Optical Therapy Devices, Systems, Kits and Methods for Providing Therapy to a body Cavity

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An optical therapy device is disclosed. The optical therapy device provides therapeutic light therapy to a body cavity. The device includes a housing adapted to be hand held, a UV light source positioned in or on the housing, and an insertion member having a distal end configured to be inserted into the body cavity to illuminate tissue in the body cavity with light from the light source.

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Description
CROSS-REFERENCE

This application is a continuation-in-part application of Ser. No. 11/152,946, filed Jun. 14, 2005, which is incorporated herein by reference in its entirety and to which application priority is claimed under 35 USC § 120.

This application claims the benefit of U.S. Provisional Application No. 60/646,818, filed Jan. 25, 2005 and U.S. Provisional Application 60/661,688 filed Mar. 14, 2005, which are incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

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; and (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: vascular access catheter infections, chemotherapy port infections, peritoneal dialysis access catheter infections, vaginal yeast infections, 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, and chronic ear infections, to name a few. There is also increasing evidence that atherosclerosis is caused by infections by micro-organisms such as Chlamydia.

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. There is a great deal of overlap among patients with atopic disease. For example, patients with atopic asthma have a greater likelihood of developing allergic rhinitis and dermatitis, and vice versa. Indeed, the pathophysiology for atopic diseases is generally the same whether or not the affected organ is the skin, the nose, the lungs, or the gastrointestinal tract.

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), 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.

The United States Centers for Disease Control (CDC) estimates that each year, nearly 2 million people in the United States acquire an infection while in a hospital, resulting in 90,000 deaths. More than 70 percent of the bacteria that cause these infections are resistant to at least one of the antibiotics commonly used to treat them. Between 1979 and 1987, it is estimated that only 0.02 percent of pneumococcus strains infecting a large number of patients surveyed by the CDC were penicillin-resistant. As of 1994 that percent was estimated to have increased to 6.6 percent, and may currently approach 25%, by some estimates. Thus, as resistance increases, the importance of developing new treatment modalities increases.

A variety of devices are known for delivering light therapy. For example, U.S. Pat. No. 1,616,722 to Vernon for Kromayer Light Attachment; U.S. Pat. No. 1,782,906 to Newman for Device for Treating the Stomach with Ultra-Violet Rays; U.S. Pat. No. 1,800,277 to Boerstler for Method for Producing Therapeutic Rays; U.S. Pat. No. 2,227,422 to Boerstler for Applicator for Use in Treatment with Therapeutic Rays; U.S. Pat. No. 4,998,930 to Lundahl for Intracavity Laser Phototherapy Method; U.S. Pat. No. 5,146,917 to Wagnieres for Fiber-Optic Apparatus for the Photodynamic Treatment of Tumors; U.S. Pat. No. 5,292,346 to Ceravolo for Bactericidal Therapeutic Throat Gun; U.S. Pat. No. 5,683,436 to Mendes for Treatment of Rhinitus by Biostimulative Illumination; U.S. Pat. No. 6,663,659 to McDaniel for Method and Apparatus for the Photomodulation of Cells; U.S. Pat. No. 6,764,501 to Ganz for Apparatus and Method for Treating Atherosclerotic Vascular Disease Through Light Sterilization; and U.S. Pat. No. 6,890,346 to Ganz for Apparatus and Method for Debilitating or Killing Microorganisms within the Body. Additionally, U.S. Patent Publ. 2002/0029071 to Whitehurst for Therapeutic Light Source and Method; U.S. Patent Publ. 2004/0030368 to Kemeny for Phototherapeutical Method and System for the Treatment of Inflammatory and Hyperproliferative Disorders of the Nasal Mucosa; and U.S. Patent Publ. 2005/0107853 to Krespi for Control of Rhinosinusitus-Related, and Other Microorganisms in the Sino-Nasal Tract. See, also PCT Publ. WO 03/013653 to Kemeny for Phototherapeutical Apparatus.

SUMMARY OF THE INVENTION

The invention relates to an optical therapy device for providing therapeutic light to a body cavity. An embodiment of the invention includes: a housing adapted to be hand-held; one or more light sources positioned in or on said housing adapted to deliver up to 50 mW of UV light; and an insertion member having a distal end configured to be inserted into the body cavity to illuminate tissue in the body cavity with light from the light source when the distal end of the insertion member is positioned in the body cavity.

Another embodiment of the invention includes: an insertion member having a distal end configured to be inserted into the body cavity; and a UV light source at the distal end of the insertion member, wherein the insertion member is adapted to illuminate tissue in the body cavity with UV light when the distal end of the insertion member is positioned in the body cavity.

Still another embodiment of the invention includes a patient interface for an optical therapy device for providing therapeutic light to a body cavity, comprising: an insertion member having a distal end configured to be positioned into a body cavity to illuminate target tissue in the body cavity with UV light from a UV light source when the distal end of the insertion member is positioned in the body cavity. The insertion member can be further adapted to have an alignment member adapted to align the insertion member within the cavity and a direction element adapted to direct light onto target tissue.

Yet another embodiment of the invention includes an optical therapy device for providing therapeutic light to a body cavity, comprising: an insertion member having a distal end configured to be inserted into the body cavity; a light source at the distal end of the insertion member and adapted to illuminate tissue in the body cavity when the distal end of the insertion member is positioned in the body cavity; the insertion member being further adapted to transfer heat proximally from the light source.

The optical therapy devices of the invention may include one or more light sources; such as light sources that are solid state or LEDs. Alternatively, the light sources may emit non-coherent light. In still other embodiments, the light sources may be UV light sources that emit non-coherent light in a range from 250 nm to 279 nm. In other embodiments, the UV light source may be limited in wavelength to 300 nm to 320 nm. In yet other embodiments, the UV light source in the range of 280 nm to 320 nm, while other embodiments may use a UV light source that is restricted to a wavelength range from 250 nm to 320 nm. In still other embodiments, the light source may be adapted to emit substantially only UV light.

The optical therapy devices of the embodiments of the invention can be adapted and configured to provide any of the light sources at the distal end of the insertion member. In some embodiments, the light sources are provided along the length of the insertion member or tube. In still other embodiments, the light sources are provided in the body or hand-piece. In yet other embodiments, light sources are provided at a plurality of locations within or along the device.

The optical therapy devices of the embodiments of the invention can be adapted and configured to provide a housing supporting the insertion member and a power source disposed in or on the housing, the power source being adapted to provide power to the light source.

The optical therapy device of the embodiments of the invention can be adapted and configured such that the insertion member is further adapted to transfer heat proximally when the light source is at the distal end of the insertion member. In other embodiments, the insertion member can be adapted to focus eight from the light source.

In other embodiments, the insertion member is further adapted to comprise an expandable member adapted and configured to expand within the body cavity. In some embodiments of the invention, a balloon is used. The balloon may be an optical conditioner that is at least partially transparent to UV light and at least partially covers one or more light sources. In other embodiments, the balloon may be configured to partially absorb light from one or more light sources. The expandable member can be adapted to be transparent to UV light. In other embodiments, the expandable member can be adapted to focus light from the light source. In some embodiments, the expandable member can be adapted to cool the device when expanded.

The insertion member can be configured, in some embodiments, to have a shape adapted to enter a body cavity. In some embodiments, the insertion member can be further adapted to emit light into more than one body cavity simultaneously. The insertion member can be adapted to bend light at an angle defined by the insertion member. In other embodiments, the insertion member is adapted to be flexible and to form a variable angle. The insertion member may be adapted to split into one or more elongate tubes. In still other embodiments, the insertion member is adapted to be rigid with a fixed angle. In still other embodiments, the insertion member is adapted to be partially transparent to UV light and to at least partially cover one or more light sources.

The optical therapy devices of the embodiments of the invention are suitable for use in a body cavity. Body cavities include, for example, the nasal cavity, a vestibule of the nasal cavity, the thoracic cavity, the abdominal cavity, lumen of a vessel, the gastrointestinal cavity, the pericardial cavity, and the heart, to name a few.

The optical therapy devices of the embodiments of the invention may further comprise a data collection unit connectable to a controller. In other embodiments, the controller may be adapted to connect a power source to the light source. The controller may be configured to individually control one or more of a plurality of light sources. Additionally, the controller may be configured to store the total amount of energy emitted by one or more of a plurality of light sources. In some embodiments, the controller can be configured to control which of the plurality of light sources is powered on or powered off based on the total energy emitted by the light source. Alternatively, the controller can be configured to control which of the light sources is powered on or powered off based on a structure of the body cavity. In yet another embodiment, the controller can be configured to control which of the plurality of light sources is powered on or powered off based on programming by an operator. A controller may be provided that is adapted to connect a power source to the light source. The controller can also be adapted to separately address each of the light sources provided.

The optical therapy devices of the embodiments of the invention may further comprise a recharger adapted to connect to a power source. In some embodiments, the device further comprises a power source disposed in or on the housing. The power source can be any suitable power source, including AC, DC, rechargeable, etc. Where a rechargeable power supply is provided, an embodiment of the invention can include a recharger adapted to recharge the power source.

Embodiments of the device can be configured such that the insertion member is adapted to transfer heat away from the body cavity. In some embodiments, the device includes a heat transfer device. Suitable heat transfer devices may include, for example, heat pipes, cooling modules, heat fins, heat conductors and cooling tubes. In some embodiments, the heat transfer device can be adapted to surround the light source. In other embodiments, the heat transfer device can be adapted to provide a thermal interface adapted to draw heat away from a heat sink. In still other embodiments, the heat transfer device can be adapted, or further adapted, to extend axially along the longitudinal axis of the hand piece.

INCORPORATION BY REFERENCE

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

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

FIG. 1A is a cross-sectional view of an optical therapy device in accordance with an embodiment of the present invention; FIG. 1B is a cross-sectional view of a sheath of the optical therapy device of FIG. 1A;

FIG. 2 illustrates an optical therapy system of the invention utilizing the optical therapy device of FIG. 1;

FIGS. 3 and 4A are cross-sectional views of optical therapy devices in accordance with an embodiment of the present invention; FIG. 4B is a cross-sectional view taken along line 4B-4B of FIG. 4A;

FIGS. 5A, 5B, and 6A are cross-sectional views of optical therapy device in accordance with additional embodiments of the present invention; FIG. 6B is a cross-sectional view taken along line 6B-6B of FIG. 6A;

FIG. 7A is a cross-sectional view of an optical therapy device in accordance with other embodiments of the present invention; FIG. 7B is a cross-sectional view taken along line 7B-7B of FIG. 7A;

FIGS. 8A-B are cross-sectional views of an optical therapy device according to additional embodiments of the present invention; FIG. 8c is a cross-sectional view taken along line 8C-8C of FIG. 8B; FIG. 8D is a cross-sectional view taken along line 8D-8D of FIG. 8c;

FIGS. 9A-C are additional embodiments of optical therapy devices that include visualization assistance;

FIG. 10A is a cross-sectional view of an optical therapy device in accordance with another embodiment of the present invention; FIG. 10B is an end view of the optical therapy device of FIG. 10A; FIG. 10C is a partial cross-sectional view of the distal end of a medical instrument coupled to the optical therapy device of FIGS. 10A-B;

FIGS. 11A-H 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. 12A-B illustrate another optical therapy device in accordance with another embodiment of the present invention;

FIG. 13A illustrates another embodiment of an optical therapy device positioned at the end of a flexible medical device; FIG. 13B illustrates one embodiment of an indwelling catheter according to another embodiment of the present invention; FIG. 13C illustrates one embodiment of an optical therapy device located inside of an at least partially optically-transparent balloon;

FIG. 14A illustrates a light emitting diode (LED) device in accordance with one embodiment of the present invention; FIG. 14B is an exploded view of the LED of FIG. 14A;

FIG. 14c illustrates a spectroradiometer measurement of the optical output from an LED device, such as the LED of FIG. 14A, having a peak at about 308 nm; FIG. 14D illustrates the output from one embodiment of a set of three white-light emitting LEDs (wLED); FIG. 14E illustrates a spectroradiometer measurement of the optical output from a multi-chip LED (mLED);

FIGS. 15A-B illustrate an optical therapy device inserted into a person's nasal cavity;

FIG. 16A is another embodiment showing the optical therapy device of 9D and 9J inserted into the anterior portion of a patient's nasal cavity;

FIG. 16B is another embodiment of an optical therapy device having an annular tunnel for the optical therapy device;

FIG. 16C is a coronal view of a patient's head showing the optical therapy device of FIG. 16A inserted into a sinus cavity;

FIG. 17 is a sagittal view of a patient's head with a nasal adapter inserted therein;

FIGS. 18A-18B illustrates one embodiment of an optical therapy system to treat transplanted organs, such as transplanted kidney; and

FIG. 19 is a flow chart illustrating a method of the invention.

 DETAILED DESCRIPTION OF THE INVENTION

In the 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, embodiments of the present invention can be configured to optimize portability, and may be implemented with a variety of light sources. Additionally, specific desired illumination pattern(s) and spectral output control may be achieved in the various embodiments.

The embodiments of the invention employ lighting technologies. Suitable 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, offer the potential for less expensive and more flexible phototherapeutical units. As will be appreciated by those skilled in the art, 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, LEDs are generally less expensive than traditional light sources in terms of cost per lumen of light; are generally smaller, even when providing a similar amount of therapeutic power; offer well-defined and precise control over wavelength and power; and 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. LEDs also generally allow for easy integration with other microelectronic sensors (e.g., photodiodes) to achieve low cost integrated components; and 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 (which will likely enhance patient compliance with treatment protocols) 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 non-coherent 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. While LEDs with light emission >365 nm have been optimized with respect to their output efficiency (optical power out versus input power) which can range from 1% to greater than 20%, LED dies with outputs from 240 nm to 365 nm have far less efficiency, which is well below 5% at the current time. In addition, the lifetime of LEDs in the 240-365 nm range is a lot lower (hundreds of hours) than LEDs greater than 365 nm (typically tens of thousands of hours). As a consequence of the decreased efficiency, heat transfer is a critical issue with ultraviolet LEDs in the 240-365 nm range. Similarly, the lifetime being short requires that efficiency be optimized by placing the light sources closer to the point of therapy which can compound the heat transfer issues. In addition, however, there are many other reasons to have the light source closer to the point of therapy; for example, the resulting device can be made light weight and portable and easier to apply to a patient. Furthermore, there are many reasons that LEDs specifically are a preferred light source for the close application of therapeutic light delivery to a patient; for example, the LEDs emit light from a small volume which allows for improved directionality of the therapeutic light and in addition, the LEDs can be integrated well with other electronic components such as imaging or data collection elements.

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 (Woburn, 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.

As will be appreciated by those skilled in the art, a variety of suitable lighting sources can be employed in the embodiments disclosed herein, without departing from the scope of the invention.

Turning now to the embodiments of the invention, an optical therapy device 100 for providing therapeutic light to a body cavity in accordance with one embodiment of the present invention is illustrated in FIG. 1. The optical therapy device 100 generally includes a housing or body adapted to be hand-held; and a UV light source 126 positioned in or near the housing. An insertion member or tube 106 is provided having a distal end configured to be inserted into a target body cavity to illuminate tissue within the body cavity from the light source when the distal end of the insertion member is positioned within the body cavity.

As will be appreciated by those skilled in the art, the body can also generally refer to the optical therapy device 100 without the light source 126 and without the power supply 110 or power cords 114 connected. The body of the optical therapy device in combination with the light source 126 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, due to the lightweight, portable design of the device.

In one embodiment, the insertion member or tube 106 includes a tip 118 at the distal end 116 of the tube 106. The tip 118 of the tube 106 is any of a variety of optically transparent or partially transparent structures. As will be appreciated, optically transparent components or materials can include components or materials that are transparent to wavelengths between about 200 nm and about 800 nm. In some cases, optically transparent can refer to more narrow ranges of transparency. For example, optically transparent to ultraviolet (UV) light can refer to transparency in the range from about 200 mm to 400 nm; while optically transparent to ultraviolet B (UVB) can refer to transparency in the range from about 280 mm to about 320 nm.

In one embodiment, the tip 118 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 lens can include, for example, a device that causes radiation or light to converge or diverge. The conditioner can be configured to modify the spectral output or the geometric illumination pattern of the device. In one embodiment, to provide a desired output spectrum, three types of tips can be used in series within the tube 106. 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 the tube 106 is transferred through tip 118 through a series of internal reflections. In one embodiment, the tip 118 is made at least in part from a different material than that of the tube 106. The tip 118 of the tube 106 may be shaped or designed to disperse light as it exits the reflecting tube 106 and is transmitted to a patient.

The tube 106 can be configured as 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.

Additionally, the reflecting tube 106 can be configured such that it is hollow. Where the reflecting tube 106 is hollow, the inside wall 120 of the reflecting tube 106 can at least partially reflects light of a selected wavelength. Thus, the inside wall 120 may include a reflecting layer 122 applied over its entire surface although in other embodiments the inside wall 120 does not include a reflecting layer 122. In one embodiment, the reflective layer 122 includes a coating of a reflecting material such as, for example, aluminum, silica carbide, or other suitably reflective material.

The proximal end 108 of the tube 106 is coupled to the distal end 105 of the hand piece 102 by any of a variety of couplings 124 well known to those of skill in the art. For example, in one embodiment, the coupling 124 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. Coupling 124 includes mechanical, optical, and electrical couplings, as well as combinations thereof.

In one embodiment, the coupling 124 is releasable so that the tube 106 may be decoupled or removed from the hand piece 102. Such coupling 124 may also be made from a disposable material. In another embodiment, the reflecting tube 106 is permanently attached to the hand piece 102. In such case, the coupling 124 is a permanent connection.

In one embodiment, the hand piece 102 of the body includes a light source 126. 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 the light source 126 of FIG. 1 is shown in the hand piece 102, the light source 126 can be placed anywhere on, in, or along the optical therapy device 100, including on or in the distal end of the insertion member. In some of the embodiments discussed below, multiple light sources are adapted for delivery by the optical therapy device 100, some of which may reside in the hand piece 102 and some of which may reside on or in the insertion member or tube 106, and some of which may reside on or in the tip 118.

The light source 126 can be configured to include 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 reflecting tube 106 or is incorporated into the tip 118. Optical emitter 128 illuminates the light emitting portion of the light source 126. When light source 126 is a mercury vapor lamp, optical emitter 128 can be an inner capillary tube where the mercury plasma emits photons. Leads 132 extending from the light source 126, electrically couple the light source 126 with a control circuit 134. In one embodiment, the control circuit 134 is in electrical communication with a controller 136 and with power supply 110 via the power coupling 114.

Optical emitter 128 can also comprise a filament. Such filaments may be used when light source 126 is an incandescent or halogen lamp.

As will be appreciated by those skilled in the art, it may be desirable to control variables or control parameters associated with the output of the optical therapy device 100. Examples of such variables include power, timing, frequency, duty cycle, spectral output, and illumination pattern. In one embodiment, the control circuit 134 controls the delivery of power from the power supply 110 to the light source 126 according to the activation or status of the controller 136. For example, in one embodiment, the control circuit 134 includes a relay, or a transistor, and the controller 136 includes a button, or a switch. When the button or switch of the controller 136 is pressed or activated, power from the power supply 110 is able to flow through the control circuit 134 to the light source 126.

The variables can be controlled in response to, for example, at least one photoreflectance parameter, which, for example, may be measured or obtained at the distal end 116 of the therapy device 100. Other variables or control parameters include 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 the optical therapy device 100. In some embodiments, controller mechanisms, which can be integral to the optical therapy device 100, 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., seconds, minutes, hours, days, months, years) and can prohibit the device from delivering additional doses after the preset dosage is achieved.

Although the control circuit 134 is illustrated within the hand piece 102 of the optical therapy device 100, in another embodiment, the control circuit 134 is located within the power supply 110. Other configurations can be employed without departing from the scope of the invention. In such embodiments, the controller 136 communicates with the control circuit 134 through the power coupling 114. Control data, commands, or other information may be provided between the power supply 110 and the hand piece 102 as desired. In one embodiment, control circuit 134 stores information and data, and can be coupled with another computer or computing device.

In one embodiment, power from the power supply 110 flows to the control circuit 134 of the hand piece 102 through a power coupling 114. The power coupling 114 may be 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, the power coupling 114 includes a wire, a radio frequency (RF) link, or a cable.

The light source 126 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 source 126 emits light in the visible spectrum in combination with ultraviolet light or by itself. Finally, in yet another embodiment, the light source 126 emits light within the infrared spectrum, in combination with white light and/or ultraviolet light, or by itself. Light source 126 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, the light source 126 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 band gap of about 10-20 nm and broad-band is over a band gap of about 20-50 nm.

The spectrum delivered can be 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, the light source 126 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, the light source 126 emits light having a narrow-band wavelength of approximately 308 nm within the UVB portion of the UV spectrum. In another embodiment, the light source 126 emits light having a wavelength below approximately 300 nm. In other embodiments, the light source 126 emits light having a wavelength between about 254 nm and about 313 nm.

The optical therapy device 100 can be configured to include more than one light source 126, where each light source 126 has an output centered at a different wavelength. Each light source 126 can have an output that can be characterized as broad-band, narrow-band, or substantially single band. All light sources 126 can be the same characterization, or may have one or more different characterizations. For example, in one embodiment, the optical therapy device 100 includes three light sources 126: 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. The optical therapy device 100 may be configured to provide light from three light sources 126, 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 the light source 126 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 the optical therapy device 100. In one embodiment, the optical energy emitted from the light source 126 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 the optical therapy device 100. In one embodiment, the optical energy emitted from the light source 126 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 the optical therapy device 100.

In one embodiment, the optical therapy device 100 includes a UVA light source 126, a UVB light source 126, and a visible light source 126, where the UVA light source 126 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 the optical therapy device 100. For example, in one embodiment, the optical therapy device 100 provides a dose to the surface it is illuminating (e.g., the nasal mucosa) of about 2 J/cm2, where the UVA light source 126 provides about 0.5 J/cm2, the UVB light source 126 provides about 0.1 J/cm2, and the visible light source 126 provides about 1.4 J/cm2. In another embodiment, the optical therapy device 100 provides a dose of about 4 J/cm2, where the UVA light source 126 provides about 1 J/cm2, the UVB light source 126 provides about 0.2 J/cm2, and the visible light source 126 provides about 2.8 J/cm2. In another embodiment, the optical therapy device 100 provides a dose of about 6 J/cm2, where the UVA light source 126 provides about 1.5 J/cm2, the UVB light source 126 provides about 0.3 J/cm2, and the visible light source 126 provides about 4.2 J/cm2. In yet another embodiment, the optical therapy device 100 provides a dose of about 8 J/cm2, where the UVA light source 126 provides about 2 J/cm2, the UVB light source 126 provides about 0.4 J/cm2, and the visible light source 126 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 from 40:1 to 80:1 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 powered 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 the tip 118 of the optical therapy device 100. For example, in one embodiment, fluence is measured substantially at the tip 118 of the optical therapy device 100. 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 the tip 118 of the optical therapy device 100.

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 the optical therapy device 100, 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 the tip 118 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 treatment site, may be 5-10 times this amount because of the optical therapy distance 100 from the treatment site 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 the optical therapy device 100 at the tip 118 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 tip 118) 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 the optical therapy device 100 accordingly. In addition, the practitioner can evaluate the mucosa visually with a rhinoscope and adjust the optical parameters accordingly; in another embodiment, tube 106 delivers an image from the region surrounding the distal tip 118.

The dosage may be measured at a planar or curved surface with respect to the tip 118 of the optical therapy device 100. For example, in one embodiment, the dosage is measured at a plane that is tangential to the surface of the tip 118 of the optical therapy device 100. 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 the tip 118 of the optical therapy device 100.

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 the tip 118 of the optical therapy device 100. The selection of planar or curved surface for dosage measurement, and the distance between the measurement plane and the optical therapy device 100 tip 118 may be selected based upon the particular geometry of tip 118 utilized.

In one embodiment, the output portion 130 of the light source 126 is positioned so that it resides within at least a portion of the tube 106. When the output portion 130 of the light source 126 is so positioned, light emitted from the light source 126 is transmitted directly into the tube 106. In this embodiment, the tube is a reflecting tube. In such a case, optical losses may be minimized, or reduced. In addition, by positioning the output portion 130 of the light source 126 inside of the tube 106, 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, the optical reflectance tube 120 includes one or more optical fibers that capture and guide the light from the light source/s 126. When the light sources 126 are small semiconductor structures, the fibers can encapsulate the semiconductor structure and faithfully transmit substantially all of the light from the light source 126. More than one fiber can be used to direct the light from multiple light sources 126. For example, each fiber can transmit light from one light source 126. In other embodiments, the optical tube 106 is or includes a light guide such as a liquid light guide (e.g., such as those available from EXFO in Ontario, Calif.).

The tube 106 may taper from a large diameter at its proximal end 108 to a smaller diameter at its distal end 116, in which case the tube 106 has a larger diameter at its proximal end 108 than at its distal end 116. In another embodiment, the tube 106 may taper from a larger diameter at its distal end 116 to a smaller diameter at its proximal end 108. In such case, the tube 106 has a larger diameter at its distal end 116 than at its proximal end 108. In other embodiments, the insertion member or tube 106 is substantially cylindrical. In such case, the diameter of the tube 106 may be substantially constant along its entire length.

In one embodiment, the tube 106 is flexible so that its shape and orientation with respect to the housing or hand piece 102 may be adjusted. A flexible material, such as rubber, plastic, or metal may be used to construct the tube 106, and to provide flexibility thereto. In one embodiment, a goose-neck tube, or spiral wound coil is used to provide a flexible tube 106. In such embodiments, an outer sheath 142 may be provided with the tube 106 to isolate the flexible portion of the tube 106 from the body cavity, such as a patient's nasal cavity.

An outer sheath 142 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. The outer sheath 142 can also have beneficial optical properties. For example, the outer sheath can diffuse or otherwise pattern the light entering it from the optical tube 106. 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 surrounds tube 106 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, tube 106 is sized so it may be inserted into a cavity of a patient or user. For example, when the insertion member or tube 106 is inserted into the nasal cavity until its tip 118 reaches the turbinates, the sinuses, or the ostia to the sinuses. The tube 106 may be made of flexible materials so that it can bend, or be steered around corners, or conform to the shape of the cavity, as required.

The insertion member or tube 106 may be made from any one or a combination of materials as described above. For example, the tube 106 may be made from polymers. In such case, since many polymers absorb light in the ultraviolet portion of the spectrum, the inside wall 120 of the tube 106 may be coated with a reflective coating or layer 122, as described above. The outside of the tube 106 can also be coated with a polymer with the inner material being one of the materials noted above.

In one embodiment, the reflective layer 122 includes an electrolessly-deposited metal. For example, layer 122 may include nickel, nickel-phosphorous, cobalt, cobalt-phosphorous, nickel-cobalt-phosphorous and/or a noble metal. In other embodiments, the layer 122 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, the tube 106 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.

The optical therapy device 100 generally allows for the use of low pressure light sources 126 and can be manufactured at low cost using safe light sources 126. By utilizing a low pressure light source 126, the light source 126 may be manufactured at a small size so that it can fit within a hand-held hand piece 102 of the optical therapy device 100.

The controller 136 of the optical therapy device 100 is adapted to control the quantity (e.g., total energy) and intensity (e.g., power) of light emitted by the light source 126 and thereby exiting the tip 118 of the optical therapy device 100. For example, in one embodiment, the controller 136 determines and/or controls the power from the power supply 110. The controller 136 may be programmed and may include a timer so that only a pre-specified amount of light can be provided by the optical therapy device 100 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). The controller 136 can also be configured to control the illumination pattern. For example, by turning one or more light sources powered on and powered off, the illumination pattern can be controlled. The controller 136 can further control the illumination pattern by moving (actively or passively) or otherwise altering the aperture or pattern of the tip 118. The controller 136 can also apply current to the light sources at a desired frequency or duty cycle.

In another embodiment, the controller 136 is adapted to deliver a large current or a current or voltage pulse to the light source 126 to “burn out” or destroy the light source 126 after a selected period of time. For example, after a predetermined “useful lifetime” of the optical therapy device 100 expires, a “burn out” current is provided and the optical therapy device 100 essentially ceases to function. At this time, the optical therapy device 100 is discarded. The controller 136 can also respond to or receive a control signal from one or more photodetectors placed in or on the tube 106 or the controller can respond to receive a control signal from one or more photodetector devices in an external calibration unit.

The power supply 110 of the optical therapy device 100 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 supply 110 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. Thus, where a device is configured to use more than one light source, it may be necessary to provide more than one power source.

In one embodiment, the light source 126 includes a low pressure lamp with an output (measured at any of the locations described above) between about 100 μW/cm2 and about 5 mW/cm2. In one embodiment, the light source 126 generates ultraviolet light and it includes at least a small amount of mercury within a nitrogen atmosphere. As discussed above, the output portion 130 of the light source 126 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.

When mercury vapor is used in connection with the light source 126, the light source 126 provides ultraviolet light having an output peak concentrated at 254 nm. The light source 126 can include 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. Suitable mercury vapor lamps include the type 2095 lamp manufactured by Gelight Corporation. Additionally, 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 the light source 126, the output peaks from the light source 126 can be customized based upon the desired clinical application and action spectra for the disease process being treated.

Additionally, the light source 126 can include or be selected from 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. More specific wavelength, such as a wavelength of 275 nm, can be used. 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.

Power delivery to the LEDs can be modified to optimize the optical power of the LEDs. In such cases, the LEDs can be configured to switch 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 the power supply 110 of the optical therapy device 100 is illustrated in FIG. 1 as tethered to the proximal end 112 of the hand piece 102, it should be well understood by those of skill in the art that the power supply 110 may be incorporated into or included on or within the body of the device, including the hand piece 102. In such cases, the power supply 110 may include a battery, a battery pack, a capacitor, or any other power source. The power coupling 114 in such embodiments may include contacts or wires providing electrical communication between the power supply 110 and the control circuit 134.

A sleeve 140 may be provided to at least partially cover the tube 106. In one embodiment, the sleeve 140 is disposable and in another embodiment, the sleeve is not disposable. In addition, as will be appreciated by those skilled in the art, disposable can also refer to the cost of production and sales price of a component, as well as the ability to use procedures to sterilize or otherwise clean a component between uses.

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. The sheath or the sleeve can be molded, thermoformed, machined or extruded. As will be appreciated, the sleeve or sheath can be 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 the light source 126 to travel through the tube 106 and exit both the tip 118 of the tube 106 and the tip 140 of the sleeve. In such embodiments, light energy is emitted from the optical therapy device 100 and absorbed by the tissue within the body cavity (e.g., nasal cavity of the patient's nose).

The optical emitter 128 of the light source 126 is generally in electrical communication with leads 132. The optical emitter 128 can be adapted to extend in a direction that transverses an axis of the light source 126. As will be appreciated, the optical emitter 128 schematically represents only one embodiment of the light emitting portion of the hand piece 102 and light source 126. Optical emitter 128 (e.g., the light emitting portion of the light source 126) can be made from any of a variety of materials known to those of skill in the art; in cases where the optical emitter 128 represents a wire-filament type light source, the optical emitter 128 can include tungsten.

In embodiments where the light source 126 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 the optical emitter 128 of the light source 126 is shown at the distal end 124 of the hand piece 102, in other embodiments, the optical emitter 128 is positioned closer to the proximal end 112 of the hand piece 102. By moving the optical emitter 128 proximal with respect to the tip 118 of the tube 106, heat generated by the light source 126 may be at least partially separated from the tube 106, thereby lessening thermal communication with the patient's tissues.

Heat generated by the light source 126 may be removed from the optical therapy device 100 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 the hand piece 102 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 the optical therapy device 100.

In one embodiment, the light source 126 includes a solid state light emitter (e.g., an LED or laser diode module) and the light source 126 is positioned at or near the distal end 116 of the tube 106 instead of within the hand piece 102.

In another embodiment, the light source 126 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. Multiple solid state emitters may be employed to achieve the same or similar results. Additionally, a visible light solid state emitter is combined with a mercury vapor or halogen lamp to enhance wavelengths in the visible light region can be used. 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.

The tube 106 may include a soft coating on its outside surface 138. A soft coating, such as a polymer, rubber, or fluid-filled jacket, provides a comfortable interface between the outside surface 138 of the reflecting tube 106 and the patient's nose. In addition, the reflecting tube 106 may include one or more filters along its length. A filter can be positioned within the reflecting tube 106 near its proximal end 112 or near its distal end 116. The filter may function as a lens if cut into an appropriate shape and placed at the distal end 116 of the reflecting tube 106. 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.

The light source 126 typically is about 10% to about 15% efficient. The light source or combinations of light sources 126 can be configured to generate about 10 mW to about 100 mW of optical power. The light source can be configured to dissipate between about 10 W to about 20 W of power in order to generate about 10 mW to about 100 mW of optical power. Excess heat is typically dissipated so that the optical therapy device 100 does not overheat, and/or so that the patient does not experience discomfort during its use.

Heat transfer control may become increasingly important when the optical therapy device 100 includes a light source 126 that is located near the distal end 116 of the tube 106 (e.g., heat may be closer to the patient's tissue). For example, where the light source 126 is a mercury vapor light source, heat is generated near the output portion 130 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 the distal end 116 of the tube 106 and enter the tissue of the patient. Therefore, in such embodiments, heat transfer mechanisms are generally confined to the output portion 130 of the light source 126, close to where the light is generated.

In one embodiment, a fan is used to transfer heat or to remove heat from the optical therapy device 100. The fan may be configured to surround at least a portion of the output portion 130 of the light source 126 or the entire light source 126 itself. Thus, the fan may surround the light source 126, or a portion thereof, in an annular fashion, and can direct heat away from the light source 126 and away from the patient via convection.

Alternatively, a heat tube is placed around the light source 126 and the heat tube directs heat away from the patient towards the proximal end 112 of the hand piece 102. At the proximal end 112 of the optical therapy device 100, heat may be released into the environment. The heat tube can be configured to terminate 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 the proximal end 112 of the optical therapy device 100 and at the proximal end of the heat tube. The fan provides active convection to carry heat away from the optical therapy device 100.

A controller 136 can also be provided that is adapted to control the power output from the power supply 110 so that the light source 126 is activated for a predetermined time period. The controller 136 may include a switching mechanism that 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. The controller 136 helps avoid misuse or overuse of the optical therapy device 100. The controller 136 may also allow optimization to be carried out by the physician prescribing the device. In another embodiment, the controller 136 provides for preset dose quantity and frequency. These parameters can be set by the patient's physician, controller, a nurse, caregiver, patient, or other individual, or may be set according to prescription set forth by clinician.

The optical therapy device 100 can be adapted to include software (not shown) to control the dosage of optical energy to a patient. Thus, the energy, power, intensity, and/or fluence of the optical output may be adjusted. Thereafter, adjustments and settings may be saved within or loaded onto the optical therapy device 100 to correspond to the requirements of a particular patient, or clinical result.

The treatment dose can be configured to include timing controls. Timing controls may include the amount of time the light source 126 of the optical therapy device 100 may be activated for a treatment. Timing controls include pulsing parameters, such as pulse width, timing of optical pulses, or relative sequence of pulses of light emitted from one or multiple light sources 126. Thus, the light source 126 can be adapted to provide 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.

As described with respect to FIG. 2 below, the controller 136 need not be included within the hand piece 102 of the optical therapy device 100. In such embodiment, power delivery and timing controls are provided to the hand piece 102 from a source (such as control unit 202) outside of the hand piece 102. In such embodiment, the hand piece 102 may be disposable, and the physician may control the doses to the individual patient from a personal computer 204 or directly from power supply components, such as described below in additional detail.

The optical therapy device 100 may be used to treat or diagnose any of a variety of diseases. In one embodiment, the optical therapy device 100, 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, the optical therapy device 100 is used to treat allergic rhinitis, chronic allergic sinusitis, hay fever, as well as other immune-mediated mucosal diseases. In addition, the optical therapy device 100 may be used to treat any symptom associated with such conditions, such as sneezing, rhinorrhea, palate itching, ocular itching, congestion, and/or nasal itching. Kemeny et. al. describe the use of local ultraviolet light to treat allergic rhinitis in US Patent Publication Nos. 20040030368 and 20040204747. Ultraviolet light allows for the treatment of disorders such as allergic rhinitis without having to resort to systemically absorbed drugs with their related systemic side effects. Intranasal light therapy (rhinophototherapy) is also potentially an improvement over intranasal steroids because the light can instantly penetrate instantly through the mucosa in the spot where the light is directed, resulting in apoptosis of inflammatory cells. Intranasal steroids do not penetrate immediately into the nasal mucosa and furthermore, when they are applied to the nasal cavity, the steroid dose is difficult to consistently apply because some of the dose is swallowed and some is washed away in the mucus flow. Phototherapy, and specifically ultraviolet light therapy, has the ability to penetrate through the mucosa instantaneously and effect cellular changes. In some embodiments, the optical therapy device also diagnoses disease in combination with therapeutic delivery or alone without therapy.

In other embodiments, the optical therapy device 100 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.

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 nanoparticle 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). 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, an optical therapy device 100, including a mercury vapor lamp light source 126, may be utilized. Such a light source 126 generally emits light primarily at a 254 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) and 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.

An optical therapy system 200 is illustrated in FIG. 2. The optical therapy system 200 includes an optical therapy device 100, a control unit 202, and at least one computer 204. Control unit 202 communicates with optical therapy device 100 via power coupling 114, such as power coupling 114 described above, with respect to FIG. 1. Power coupling 114 may provide communication of power and electronic control signals between control unit 202 and the optical therapy device 100. The control unit 202 is also coupled to at least one computer 204 via computer coupling 206. Computer coupling 206 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 computer coupling 206 is a cable, such as a USB or Ethernet cable. The computer coupling 206 can also be a wireless link. Computer 204 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 coupling 206 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 unit 20; and computer 204 may form a network within which multiple computers 204 or computing devices, or control units 202 may be included.

In one embodiment, control unit 202 is connected to a power supply via a power cord 208. Control unit 202 also generally includes a display 210, a keypad 212, controls 214, and a cradle 216. Display 210 may include a screen or other output device, such as indicators, lights, LEDs, or a printer. The display 210 can be a touch screen that includes touch controls to control the parameters of the optical therapy device 100. Controls 214 include any of a variety of input devices, including knobs, levers, switches, dials, buttons, etc. Cradle 216 can be adapted to receive the hand piece 102 of the optical therapy device 100 when not in use. Such a cradle 216 may furthermore be configured to provide electrical power (e.g., a rechargeable battery) to the hand piece of the optical therapy device 100 and/or control signals. Power coupling 114 may not be provided, or may be provided via the cradle 216 through electrical contacts. The cradle 216 can be adapted to include an optical detector, such as a photodiode, which can provide an indication of the output or strength of the optical light source 126 and can provide for calibration of the optical therapy device 100 over time.

An optical therapy device 100, in accordance with another embodiment of the present invention, is illustrated in FIG. 3. The optical therapy device 100 of FIG. 3 includes a hand piece 102 and tube 106 similar to the optical therapy devices discussed above. In addition, the optical therapy device 100 of FIG. 3 includes multiple light sources 126, 126′, 126″. For example, as illustrated, optical therapy device 100 includes three light sources 126. Any number of light sources 126 may be utilized, including one, two, three, or more than three light sources 126. Light source 126 may be any suitable light source or combinations thereof, including those discussed above. Any of the control systems and power delivery systems discussed above may be incorporated into the optical therapy device 100 of FIG. 3.

Although the multiple light sources 126 of FIG. 3 are shown in close proximity, individual light sources 126 can be placed anywhere along the tube 106 or hand piece 102, and need not be grouped together The light source(s) 126 can be located close to the distal tip 118. For example, in one embodiment, a UVB emitting source is placed close to the distal tip 118 and a white light source and/or UVA light source are/is placed proximally, toward the hand piece 102. 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 and white light sources 126 may have more losses than the UVB light source 126, this is acceptable since, in at least one embodiment, the UVA and white light sources 126 generate a higher amount of optical energy or power and typically undergo less loss along an optical guidance system than UVB light.

An optical therapy device 100 in accordance with yet another embodiment of the present invention, is illustrated in FIG. 4A. Optical therapy device 100 includes an insertion member or tube 106 and a hand piece 102, such as those described above with reference to FIGS. 1-3. However, in the present embodiment, optical therapy device 100 includes a passive cooling mechanism integrated therein. In one embodiment, the passive cooling mechanism includes a cooling sleeve in thermal communication with a heat diffuser 502 located at the proximal end 112 of the hand piece 102. A thermal interface 504 covers at least a portion of the proximal end 112 of the hand piece 102, and provides for dissipation of heat from the heat diffuser 502. In one embodiment, the cooling sleeve at least partially surrounds light source 126 of the hand piece 102.

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, Freon®, Dowtherm™ A (a eutectic mixture of biphenyl ether and diphenyl oxide, used for heat transfer), 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 diffuser 502 includes cooling for to increase its surface area. Increased surface area of the heat diffuser 502 provides efficient cooling for the light source 126 of the optical therapy device 100. The thermal interface 504 and/or heat sink 502 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 the thermal interface 504 protects the user and his or her hand from sharp or jagged edges of the heat sink 502. The thermal interface 504 can further be perforated to allow for convective flow from the heat sink 502.

Cooling sleeve can be configured from a series of cooling pipes, or heat pipes 500, as is well-known in the art, such as those illustrated in FIGS. 4A-4B. Heat pipes 500 extend axially along the longitudinal axis of the hand piece 102 and generally run parallel to the light source 126.

A cross-sectional view of optical therapy device 100, taken along line 4B-4B, is illustrated in FIG. 4B. In the illustrated embodiment, a circumferential arrangement of heat pipes 500 is shown. As is well-known in the art, heat pipes 500 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, Freon, and Dowtherm A, which has a boiling point temperature range of about 500-1000° C. A second portion of the heat pipe 500 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 source 126), is vaporized and travels down the center of the pipe, where the fluid then condenses at the cooler portion of the heat pipe 500, and then wicks back through the wicking portion of the heat pipe 500. The configuration of heat pipes 500 in FIG. 4B is only one example of any numerous shapes, sizes, and configurations of heat pipes 500, which may include flat, horseshoe shaped, annular, as well as any other shape. The heat pipes 500 can be placed anywhere along the insertion member or tube 106 and even at its distal portion. The heat pipes 500 can be used in combination with any of the configurations, devices, and light sources above.

FIG. 5A and FIG. 5B illustrate an optical therapy device 100 in accordance with yet another embodiment of the present invention. A fan 610 is provided near the distal end 104 of the hand piece 102 to actively transfer heat away from the optical therapy device 100. Hand piece 102 also includes at least one light source 126 as described in greater detail above. The fan 610 provides for active cooling by pulling air 603 into the hand piece through distal heat vents 600, through the hand piece 102 (e.g., in the direction of the arrows) via channel 602, and out the proximal end 112 of the hand piece 102 via heat vents 604 located in the thermal interface 504. In some embodiments, fan 610 is used in conjunction with fins, heat pipes, cooling pipes, cooling sleeves, and/or cooling tubes as described above. In another embodiment, fan 610 provides cooling by pulling or pushing air through the hand piece 102.

In another embodiment, such as illustrated in FIG. 5B, fan 610 is located at the proximal end 112 of the hand piece 102. Air is pulled through a channel 602 in the hand piece via distal heat vents 600. Air flowing through the hand piece 102 via channel 602 removes heat from light source 126. In this manner, the light source 126 can be cooled.

An optical therapy device 100 in accordance with another embodiment of the present invention is illustrated in FIG. 6A. Optical therapy device 100 includes housing or hand piece 102 and insertion member or tube 106, as described above with respect to FIGS. 1-5. However, in the present embodiment, the light source 126 of the optical therapy device 100 is located at the distal end 116 of tube 106 near its distal tip 118. In the illustrated embodiment, tube 106 may not be configured to guide or reflect light since the light source 126 is located at or near its distal end 116. The tube 106 may be configured to guide light in cases when light exiting the tip of the device 118 includes light originating in the hand piece 102 and at the distal tip 118 of the tube 106.

In addition to the light source components and configurations discussed above, an optical guidance system may be used to transmit or guide the light generated by the light source 126 located in the hand piece 102 to the distal tip.

Since the majority of heat generated by the light source 126 is generated at the light source's distal end, heat pipes 500 are used to remove the heat therefrom. Thus, for example, when the light source 126 includes a double-bore mercury vapor lamp, optical emitter 128 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. When light source 126 consists of LEDs, optical emitter 128 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 the distal end 116 by heat pipes 500. In the case when light source 126 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. For example, 10 mW of LED power in the UV spectrum at less than 1% efficiency can generate several Watts of heat. Heat pipes (e.g. Thermacore International, Lancaster, Pa.) can transfer up to 10 Watts of heat at less than a 5 degree temperature change between two ends (e.g. one end in a body cavity and the other in the hand of a patient) located at 15 cm apart where the pipe is made of copper and its diameter is between 5 and 7 mm in diameter. In such and other cases, heat pipes 500 including heat conduction rods produced from materials that have good thermal conductivity, such as aluminum, copper, steel, stainless steel, etc., may be used.

Heat pipes 500 generally run parallel to the light source 126 along the axial length of the optical therapy device 100. Heat is transmitted, or is conducted, through the heat pipes 500 to the heat sink, as discussed in greater detail above. In other embodiments, heat pipes 500 are circumferentially wrapped around the light source 126 or tube 106.

Heat is carried from the light source 126 through the heat pipes 500 to the heat sink 502 located at the proximal end 112 of the hand piece 102. In one embodiment, heat is dissipated from the housing or hand piece 102 through a heat sink 502 (which may include cooling fins), after which the heat exits hand piece 102 via a thermal interface 504.

FIG. 6B shows a cross-section of the optical therapy device 100 of FIG. 6A along line 6B-6B. In this configuration, the heat pipes 500 are configured around the light source 126 and positioned within the insertion member or tube.

FIG. 7A illustrates an optical therapy device 100 in accordance with yet another embodiment of the present invention. Optical therapy device 100 includes a housing or hand piece 102 and insertion member or tube 106 (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 in FIGS. 7A and 7B), light source 126 is located near the distal end 116 of the tube 106 similar to that described above with respect to FIG. 6A. However, in the present embodiment, light source 126 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, tube 106 does not have to be a reflecting tube. In such cases, the insertion member or tube 106 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, the tube 106 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 an optical tube 106, as described above.

A cross-sectional view of optical therapy device 100 taken along line 7B-7B is illustrated in FIG. 7B. A diode array light source 126 is illustrated in the cross-section view of FIG. 7B. In one embodiment, all desired wavelengths are provided by the array 126, and a region 127 is adapted to transfer heat by any or all of the mechanisms discussed above. The region 127 can also be used to transmit additional optical spectra through optical fibers, tubes, or any of the devices described above.

FIGS. 8A-c illustrate additional embodiments of an optical therapy device 100, which may incorporate any one of or a combination of uLeds, wLEDs, and/or mLEDs as its light source 126. The probe can also incorporate LEDs with individual wavelengths in the white or infrared region of the electromagnetic spectrum. The light source 126 can be located at the distal end of a probe 106 adapted to be inserted into a patient's body. The probe 107 may be similar to or the same as the tube 106 described with respect to the various embodiments discussed above. The device 100 has a simplified structure when LEDs are used as the light source 126. In the case of rhinophototherapy, LEDs at a handheld housing or at the distal end of a therapy device enable portability of the rhinophototherapy device which will lead to more widespread use because the device can be mass produced and installed in many physician offices or patient homes affordably and with low device maintenance. Furthermore, LEDs provide for the ability to localize therapy to specific areas at specific times and not other areas by individually turning one or more LEDs on or off. Such power customization can lead to better patient outcomes through the ability to customize the phototherapy dose.

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 the probe 107 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 the optical therapy device 100.

Such components and designs considerably simplify the device 100 in terms of the logistics of the therapy and ultimately the cost of the device 100, 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 the handle 102 and the light source 126 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 the light source 126 at the distal end of the device and deliver power to the distal end of the device. The LED chipset at the end of the device 100 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. Persons of skill in the art would be familiar with the structure and design of catheters. See, e.g., More detailed information on the configurations of catheters is contained in U.S. Pat. Nos. 6,355,027 to Le et al. for Flexible Microcatheter; 6,733,487 to Keith et al. for Balloon Catheter with Distal Guide Wire Lumen.

The spectral output of the device 100 of FIGS. 8A-D is derived from combinations of the LEDs and LED packages (discussed below), 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 LED light sources 126 can also be fit into the probe 107. Depending on the ultimate size of the probe 107 and the body cavity to which it is desired to apply therapy, additional LEDs (e.g., white light LEDs with the spectral output shown in FIG. 14D, below) 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. Publication Nos. 2004/0204747 and 2004/0030368 both to Kemeny et al. for Phototherapeutical Apparatus and Method for the Treatment and Prevention of Diseases of Body Cavities and Phototherapeutical Method and System for the Treatment of Inflammatory and Hyperproliferative Disorders of the Nasal Mucosa, respectively.

FIG. 8B illustrates one embodiment of a device 100 that incorporates white light generating LEDs 400 (as further illustrated in FIG. 8c taken along line C-C of FIG. 8B) and an ultraviolet emitting center portion 402 (as further illustrated in FIG. 8D taken along line D-D of FIG. 8B). The illustrated embodiment of FIG. 8B is similar to the uLED or the mLEDs depicted in FIG. 14, below. The white light is transmitted from their respective LEDs 400 (which may be surface mounted, chips, or otherwise) through an optical guidance system (as illustrated in FIG. 8D) and are directed into an annulus 404 around a uLED and/or an MLED 402. The uLEDs and/or mLEDs may not have an optical guidance system to transmit light, for example, if placed at or near the distal end, including at position D-D in FIG. 8B.

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 in FIG. 8B). 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. 8A-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. Publication Nos. 2004/0204747 and 2004/0030368 to Kemeny et al. Although, FIG. 8B illustrates the individual sets of LED chips as being at different positions along the axis of the device 100, the surface mountable wLEDs 400 and/or all LED chips may be placed at substantially the same position along the device 100 longitudinal axis. For example, in one embodiment, the wLEDs 400 and other LED chips are placed at the distal end of the device 100.

In some embodiments, the mLEDs 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. Other scopes, including, but not limited to, colonoscopes, thoracoscopes, and/or laparoscopes, can also be used, depending upon the location of the target site to be accessed. Additional information pertaining to manufacture, operation and design of various types of scopes would be known to those skilled in the art and is available in, for example, U.S. Pat. Nos. 6,478,730 entitled Zoom Laparoscope (Bala et al.); 6,387,044 entitled Laparascope Apparatus (Tachibana et al.); 6,494,897 entitled Method and System for Performing Thoracoscopic Cardiac Bypass Surgery (Sterman et al.); 6,964,662 entitled Endoscopic Forceps Instrument (Kidooka); 6,967,673 entitled Electronic Endoscope System with Color-Balance Alteration Process (Ozawa et al.).

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. 9A illustrates an optical therapy system 730 in accordance with another embodiment of the present invention. The optical therapy system 730 includes a medical instrument (e.g., an endoscope, bronchoscope, colonoscope, etc.) 732 and an optical therapy device 734. The optical therapy device 734 extends along the axial length of the medical instrument 732 and terminates at a tip 736, which is the distal end of the optical therapy device 734. The tip 736 can be flush with the distal end 738 of the medical instrument 732.

In the illustrated embodiment, the optical therapy device 734 is externally coupled to the medical instrument 732. Clips 740 can be used in one embodiment to attach the optical system 734 to the medical instrument 732; however, any attachment device (for example, a sheath which slides on the medical instrument 732) can be used to couple the optical therapy device 734 to the medical instrument 732. Other examples include a band, ring, annulus, o-ring, snap, wire, cord, string, adhesive, tape, weld, lock, pin and/or tie can be used for coupling. The clips 740 allow the medical instrument 732 and optical system 734 of the optical therapy device 730 to be manipulated and controlled together and/or in tandem. When the optical therapy device is used in nasal phototherapy, the diameter of the medical instrument 732 and the optical therapy system 734 will typically not exceed about 1 cm, though the diameter of the instrument and therapy device combination in some embodiments may not exceed 8 mm and in other embodiments, will not exceed 6 mm, and is still other embodiments, will not exceed 3 mm. Where the device is applied to the patient's nasal cavity, the body or insertion member can be configured such that it is not longer than about 20 cm, 30 cm, or about 50 cm. Thus, with this configuration, the therapy device is sized and configured for portability such that it fits compactly within a suitcase or bag.

The optical therapy device 734 can include a link 742 that extends from the proximal end 744 of the optical therapy device 734 to its distal end 746 (which is also the distal end 738 of the medical instrument 732). The link 742 can conduct electrical and/or optical energy from a source 743 at the optical therapy device's proximal end 744 to the tip 736 located at the optical therapy device's distal end 746.

The source 743 can include a light source or an electrical energy source. When the source 743 is a light source located at the proximal end 744 of the optical therapy device 734, the link 742 conducts optical energy from the source 743 to the tip 736. The optical energy is then emitted from the tip 736 to tissue inside of the patient's body. When the source 743 is an electrical energy source located at the proximal end 744 of the optical therapy device 730, the link 742 conducts electrical energy from the source to a light source at the tip 736. The link 742 can include an optical guide, such as an optical guide tube, a light pipe, an articulating arm, a fiber optic, a fiber optic bundle and/or any other device capable of conducting optical energy. Additionally, the link 742 can include an electrical conduit, such as a wire, cable, or conductor, which can be shielded and/or insulated.

In some cases the source 743 is an electrical energy source located at the proximal end 744 of the optical therapy device 734, and a light source is located at the distal end 746, at the tip 736. In such cases, the link 742 includes at least one conductor extending from the electrical energy source to the light source. The light source can include ultraviolet light emitting diodes (UV LEDs), white LEDs, infrared LEDs (IR LEDs), any other light source known to those of skill in the art, including those described in greater detail above, and/or a combination of any of the above.

In other cases, the source 743 is a light source at the proximal end 744 of the optical therapy device 734 and the link 742 includes an optical cable, such as a fiber optic bundle. In such cases, light is carried by the link 742 from the light source to the tip 746 at the distal end 746 of the optical therapy device 734. In any case, the tip 736 can include a spectral conditioner to modify the shape, pattern, dispersion, focus, geometry, output, scatter, etc. of the light source output.

In yet other cases, the optical therapy device 734 includes a light source and an electrical energy source, and both are located at or near the distal end 746, for example, in the tip 736. In such cases, the optical therapy device 734 might not include a link 742 and/or clips 740 and there may only be one clip at the distal end of the medical instrument 730. One embodiment of such an optical therapy device 734 is described below with respect to FIGS. 10A-B.

As illustrated in FIG. 9B, the optical therapy device 734 is adapted to fit through a multilumen medical instrument 732 (e.g., an endoscope) that has at least two lumens, such as an imaging lumen 748 and an optical therapy lumen 750 adapted to carry at least part of an optical therapy device. FIG. 9B is a cross-sectional view of a portion of such optical therapy device 734. The optical imaging lumen 748 can provide general illumination for the medical instrument 732. The optical therapy lumen 750 can provide a conduit for at least part of an optical therapy device 734, such as a link 742, as described above. Alternatively, the inside wall of the optical therapy lumen 750 can be made from and/or coated with an optically reflective material such that the optical therapy lumen 750 acts as the link 742, and conducts optical energy from a proximal source (e.g., source 743) to the distal tip (e.g., tip 746).

Although the medical instrument 732 in the embodiment of FIG. 9B is described as having at least two lumens, it should be clear that any medical instrument 732 can be adapted to carry or be coupled to an optical therapy device 734. For example, a medical instrument 732 having an elongate body with a single lumen could be used to carry the optical therapy device 734. In addition, a medical instrument 732 not having any lumens could also be used to carry an optical therapy device 734, for example, in the manner described above with respect to FIG. 9A.

The optical therapy device 734 can be adapted to couple to a flexible medical instrument 732 (as illustrated in FIG. 9A), or a rigid (or semi-rigid) medical instrument 732 (e.g., a rigid endoscope), as illustrated in FIG. 9c. In either case, the instrument 732 allows the therapeutic light from the optical therapy device 734 source 743 to be controlled by a user and pointed in the desired direction. When the medical instrument 732 is an endoscope, the medical instrument 732 provides direct visualization of an area to be illuminated inside of the nasal cavity so phototherapy from the optical therapy device 734 can be targeted to a desired location. The clips 740 allow the optical therapy device 734 to be retrofitted to almost any medical instrument, providing the proper coupling devices (e.g., clips 740) are used. For example, the medical instrument can be any shape or size (e.g., square, round, ellipse, circular) and can be flexible or rigid. The medical instrument can be a probe, an endoscope, a hysteroscope, an arthroscope, a thoracoscope, a laparopscope, or any other medical instrument which can be applied to an internal body surface. The ability to retrofit the optical therapy device to a medical instrument minimizes the inconvenience to the medical practitioner. In additional embodiments, the optical therapy devices are designed such that additional sterilization steps are not required. For example, many endoscopes are designed and produced such that they can be disinfected and/or cleaned

FIGS. 10A-B illustrate an optical therapy device 752, which is adapted to be retrofit onto the distal end of a medical instrument (e.g., an endoscope or any other medical instrument). Alternatively, the optical therapy device 752 of FIG. 10A can be manufactured as part of the distal end of a medical instrument. The optical therapy device 752 includes a mount 754 on which light elements 756 are mounted. The optical therapy device 752 also includes a source (not shown) that can be located within the mount 754, attached to the mount 754, or electrically and/or optically coupled to the mount 754.

The mount 754 can be made from any of a variety of materials, including stainless steel, plastic, rubber, metal or a combination of materials. The mount 754 has a diameter of about 10 mm, but can have a diameter of about 5 mm cm or about 1 mm depending on the application.

The light elements 754 can be electrically powered light emitting devices, such as lamps or LEDs, including UV LEDs, white LEDs, and/or IR LEDs. The light elements 754 can also be the distal ends of fiber optic cables or light guide cables coupled to a light source at their proximal ends. Any number of light elements 754 can be provided with the optical therapy device 752. In some cases, 6, 12, 18, 24, or 30 light elements 754 are provided.

The mount 754 can have any desired shape or configuration. In the illustrated embodiment, the mount 754 has an annular shape, forming a ring of light elements 754 about its distal end. However, the mount 754 can also be elliptical, circular, square, or have an irregular or flexible form, for example, to conform to the space into which it is to be inserted. In some cases, the mount 754 is merely a single light element 754 holder that attaches to the distal end of a medical device. Any number of such mounts 754 can be provided.

When the optical therapy device 752 is attached to the distal end of a medical instrument 764 (as shown in the cross sectional view of FIG. 10c), the light elements 756 are disposed at an angle 758 with respect to the longitudinal axis 762 of the medical instrument 764. The angle 758 is shown at approximately 45°. In other cases, the angle 758 is in the range between about 0° and about 90°, sometimes between about 30° and about 85°, often between about 45° and about 90°, and in some cases, about 60°. Such angles facilitate light delivery to regions of body cavities; furthermore, placement of LEDs at the end of these devices facilitates ultraviolet light delivery to specific regions within these cavities while excluding other regions.

The angle 758 can be selected so the light beams emitted from each of the light elements 756 of the optical therapy device 752 converge at a focal point 766 located along the longitudinal axis 762 a predetermined distance 768 from the distal end of the optical therapy device 752. In some cases, angles 758 of the light elements 756 are not all the same, and the focal point 766 is not located along the longitudinal axis 762 of the optical therapy device 752. In some embodiments, the light emitted from the light elements 756 do not converge and each light element 756 is directed in a different direction. Nonetheless, the light elements 756 in this embodiment, emit light in a direction controlled by the underlying topography of the distal end of the optical therapy device 752. Such light delivery is efficiently delivered to the body cavity in this embodiment without the need for a more complex and expensive ultraviolet light delivery and lensing system.

The optical therapy device 752 can be permanently, semi-permanently, or removably attached to the distal end of an elongate body 764 of a medical instrument 764. Any of a variety of mechanisms well known to those of skill in the art can be used to couple the optical therapy device 752 to the medical instrument 764, including threads, friction, a pin, adhesive, a weld, a compression fit, a snap fit, or any other suitable mechanism.

The optical therapy device 752 can be mounted flush with the distal end of the medical instrument 764, or it can extend distally past the distal end of the medical instrument 764 (as shown in FIG. 10C). In some cases, the optical therapy device 752 forms the distal-most surface of the medical instrument 764, and a heat transfer structure, such as a heat pipe, extends proximally therefrom. In one embodiment, a heat pipe is placed in the center 760 of the optical therapy device 752. In other embodiments, the heat pipe shares the center 760 of the optical therapy device 752 with another medical instrument, such as an endoscope.

FIGS. 11A-11H represent optical therapy devices 100 having different tubes 106 in accordance with alternative embodiments of the present invention and generally configured to treat the sinus cavities of a patient. The hand piece 102 is shown in a cutaway view, as it may be substantially the same for these embodiments. Each tube 106 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, tubes 106 having varying lengths, shapes, curvatures, diameters, radiuses, bends, and tapers may be utilized or selected by a clinician as required. The insertion member or tube 106 may also have light sources 126 placed anywhere in, on, or along the tubes 106. In some embodiments, the tube 106 is not optically reflecting because the light is generated at its distal end. In such embodiment, the tube 106 may serve as a conduit for electrical or heat transfer.

In the optical therapy device 100 illustrated in FIG. 11A, hand piece 102 is connected to reflecting tube 106 that has a bend at its distal end 116. The distal end 116 of the tube 106 is bent at a bend angle 900 to create a distal segment 902. The distal segment 902 has a distal length 904 that may be selected to configure to the anatomy of a particular patient. In some embodiments, optical therapy device shown in FIG. 11A is adapted to treat the sinuses of a patient.

In some embodiments, tip 902 can be flexible and may include a hinge (not shown) and/or a flexible material so that angle 900 can be adjusted by the practitioner. A light source 126 or combinations of light sources 126 can be placed anywhere along tube 106 as described above. The light source 126 can also reside in hand piece 102, as described above. Tube 106 can also contain an optical fiber bundle or it can be hollow and configured to reflect light, as discussed above. Furthermore, depending on the light source 126 selected, the tube 106 can be configured to transfer heat from the light source 126, as described above.

Similarly, as illustrated in FIG. 11B, optical therapy system 100 includes a hand piece 102 that is connected to a reflecting or non-reflecting tube 106 having a distal segment 902 of a different bend angle 900 at its distal end 116. The distal length 904 of the distal segment 902 may be the same or different than that of FIG. 11A. In addition, the bend angle 900 is shown at a greater angle than that shown in FIG. 11B is greater than that shown in FIG. 11A. Similarly, such designs are used to reach the sinuses or other internal cavities or surfaces of a patient.

The distal length 904 of the distal segment 902 may be varied as clinically required, as illustrated in FIG. 11c. The distal length 904 may vary between 1 cm and 4 cm. Proximal length 905 varies between about 6 and 12 inches. Bend angle 900 varies from about 45-60 degrees in some embodiments, and from about 60-80 degrees in other embodiments.

An optical therapy device 100 in accordance with yet another embodiment of the present invention is illustrated in FIG. 11D. The optical therapy device 100 of FIG. 11D includes a hand piece 102 coupled to a reflecting tube 106 that includes an expandable balloon 906 at the reflecting tube's distal end 116. The reflecting tube 106 may be inserted into a patient's nose and/or sinus and the expandable balloon 906 may thereafter be inflated with a liquid, gas, polymer, a hydrogel, or a combination thereof, including a combination of fluids. By inflating the expandable balloon 906, 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 the expandable balloon 906 allows the optical therapy device 100 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 the optical therapy device 100.

The compression balloon 906 can be configured 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 to Akira et al. (Bando Chem Ind Ltd) for Pellicle Film; 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.

The compression balloon 906 may be inflated by passing a fluid, liquid, gas, or a combination through an inflation lumen 908 from the hand piece 102 to the compression balloon 906. The compression balloon 906 may be deflated in a similar matter.

The reflecting tube 106 of the optical therapy device 100 may include more than one distal segment 902 such as is illustrated in FIG. 11E. In the embodiment of FIG. 11E, optical therapy device 100 includes a tube 106 having two distal segments 902. In one embodiment, the distal segments 902 have equal distal lengths 904 although in other embodiments, the distal lengths of the distal segments 902 are different.

In another embodiment, the distal segments 902 are flexible so that the relative spacing 903 between the distal segments 902 may be adjusted to accommodate the anatomy of particular patients. Incorporating more than one distal segment 902 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, the distal segments 902 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 reflecting tube 106. For example, in one embodiment, distal segment 902 projects at an angle between about 1 and 15 degrees with respect to the axis of the reflecting tube 106.

In the distal segments 902, flexibility may be achieved by forming the distal segment 902 from a flexible material. For example, the distal segment 902 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 device 100 (such as the optical therapy device illustrated in FIG. 11E) includes pivots (not shown) on the end of each of the distal segments 902, 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 reflecting tubes 902.

An optical therapy device 100, in accordance with another embodiment of the present invention, is illustrated in FIG. 11F. The optical therapy device 100 includes a hand piece 102 and a tube 106. At the distal end 116 of the tube 106 is a rotational member 910 mounted thereto. Rotational member includes an aperture 912 through which light energy emitted from the light source 126 may be transmitted. In one embodiment, the rotational member 910 is able to rotate about an axis parallel to the central axis of the reflecting tube 106.

In one embodiment, the rotational member 910 is shaped to focus the light from the light source 126 to the aperture 912 of the rotational member 910. The rotational member 910 is, in one embodiment, substantially non-transmissive and substantially reflects all of the light emitted by the light source 126 to the aperture 912. By rotating within the nose, the rotational member 910 is able to provide the light from the light source 126 through the aperture 912 to the soft tissue of the inside of the nose or other body cavity in a circumferential manner.

FIG. 11G illustrates another optical therapy device in accordance with yet another embodiment of the present invention. In the optical therapy device 100 of FIG. 11G, tube 106 includes light guides 114 mounted at the tube's distal end 116. Adjustable light guides 914 may be oriented at an adjustment angle 916 with respect to the tube 106.

In one embodiment, adjustment angle 916 may be adjusted between an angle of about 0 and about 60 degrees with respect to the reflecting tube 106. In another embodiment, the adjustment angle is between about 10 and 30 degrees.

The inside surface of the light adjustable light guides 914 are generally reflective or covered with a reflective material so that light emitted from the light source 126 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.

An optical therapy device 100, in accordance with yet another embodiment of the present invention, is illustrated in FIG. 11H. The optical therapy device 100 of FIG. 11H includes a hand piece 102 coupled to a tube 106. The tube 106 includes multiple apertures 916 at its distal end 116. Apertures 116 may be provided around the entire circumference of the reflecting tube 116 or may be provided on only one side or along only a selected portion of the reflecting tube 106.

The apertures 916 may be between 0.1 and 1 mm diameter, or may be between 0.5 and 2 mm in diameter. The apertures 916 may be spaced between 0.5 to 1.0 mm, or between 1 to 3 mm from one another. In one embodiment, the distal end 116 of the tube 106 includes at least four apertures. In another embodiment, tube 106 includes between two and ten apertures. In another embodiment, tube 106 includes greater than ten apertures. Apertures 916 allow light emitted from light source 126 to escape from the insider of the tube 106 and enter the patient's nose. In this embodiment, light is emitted through the apertures 916 of the reflecting tube 106 in a longitudinal fashion (e.g., along the length of the tube) rather than at a distal end alone.

FIGS. 12A-B illustrate additional embodiments of the present invention. Hand piece 102 is connected to a flexible component 122 which has a lumen 125 within flexible component 122. As described above and below, flexible component 122 can transmit light, can comprise the pathway to transmit electrical power, conduct heat, or can perform all three functions. Lumen 125 is sized to at least allow a second flexible device such as a guidewire 120 (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 the guidewire 120 gains access to or purchase in the desired small orifice, the catheter 122 is fed over the guidewire 120. The guidewire 120 can have an expandable component 124, such as a balloon or anchor, on its end, such that the expandable component 124 can hold the guidewire 120 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 hand piece of the optical therapy device and delivered to the expandable component, or light can be generated in the expandable component 124. In the embodiment illustrated in FIG. 12B, a light source 127 is located at the distal end of the guidewire 120.

FIG. 13A illustrates an optical therapy device 422 at the end of a flexible medical device 424, such as an endoscope, a catheter, or handheld probe. The device 422 can be flexible, as illustrated in FIG. 13A, rigid or semi-rigid. In addition, the device 422 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 a method of using the devices disclosed herein is used 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.

FIG. 13B illustrates an indwelling catheter 410 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. Catheter 410 may also be used to provide chronic implants, such as those used for chronic dialysis access or other permanent vascular or nonvascular devices. A second catheter 412 is shown disposed within the indwelling catheter 410. The second catheter 412 has a series of LEDs 414 along its length with corresponding optical windows 416 in the second catheter 412 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 in FIG. 13B, in some embodiments a light guide is used to transport light some distance 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), 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. 13c depicts a device incorporated into an optically transparent balloon 418 (e.g., a balloon that is at least partially transparent to at least some ultraviolet light wavelengths) to transmit the light directly to a lesion 420 within a body cavity. The balloon 418 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 the lesion 420 without interfering blood.

FIG. 14A illustrates a light emitting diode (LED) device 500 in accordance with one embodiment of the present invention. FIG. 14C illustrates a recording by a spectroradiometer of the optical output from an LED device 500 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. 14A shows the size of the LED device 500 relative to an average size finger. The temperature of the LED 500 is often negligible, as it can be held in one's hand as shown without a perceptible temperature change. Embodiments of an LED package 502 are provided in FIGS. 14A-B. The package 502 includes its ordinary meaning and also generally refers to the structures supporting the LED chip 504, including the electrical leads 510, 511, the heat conducting element 506, and the covering optical element 508. Covering optical element 508 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 the LED 500 of FIG. 14c, in another embodiment, the LED 500 has more than one spectral peak. For example, multiple chips (e.g., dies) may be included in the same LED package 502. In another embodiment, the multiwiavelength spectrum emanates from one chip. The spectrum of one embodiment of a multi-wavelength, multi-chip LED 500 (mLED) is illustrated in FIG. 14E. The arrows of FIG. 14E point to the mLED's spectral peaks, which, in the illustrated embodiment, occur at 308 nm, 310 nm, 320 nm, and 330 nm.

The mLED device 500 appears (on the outside) the same as LED device 500 of FIG. 14A; 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 powered “on” time is a small fraction of the powered “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 in FIG. 14E, the relative power of each die can be varied using a combination of current and duty cycle.

The total optical power provided by the LED devices 500 of FIGS. 14A-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 the light conditioning structure 508, 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.

FIG. 14B illustrates a partial exploded view of the LED (or mLED) package 502 of FIG. 14A. The light emitting portion of the package includes LED chips (e.g., dies) 504 on a platform 506. 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.

An LED chip 504 can be a cluster of multiple chips (otherwise referred to as a chipset) located on a platform 506, as shown in FIG. 14B. The platform 506 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 thermoelectric cooling device. Such heat transfer modules are well known to those skilled in the art of semiconductor and LED packaging. Additional elements on the platform 506 include reflectors, which are also well known to those skilled in the art. A light conditioner in the form of a lens 508 can receive and direct light from the LED chip or chips 504 as desired. In one embodiment, the lens 508 focuses the light from the LED cluster 504. The lens 508 can be made from materials which are generally transparent to the wavelengths of interest (e.g., silicone or quartz). In another embodiment, the conditioner 508 scatters or diffuses light from the LED cluster 504. In another embodiment, the conditioner 508 contains a coating or contains particles within the material of the conditioner 508 which act as phosphors to alter the wavelength of output. In another embodiment, the conditioner 508 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, the lens 508 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 or chips 504 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 the leads 511 of FIG. 14B. The leads 511 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 the chipset 504 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 chips 504 (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 an LED package 502. The single and multi-chip packages 502 shown in FIG. 14B 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 on platform 506, the illumination pattern (e.g., the optical power applied to specific tissue regions) can be well controlled.

FIG. 14D 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 casing 508 (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.

The 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 package 502 (package within a larger package) shown in FIG. 14B or the surface mounts can be placed along side of another LED package 502.

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. 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 the devices 100 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 particularly in the shorter wavelength (e.g. ultraviolet) regimes. Light generation at the point of use also facilitates providing a device that is disposable after one or several uses.

FIG. 15A illustrates one embodiment of the use of the optical therapy device 100, such as that depicted in FIG. 1. In the illustrated embodiment, the user (e.g., medical practitioner, nurse, doctor, or patient) holds the hand piece 102 of the optical therapy device 100 and inserts the tube 106 into his or her nose 300 (or into the nose of the patient when the medical practitioner is the user of the device). The light-emitting distal end 116 of the reflecting tube 106 is inserted inside of the nasal cavity 302 of the patient. Light is emitted from the optical therapy device 100 along a light propagation access 304 where it is absorbed by the mucosa and other soft tissues within the nasal cavity 302.

FIG. 15B illustrates one embodiment of an optical therapy device 100 adapted to be inserted into the paranasal sinus cavities 154, to treat conditions such as sinusitis. Optical therapy device 100 can be configured with a specific shape or contour to reach the sinus as described herein. The various wavelengths of the optical therapy device 100 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 the optical therapy device 100 is illustrated and described herein as used for treating a patient's nose 300, the optical therapy device 100 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, the optical therapy device 100 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, the optical therapy device 100 may be used to reduce inflammation within any mucosa of the body.

Furthermore, the optical therapy device 100 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 the optical therapy device 100 is placed inside the chest cavity to treat the lungs, heart, or the esophagus. Such is also the case when the optical therapy device 100 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, the optical therapy device 100 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, the optical therapy device 100 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, the optical therapy device 100 can ameliorate the internal consequences of T-cell-mediated diseases, such as autoimmune and collagen vascular diseases, such as rheumatoid arthritis, systernic lupus erythematosis, etc. In yet another embodiment, the optical therapy device 100 is adapted to be inserted into the vagina to treat any of a variety of conditions, including yeast infection, vaginitis, vaginosis, candidiasis, parasites, bacteria, and even an unwanted pregnancy. The optical therapy device 100 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 device 100 may be provided to the bladder, kidney, ureter, and/or urethra to treat and/or reduce inflammation. The optical therapy device 100 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, the optical therapy device 100 is adapted for veterinary use. For example, in one embodiment, the optical therapy device 100 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 the optical therapy device 100, including domestic animals, such as dogs, cats, and rabbits, as well as exotic animals, such as cheetah, gorilla and panda.

FIG. 16 illustrates another embodiment of an optical therapy device 700. The optical therapy device 700 is shown partially inserted into a patient's nasal cavity 702. The optical therapy device 700 includes a handle 704 and a body 706. In the illustrated embodiment, the insertion member or body 706 is elongated, and may also be referred to interchangeably as a body 706 or elongate body 706; however, it should be clear to those of skill in the art that the body 706 need not be elongated.

Light is emitted from the distal end 708 of the elongate body 706 and a cavity expander or expander 710 is coupled to the distal end 708 of the elongate body 706. The expander 710 can include any suitable expanding and/or anchoring device, including a balloon, an anchor, a solid structure, a spring, a coil, a ball, a ring, an annulus, a ridge, or any other expanding and/or anchoring device known to those of skill in the art. In the illustrated embodiment, the expander 710 is an inflatable balloon. The terms expander and balloon may be used interchangeably in the description of the illustrated embodiment. Furthermore, although expander is used herein and has its ordinary meaning, the function of the expander is to position the phototherapy light in the nasal cavity so as to prevent therapeutic light from reaching some portions of the nasal cavity while preventing the therapeutic light from reaching other portions of the nasal cavity. The expander is one type of positioner; similarly, a nasal expander is a type of nasal positioner. Other methods and devices for positioning the phototherapeutic device in the nasal cavity exist and they may not require actual expansion. For example, the distal end of the phototherapeutic device can be shaped or angled for placement into the vestibule (see below), beyond the region of the limen, to illuminate the non-vestibular portion of the nasal cavity. The distal end can also contain an imaging element such as a CMOS or CCD chip or chipset which can assist in visualizing the anterior nasal cavity, preventing therapeutic light from reaching unintended regions. In the embodiment above where LED chips are placed at the distal end of the optical therapy device, the imaging chip can be included in the chipset. Alternatively, when the light sources are placed outside the nasal cavity, the imaging chips can be included in the optical therapy device for positioning.

The light emitted from the distal end 708 of the elongate body 706 is generated from a light source coupled to the elongate body. The light source can be proximal with respect to the housing such as handle 704, it can be within the handle 704, it can be within the elongate body 706, it can be at the distal end 708 of the elongate body 706, or anywhere else in communication with the elongate body 706 as described in any of the optical therapy devices embodiments described above. The light coming from the light source, therefore, can be generated within the nasal cavity 702 or can be generated outside of the nasal cavity 702. In the illustrated embodiment, light is transmitted from the distal end 708 of the elongate body 706 through the expander 710 to tissue inside the nasal cavity 702.

The expander 710 can include an inflatable, enlargeable, expandable and/or fillable balloon. In some cases, the elongate body 708 includes an inflation channel 712. The inflation channel 712 can be used to transfer gas or fluid into and out of the balloon to inflate or deflate, respectively. In some cases, the inflation channel 712 is a lumen or fluid transmission line located within the elongate body 706. In other cases, the inflation channel 712 is a tube or fluid transmission line that is at least partially externally located with respect to the elongate body 706.

Water, air, saline, a hydrogel, any material with sufficient viscosity to cause the balloon to conform to the anterior portion of the nasal cavity 702, and/or any combination of the above can be used to inflate the expander 710. In one embodiment, the expander 710 is made from silicone and is filled with water.

In some embodiments, the expander is not fillable and includes a compliant or semi-compliant material which can be reduced to a non-expanded state, placed in the nasal cavity, and then expanded to its expanded state. The expander 710 in this embodiment can be formed from a soft semi-compliant material such as foam, hydrogel, or any other such material known to those of skill in the art.

The expander 710 can be positioned at the distal end 708 of the elongate body 706 such that it extends proximally and distally with respect to the distal end 708. In some embodiments, such as that in FIG. 16A, the light source is emitted within the expander 710. In such embodiments, the expander 710 generally includes at least a portion that is at least partially transparent to the therapeutic light wavelengths of the optical therapy device 700. In other embodiments, such as described below with respect to FIG. 16B, the expander 710 can be positioned at the distal end 708 such that it extends only proximally with respect to the distal end 708. In this embodiment the expander surrounds the distal end of the optical therapy tip and can be opaque because the light radiates from the device into the cavity and not through the expander. Alternatively, the expander 710 can be positioned so it extends only distally with respect to the distal end 708.

The nasal cavity 702 can be divided into a vestibular portion 714 which is separated from the remaining nasal cavity 716 (non-vestibular portion) at the limen 718 (Lang, J., Clinical Anatomy of the Nose, Nasal Cavity and Paranasal Sinuses, pp. 31-55, 1989). The limen 718 marks the beginning of the respiratory epithelium, the vestibular portion being composed of squamous epithelium similar to the skin. The limen 718 separates the vestibular portion 714 from the non-vestibular portion of the nasal cavity.

The optical therapy device 700 is inserted into the nasal cavity 702 such that the expander 710 resides at least within the vestibular portion 714. When the expander 710 is inflated, or if not inflatable, when otherwise positioned and inserted into the nasal cavity 702, the expander 710 can wedge open the vestibular portion 714 of the nasal cavity 702, which does not have respiratory mucosa. In some embodiments, the expander 710 does not expand and is positioned within the nasal cavity 702 such that the therapeutic light reaches one portion the nasal cavity but shields another portion from the therapeutic light. For example, in one embodiment, light reaches the turbinates 719 but not the vestibular surface where there is no respiratory epithelium and which will have a very different response to the therapeutic light. The expander 710 can be filled or inflated prior to placement in the nose or after insertion into the nasal cavity 702.

The expander 710 of the optical therapy device 700 can hold the optical therapy device 700 in place while phototherapy is delivered to the nasal cavity 702 from the optical therapy device 700. Since the expander 710 is usually produced from a flexible or compliant material, such as a balloon, the optical therapy device 700 is able to pivot and change its orientation in the nasal cavity 702. In addition, the expander 710 allows the optical therapy device 700 distal end 708 to be manipulated within the nasal cavity 702 without mechanically irritating the sensitive soft tissue located at the region of the vestibule.

Further to the device depicted in FIG. 16A where the therapeutic light travels through the expander 710, the expander 710 can include an opaque portion 720 and a transparent portion 722. The opaque portion 720 blocks light emitted from the distal end 708 of the optical therapy device 700 and prevents light from being absorbed by a predetermined portion of the nasal cavity 702. For example, in the illustrated embodiment, a proximal portion of the expander 710 is the opaque portion 720, which blocks light from being absorbed by the vestibular portion 714 of the nasal cavity 702. A distal portion of the expander 710 is the transparent portion 722, which allows light to be transmitted from the distal end 708 of the optical therapy device 700, through the wall of the expander 710, and to the tissue of the nasal cavity 702.

FIG. 16B illustrates another embodiment of a distal portion of an optical therapy device 700. The optical therapy device 700 also includes an expander 710; however, the expander 710 of the illustrated embodiment has an annular configuration and a lumen 724 through which the elongate body 706 of the optical therapy device 700 extends. Light is emitted from the distal end 708 of the elongate body 706. The distal end 708 of the elongate body 706 can also include an atraumatic tip 726.

The atraumatic tip 726 can be made from a material which is optically transparent to the light emitted from the optical therapy device 700. In addition, the atraumatic tip 726 can be designed to scatter, focus, or otherwise condition the light exiting the optical therapy device 700 distal end, as desired. The atraumatic tip can have a smooth and/or soft surface so that it does not irritate the inside wall of the nasal cavity 702 when inserted and manipulated therein.

The expander 710 can be made from a completely opaque material so that it blocks light emitted from the optical therapy device from being absorbed by the epithelium of the nasal cavity 702 at the region where the expander 710 contacts the nasal tissue. As in the embodiment of FIG. 16A, the expander 710 holds, or otherwise positions, the optical therapy device 700 in place on the region in the nasal cavity 702 while phototherapy is delivered. This allows the optical therapy device 700 to pivot and change direction and orientation within the nasal cavity 702 without mechanically irritating the nasal cavity 702. Although in one embodiment, the expander is made from an opaque material to prevent light from reaching the area touched by the expander, the expander can be made from an optically transparent material. In this case, the optical therapy device, by virtue of the expander positioning the therapeutic light such that the light is always directed forward into the nasal cavity, illuminate only the regions intended to receive therapeutic phototherapy.

FIG. 16c illustrates a coronal view of a human skull with an optical therapy device 700 inserted partially within the paranasal sinus of a nasal cavity 702. The nasal cavity 702 is in communication with several paranasal sinuses 726. The sinuses 726 on the left side of the head are separated from those on the right side by the nasal septum 728. The optical therapy device 700 is inserted through the nasal cavity 702 until it reaches the paranasal sinuses 726. In one embodiment, the device shown in FIGS. 12A-B is placed in the sinuses. Guiding wire 120 is first placed in the sinus and then the optical therapy device 124 is placed over the wire in the sinus.

The expander 710 of the optical therapy device 700 is inflated so that it enters at least one of the paranasal sinuses 726 as well. In addition, the expander 710 provides a mechanical protection or insulation layer between the distal end of the optical therapy device 700 and the inside surface of the sinuses 726. The expander or balloon 710 is positioned to grip the sinus 726 ostium. The optical therapy device 700 can then be pivoted and/or manipulated with respect to the balloon 710 to direct light to different portions of the sinuses 726 while the expander wedges the device in the sinus, holding the device in place within the sinus. As discussed above, the expander is a positioner in some embodiments and does not have to expand tissue. The requirements for positioning may be different in the sinuses and therefore the distal tip of the device may include a drill (for example), anchor, chisel, dilator, mallet, or dilator in place of or in addition to a balloon.

The expander 710 can have opaque and transparent portions, as described above with respect to FIG. 16A, or it can be totally opaque and have a configuration as shown above in FIG. 16B. The expander 710 can cover the output of the distal end of the optical therapy device 700 as shown in FIG. 16c, or it can wrap around the distal end of the optical therapy device 700, as shown in FIG. 16B. In some cases, the expander 710 is used to compress the mucosa of the sinus 726 so the optical therapy device 700 can provide a relatively uniform distribution of light to the sinus 726 wall. As will be appreciated by those skilled in the art, the expander 710 can be configured for use in any of the embodiments described herein or for any of the target tissues without departing from the scope of the invention. The expander 710 has been described in the context of the sinuses for purposes of illustration only.

FIG. 17 shows an expander 770 according to yet another embodiment of the present invention. The expander 770 includes a mating portion 772 that is adapted to be removably coupled to the distal end of an optical therapy device 774. The mating portion 772 can be a clip, o-ring, band, snap, thread, groove, recess, or any other suitable mating portion 772. The optical therapy device 774 has a corresponding mating portion 776 to mate with the mating portion 772 of the expander 770. The mating portions 772, 776 allow the expander 770 and optical therapy device 774 to be removably coupled to each other. The mating portion can be inserted into the nasal cavity prior to the device and then the device can be coupled to the mating portion. In some embodiments, the mating portion 776 is a friction mate. In one embodiment, the mate is a sticky material or has a sticky material attached to assist in the mate. The optical therapy device 774 is placed in the expander 770 and held in place by a frictional force between the optical therapy device 774 and the mating portion 772.

The expander 770 is inserted into the nasal cavity 702 and positioned so that it is comfortable for the patient and protects the region of the nasal vestibule. As above, the expander 770 does not have to actually expand tissue but can act to position the device without expanding. The expander or positioner 770 is typically made from a soft elasomeric material, such as rubber, polymer, ePTFE, a hydrogel, or any other soft comfortable material. The expander 770 can have elastic properties so that it can expand to conform to the inside shape of the anterior portion of the nasal cavity 702. The inside surface of the expander 770 conforms to the outside surface of the optical therapy device 774. When attached (e.g., friction coupled), the expander 770 can block or filter light emitted from the optical therapy device 774 from being absorbed by the tissue in the vestibular portion of the nasal cavity 702. In addition, the expander 770 can act as a pivot about which the distal portion of the optical therapy device 774 can be manipulated, rotated, translated, and/or moved. As in the expanders and positioners described above, the expander protects the tissue of the nasal cavity 702 from the therapeutic light and mechanical irritation from the distal end of the optical therapy device 774.

In another embodiment, the vestibular region of the nasal cavity is protected from the therapeutic light by placing a light absorbing substance on the surface of the vestibule of the nasal cavity. One example is a sunscreen but any substance which is opaque to white light and/or ultraviolet light can be used to protect the vestibular region of the nasal cavity from the therapeutic light. The light absorbing substance can be applied with a medical instrument, can be applied with the optical therapy device itself, or can be applied with a nasal spray, syringe applicator, or a finger. In one embodiment, the light absorbing substance is applied to the optical therapy device and therefore is applied as the device is used.

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.

FIGS. 18A-B illustrate an embodiment of a system to treat transplanted organs that are being rejected. A catheter 426 with a light source 126, such as uLEDs or mLEDS, is placed in an artery leading to a transplanted organ 428 (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 in FIG. 18B.

Red blood cells and platelets generally flow in the blood vessel's flow through lumen 430. The optical therapy device 100 is generally configured such that it has a lumen in its center for blood flow therethrough. The surface of the optical therapy device 100 is directed toward the outside of the vessel 432 wherein the white blood cells and the T cells flow over the surface of the device. With this device 100 positioned as illustrated in the cross-sectional view of FIG. 18B, as blood flows past the catheter 100 and along its outer circumference 434, the UV light induces T cells to undergo apoptosis. The device 100 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. As will be appreciated by those skilled in the art, any of the features described above, such as the expander, lens, etc. can be incorporated into the any of the designs or therapeutic applications.

FIG. 19 illustrates a flow chart with the steps followed for using the devices disclosed herein. The first step is to identify a target tissue for therapy 1900. Target tissue includes, for example, tissue within the nasal cavity, tissue within the thoracic cavity, tissue within the abdominal cavity, tissue within the lumen of a blood vessel, tissue within the gastrointestinal tract, tissue within the pericardial cavity, tissue within the heart. Once the target tissue has been identified, the tissue is accessed through a body cavity 1910 using a device, such as those described above, adapted and configured to access the body cavity. Thereafter, a therapeutic light dose is selected 1915 for delivery to the target tissue. The therapeutic light dosage selected can be selected for any of a variety of parameters as discussed in more detail above. A plurality of dosages may be appropriate in some instances, as will be appreciated by those skilled in the art. Finally, light therapy is delivered to target tissue 1920. As will be appreciated, the steps need not be performed in this exact sequence, Additionally, steps may be eliminated or replaced without departing from the scope of the invention.

Kits can also be provided that are comprised of a components. For example, The optical therapy device 100 disclosed above can be provided with a plurality of sized tips, removable sheaths, etc. Thus, allowing a practitioner to reuse the device where clinically appropriate multiple times while adapting the device for use with a particular patient.

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

Claims

1. An optical therapy device for providing therapeutic light to a body cavity, comprising:

a housing adapted to be hand-held;
one or more light sources positioned in or on said housing adapted to deliver up to 50 mW of UV light; and
an insertion member having a distal end configured to be inserted into the body cavity to illuminate tissue in the body cavity with light from the light source when the distal end of the insertion member is positioned in the body cavity.

2-44. (canceled)

Patent History
Publication number: 20080208297
Type: Application
Filed: Jan 25, 2006
Publication Date: Aug 28, 2008
Applicant:
Inventors: Michael Gertner (Menlo Park, CA), Erica Rogers (Redwood City, CA)
Application Number: 11/814,635
Classifications
Current U.S. Class: Internal Application (607/92)
International Classification: A61N 5/06 (20060101);