about 1 J/cm2, theUVB light source126 provides about 0.2 J/cm2, and the visiblelight source126 provides about 2.8 J/cm2. In another embodiment, theoptical therapy device100 provides a dose of about 6 J/cm2, where the UVAlight source126 provides about 1.5 J/cm2, theUVB light source126 provides about 0.3 J/cm2, and the visiblelight source126 provides about 4.2 J/cm2. In yet another embodiment, theoptical therapy device100 provides a dose of about 8 J/cm2, where the UVAlight source126 provides about 2 J/cm2, theUVB light source126 provides about 0.4 J/cm2, and the visiblelight source126 provides about 5.6 J/cm2. In some embodiments, the white light is omitted from the therapy leaving only the doses of the ultraviolet light. In some embodiments, the white light and the UVA are omitted leaving only the UVB doses. In other embodiments, the UVB and the white light are omitted leaving only the UVA dose. In other embodiments the UVB dosage is concentrated in the range from 305 nm to 320 nm, sometimes referred to as UVB1. UVB1 can be used in place of UVB in any of the combinations and doses above. In other embodiments, UVA1 (e.g., 340-400 nm) is used in any of the embodiments above in place of UVA. In yet other embodiments, UVA2 (e.g., 320-340 nm) is used in the embodiments above in place of UVA. In some embodiments, blue light (e.g., 400-450 nm) or a combination of blue light and long wavelength UVA (e.g., 375-450 nm) is used to treat tissue. In some embodiments, the dose of blue light or combination UVA-blue light is about 20-100 times greater than UVB. In some embodiments, the fluence in the above measurements represents energy delivered to a body cavity. For example, when the body cavity is the nasal cavity, the area over which the light is delivered can be approximately 5-30 cm2; therefore the energy in each region of the optical spectrum leaving the optical therapy device is in some embodiments 5-30 times the energy reaching the surface of the body cavity.
• In some embodiments, a ratio is defined between the wavelengths. In one embodiment, the ratio between the total UVA power and the total UVB power (the power ratio) is about 5:1. In other embodiments, the ratio is between 5 and 10:1. In other embodiments, the ratio is between 10 and 15:1. In some embodiments, UVB1 is substituted in the defined ratios. In any of the above ratios, visible light can be excluded or included. In some embodiments, the power ratio is further defined between UVA1 and UVB1; for example, the power ratio can be from40:1 to80:1 for a ration of UVA1 to UVB1.
• Optical energy densities are generally derived from a power density applied over a period of time. Various energy densities are desired depending on the disorder being treated and may also depend on the light source used to achieve the optical output. For example, in some embodiments, the energy densities are achieved over a period of time of about 0.5 to 3 minutes, or from about 0.1 to 1 minute, or from about 2 to 5 minutes. In some embodiments, for example, when a laser light source is used, the time for achieving these energy density outputs may be from about 0.1 seconds to about 10 seconds. Certain components of the optical spectrum can be applied for different times, powers, or energies. In the case where multiple light sources are used, one or more light sources can be turned off after its energy density is provided or achieved.
• Energy density or fluence or other dosage parameter, such as, for example, power, energy, illumination, or irradiance, may be measured at any of a variety of positions with respect to thetip118 of theoptical therapy device100. For example, in one embodiment, fluence is measured substantially at thetip118 of theoptical therapy device100. In this case, the dosage at the illumination surface is the fluence multiplied by the fluence area (for total power) and then divided by the illuminated surface area (e.g., in the nasal cavity, the surface area can range between 5 and 25 cm2). Therefore to achieve the desired dosage density, the fluence at the tip is approximately the dosage multiplied by illuminated surface area and then divided by the tip area. In another embodiment, the fluence is measured at a distance of about 0.5 cm, about 1 cm, or about 2 cm from the surface of thetip118 of theoptical therapy device100.
• The particular clinical application and/or body cavity being treated may determine the energy density or dosage requirements. If the lining of the cavity is particularly far away from theoptical therapy device100, a higher energy, fluence, or intensity may be chosen. In the case where the nasal cavity is being treated and rhinitis is the disease, the dosage from thetip118 may be chosen appropriately. For example, it has been shown by in-vitro work that T-cells undergo apoptosis at energy densities of about 50-100 mJ/cm2 of combined UVA, UVB, and white light. The energy densities exiting from the tip of the optical therapy device used to achieve such energy densities as measured at the mucosa, or treatment site, may be 5-10 times this amount because of theoptical therapy distance100 from the nasal mucosa cells during treatment.
• The energy densities may be further increased from that achieved in-vitro because of intervening biologic materials that may absorb light. For example, the mucus, which is present on top of the nasal mucosa in all patients, may absorb light in the desired region of the spectrum. In this case, the fluence or output of theoptical therapy device100 at thetip118 can be corrected for the extra absorption. Furthermore, the mucosa may absorb more or less light at different time points during an allergy season (for example) and therefore the fluence of the optical therapy device may be controlled at these times. In many embodiments, this control is provided by the optical therapy devices. Photoreflectance data from the mucosa can be used by the patient, the medical practitioner, or automatic feedback (e.g., from the tip118) to a controller and/or data processor. Such data can be used to estimate the thickness of the mucus layer and adjust the output of theoptical therapy device100 accordingly. In addition, the practitioner can evaluate the mucosa visually with a rhinoscope and adjust the optical parameters accordingly; in another embodiment,tube106 delivers an image from the region surrounding thedistal tip118.
• The dosage may be measured at a planar or curved surface with respect to thetip118 of theoptical therapy device100. For example, in one embodiment, the dosage is measured at a plane that is tangential to the surface of thetip118 of theoptical therapy device100. In another embodiment, the dosage is measured at a plane that is a distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm from the surface of thetip118 of theoptical therapy device100. In another embodiment, the dosage is measured at a partially spherical plane that is at least partially tangential to, or at a distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm from the surface of thetip118 of theoptical therapy device100. The selection of planar or curved surface for dosage measurement, and the distance between the measurement plane and theoptical therapy device100tip118 may be selected based upon the particular geometry oftip118 utilized.
• In one embodiment, theoutput portion130 of thelight source126 is positioned so that it resides within at least a portion of thetube106. When theoutput portion130 of thelight source126 is so positioned, light emitted from thelight source126 is transmitted directly into thetube106. In this embodiment, the tube is a reflecting tube. In such a case, optical losses may be minimized, or reduced. In addition, by positioning theoutput portion130 of thelight source126 inside of thetube106, additional optical focusing elements, such as lenses or mirrors, may not be required; moreover, the geometry of the tube can be optimized, such that light conduction is optimized by for example, creating surfaces within the tube designed to reflect light through and along the tube to transport the light to the distal end of the tube. In addition, the tube can be created to optimize total internal reflection of the light from the light source.
• In some embodiments, theoptical reflectance tube120 includes one or more optical fibers that capture and guide the light from the light source/s126. When thelight sources126 are small semiconductor structures, the fibers can encapsulate the semiconductor structure and faithfully transmit substantially all of the light from thelight source126. More than one fiber can be used to direct the light from multiplelight sources126. For example, each fiber can transmit light from onelight source126. In other embodiments, theoptical tube106 is or includes a light guide such as a liquid light guide (e.g., such as those available from EXFO in Ontario, CA).
• Thetube106 may taper from a large diameter at itsproximal end108 to a smaller diameter at itsdistal end116, in which case thetube106 has a larger diameter at itsproximal end108 than at itsdistal end116. In another embodiment, thetube106 may taper from a larger diameter at itsdistal end116 to a smaller diameter at itsproximal end108. In such case, thetube106 has a larger diameter at itsdistal end116 than at itsproximal end108. In other embodiments, thetube106 is substantially cylindrical. In such case, the diameter of thetube106 may be substantially constant along its entire length.
• In one embodiment, thetube106 is flexible so that its shape and orientation with respect to thehandpiece102 may be adjusted. A flexible material, such as rubber, plastic, or metal may be used to construct thetube106, and to provide flexibility thereto. In one embodiment, a goose-neck tube, or spiral wound coil is used to provide aflexible tube106. In such embodiments, anouter sheath142 may be provided with thetube106 to isolate the flexible portion of thetube106 from the inside of a patient's nasal cavity.
• Anouter sheath142 can be made from any of a variety of biocompatible materials well-known in the art such as, but not limited to, PTFE, ePTFE, FEP, PVDF, or silicone elastomers. The outer sheath can be disposable so that a clean, sterilized sheath can be used for each newly treated patient. Theouter sheath142 can also have beneficial optical properties. For example, the outer sheath can diffuse or otherwise pattern the light entering it from theoptical tube106. The outer sheath can be made of more than one material. For example, in some embodiments, the portion of the sheath where the light exits (e.g., the lens)140 can be produced from an optically transparent material such as silicone, fused silica, or quartz, and the biocompatible portion which surroundstube106 can be produced from a material which is more flexible or lubricious, such as PTFE, but which does not necessarily transmit ultraviolet light.
• In one embodiment,tube106 is sized so it may be inserted into the nasal cavity of a patient or user as discussed above. In one embodiment, thetube106 is inserted into the nasal cavity until itstip118 reaches the turbinates, the sinuses, or the ostia to the sinuses. Thetube106 may be made of flexible materials so that it can bend, or be steered around corners, or conform to the shape of the nasal cavity, as required. In other embodiments, the light is emitted from just beyond the nares and diffuses along a cylindrical path toward the nasal mucosa.
• Thetube106 may be made from any one or a combination of materials as described above. For example, thetube106 may be made from polymers. In such case, since many polymers absorb light in the ultraviolet portion of the spectrum, theinside wall120 of thetube106 may be coated with a reflective coating orlayer122, as described above. The outside of thetube106 can also be coated with a polymer with the inner material being one of the materials noted above.
• In one embodiment, thereflective layer122 includes an electrolessly-deposited metal. For example,layer122 may include nickel, nickel-phosphorous, cobalt, cobalt-phosphorous, nickel-cobalt-phosphorous and/or a noble metal. In other embodiments, thelayer122 includes a reflective polymeric coating. In other embodiments, the reflecting layer is a specialty thin film, such as silica carbide deposited in a chemical vapor deposition process.
• In one embodiment, thetube106 includes quartz, fused silica, aluminum, stainless steel, or any material which reflects a substantial amount of light in the ultraviolet region and/or visible region of the electromagnetic spectrum.
• Theoptical therapy device100 generally allows for the use of low pressurelight sources126 and can be manufactured at low cost using safelight sources126. By utilizing a low pressurelight source126, thelight source126 may be manufactured at a small size so that it can fit within a hand-heldhandpiece102 of theoptical therapy device100.
• Thecontroller136 of theoptical therapy device100 is adapted to control the quantity (e.g., total energy) and intensity (e.g., power) of light emitted by thelight source126 and thereby exiting thetip118 of theoptical therapy device100. For example, in one embodiment, thecontroller136 determines and/or controls the power from thepower supply110 as described in greater detail above. In one embodiment, thecontroller136 may be programmed and may include a timer so that only a pre-specified amount of light can be provided by theoptical therapy device100 at any given time, and such that a user cannot receive more than a predetermined dose in a specified short time period (e.g., over a period of one day) or a number of doses in a specified time period (e.g., over a period of months, for example). In other embodiments, thecontroller136 determines the illumination pattern. For example, by turning one or more light sources on and off, the illumination pattern can be controlled. Thecontroller136 can further control the illumination pattern by moving (actively or passively) or otherwise altering the aperture or pattern of thetip118. Thecontroller136 can also apply current to the light sources at a desired frequency or duty cycle.
• In another embodiment, thecontroller136 delivers a large current or a current or voltage pulse to thelight source126 to “burn out” or destroy thelight source126 after a selected period of time. For example, after a predetermined “useful lifetime” of theoptical therapy device100 expires, a “burn out” current is provided and theoptical therapy device100 essentially ceases to function. At this time, theoptical therapy device100 is discarded. Thecontroller136 can also respond to or receive a control signal from one or more photodetectors placed in or on thetube106 or the controller can respond to receive a control signal from one or more photodetector devices in an external calibration unit.
• Thepower supply110 of theoptical therapy device100 is adapted to receive power from an alternating current (AC) source, a direct current (DC) source, or both depending on the number and types of light sources. For example, in one embodiment,power supply110 includes a battery, battery pack, rechargeable DC source, capacitor, or any other energy storage or generation (for example, a fuel cell or photovoltaic cell) device known to those of skill in the art. In some embodiments, an LED may utilize a DC power source whereas a mercury vapor lamp may utilize an AC power source.
• In one embodiment, thelight source126 includes a low pressure lamp with an output (measured at any of the locations described above) between about 100 □W/cm2 and about 5 mW/cm2. In one embodiment, thelight source126 generates ultraviolet light and it includes at least a small amount of mercury within a nitrogen atmosphere. As discussed above, theoutput portion130 of thelight source126 may be any material translucent to ultraviolet light, such as, for example, but not limited to, quartz, silicone or fused silica. The output portion can direct the light in a uniform or non-uniform pattern.
• In one embodiment, when mercury vapor is used in connection with thelight source126, thelight source126 provides ultraviolet light having an output peak concentrated at254 nm. In another embodiment, a phosphor or a combination of phosphors can be used, as is widely known to those skilled in the art. In one embodiment, phosphors are added to thelight source126 such that the output peaks from thelight source126 are customized based upon the desired clinical application and action spectra for the disease process being treated. In one embodiment, thelight source126 includes a mercury vapor lamp having a spectral output which resides in longer wavelengths of the ultraviolet spectrum and in some embodiments extends into the visible spectrum.
• In one embodiment,light source126 is a mercury vapor lamp such as the type2095 lamp manufactured by Gelight Corporation. In another embodiment, thelight source126 includes a light emitting diode (LED) such as the UV LED manufactured by S-ET Corporation (Columbia, S.C.), which can be produced to emit narrowband light at any wavelength from about 250 nm to 365 nm. In another embodiment, thelight source126 emits at a wavelength of 275 nm. In such cases, the UV LED may have a sapphire substrate with conductive layers of aluminum gallium nitrite. For example, in one embodiment, the UV LED has about 50% aluminum. By varying the concentration of aluminum, the wavelength peak can be adjusted. In some embodiments, the several LEDs are packaged together such that light output with multiple peaks in the ultraviolet range can be achieved. In some embodiments, the aluminum concentration is varied along a dimension of the chip such that a more continuous spectrum is achieved when current is passed through the chip. In addition, the UV LED packaging may include flip-chip geometry. In such case, the LED die is flipped upside down and bonded onto a thermally conducting sub-mount. The finished LED is a bottom-emitting device that may use a transparent buffer layer and substrate.
• In such embodiments, the light is two-times brighter when the LEDs are in a flip-chip geometry. This is due to the fact that light emitted from the LED is not physically blocked by an opaque metal contact on the top of the LED. In addition, flip-chip sub-mount pulls heat away from the device when made from materials having high thermal conductivity. This improves efficiency levels with less energy being converted to heat and more energy being converted to light. The resulting device will have a lower weight, will be smaller, and will be resistant to vibrations and shock.
• In other embodiments, power delivery to the LEDs can be modified to optimize the optical power of the LEDs. In such cases, the LEDs are switched on and off in order to prevent heat build up which would otherwise decreases the efficiency of the LEDs. For example, a temperature rise may decrease the potential optical power. Such switching can increase the power output several-fold. In other embodiments, the semiconductor structure takes the form of a laser diode module wherein the semiconductor package contains reflecting optics to turn the non-coherent light into coherent light.
• Although thepower supply110 of theoptical therapy device100 is illustrated inFIG. 1 as tethered to theproximal end112 of thehandpiece102, it should be well understood by those of skill in the art that thepower supply110 may be incorporated into or included on or within the body of the device, including thehandpiece102. In such cases, thepower supply110 may include a battery, a battery pack, a capacitor, or any other power source. Thepower coupling114 in such embodiments may include contacts or wires providing electrical communication between thepower supply110 and thecontrol circuit134.
• Asleeve140 may be provided to at least partially cover thetube106. In one embodiment, thesleeve140 is disposable and in another embodiment, the sleeve is not disposable. The term “disposable” is intended to have its ordinary meaning. In addition, as is known to those skilled in the art, disposable can also refer less to the particular material used and more to the cost of production and sales price of a component, as well as the procedure required to sterilize or otherwise clean the component between uses.
• In some embodiments, the sleeve is sterilizable and in other embodiments, the sleeve is not sterilizable. Sterilizing methods include, without limitation, ethylene oxide (ETO), autoclaving, soap and water, acetone, and alcohol. In some embodiments, the sheath is machined and in other embodiments, the sleeve is formed from a mold. In still further embodiments, the sleeve is produced from a thermoforming process. In some embodiments, the sleeve is composed of multiple materials. For example, the body of the sleeve is produced from a material such as aluminum or a plastic coated with aluminum and the end of the sleeve is an optically transparent material. The end of the sleeve can also have an open configuration where the light diverges as it leaves the sleeve. The sleeve can also be solid and produced from the same or different materials. In this embodiment, the inner material will transmit light without absorbing the light. These configurations generally allow optical energy, or light, generated by thelight source126 to travel through thetube106 and exit both thetip118 of thetube106 and thetip140 of the sleeve. In such embodiments, light energy is emitted from theoptical therapy device100 and absorbed by the tissue within the body cavity (e.g., nasal cavity of the patient's nose).
• Theoptical emitter128 of thelight source126 is generally in electrical communication with leads132. In one embodiment, theoptical emitter128 extends in a direction transverse the axis of thelight source126. As discussed above, theoptical emitter128 schematically represents only one embodiment of the light emitting portion of thehandpiece102 andlight source126. Optical emitter128 (e.g., the light emitting portion of the light source126) can be made from any of a variety of materials known to those of skill in the art; in cases where theoptical emitter128 represents a wire-filament type light source, theoptical emitter128 can include tungsten.
• In embodiments where thelight source126 includes a gas-filled tube, such gases may include xenon, helium, argon, mercury, or mercury vapor, or a combination thereof, in order to produce a desired spectral output.
• Although theoptical emitter128 of thelight source126 is shown at thedistal end124 of thehandpiece102, in other embodiments, theoptical emitter128 is positioned closer to theproximal end112 of thehandpiece102. By moving theoptical emitter128 proximal with respect to thetip118 of thetube106, heat generated by thelight source126 may be at least partially separated from thetube106, thereby lessening thermal communication with the patient's tissues.
• Heat generated by thelight source126 may be removed from theoptical therapy device100 by any of a variety of methods and devices known to those of skill in the art. For example, in one embodiment, heat is directed away from thehandpiece102 by convection or conduction. In other embodiments, active cooling devices, such as thermo-electric coolers or fans may be employed. Alternatively, or in addition, passive cooling structures, such as heat fins, heat conductors and/or cooling tubes may be used to remove heat from theoptical therapy device100.
• In one embodiment, thelight source126 includes a solid state light emitter (e.g., an LED or laser diode module) and thelight source126 is positioned at or near thedistal end116 of thetube106 instead of within thehandpiece102.
• In another embodiment, thelight source126 includes a solid state emitter and a mercury vapor lamp (or other analog-type light source that emits ultraviolet light as described above). Such combinations may be useful to provide light of multiple wavelengths or intensities that correspond to select spectral peaks. In another embodiment, multiple solid state emitters may be employed to achieve the same or similar results. In yet another embodiment, a visible light solid state emitter is combined with a mercury vapor or halogen lamp to enhance wavelengths in the visible light region. Alternatively, an array of solid state emitters may be arranged on an integrated circuit layout to produce spectral output that can be continuous or semi-continuous depending upon the wavelength, number and bandwidth of each emitter.
• Thetube106 may include a soft coating on itsoutside surface138. A soft coating, such as a polymer, rubber, or fluid-filled jacket, provides a comfortable interface between theoutside surface138 of the reflectingtube106 and the patient's nose.
• In addition, the reflectingtube106 may include one or more filters along its length. In one embodiment, a filter is placed inside the reflectingtube106 near itsproximal end112 or near itsdistal end116. The filter may function as a lens if cut into an appropriate shape and placed at thedistal end116 of the reflectingtube106. One such optical filter well known to those of skill in the art is manufactured by Schott and includes glass optimized for absorption at certain wavelengths.
• In one embodiment, thelight source126 is about 10% to about 15% efficient. In another embodiment, the light source or combinations oflight sources126 generates about 10 mW to about 100 mW of optical power. In another embodiment, the light source dissipates between about 10 W to about 20 W of power in order to generate about 10 mW to about 100 mW of optical power. In one embodiment, excess heat is dissipated so that theoptical therapy device100 does not overheat, and/or so that the patient does not experience discomfort during its use.
• Heat transfer control may become increasingly important when theoptical therapy device100 includes alight source126 that is located near thedistal end116 of the tube106 (e.g., heat may be closer to the patient's tissue). In one embodiment where thelight source126 is a mercury vapor light source, heat is generated near theoutput portion130, for example, where the mercury plasma is generated. Since, in this embodiment, most of the light generated is non-blackbody radiation, very little heat is generated as photons propagate towards thedistal end116 of thetube106 and enter the tissue of the patient. Therefore, in such embodiments, heat transfer mechanisms are generally confined to theoutput portion130 of thelight source126, close to where the light is generated.
• In one embodiment, a fan is used to transfer heat or to remove heat from theoptical therapy device100. For example, the fan may surround theoutput portion130 of thelight source126 or the entirelight source126 itself In such embodiments, the fan may surround thelight source126, or a portion thereof, in an annular fashion, and can direct heat away from thelight source126 and away from the patient via convection.
• In another embodiment, a heat tube is placed around thelight source126 and the heat tube directs heat away from the patient towards theproximal end112 of thehandpiece102. At theproximal end112 of theoptical therapy device100, heat may be released into the environment. In one embodiment, the heat tube terminates in a structure optimized for heat transfer into the surrounding environment, for example, cooling fins. Alternatively, or in combination, in another embodiment, a fan is provided at theproximal end112 of theoptical therapy device100 and at the proximal end of the heat tube. The fan provides active convection to carry heat away from theoptical therapy device100.
• In one embodiment, acontroller136 controls the power output from thepower supply110 so that thelight source126 is activated for a predetermined time period. Thecontroller136 may include a switching mechanism that, in one embodiment, is controlled external to the device. Such external control may be implemented by any of a variety of mechanisms, such as, for example, a radio frequency communicator. Thecontroller136 helps avoid misuse or overuse of theoptical therapy device100. Thecontroller136 may also allow optimization to be carried out by the physician prescribing the device. In another embodiment, thecontroller136 provides for preset dose quantity and frequency. In one embodiment, these parameters are set by the patient's physician. In one embodiment, parameters are set by the controller, a nurse, doctor, caregiver, patient, or other individual, or may be set according to prescription set forth by clinician.
• In one embodiment, theoptical therapy device100 includes software (not shown) to control the dosage of optical energy to a patient. In one embodiment, the energy, power, intensity, and/or fluence of the optical output may be adjusted. Adjustments and settings may be saved within or loaded onto theoptical therapy device100 to correspond to the requirements of a particular patient, or clinical result.
• In one embodiment, the treatment dose includes timing controls. Timing controls may include the amount of time thelight source126 of theoptical therapy device100 may be activated for a treatment. In another embodiment, timing controls include pulsing parameters, such as pulse width, timing of optical pulses, or relative sequence of pulses of light emitted from one or multiplelight sources126. In one embodiment, thelight source126 provides continuous (non-pulsed) optical output, and the timing controls include the duration of treatment, the time between treatments, and the number of treatments allowed in a specified time period, for example, one day.
• In another embodiment, such as described with respect toFIG. 2 below, thecontroller136 is not included within thehandpiece102 of theoptical therapy device100. In such embodiment, power delivery and timing controls are provided to thehandpiece102 from a source (such as control unit202) outside of thehandpiece102. In such embodiment, thehandpiece102 may be disposable, and the physician may control the doses to the individual patient from apersonal computer204 or directly from power supply components, such as described below in additional detail.
• Theoptical therapy device100 may be used to treat or diagnose any of a variety of diseases. In one embodiment, theoptical therapy device100, is used to modulate immune or inflammatory activity at an epithelial or mucosal surface. Different immune and/or inflammatory reactions may be treated with combinations of ultraviolet and/or white light. In one embodiment, theoptical therapy device100 is used to treat allergic rhinitis, chronic allergic sinusitis, hay fever, as well as disease states such as dry eyes, allergic conjunctivitis or other immune-mediated mucosal diseases. In addition, theoptical therapy device100 may be used to treat any symptom associated with such conditions, such as sneezing, rhinorrhea, palate itching, ocular itching, congestion, and/or nasal itching. In other embodiments,optical therapy device100 is used to treat skin disorders such as alopecia, acne, vitiligo, dermatoses, psoriasis, atopic dermatitis, and scleroderma. In some embodiments, the optical therapy device also diagnoses disease in combination with therapeutic delivery or alone without therapy.
• Allergic rhinitis is an immune mediated process resulting from an allergen, such as ragweed, cat dander, mountain cedar, etc. The allergen combines with IGE present in and on cells of the mucosal surface of the nose or other mucosal surface, which leads to the degranulation of mast cells. This releases histamine and other mediators, which then lead to an immediate inflammatory reaction as well as an organized immune response that may last for days to weeks, or even months.
• In other embodiments, theoptical therapy device100 is used to directly treat microbial pathogens or non-pathogens, such as fungi, parasites, bacteria, viruses that colonize, infect, or otherwise inhabit epithelial and/or mucosal surfaces. For example, patients with chronic sinusitis frequently have fungal colonization or a frank infectious process leading to the disease process. One clinical advantage of utilizing ultraviolet light to eradicate infections is that it avoids problems associated with antibiotic resistance. Antibiotic resistance is becoming an increasingly difficult problem to contend with in the medical clinic. In particular, patients with sinusitis generally undergo multiple courses of antibiotic therapy, which is typically ineffective. Antibiotic therapy is typically ineffective because the chronic nature of the sinuses in chronic sinusitis leads to production of a biofilm, which by its nature can prevent antibiotics from reaching the sinuses. Adjunctive phototherapy is another weapon in the armamentarium against microbes.
• In some disease states, patients are allergic to allergens shed by microbes, such as in allergic fungal sinusitis. Microbes, and in particular fungi, are particularly sensitive to light with wavelengths ranging from 250 nm to 290 nm. At these wavelengths, the light directly affects the cellular macromolecules and can, for example, crosslink and/or dimerize DNA. Although the 250-290 nm wavelength light may be useful to injure or destroy pathogens, light having higher wavelengths (e.g., 300-450 nm) can also lead to cellular injury, albeit at higher optical powers. Ultraviolet light in the range 150-250 nm can also be used to destroy pathogens.
• When combined with other chemicals or pharmaceuticals (e.g., moieties), light of different wavelengths can be used to treat pathogens. Such therapy, generally referred to as photodynamic therapy, allows almost any wavelength of light to be used to cause a biologic effect. This is because the light is absorbed by the moiety, which causes a toxic effect. The moiety can be chosen based upon its absorption characteristics, the light wavelength, or molecular specificity.
• In some cases, the moiety or chemical entity resides in or around an epithelialized surface. For example, ultraviolet light can induce oxygen to become ozone, which can spontaneously release a toxic oxygen radical. The toxic oxygen radical can injure or destroy the pathogens.
• Other examples of photodynamic moieties include psoralen, a DNA cross-linker, which has been used for many years in PUVA treatment for psoriasis and other skin diseases because it potentiates the actions of UVA. Another FDA approved and widely used photodynamic therapy is 5-aminolevulinic acid which is a photosensitizer with an absorption maximum at 630 nm and which generates oxygen free radicals upon light exposure. More recently, photodynamic moieties have become increasingly complex and can include nanoparticles, such as those described by Loo, et al. in Nanoshell-Enabled Photonics-Based Imaging and Therapy of Cancer, 3(1) Technol Cancer Res Treat 33-40 (February 2004), which is incorporated by reference.
• Nanoparticle-based therapy systems allow for wavelength tuning so that the wavelength of maximal absorption can be customized to the application. Nanoparticles also allow for surface modifications so that the particle can target a specific tissue and then when the light focuses on that particular region, the specifically targeted nanoparticle will absorb the specific wavelength of light; therefore, regional specificity as well as wavelength specificity can be achieved with one particle. It is possible that the moieties resonate in response to specific frequencies (e.g., on-off frequency as opposed to electromagnetic frequency) in addition to wavelengths so that certain particles are activated when the optical therapy device deliver light of specific wavelength and with a specific on-off frequency.
• When it is desired to treat microbes at epithelial or mucosal surfaces, such as the sinuses, anoptical therapy device100, including a mercury vapor lamplight source126, may be utilized. Such alight source126 generally emits light primarily at a254 nm wavelength, which can destroy bacteria, fungi, viruses, and even fungal spores (discussed above). In other embodiments, an array (e.g., one or more) of light emitting diodes (LEDs) or laser diode modules is used. The array emits light (typically in the ultraviolet C and short wavelength ultraviolet B regimes) at one or more wavelengths selected to destroy polynucleotides (e.g., DNA and/or RNA), cell membranes, and/or proteins of the pathogens. In other embodiments, LEDs are used in photodynamic therapy and activate the moiety to exert its biologic effect.
• Anoptical therapy system200, in accordance with another embodiment of the present invention, is illustrated inFIG. 2. Theoptical therapy system200 includes anoptical therapy device100, acontrol unit202, and at least onecomputer204.Control unit202 communicates withoptical therapy device100 viapower coupling114, such aspower coupling114 described above, with respect toFIG. 1.Power coupling114 may provide communication of power and electronic control signals betweencontrol unit202 and theoptical therapy device100. Thecontrol unit202 is also coupled to at least onecomputer204 viacomputer coupling206.Computer coupling206 may be any of a variety of structures, devices, or methods known to those of skill in the art that enable communication between computers or computing devices. For example, in one embodiment,computer coupling206 is a cable, such as a USB or Ethernet cable. In another embodiment, thecomputer coupling206 is a wireless link. The at least onecomputer204 may include a personal computer, such as a PC, an Apple computer, or may include any of a variety of computing devices, such as a personal digital assistant (PDA), a cellular telephone, a BLACKBERRY™, or other computing device.
• Computer coupling206 may include any wired or wireless computing connection, including a Bluetooth™, infrared (e.g., IR), radiofrequency (e.g., RF), or IEEE 802.11(a)-, (b)-, or (g)-standard connection.Control unit202 andcomputer204 may form a network within whichmultiple computers204 or computing devices, orcontrol units202 may be included.
• In one embodiment,control unit202 is connected to a power supply via apower cord208.Control unit202 also generally includes adisplay210, akeypad212, controls214, and acradle216.Display210 may include a screen or other output device, such as indicators, lights, LEDs, or a printer. In some embodiments, thedisplay210 is of the touchscreen variety and includes touch controls to control the parameters of theoptical therapy device100.Controls214 include any of a variety of input devices, including knobs, levers, switches, dials, buttons, etc. In some embodiments,cradle216 is adapted to receive thehandpiece102 of theoptical therapy device100 when not in use. Such acradle216 may furthermore be configured to provide electrical power (e.g., a rechargeable battery) to the handpiece of theoptical therapy device100 and/or control signals. In such embodiment,power coupling114 may not be provided, or may be provided via thecradle216 through electrical contacts. In some embodiments, thecradle216 includes an optical detector, such as a photodiode, which can provide an indication of the output or strength of the opticallight source126 and can provide for calibration of theoptical therapy device100 over time.
• FIG. 3A illustrates one embodiment of the use of theoptical therapy device100. In the illustrated embodiment, the user (e.g., medical practitioner, nurse, doctor, or patient) holds thehandpiece102 of theoptical therapy device100 and inserts thetube106 into his or her nose300 (or into the nose of the patient when the medical practitioner is the user of the device). The light-emittingdistal end116 of the reflectingtube106 is inserted inside of thenasal cavity302 of the patient. Light is emitted from theoptical therapy device100 along alight propagation access304 where it is absorbed by the mucosa and other soft tissues within thenasal cavity302.
• FIG. 3B illustrates one embodiment of anoptical therapy device100 adapted to be inserted into theparanasal sinus cavities154,to treat conditions such as sinusitis.Optical therapy device100 has a specific shape or contour to reach the sinus as will be described below. The various wavelengths of theoptical therapy device100 may be chosen depending upon whether fungal sinusitis or allergic sinusitis is to be treated. When allergic sinusitis is to be treated, wavelengths including visible light and ultraviolet light may be utilized. In the case where it is desired to treat fungi and/or other microbes, a lower wavelength, such as from 250-300 nm, may be used. In some cases, it is desirable to use all of these wavelengths separately or in combination, sequentially or concomitantly.
• Although theoptical therapy device100 is illustrated and described herein as used for treating a patient'snose300, theoptical therapy device100 may be adapted to treat any of a variety of cavities, surfaces, portions, or organs of the human or animal body. For example, in one embodiment, theoptical therapy device100 is adapted to treat the skin, or to be inserted into and treat tissue within the mouth, ear, vagina, stomach, esophagus, small intestine, bladder, renal pelvis, rectum and/or colon. For example, theoptical therapy device100 may be used to reduce inflammation within any mucosa of the body.
• Furthermore, theoptical therapy device100 may be inserted into a body cavity to treat the walls of an organ without entering the lumens of the organ or the organ itself. Such is the case, for example, when theoptical therapy device100 is placed inside the chest cavity to treat the lungs, heart, or the esophagus. Such is also the case when theoptical therapy device100 is placed inside of the abdominal cavity to treat the intestines, stomach, liver, or pancreas. The optical therapy device can be adapted for insertion through a laparoscope, hysteroscope, thoracoscope, endoscope, otoscope, bronchoscope, cystoscope, or cardioscope.
• In one such embodiment, theoptical therapy device100 is used to treat the clinical disease state of diastolic heart failure. In diastolic heart failure, collagen deposition in between or in place of (as is the case of ischemic cardiomyopathy) the myocardial fibers lead to a decreased compliance of the myocardium and a failure of the myocardium to relax properly during diastole. Ultraviolet light therapy, specifically ultraviolet A (UVA) light therapy, can activate the native collagenase system in human skin and lead to an increased compliance in diseases such as scleroderma, as discussed in greater detail above. A similar collagenase system is present within the myocardium and if activated, can decrease the compliance of the myocardium with a similar mechanism as in the skin.
• In one embodiment, theoptical therapy device100 is adapted to treat inflammation and/or infection of the gastrointestinal tract caused by any of a variety of conditions, such as, Crohn's disease, ulcerative colitis (inflammatory bowel diseases), C. difficile colitis, and/or esophagitis. In some embodiments, theoptical therapy device100 can ameliorate the internal consequences of T-cell-mediated diseases, such as autoimmune and collagen vascular diseases, such as rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, etc. In some embodiments, theoptical therapy device100 is adapted to treat skin conditions, such as psoriasis. In yet another embodiment, theoptical therapy device100 is adapted to be inserted into the vagina to treat any of a variety of conditions, including yeast infection, vaginitis, vaginosis, Candida, parasites, bacteria, and even an unwanted pregnancy. Theoptical therapy device100 may be inserted within the ear, and deliver light to the external or internal auditory canals to reduce inflammation and/or infection therein. In yet another embodiment, the optical therapy device100 may be provided to the bladder, kidney, ureter, and/or urethra to treat and/or reduce inflammation. Theoptical therapy device100 may also be used to treat rheumatoid arthritis, or to reduce or eliminate herpetic lesions (e.g., cold sores) by decreasing viral shedding time and/or time to healing.
• In yet another embodiment, theoptical therapy device100 is adapted for veterinary use. For example, in one embodiment, theoptical therapy device100 is adapted to be inserted inside the nose of an equine, such as a racehorse, to treat rhinitis, reduce inflammation, or treat any of the diseases of conditions described herein. Other animals may benefit from treatment with theoptical therapy device100, including domestic animals, such as dogs, cats, and rabbits, as well as exotic animals, such as cheetah, gorilla and panda.
• Anoptical therapy device100, in accordance with another embodiment of the present invention, is illustrated inFIG. 4. Theoptical therapy device100 ofFIG. 4 includes ahandpiece102 andtube106 similar to the optical therapy devices discussed above. In addition, theoptical therapy device100 ofFIG. 4 includes multiplelight sources126. For example, as illustrated,optical therapy device100 includes threelight sources126. Any number oflight sources126 may be utilized, including one, two, three, or more than threelight sources126.Light source126 may be a bulb-type light source, such as a mercury vapor lamp or filament based light source, as discussed above, or an LED light source, or a combination thereof. Any of the control systems and power delivery systems discussed above may be incorporated into theoptical therapy device100 ofFIG. 4.
• Although the multiplelight sources126 ofFIG. 4 are shown in close proximity, individuallight sources126 can be placed anywhere along thetube106 orhandpiece102. In one embodiment, the light source(s)126 is (are) located close to thedistal tip118. For example, in one embodiment, a UVB emitting source is placed close to thedistal tip118 and a white light source and/or UVA light source are/is placed proximally, toward thehandpiece102. Such a configuration can assure that UVB wavelengths reach the nasal mucosa because in many cases UVB light is difficult to transport faithfully. Even though the UVA andwhite light sources126 may have more losses than theUVB light source126, this is acceptable since, in at least one embodiment, the UVA andwhite light sources126 generate a higher amount of optical energy or power and typically undergo less loss along an optical guidance system than UVB light.
• Anoptical therapy device100 in accordance with yet another embodiment of the present invention, is illustrated inFIG. 5A.Optical therapy device100 includes atube106 and ahandpiece102, such as those described above with reference toFIGS. 1-4. However, in the present embodiment,optical therapy device100 includes a passive cooling mechanism integrated therein. In one embodiment, the passive cooling mechanism includes a cooling sleeve in thermal communication with aheat diffuser502 located at theproximal end112 of thehandpiece102. Athermal interface504 covers at least a portion of theproximal end112 of thehandpiece102, and provides for dissipation of heat from theheat diffuser502. In one embodiment, the cooling sleeve at least partially surroundslight source126 of thehandpiece102.
• The cooling sleeve may be made from any of a variety of thermally conductive materials, including aluminum, copper, steel, stainless steel, etc. In addition, the cooling sleeve may be filled with a thermally conductive material or a cooling material such as water, alcohol, freons, dowtherm A, etc. For higher temperature lamps, the cooling fluid could include sodium, silver, and others materials as are generally well-known in the art. In one embodiment,heat diffuser502 includes cooling fins to increase its surface area. Increased surface area of theheat diffuser502 provides efficient cooling for thelight source126 of theoptical therapy device100. Thethermal interface504 and/orheat sink502 may be made from any of a variety of thermally conductive materials, including metals, such as aluminum, copper, steel, stainless steel, etc. The rounded surface of thethermal interface504 protects the user and his or her hand from sharp or jagged edges of theheat sink502. Thethermal interface504 can further be perforated to allow for convective flow from theheat sink502.
• In one embodiment, cooling sleeve is or includes a series of cooling pipes, orheat pipes500, as is well-known in the art, such as those illustrated inFIGS. 5A-5B.Heat pipes500 extend axially along the longitudinal axis of thehandpiece102 and generally run parallel to thelight source126.
• A cross-sectional view ofoptical therapy device100, taken alongline5B-5B, is illustrated inFIG. 5B. In the illustrated embodiment, a circumferential arrangement ofheat pipes500 is shown. As is well-known in the art,heat pipes500 include a liquid (the coolant) that generally has a boiling point in the range of temperature of the portion to be cooled. Common fluids include water, freons, and dowtherm A, which has a boiling point temperature range of about 500-1000° C. A second portion of theheat pipe500 is a wicking portion, which transmits the coolant in its liquid state. The coolant picks up heat at the hot region (e.g., proximate to the light source126), is vaporized and travels down the center of the pipe, where the fluid then condenses at the cooler portion of theheat pipe500, and then wicks back through the wicking portion of theheat pipe500. The configuration ofheat pipes500 inFIG. 5B is only one example of any numerous shapes, sizes, and configurations ofheat pipes500, which may include flat, horseshoe shaped, annular, as well as any other shape. Theheat pipes500 can be placed anywhere along thetube106 and even at its distal portion. Theheat pipes500 can be used in combination with any of the configurations, devices, and light sources above.
• FIG. 6A andFIG. 6B illustrate anoptical therapy device100 in accordance with yet another embodiment of the present invention. In one embodiment, afan610 is provided near thedistal end104 of thehandpiece102 to actively transfer heat away from theoptical therapy device100.Handpiece102 also includes at least onelight source126 as described in greater detail above. Thefan610 provides for active cooling by pullingair603 into the handpiece through distal heat vents600, through the handpiece102 (e.g., in the direction of the arrows) viachannel602, and out theproximal end112 of thehandpiece102 via heat vents604 located in thethermal interface504. In some embodiments,fan610 is used in conjunction with fins, heat pipes, cooling pipes, cooling sleeves, and/or cooling tubes as described above. In another embodiment,fan610 provides cooling by pulling or pushing air through thehandpiece102.
• In another embodiment, such as illustrated inFIG. 6B,fan610 is located at theproximal end112 of thehandpiece102. Air is pulled through achannel602 in the handpiece via distal heat vents600. Air flowing through thehandpiece102 viachannel602 removes heat fromlight source126. In this manner, thelight source126 is cooled.
• Anoptical therapy device100 in accordance with another embodiment of the present invention is illustrated inFIG. 7A.Optical therapy device100 includeshandpiece102 andtube106, as described above with respect toFIGS. 1-6B. However, in the present embodiment, thelight source126 of theoptical therapy device100 is located at thedistal end116 oftube106 near itsdistal tip118. In the illustrated embodiment,tube106 may not be configured to guide or reflect light since thelight source126 is located at or near itsdistal end116. Thetube106 may be configured to guide light in cases when light exiting the tip of thedevice118 includes light originating in thehandpiece102 and at thedistal tip118 of thetube106.
• As discussed above,light source126 can be any of a number of different light sources. In one embodiment,light source126 is an LED or multiple LEDs. In another embodiment,light source126 includes one or more LEDs for generating UVB light and one or more LEDs for generating white light and/or UVA light. Additionallight sources126 can be combined (e.g., at the distal end116), or one or morelight sources126 can be located closer to theproximal end112. Of course, in this embodiment, an optical guidance system may be used to transmit or guide the light generated by thelight source126 located in thehandpiece102.
• Since, in one embodiment, the majority of heat generated by thelight source126 is generated at the light source's distal end,heat pipes500 are used to remove the heat therefrom. In one embodiment, when thelight source126 includes a double-bore mercury vapor lamp,optical emitter128 is a double-bore quartz capillary tube. Mercury vapor lamps typically generate heat at their cathode and anode, which are generally located at the ends of the inner capillary tube. Therefore, in some embodiments, heat is generated primarily at the ends of the inner capillary tube. In another embodiment, whenlight source126 consists of LEDs,optical emitter128 is the chip array or package used to create light, such as solid state light. Heat generated at the circuitry may be carried away from thedistal end116 byheat pipes500. In the case whenlight source126 is an LED or a combination of LEDs, the heat generation from the conversion from electricity to light is minimal, or less significant; however, significant heat can be generated in the circuitry—especially when several LEDs are used in combination. In such and other cases,heat pipes500 including heat conduction rods produced from materials that have good thermal conductivity, such as aluminum, copper, steel, stainless steel, etc., may be used.
• Heat pipes500 generally run parallel to thelight source126 along the axial length of theoptical therapy device100. Heat is transmitted, or is conducted, through theheat pipes500 to the heat sink, as discussed in greater detail above. In other embodiments,heat pipes500 are circumferentially wrapped around thelight source126 ortube106.
• Heat is carried from thelight source126 through theheat pipes500 to theheat sink502 located at theproximal end112 of thehandpiece102. In one embodiment, heat is dissipated from thehandpiece102 through a heat sink502 (which may include cooling fins), after which the heat exitshandpiece102 via athermal interface504.
• FIG. 7B shows a cross-section of theoptical therapy device100 ofFIG. 7A alongline7B-7B.
• FIG. 8A illustrates anoptical therapy device100 in accordance with yet another embodiment of the present invention.Optical therapy device100 includes ahandpiece102 and tube106 (which may or may not be a reflecting tube depending on the combination of light sources used) as described in greater detail above. In the present embodiment (illustrated inFIGS. 8A and 8B),light source126 is located near thedistal end116 of thetube106 similar to that described above with respect toFIG. 7A. However, in the present embodiment,light source126 includes a solid state array of light sources, or a multitude of light sources arranged in a two- or three-dimensional array. In the case where all the desired wavelengths are emitted from the diode array,tube106 does not have to be a reflecting tube. In such cases, thetube106 can serve as a conducting tube for heat transfer (depending on the number and efficiency of the light emitting diodes, specialized heat transfer may or may not be employed). In addition, thetube106 may be made from a soft, flexible material comfortable to the patient. In some embodiments, only certain wavelengths are provided by LED array and other wavelengths are transmitted through anoptical tube106, as described above.
• A cross-sectional view ofoptical therapy device100 taken alongline8B-8B is illustrated inFIG. 8B. A diode arraylight source126 is illustrated in the cross-section view ofFIG. 8B. In one embodiment, all desired wavelengths are provided by thearray126, and aregion127 is adapted to transfer heat by any or all of the mechanisms discussed above. Theregion127 can also be used to transmit additional optical spectra through optical fibers, tubes, or any of the devices described above.
• FIGS. 9A-9H representoptical therapy devices100 havingdifferent tubes106 in accordance with alternative embodiments of the present invention and generally configured to treat the sinuses of a patient. Thehandpiece102 is shown in a cutaway view, as it may be substantially the same for these embodiments. Eachtube106 is configured to optimize a particular parameter based upon specific clinical needs and/or reach a particular body region such as the maxillary sinus, the ethmoid sinus, the frontal sinus, etc. As such,tubes106 having varying lengths, shapes, curvatures, diameters, radiuses, bends, and tapers may be utilized or selected by a clinician as required. Thetube106 may also havelight sources126 placed anywhere in, on, or along thetubes106. In some embodiments, thetube106 is not optically reflecting because the light is generated at its distal end. In such embodiment, thetube106 may serve as a conduit for electrical or heat transfer.
• In theoptical therapy device100 illustrated inFIG. 9A,handpiece102 is connected to reflectingtube106 that has a bend at itsdistal end116. Thedistal end116 of thetube106 is bent at abend angle900 to create adistal segment902. Thedistal segment902 has adistal length904 that may be selected to configure to the anatomy of a particular patient. In some embodiments, optical therapy device shown inFIG. 9A is utilized to treat the sinuses of a patient.
• In some embodiments,tip902 can be flexible and may include a hinge (not shown) and/or a flexible material so thatangle900 can be adjusted by the practitioner. Alight source126 or combinations oflight sources126 can be placed anywhere alongtube106 as described above. Thelight source126 can also reside inhandpiece102, as described above.Tube106 can also contain an optical fiber bundle or it can be hollow and configured to reflect light, as discussed above. Furthermore, depending on thelight source126 selected, thetube106 can be configured to transfer heat from thelight source126, as described above.
• Similarly, as illustrated inFIG. 9B,optical therapy system100 includes ahandpiece102 that is connected to a reflecting ornon-reflecting tube106 having adistal segment902 of adifferent bend angle900 at itsdistal end116. Thedistal length904 of thedistal segment902 may be the same or different than that ofFIG. 9A. In addition, thebend angle900 is shown at a greater angle than that shown inFIG. 9B is greater than that shown inFIG. 9A. Similarly, such designs are used to reach the sinuses or other internal cavities or surfaces of a patient.
• Thedistal length904 of thedistal segment902 may be varied as clinically required, as illustrated inFIG. 9C. Thedistal length904 may vary between 1 cm and 4 cm.Proximal length905 varies between about 6 and 12 inches.Bend angle900 varies from about 45-60 degrees in some embodiments, and from about60-80degrees in other embodiments.
• Anoptical therapy device100 in accordance with yet another embodiment of the present invention is illustrated inFIG. 9D. Theoptical therapy device100 ofFIG. 9D includes ahandpiece102 coupled to a reflectingtube106 that includes anexpandable balloon906 at the reflecting tube'sdistal end116. The reflectingtube106 may be inserted into a patient's nose and/or sinus and theexpandable balloon906 may thereafter be inflated with a liquid, gas, polymer, a hydrogel, or a combination thereof, including a combination of fluids. By inflating theexpandable balloon906, the tissue (e.g., mucosa) on the inside surface of the patient's nose or sinus is flattened out to allow a more even distribution of light energy thereto. In addition, inflating theexpandable balloon906 allows theoptical therapy device100 to be positioned within the patient's body in such a way as to allow more exposure of mucosal surface area. The temperature of the fluid inserted into the balloon described above can be varied from low temperature (e.g., lower than body temperature) to high temperature (e.g., above body temperature) to treat the mucosa of the sinuses and to work independently or synergistically with theoptical therapy device100.
• In one embodiment, thecompression balloon906 is made from an optically transparent material; for example, a material which is transparent to ultraviolet light. Examples of transparent materials include certain formulations of PVDF as can be found in Japanese Patent No 01241557, which is incorporated by reference herein; certain fluoropolymers such as fluorinated ethylene propylene (FEP) produced by Zeus Inc; certain derivatives of Teflon (e.g., Teflon-AF produced by Dupont); certain formulation of silicone; and/or certain elastomeric formulations of silicone dioxide. The balloon may be compliant or non-compliant and may have single, double or multiple lumens.
• Thecompression balloon906 may be inflated by passing a fluid, liquid, gas, or a combination through aninflation lumen908 from thehandpiece102 to thecompression balloon906. Thecompression balloon906 may be deflated in a similar matter.
• The reflectingtube106 of theoptical therapy device100 may include more than onedistal segment902 such as is illustrated inFIG. 9E. In the embodiment ofFIG. 9E,optical therapy device100 includes atube106 having twodistal segments902. In one embodiment, thedistal segments902 have equaldistal lengths904 although in other embodiments, the distal lengths of thedistal segments902 are different.
• In another embodiment, thedistal segments902 are flexible so that therelative spacing903 between thedistal segments902 may be adjusted to accommodate the anatomy of particular patients. Incorporating more than onedistal segment902 can be highly beneficial in the clinical setting since the total amount of time the patient spends receiving the optical therapy may be reduced. This results in improved patient compliance because of the decreased treatment times.
• In one embodiment, thedistal segments902 are parallel to one another although in other embodiments, they are not. In one embodiment, each distal segment is oriented at an angle with respect to the axis of the reflectingtube106. For example, in one embodiment,distal segment902 projects at an angle between about 1 and 15 degrees with respect to the axis of the reflectingtube106.
• In thedistal segments902, flexibility may be achieved by forming thedistal segment902 from a flexible material. For example, thedistal segment902 may be manufactured from a polymer coated in rubber or a thin metal sleeve coated in rubber or other flexible coating. In other embodiments, the optical therapy device100 (such as the optical therapy device illustrated inFIG. 9E) includes pivots (not shown) on the end of each of thedistal segments902, which may be parallel. Pivots will allow for the parallel end of the optical therapy device to move or be moved independently of the linear portions of the parallel reflectingtubes902.
• Anoptical therapy device100, in accordance with another embodiment of the present invention, is illustrated inFIG. 9F. Theoptical therapy device100 includes ahandpiece102 and atube106. At thedistal end116 of thetube106 is arotational member910 mounted thereto. Rotational member includes anaperture912 through which light energy emitted from thelight source126 may be transmitted. In one embodiment, therotational member910 is able to rotate about an axis parallel to the central axis of the reflectingtube106.
• In one embodiment, therotational member910 is shaped to focus the light from thelight source126 to theaperture912 of therotational member910. Therotational member910 is, in one embodiment, substantially non-transmissive and substantially reflects all of the light emitted by thelight source126 to theaperture912. By rotating within the nose, therotational member910 is able to provide the light from thelight source126 through theaperture912 to the soft tissue of the inside of the nose or other body cavity in a circumferential manner.
• FIG. 9G illustrates another optical therapy device in accordance with yet another embodiment of the present invention. In theoptical therapy device100 ofFIG. 9G,tube106 includes light guides114 mounted at the tube'sdistal end116. Adjustable light guides914 may be oriented at anadjustment angle916 with respect to thetube106.
• In one embodiment,adjustment angle916 may be adjusted between an angle of about 0 and about 60 degrees with respect to the reflectingtube106. In another embodiment, the adjustment angle is between about 10 and 30 degrees.
• The inside surface of the adjustable light guides914 are generally reflective or covered with a reflective material so that light emitted from thelight source126 reflects off the adjustable light guides onto the tissue on the insider surface of the nose. The outside surface of the adjustable light guide is generally covered with a nonabrasive material or coating that is comfortable to a user when inserted inside or his or her nose.
• Anoptical therapy device100, in accordance with yet another embodiment of the present invention, is illustrated inFIG. 9H. Theoptical therapy device100 ofFIG. 9H includes ahandpiece102 coupled to atube106. Thetube106 includesmultiple apertures916 at itsdistal end116.Apertures116 may be provided around the entire circumference of the reflectingtube116 or may be provided on only one side or along only a selected portion of the reflectingtube106.
• Theapertures916 may be between 0.1 and 1 mm in diameter, or may be between 0.5 and 2 mm in diameter. Theapertures916 may be spaced between 0.5 to 1.0 mm, or between 1 to 3 mm from one another. In one embodiment, thedistal end116 of thetube106 includes at least four apertures. In another embodiment,tube106 includes between two and ten apertures. In another embodiment,tube106 includes greater than ten apertures.Apertures916 allow light emitted fromlight source126 to escape from the insider of thetube106 and enter the patient's nose. In this embodiment, light is emitted through theapertures916 of the reflectingtube106 in a longitudinal fashion (e.g., along the length of the tube) rather than at a distal end alone.
• FIGS. 9I-9J illustrate additional embodiments of the present invention.Handpiece102 is connected to aflexible component122 which has alumen125 withinflexible component122. As described above and below,flexible component122 can transmit light, can comprise the pathway to transmit electrical power, conduct heat, or can perform all three functions.Lumen125 is sized to at least allow a second flexible device such as a guidewire120 (well-known in the medical device arts) to pass through. The guidewire can allow for access to small orifices such as those which lead to the sinuses. After theguidewire120 gains access to or purchase in the desired small orifice, thecatheter122 is fed over theguidewire120. Theguidewire120 can have anexpandable component124, such as a balloon or anchor, on its end, such that theexpandable component124 can hold theguidewire120 in the nose. The optical therapy can then be delivered through the guidewire with therapy that is generated by a light source located along the body or handpiece of the optical therapy device and delivered to the expandable component, or light can be generated in theexpandable component124. In the embodiment illustrated inFIG. 9J, alight source127 is located at the distal end of theguidewire120.
• FIG. 10A illustrates a light emitting diode (LED)device500 in accordance with one embodiment of the present invention.FIG. 10C illustrates a recording by a spectroradiometer of the optical output from anLED device500 that emits light centered at a 308 nm wavelength peak. In the illustrated embodiment, the total output (e.g., optical power or area under the spectral output curve) at the 308 nm wavelength peak is in the range of from about 0.1 μW/cm2 to about 500 μW/cm2, from about 500 μW/cm2 to about 1 mW/cm2, or from about 1 mW/cm2 to about 5 mW/cm2 .
• FIG. 10A shows the size of theLED device500 relative to an average size finger. The temperature of theLED500 is often negligible, as it can be held in one's hand as shown without a perceptible temperature change. Embodiments of anLED package502 are provided inFIGS. 10A and 10B. Thepackage502 includes its ordinary meaning and also generally refers to the structures supporting theLED chip504, including theelectrical leads510,511, theheat conducting element506, and the coveringoptical element508. Coveringoptical element508 can accomplish a number of functions, including conditioning the light. Conditioning can include diffusing the light from the LED chip, focusing the light from the LED chip, directing the light, combining the light with a phosphor, or mixing and combining the light from multiple chips. Although one spectral peak is shown for theLED500 ofFIG. 10C, in another embodiment, theLED500 has more than one spectral peak. For example, multiple chips (e.g., dies) may be included in thesame LED package502. In another embodiment, the multiwavelength spectrum emanates from one chip. The spectrum of one embodiment of a multi-wavelength, multi-chip LED500 (mLED) is illustrated inFIG. 10E. The arrows ofFIG. 10E point to the mLED's spectral peaks, which, in the illustrated embodiment, occur at 308 nm, 310 nm, 320 nm, and 330 nm.
• TheMLED device500 appears (on the outside) the same asLED device500 ofFIG. 10A; however, on the inside of the package,502 there may be differences in that the individual diode chips (e.g., dies) are assembled in a cluster, or chipset. Each diode chip (e.g., die) can further be driven at an independent current (e.g., 20 mA) and its duty cycle (e.g., the ratio of the on time divided by the sum of the time and the off time) can be adjusted independently. The drive current is generally directly proportional to the optical output power and the optical efficiency is substantially unchanged at low temperatures. The duty cycle variable determines the amount of optical power available from each led die. For example, LED dies typically become less efficient at higher temperature (for example, due to an increase in resistance) and will generate more heat than light per electron than they would at lower temperature. If the “on” time is a small fraction of the “off” time, then the chip has time to cool down; therefore the short burst of current during the “on” period can result in a short duration of very high power. Thus, despite the fact that the relative power at each wavelength is shown to be similar inFIG. 10E, the relative power of each die can be varied using a combination of current and duty cycle.
• The total optical power provided by theLED devices500 of FIGS.10A-E may be in the range of between approximately 100 μW and approximately 1 mW, between about 1 mW to about 5 mW, or between about 5 mW to about 15 mW. Depending on thelight conditioning structure508, the intensity of the output can be concentrated greatly into a smaller spot size. Focused intensities can range from about 1 mW/cm2 to about 1 W/cm2 depending on how small the spot size is at the focal distance. The focal distance can range from 0.5 mm to 10 mm depending on the focal length of the light conditioner.
• In one experiment, the device depicted inFIG. 10A was attached to the skin of a human subject. After 14 minutes, the device was removed. Within the following 12 hours, a “sunburn” was detected over an area of 1 cm2 thereby demonstrating a biological effect of the ultraviolet semiconducting structures (UV LEDs).
• FIG. 10B illustrates a partial exploded view of the LED (or MLED)package502 ofFIG. 10A. The light emitting portion of the package includes LED chips (e.g., dies)504 on aplatform506. The platform is also referred to as the header, submount, or combination of header and submount, and can serve as a heat dissipating module. Typical LED chips include several semiconductor layers having specific bandgap differences between them. When voltage is applied across the semiconductor, light of a particular wavelength is emitted as the current flows through the different layers of the die.
• AnLED chip504 can be a cluster of multiple chips (otherwise referred to as a chipset) located on aplatform506, as shown inFIG. 10B. Theplatform506 can include a heat transferring element. For example, the heat transfer element can be a ceramic heat sink and/or diffuser. Alternatively, the heat transfer module can be an active device, such as a thermo-electric cooling device. Such heat transfer modules are well known to those skilled in the art of semiconductor and LED packaging. Additional elements on theplatform506 include reflectors, which are also well known to those skilled in the art. A light conditioner in the form of alens508 can receive and direct light from the LED chip orchips504 as desired. In one embodiment, thelens508 focuses the light from theLED cluster504. Thelens508 can be made from materials which are generally transparent to the wavelengths of interest (e.g., silicone or quartz). In another embodiment, theconditioner508 scatters or diffuses light from theLED cluster504. In another embodiment, theconditioner508 contains a coating or contains particles within the material of theconditioner508 which act as phosphors to alter the wavelength of output. In another embodiment, theconditioner508 configures the pattern of light to generate a relatively uniform illumination pattern in an internal body cavity, such as the nasal cavity. For example, in one embodiment, thelens508 projects light to 70% of the exposed area of a body cavity (e.g., the nasal cavity) such that the illumination is substantially uniform (for example, does not vary more than 10%-20% across the surface of the body cavity).
• The LED chip orchips504 can include about 1-5 LED chips, about 5-10 LED chips, about 11-20 chips, or greater than about 20 chips. The electrical power to each chip can be controlled independently by one or more of theleads511 ofFIG. 10B. The leads511 can be extended and/or combined into a larger connector, leads or computer bus,510. Furthermore, in addition to power, the duty cycle of one or more of the chips in thechipset504 can be controlled independently and may be turned on or off at any given time. For example, the duty cycle of an individual or multitude of chips504 (e.g., dies) can be controlled at a frequency of from about 1 Hz to about 1000 Hz, from about 1000 Hz to about 10,000 Hz, from about 10 kHz to about 1000 kHz, from about 1 MHz to about 100 MHz, from about 100 MHz to about 1 GHz, and/or from about 1 GHz to about 1000 GHz. It may be desired to have a very high frequency for its own sake and not to limit the heat generation from the chip or chips.
• Thus, it is possible to integrate such packaged LED chips (e.g., mLEDs) into a medical device to perform phototherapy to treat diseases (as discussed above and below) with a defined or pre-selected set of wavelengths and power outputs from anLED package502. The single andmultichip packages502 shown inFIG. 10B allows the light source of a medical device to be reduced in size, and to be placed inside of catheters and endoscopes to deliver phototherapy to internal organs, cavities, surfaces, and lumens. The LEDs on such internal medical devices can be any of the wavelengths from about 240 nm to well into the infrared portion of the electromagnetic spectrum, such as for example, about 1.5 micron wavelength electromagnetic energy. In addition, solid state technology, specifically LEDs, allow for abrupt changes in spectral output and illumination pattern. Standard light sources in use today offer very limited control of spectral output, illumination pattern, and on-off frequency. Furthermore, because the LED chips can be placed anywhere onplatform506, the illumination pattern (e.g., the optical power applied to specific tissue regions) can be well controlled.
• FIG. 10D illustrates the output from one embodiment of a set of three white-light emitting LEDs (wLED). The relatively broadband white light from these wLEDs is generated with a phosphor placed between the light emitting chips and the protective casing508 (e.g., epoxy) overlying the chips. The total output of the wLEDs in this spectrum can be in the range of about 20 mW/cm2 to about 30 mW/cm2 , about 10 mW/cm2 to about 40 mW/cm2 , or about 5 mW/cm2 to about 50 mW/cm2.
• he package size of the wLEDs may be in the range of about 3 mm to about 4 mm, about 2.5 to about 5 mm, or about 2 to about 6 mm. The size of a wLED package is often smaller than that of a uLED package. In addition, at least three fully packaged wLEDs can fit into an area of about 1-2 cm in diameter. White light may therefore be less expensive in terms of size and cost. In addition, white light is often more easily transmitted through optical guidance systems.
• In other embodiments, LED chips are packaged as surface mounts (SMTs) (such as those available from Nichia Corporation, Southfield, Mich.), which may be produced in sizes as small as about 1-3 mm, about 2-5 mm, about 0.5-3.5 mm, or smaller than about 3 mm in diameter and having white light power outputs from about 1 mW to about 100 mW. Surface mounts can be placed directly in the LED package502 (package within a larger package) shown inFIG. 10B or the surface mounts can be placed along side of anotherLED package502.
• In one embodiment, an ultraviolet LED, or uLED, is used without an optical guidance system. The uLED may be placed at the end of a probe that is inserted into a body cavity or is placed on or close to an external surface of a patient. The external surface of a patient includes the skin, conjunctiva, cornea, finger nails, toe nail, etc. An internal body cavity includes the nasal cavity, sinuses, tracheobronchial tree and any of the cavities mentioned above; also included, are cavities, such as the chest, and organs, such as the heart or lungs. The term probe is intended to have its ordinary meaning, and in addition can mean any device, including any of thedevices100 described herein. The probe may emit one wavelength of ultraviolet light (e.g., one narrow band, such as may be emitted by an uLED) or it can emit several wavelengths (e.g., peaks) of ultraviolet light (e.g., such as emitted by the MLED described above). The probe can also combine several wavelength peaks from the white light spectrum or it can combine a phosphor-based white light LED system as described above to produce almost any pattern of spectrum. The probe can also be used to cure adhesive compositions inside the body.
• In this embodiment, the probe (and light) are brought very close to the treatment area, which has many beneficial effects in treating disease. The probe being close to the treatment area also creates a very beneficial economic effect in the sense that light therapy is generated at the point of use rather than being generated away from the point of use and then transported to the point of use. Often times, the light-transport mechanism is highly inefficient and costly. Light generation at the point of use also facilitates providing a device that is disposable after one or several uses.
• FIGS.11A-C illustrate additional embodiments of anoptical therapy device100, which may incorporate any one of or a combination of uLeds, wLEDs, and/or mLEDs as itslight source126. The probe can also incorporate LEDs with individual wavelengths in the white or infrared region of the electromagnetic spectrum. Thelight source126 can be located at the distal end of aprobe106 adapted to be inserted into a patient's body. Theprobe107 may be similar to or the same as thetube106 described with respect to the various embodiments discussed above. Thedevice100 has a simplified structure when LEDs are used as thelight source126.
• Because LEDs are efficient light generators and because they emit a relatively narrow band of light, they generate very little heat and can therefore be positioned at the distal end of theprobe107 and can be placed directly into a patient's or user's body cavity. Because of the size of the mLEDs and uLEDs and their minimal heat creation, they can be placed directly into the body cavity of interest without an optical guidance system and with minimal heat transfer requirement from the device. Thus, an optical guidance system may not be required for the ultraviolet light portion of the action spectrum of theoptical therapy device100.
• Such components and designs considerably simplify thedevice100 in terms of the logistics of the therapy and ultimately the cost of thedevice100, particularly to the physician. The optical portion (e.g., the LED chipset) can even be placed at the end of a catheter, endoscope, or laparoscope and inserted into the body cavity of interest. In this case, the probe portion between thehandle102 and thelight source126 can be a long flexible catheter, endoscope, or laparoscope, etc. The probe portion in this embodiment is merely a structural element to allow control of thelight source126 at the distal end of the device and deliver power to the distal end of the device. The LED chipset at the end of thedevice100 provides the efficient light generation relative to heat output and can minimize unwanted wavelengths in the spectrum. In some embodiments, the LEDs chipset at the end of the catheters, endoscopes, and laparoscopes deliver only white for the purpose of visualization. In other embodiments, the LEDs deliver therapeutic optical energy to a body region as discussed in many of the embodiments above.
• The spectral output of thedevice100 of FIGS.11A-D is derived from combinations of the LEDs and LED packages shown in FIGS.10A-E, which can be centered in a single narrow band (e.g., when using an uLED), a summation of distinct bands (e.g., when using a MLED), and/or combined with white light (e.g., either phosphor based or through a combination of LEDs to produce to sum to white light). Additional LEDlight sources126 can also be fit into theprobe107. Depending on the ultimate size of theprobe107 and the body cavity to which it is desired to apply therapy, additional LEDs (e.g., white light LEDs with the spectral output shown inFIG. 10D) can be added to achieve combinations of ultraviolet light such as a combination of UVA, UVB, and white light as described above and in U.S. patent application Ser. Nos. 10/410,690 and 10/440,690, filed Apr. 9, 2003 and May 19, 2003, and published as U.S. Publication Nos. 2004/0204747 and 2004/0030368, respectively, which are incorporated by reference herein.
• FIG. 11B illustrates one embodiment of adevice100 that incorporates white light generating LEDs400 (as further illustrated inFIG. 11C taken along line C-C ofFIG. 11B) and an ultraviolet emitting center portion402 (as further illustrated inFIG. 11D taken along line D-D ofFIG. 11B). The illustrated embodiment ofFIG. 11B is similar to the uLED or the mLEDs depicted in FIGS.10A-D. The white light is transmitted from their respective LEDs400 (which may be surface mounted, chips, or otherwise) through an optical guidance system (as illustrated inFIG. 11D) and are directed into anannulus404 around a uLED and/or anmLED402. The uLEDs and/or mLEDs may not have an optical guidance system to transmit their light, for example, if they are placed at or near the distal end, including at position D-D inFIG. 11B.
• It is also possible to mount the surface mounted wLEDs directly on the same chip platform as the mLEDs (e.g., at the level D-D inFIG. 11B). Although in many cases, phosphor based wLEDs are preferable, in other embodiments, the chip LEDs from the white light spectrum (e.g. blue, green, red, amber, yellow dies, etc.) are mounted directly on the chipset with the mLEDs and/or uLEDs (see above) rather than using a phosphor based white light surface mount and setting the entire surface mountable wLEDs behind the ultraviolet LEDs. Independent of the final configuration, the arrangement of light sources in FIGS.11A-D generates an equivalent or greater amount of optical power than the larger, less efficient light sources (e.g., xenon, mercury vapor, halogen, etc.) discussed above and at a fraction of the heat output, power, and cost. A portion of the increase in efficiency may be due to the elimination of the coupling steps required for more traditional light sources (e.g., the requirement to collect the light and direct into an optical fiber). LEDs and other semiconductor technology allow for efficient and precise delivery of light to body surfaces and cavities.
• Such a device is also more portable and practical for a medical practitioner or patient because the ultraviolet generating light source is directly inside the body cavity or is positioned directly on, in or adjacent the body surface. This arrangement of LEDs also can obviate the need for a complex heat transfer system within the optical therapy device or in a table top box as in U.S. patent application Ser. Nos. 10/410,690 and 10/440,690, filed Apr. 9, 2003 and May 19, 2003, and published as U.S. Publication Nos. 2004/0204747 and 2004/0030368. AlthoughFIG. 11B illustrates the individual sets of LED chips as being at different positions along the axis of thedevice100, the surfacemountable wLEDs400 and/or all LED chips may be placed at substantially the same position along thedevice100 longitudinal axis. For example, in one embodiment, thewLEDs400 and other LED chips are placed at the distal end of thedevice100.
• In some embodiments, the μLEDs and uLEDs can be placed at the end of a flexible device (e.g., a catheter, endoscope, ureteroscope, hysterocope, laryngoscope, bronchoscope) to enter body cavities or body lumens and deliver ultraviolet light without guiding the light from one place to another. For example, the mLEDs and uLEDs can be placed at the end of a catheter or an endoscope to treat the lumen of an internal organ. In some embodiments, the LEDs are placed inside a balloon inside a body cavity. In these embodiments, the mLEDs can include wavelengths in the visible to infrared, or from the ultraviolet to visible, or combinations of wavelengths from the ultraviolet to the infrared.
• There are any number of disease states which can be treated with devices where LEDs are placed at the point of therapeutic application and on devices which can be delivered into body cavities, surfaces, and/or lumens. One example is treatment of infected indwelling catheters and implants. For example, indwelling vascular catheters often become infected and have to be removed at a very high cost to the patients and health care system. A system of mUV LEDs or uLEDs which emit light in the wavelength range of about 250 nm to about 400 nm at the region of infection would eradicate infection within the catheters and obviate or delay the need to remove the catheters and replace them.
• FIG. 12B illustrates anindwelling catheter410 which is used to administer parenteral nutrition (TPN) (for example) to a patient by providing venous access in a patient. Such a catheter can also be used for chronic or semi-chronic delivery of chemotherapy, for dialysis access, or for a variety of additional applications.Catheter410 may also be used to provide chronic implants, such as those used for chronic dialysis access or other permanent vascular or nonvascular devices. Asecond catheter412 is shown within theindwelling catheter410. Thesecond catheter412 has a series ofLEDs414 along its length with correspondingoptical windows416 in thesecond catheter412 which allow for transmission of sterilizing wavelengths. The therapy (e.g., sterilizing wavelengths) can be applied periodically (e.g., on a maintenance basis to prevent infections from occurring) or the therapy can be applied at the time of an acute infection. Although the LEDs are shown at the point of therapy inFIG. 12B, in some embodiments a light guide is used to transport light some distance prior to the point of therapy. The light guide can be a flexible fiber optic light guide with total internal reflection or the light guide can be more rigid as illustrated in several of the embodiments above. The LEDs can deliver light to the indwelling implants from any point along the light guide.
• In another embodiment (not shown), an indwelling vascular graft is placed in the aorta or peripheral vessels or is used in dialysis. Similar to the case of indwelling vascular catheters, indwelling vascular conduits often become infected and lead to substantial morbidity and mortality in patients. A catheter based system to deliver ultraviolet light sterilizing therapy to treat infected indwelling grafts would be highly beneficial and may obviate or delay the need to remove these implants. Implanted vascular conduits such as dialysis grafts also become occluded secondary to a process called restenosis or intimal hyperplasia. This is a similar process to that seen in smaller vessels such as coronary arteries when a device such as a stent is placed. Because of the anti-proliferative properties of UV light (see Perree, et al., UVB-Activated Psoralen Reduces Luminal Narrowing After Balloon Dilation Because of Inhibition of Constrictive Remodeling, 75(1) Photochem. Photobiol. 68-75, which is incorporated by reference), a device carrying LEDs can be used at the region of the lesion to treat the lesion and prevent the process of restenosis or intimal hyperplasia.
• FIG. 12C depicts such a device incorporated into an optically transparent balloon418 (e.g., a balloon that is at least partially transparent to at least some ultraviolet light wavelengths) to transmit the light directly to alesion420. Theballoon418 is expanded (e.g., with any of the fluids or liquids known to those of skill in the art) and the light therapy is then directly applied to thelesion420 without interfering blood.
• FIG. 12A illustrates anoptical therapy device422 at the end of a flexiblemedical device424, such as an endoscope, a catheter, or handheld probe. Thedevice422 can be flexible, as illustrated inFIG. 12A, rigid or semi-rigid. In addition, thedevice422 or any of the devices described above and below can be used in conjunction with one or more moieties or agents, such as psoralen, in a photodynamic therapy system.
• Another embodiment of the present method is referred to as “internal ultraviolet therapy,” and is to treat transplanted organs. Current treatment for organ rejection is hospitalization and administration of pharmaceuticals directed to the destruction of T cells. OKT3 is a monoclonal antibody directed toward CD3 positive cells, a subset of T cells. T cells orchestrate the acute and sub-acute rejection processes seen in organ rejection. Antibodies which destroy the T cells can quell the rejection process. As noted above, ultraviolet light can specifically affect T cell viability and can therefore be used to treat organ rejection.
• FIGS.13A-B illustrates one embodiment of a system to treat transplanted organs that are being rejected. Acatheter426 with alight source126, such as uLEDs or mLEDS, is placed in an artery leading to a transplanted organ428 (in this case, a kidney). Since white blood cells travel substantially along the outer diameter of blood vessels and the red blood cells travel toward the center, ultraviolet therapy can be applied more directly and specifically to the white blood cells (T cells) by implementing the arrangement shown inFIG. 13B.
• Red blood cells and platelets generally flow in the blood vessel's flow throughlumen430. Theoptical therapy device100 is generally configured such that it has a lumen in its center for blood flow therethrough. The surface of theoptical therapy device100 is directed toward the outside of thevessel432 wherein the white blood cells and the T cells flow over the surface of the device. With thisdevice100 positioned as illustrated in the cross-sectional view ofFIG. 13B, as blood flows past thecatheter100 and along itsouter circumference434, the UV light induces T cells to undergo apoptosis. Thedevice100 may be placed in the artery leading to the transplant organ, or it may systemically lead to immunosuppression through placement in any vessel of a patient. In at least this respect, “optical immunosuppression” therapy may be achieved.
• FIGS.14A-B illustrate another embodiment of an optical therapy device used to treat disorders of the external surface of the eye (e.g., allergic conjunctivitis). Allergic conjunctivitis is a common clinical problem, and there are few therapies that are well accepted. Immunosuppressive regimens which involve tacrolimus (see, Joseph, et al., Topical Tacrolimus Ointment for Treatment of Refractory Anterior Segment Inflammatory Disorders, 24(4) Cornea 24417-20, which is incorporated by reference) has been used to treat atopic keratoconjunctivitis, chronic follicular conjunctivitis, and blepharokeratoconjunctivitis. Ultraviolet light may be used to treat allergic conjunctivitis by providing a local therapy to suppress the inflammatory response and immune reaction against the offending antigen. The optical therapy device for the eyes is generally configured to prevent ultraviolet rays from affecting the patient's lens or retina. Other disease states, including dry eyes, have also been shown to respond to immunosuppressive drugs such as cyclosporine (see Tang-Liu, et al., Ocular Pharmacokinetics and Safety of Cyclosporine, a Novel Topical Treatment for Dry Eye, 44(3) Clin Pharmacokinetics 247-61 (2005), which is incorporated by reference).
• In some embodiments, the optical therapy device is used with a slit lamp to treat patients with allergies such that only the sclera435 (seeFIG. 14A-B, the portion of the eye affected by the conjunctivitis) absorbs the UV light and the lens and the retina do not. The UV is essentially focused onto anarea436 having ahole438 or region without UV light in the center. Thehole438 in the center generally corresponds to the location of thepupil440 and allows this region to be excluded from the optical therapy. In another embodiment, such as illustrated inFIG. 14A, acontact lens436 is provided. In the case of thecontact lens436, a source of ultraviolet light can be used which does not have a UV sparing region in its center. In such an embodiment, thecontact lens436 creates the pattern wherein the pupil region is excluded from the ultraviolet light.
• The mLEDs and uLEDs can be used for therapies such as psoriasis or other skin disorders currently treated with ultraviolet light (e.g., vitiligo, cutaneous T cell lymphoma, fungal infections, etc.). The preferred action spectrum to treat psoriasis is approximately 308-311 nm. In addition, narrow-band radiation is generally more effective than broad-band radiation. One limiting factor in current modalities and technologies for the treatment of psoriatic lesions is that typical devices available on the market today are large and expensive, and generally require patients to visit a physician's office for treatment. Home-treatment devices are typically large fluorescent lamps that are adapted to treat a broad area rather than a localized region. Whether in the home or in the office of the medical practitioner, the therapy takes time out of the patient's daily schedule. In addition, it is typically difficult for a patient to perform other tasks while the therapy is being applied. Furthermore, with current technology, it is difficult to treat a small area of the skin with narrowband light. Lasers are sometimes used to do so, but lasers are generally expensive and are not practical as home-based therapy devices.
• FIG. 15A depicts one embodiment of thetherapeutic device100 of the current invention applied to a patient'sskin442. The optical output is similar to any or all of the devices depicted above and can be narrow-band, broad-band a combination of narrow band and broadband (for different wavelength regions), or a combination of multiple narrow-band, and/or broadband, and/or low or high power white light. The light sources are any of the light sources in any of the configurations described above. In one example, the light sources are solid state light sources which, as described above, are easily portable by the patient and are powered with a battery pack. The dose of the therapy can be set by an integrated microcontroller which is programmed by a physician before the optical therapy device is dispensed. The uLEDs, mLEDS, and/or wLEDs are used singly or in combination. In one embodiment, the LEDs are positioned at theend116 of theprobe107. The probe can also include atip126 which can be purely passive (for example, a transmissive sheath) or thetip126 can alter the light output in some way (for example, a diffusive tip). The output of theprobe107 in each spectral region can be controlled so that some LEDs are off while others are on. For example, although a MLED is placed at the end of theprobe107, if one uLED on the chipset is activated, the mLED will output only UV wavelength light.
• Thetherapeutic device100 can also be used in conjunction with any of a multitude of moieties as a photodynamic therapy device, as described above. The diseases of the skin which can be treated with thetherapeutic device100 include but are not limited to: vitiligo, psoriasis, atopic dermatitis, mycoses fungoides (T-cell lymphomas), skin cancers, and infections (e.g., fungal infections). Thedevice100 may also contain integrated photodetectors, which can continuously readjust the device's output or can detect a disease state of the skin so that the optical therapy can be applied.
• FIG. 15B shows another embodiment of thetherapeutic device100 in which uLEDs, wLEDs, and/or mLEDs are incorporated into a device which can be worn or otherwise fixtured, carried or attached to a patient while the therapy to treat a skin disorder is being applied. Although thedevice100 of the embodiment illustrated inFIG. 15B has the form of a bracelet, thelight source126 LEDs can be incorporated into any material which can at least partially cover or are in direct or indirect contact with the patient'sskin442. For example, thetherapeutic device100 may have the form of a bandage, blanket, any articles of clothing, a ring, jewelry, a hat, a wristband, a shirt, a sock, underwear, a scarf, a headband, a patch, a gauze pad, or any other wearable article, etc.
• In another embodiment, several devices100 (e.g., bandages) are brought together or applied to treat a larger area. In one embodiment, a kit can having different sized bandages is provided. Adhesive can be a component of the kit and/or a component of the bandages. The individual sized bandages can be fit together to fit different shaped and sized areas or plaques. With such a “wearable”device100, a patient can treat his or her disorder (e.g., psoriasis) while performing other tasks or sleeping and can treat small or large areas of disease in a time- and cost-effective manner.
• Such a localized therapy is also safer than treatments which apply light over a broad area of skin because portions of the skin which are not psoriatic can be unnecessarily exposed to ultraviolet light. With the LED systems described above, broad-band or narrow-band optical therapy can easily be applied to the skin depending upon clinical requirements. In addition, photodetectors may be integrated into thetherapeutic device100 for feedback control of the therapy. Internal body cavities can be treated as well with permanent or semi-permanentoptical therapy devices100. For example, in one embodiment, inner ear infections are treated by placing anoptical therapy device100 inside of the ear canal or a nasal or para-nasal cavity or airway such as the lungs can be treated with a permanent or semi-permanent light emitting implant. In some embodiments, an implant is surgically placed inside a body cavity or organ such as an intra-abdominal organ or an intra-thoracic organ. Implants can also be placed in a genitourinary system such as the bladder, uterus, or vagina to treat infectious, allergic, and/or inflammatory diseases. An implant can also be used for contraception. The implant can be powered by directly contacting the implant with a power source or through an external power source coupled via electromagnetic coupling.
• FIG. 15C illustrates anoptical therapy device100 being applied to a finger or toe nail. In such a case, tinea infections of the nails may be treated with the device by choosing the appropriate sterilization wavelengths (e.g., 255-320 nm) for the uLEDs and mLEDs.FIG. 15D illustrates anoptical therapy device100 used to treat fungal infection of thenail beds444. Theoptical therapy device100 has the form of a bandage or band-aid. Such adevice100 allows patients to go about their daily lives while the treatment is being applied.
• Any of the above devices can be further applied to polymer curing applications internally or externally to a patient. The devices can also be used in any context with phosphors which change the effective wavelength of light. The devices can also be used as the light activating component of a photodynamic therapy, which also changes the effective wavelength desired by the optical device.
• Any of the above devices can also be used in spectroscopic applications where light (specific wavelength and/or on-off frequency) is applied to a tissue and then an optical parameter from the tissue is measured in response to the light application. The sensor to detect the optical parameter can be incorporated into the optical therapy device or can be a separate instrument.
• Although this invention has been disclosed in the context of a certain preferred embodiment, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiment to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In particular, while the present optical therapy devices, systems and methods have been described in the context of a particularly preferred embodiment, the skilled artisan will appreciate, in view of the present disclosure, that certain advantages, features and aspects of optical therapy devices, systems and methods may be realized in a variety of other combinations and embodiments. Additionally, it is contemplated that various aspects and features of the invention described can be practiced separately, combined together, or substituted for one another, and that a variety of combination and subcombinations of the features and aspects can be made and still fall within the scope of the invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (37)

1. A treatment apparatus for a nasal cavity comprising:

(a) a tubular member having a proximal end and a distal end; and

(b) an expandable member positioned at the distal end of the tubular member adapted to transfer energy to or from the nasal cavity of a patient.

2. The treatment apparatus ofclaim 1 wherein the apparatus is adapted to treat one or more paranasal sinuses of the nasal cavity.

3. The apparatus ofclaim 1 wherein the apparatus is adapted to travel over a guidewire.

4. The apparatus ofclaim 1 wherein the expandable member is constructed from a material adapted to permit energy transfer from the expandable member, through the material, and to the nasal cavity structure or from the nasal cavity structure, through the material and to the expandable member.

5. The treatment apparatus ofclaim 1 wherein the expandable member is constructed from a material adapted to facilitate energy transfer from the expandable member to the nasal cavity or to the expandable structure from the nasal cavity.

6. The treatment apparatus ofclaim 1 wherein the tube is flexible.

7. The treatment apparatus ofclaim 1 wherein the tubular member has an angular tip.

8. The treatment apparatus ofclaim 1 wherein the energy transferred is heat energy.

9. The treatment apparatus ofclaim 1 wherein the energy transferred is light energy.

10. The treatment apparatus ofclaim 1 wherein the apparatus is adapted to further comprise one or more semiconductor structures at the distal end.

11. The treatment apparatus ofclaim 10 wherein the semiconductor structure is an LED.

12. The treatment apparatus ofclaim 1 further comprising a mechanized device positioned at the distal end which automates energy delivery to the nasal cavity.

13. A method of treating a nasal cavity comprising the steps of:

(a) inserting an apparatus comprising a tubular member having a proximal end and a distal end, and an expandable member positioned at the distal end of the tubular member adapted to transfer energy through a material of the expandable member;

(b) expanding the expandable member within the nasal cavity of the patient to expose a surface area of a structure;

(c) transferring energy through the expandable member to a structure within the nasal cavity.

14. The method of treating a nasal cavity according toclaim 13 wherein the transferring step comprises withdrawing energy from the nasal structure.

15. The method of treating a nasal cavity according toclaim 13 wherein the transferring step comprises cooling the structure within the nasal cavity.

16. The method of treating a nasal cavity according toclaim 13 wherein the tubular member is flexible.

17. The method of treating a nasal cavity according toclaim 13 wherein the distal end of the tubular member is adapted to access a sinus cavity.

18. The method of treating a nasal cavity according toclaim 13 wherein the distal end of the tubular member is angled.

19. The method of treating a nasal cavity according toclaim 13 wherein the distal end of the tubular member further comprises a mechanism which automates the dose of energy delivered to the nasal cavity.

20. The method of treating a nasal cavity according toclaim 13 further comprising the step of accessing a nasal cavity with a guidewire prior to inserting an apparatus comprising a tubular member into the nasal cavity of the patient.

21. The method of treating a nasal cavity according toclaim 20 wherein the expanding step comprises applying pressure to the mucosa of the nasal cavity to transfer energy in a substantially even manner.

22. A method of treating a disease of the sinuses comprising the steps of:

(a) inserting an apparatus comprising a tubular member having a proximal end, a distal end, and an expandable member positioned at the distal end of the tubular member adapted to transfer energy within a nasal cavity of a patient;

(b) expanding the expandable member within the nasal cavity of the patient to substantially contact the mucosa of the nasal cavity; and

(c) transferring energy through the expandable device to the structure within the nasal cavity.

23. The method ofclaim 22 further comprising the step of accessing a nasal cavity with a guidewire prior to inserting an apparatus comprising a tubular member into the nasal cavity of the patient.

24. The method ofclaim 22 further comprising the step of adding heat to the structure of the sinus cavity through the expandable member.

25. The method ofclaim 22 further comprising the step of applying light through the expandable member.

26. The method ofclaim 25 wherein the light is ultraviolet light.

27. The method ofclaim 26 wherein the ultraviolet light has a wavelength below320 nm.

28. The method ofclaim 22 wherein the structure is the mucosa of the nasal cavity.

29. The method ofclaim 22 wherein the structure is a nasal polyp.

30. The method ofclaim 22 wherein the structure is one or more of the turbinates.

31. The method ofclaim 22 wherein the apparatus comprises an LED

32. A treatment apparatus for a nasal cavity comprising:

(a) a tubular member having a proximal end and a distal end; and

(b) a device positioned at the distal end of the tubular member adapted to transfer energy to or from the nasal cavity of a patient.

33. The treatment apparatus ofclaim 32 wherein said device emits electromagnetic radiation with wavelengths lower than 400 nm

34. The treatment apparatus ofclaim 32 wherein said device is an LED

35. The treatment apparatus ofclaim 32 wherein said device is a cooling device.

36. The treatment apparatus ofclaim 32 wherein said device emits electromagnetic radiation with wavelengths greater 700 nm.

37. The treatment apparatus ofclaim 36 wherein said device is an LED.

Images