WO2008066943A2

WO2008066943A2 - Light-wand and balloon catheters

Info

Publication number: WO2008066943A2
Application number: PCT/US2007/067045
Authority: WO
Inventors: Philip Levin; Peter Kazlas; Edward L. Sinofsky; Stephen P. Evans; Marvin Guiles; David P. Goncalves; Marc J. Tolkoff; Jeffrey C. Cerier; Richard Abraham
Original assignee: Lumerx, Inc.
Priority date: 2006-04-25
Filing date: 2007-04-20
Publication date: 2008-06-05
Also published as: JP2009535116A; WO2008066943A3

Abstract

One aspect of the invention relates to an apparatus which has a light emitting portion for directing light radiation from the apparatus onto the lining of a body cavity for treating an ailment in a body cavity of a patient. For example, the ailment may be a gastrointestinal ailment of a patient, such as gastritis, gastric ulcer, duodenal ulcer, gastric cancer, gastric lymphoma, ulcerative colitis, or Crohn's disease. The apparatus may also be used for treating diseases of the circulatory system, urogenital systems and other body cavities. In one embodiment, the apparatus is inserted into a body cavity, e.g., stomach or colon, of the patient to place the distal tip of the apparatus in the desired position. A balloon is then inflated around the light-emitting portion of the apparatus, e.g., an array of optical fiber ends. The body cavity of the patient is then irradiated with light radiation so as to kill or debilitate microorganisms lining the body cavity without significant destruction of the body tissue of the patient, thereby improving or alleviating one or more of the symptoms associated with the ailment. Following treatment, a probiotic may be administered to the patient to reestablish the growth of normal microbial flora after treatment of the gastrointestinal tract.

Description

Light-Wand and Balloon Catheters

RELATED APPLICATIONS

This application claims the benefit of priority to United States Provisional Patent Application serial number 60/794,658, filed April 25, 2006, the entirety of which is hereby incorporated by reference

BACKGROUND OF THE INVENTION

Infections in the gastrointestinal tract are extremely common, involving many millions of people on an annual basis These infections include bacteria, viruses, and fungi, and are responsible for significant illness and morbidity One of the most common gastrointestinal infections in the world is due to Helicobacter pylori, a bacterial pathogen that infects the stomach and duodenum In the United States, for example, Helicobacter pylori is found in approximately 20% of the adult population It is a chronic gut infection and, once acquired, is notoriously difficult to cure Most infectious bacteria can be readily destroyed by the human immune system, however, Helicobacter pylori lives in the lumen of the stomach and on the surfaces of the stomach and duodenal cells, making it relatively resistant to even a vigorous immune response

Helicobacter pylori is typically a silent infection in humans, the majority of the time it causes a relatively innocuous gastric inflammation or gastritis In a significant minority of infected people, however, Helicobacter pylori can cause symptomatic gastritis, gastric ulcer, duodenal ulcer, gastric cancer, and gastric lymphoma The organism is responsible for approximately 90% of all reported duodenal ulcers, 50% of gastric ulcers, 85% of gastric cancer, and virtually 100% of gastric lymphoma Millions of Americans have symptomatic gastritis due to Helicobacter pylori or the much more serious entities noted above Helicobacter pylori is responsible for thousands of deaths in this country due to complicated ulcer disease and cancer, and is considered by the World Health Organization to be a Class 1 carcinogen , the same classification as benzene and DDT

The organism is found in all countries in the world, causing the same symptoms, diseases, and deaths, but it is most prevalent in undeveloped countries, presumably due to poor hygiene, contaminated water supplies and crowding In Peru and other South American countries, for example, the prevalence of Helicobacter pylori infection approaches 90%

There is no vaccine available for Helicobacter pylori and none is anticipated in the foreseeable future, despite years of intensive effort The only treatment currently available is prolonged and complicated antibiotic regimens involving three or four expensive antibiotics given over a two- week period Even using a vigorous antibiotic regimen, however, up to 20% of those treated are not cured

The antibiotics used are powerful, sometimes not well tolerated, and can cause nausea, an altered taste sensation and diarrhea Allergic reactions are not uncommon In addition to the problems of efficacy and side effects, antibiotic resistance in this organism is growing rapidly Up to 50% of the Helicobacter isolates are now resistant to one or more of the best antibiotics known to cure the infection This problem of antibiotic resistance is only expected to grow in the future, leading to worsening disease outcomes and an ever- increasing health expense

Thus, a great need exists for effective, rapid and well-tolerated treatments for Helicobacter pylori infections There also exists a need for well-tolerated and effective minimally intrusive methods for debilitating or killing microorganisms in other body cavities, such as the bowel, lungs, peritoneal cavity and urinary tract

SUMMARY OF THE INVENTION

One aspect of the invention relates to an apparatus which has a light emitting portion for directing light radiation from the apparatus onto the lining of a body cavity for treating an ailment in a body cavity of a patient For example, the ailment may be a gastrointestinal ailment of a patient, such as gastritis, gastric ulcer, duodenal ulcer, gastric cancer, gastric lymphoma, ulcerative colitis, or Crohn's disease The apparatus may also be used for treating diseases of the circulatory system, urogenital systems and other body cavities In one embodiment, the apparatus is inserted into a body cavity, e g , stomach or colon, of the patient to place the distal tip of the apparatus in the desired position A balloon is then inflated around the light-emitting portion of the apparatus, e g , an array of optical fiber ends The body cavity of the patient is then irradiated with light radiation so as to kill or debilitate microorganisms lining the body cavity without significant destruction of the body tissue of the patient, thereby improving or alleviating one or more of the symptoms associated with the ailment Following treatment, a probiotic may be administered to the patient to reestablish the growth of normal microbial flora after treatment of the gastrointestinal tract

One aspect of the invention relates to treatment methods and apparatuses for debilitating or killing Helicobacter pylori and/or other microorganisms within the body of a patient In certain embodiments, the invention is especially suited for treating stomach or duodenal ulcers One aspect of the present invention involves the use of laser diodes to generate radiation, this radiation eliminates pathogenic microorganisms withm or supported upon the lining of a body cavity of a patient, e g , the stomach In certain embodiments, an elongated catheter is provided for insertion into the body in any of a variety of ways For example, a catheter may be placed endoscopically (e g , through the esophagus), placed surgically, placed laparoscopically or placed by external image-guided transluminal or percutaneous insertion A balloon may be affixed to the end of the catheter A means of conveying light (referred to as a "light wand") from laser diodes or some other external optical source to an interior portion of the body can be inserted into the catheter so that the distal light emitting portion is positioned mside the balloon, to provide radiation for destroying microorganisms within the body In certain embodiments, the means of conveying light is an assembly of optical fibers In certain embodiments, the balloon is filled with a gas or a liquid (e g , water or saline) In certain embodiments, the gas or a liquid can circulate through the balloon via lumens in the catheter In certain embodiments, fluid may circulate over the optical fibers in the light wand Radiant energy is thus transferred from the proximal end of the instrument, through the fluid-filled balloon, to the epithelium around the distal end of the instrument, in an amount sufficient to debilitate or kill the Helicobacter pylori or other microorganisms in the lining of the body cavity

These and other more detailed and specific aspects of the present invention will be better understood by reference to the following figures and detailed description which illustrate by way of example a few of the forms of the invention within the scope of the appended claims BRIEF DESCRIPTION OF THE FIGURES

Figure 1 depicts a schematic of a human subject with a novel light wand and balloon catheter deployed in the subject's stomach

Figure 2 depicts one embodiment of a balloon catheter of the invention Figure 3 depicts specific aspects of one embodiment of a balloon catheter

Figure 4 depicts specific aspects of one embodiment of a balloon catheter and corresponding cover sheath or "zip sheath "

Figure 5 depicts specific aspects of a zip sheath of the invention Figure 6 depicts one embodiment of a light wand of the invention Figure 7 depicts one embodiment of the distal end of a novel light wand

Figure 8 depicts one embodiment of the fiber optic bundle assembly of a light wand of the invention

Figure 9 depicts [a] a guide wire, wrapped zip sheath, catheter and light wand of the invention, [b] an unwrapped zip sheath and catheter balloon, and [c] an inflated catheter balloon

Figure 10 depicts one embodiment of a bellows balloon of the invention

Figure 11 depicts several embodiments of balloons of the invention [a] a single balloon with centering webs, [b] overlapping balloons, [c] a tufted balloon, [d] alternating dog-bone balloons, [e] closely spaced alternating balloons, and [fj construction method alternating balloons

Figure 12 depicts several embodiments of balloons of the invention [a] covered individual balloons, [b] multiple tubular balloons, [c] single helical balloon, [d] multiple helical balloons, and [e] quilted balloon with tubular sidecars

Figure 13 depicts one embodiment of a balloon of the invention [a] braided balloons, and [b] a photo of a model of the embodiment

Figure 14 [top] depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 3 cm diameter x 30 cm long transparent bellows balloon filled with air and the light wand consists of a staggered arrangement of 13 optical fibers surrounded by a scattering fluid, the scattering fluid is aqueous Mg(OH)₂ ("concentration A") The Mg(OH)₂ solution was made by mixing 6 mL Milk of Magnesia with water to a volume of 60 mL ("concentration A") The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is FEP loaded with 10% by weight BaSO₄ particles

Figure 14 [bottom] depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 3 cm diameter x 30 cm long transparent bellows balloon filled with a scattering fluid, the scattering fluid is aqueous Mg(OH)₂ ("concentration A"), the light wand consists of a staggered arrangement of a staggered arrangement of 13 optical fibers surrounded by clear, distilled water The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is FEP loaded with 10% by weight BaSO4 particles The Mg(OH)₂ solution was made by mixing 6 mL Milk of Magnesia with water to a volume of 60 mL ("concentration A") Figure 15 [top] depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 3 cm diameter x 30 cm long transparent bellows balloon filled with a scattering fluid, the scattering fluid is aqueous Mg(OH)₂ ("50% of concentration A"), the light wand consists of a staggered arrangement of 13 optical fibers surrounded by clear, distilled water The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is FEP loaded with 10% by weight BaSO4 particles The Mg(OH)₂ solution was made by mixing 6 mL Milk of Magnesia with water to a volume of 120 mL

Figure 15 [bottom] depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 3 cm diameter x 30 cm long transparent bellows balloon filled with a scattering fluid, the scattering fluid is aqueous Mg(OH)₂ ("25% of concentration A"), the light wand consists of a staggered arrangement of 13 optical fibers surrounded by clear, distilled water The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is FEP loaded with 10% by weight BaSθ₄ particles The Mg(OH)₂ solution was made by mixing 6 mL Milk of Magnesia with water to a volume of 240 mL Figure 16 depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 3 cm diameter x 30 cm long translucent bellows balloon (a "scattering" bellows balloon) filled with air, and the light wand consists of a staggered arrangement of 13 optical fibers surrounded by clear, distilled water The balloon material is white, translucent polyethylene The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is FEP loaded with 10% by weight BaSO₄ particles

Figure 17 depicts a comparison of optical irradiance uniformity for three variations of device construction the "3 cm dia scattering balloon" corresponds to Figure 16, the "3 cm dia clear balloon" is similar to Figure 21 (but with a 3 cm diameter rather than 4 5 cm diameter) and the "4 cm dia clear balloon" is similar to Figure 21 (but with a 4 cm diameter rather than 4 5 cm diameter) Each vertical bar in the graph shows the optical irradiance range (measured over the full length of the catheter balloon) for a given measurement trial

Figure 18 depicts selected embodiments of the invention Part [A] depicts a flexible optical delivery system that may be inserted within a body cavity or organ and that consists of a flexible, distal optical diffusing section containing multiple optical fibers terminating in a staggered pattern within an optically transmissive sheath, the sheath can be filled with and surrounded by an optically transmissive fluid medium wherein the fluid medium is contained within a distally closed-ended optically scattering sheath Part [B] depicts the assembly shown in [A] surrounded by an optically transmissive flexible balloon assembly that includes means by which a second transmissive fluid may be delivered to and then withdrawn from the flexible balloon assembly a multitude of times after insertion of the assembly in a body cavity, thus providing means to inflate and deflate the balloon at will Part [C] depicts the optical delivery system of [B] which comprises two separable units a first unit, described as an optical fiber "light wand," consisting of optical fibers terminating in a staggered pattern within a transmissive sheath through which a first transmissive fluid may be delivered from a proximal point on the assembly, and a second unit described as a "scattering catheter," consisting of a distally closed-ended scattering sheath from which the transmissive fluid may be removed from a proximal point, the first and second units are capable of being assembled and disassembled before and after use Figure 19 depicts selected embodiments of the invention Part [A] depicts the optical delivery system of Figure 18[C], wherein the flexible "scattering catheter" includes an optically transmissive flexible balloon assembly that includes means by which a second transmissive fluid may be delivered to and then withdrawn from the flexible balloon assembly a multitude of times after insertion of the assembly in a body cavity, thus providing means to inflate and deflate the balloon at will Part [B] depicts the optical delivery system of Figure 18[B], wherein a fluid seal may be effected between the "scattering catheter" and the "light wand" at a proximal location on the units after assembly, with means of delivering a first transmissive fluid to or from the "light wand" and means of delivering the first transmissive fluid from or to the "scattering catheter," and the seal may be opened for disassembly of the "scattering catheter" and the "light wand" after use Part [C] depicts the optical delivery system of Figure 18[A], wherein the stagger pattern of the optical fibers is selected to provide a specific distribution of light, including substantially equal amounts of light over the length of the optical diffusing section, depending upon the requirements of the body organ or cavity to be treated, and the optically transmissive sheath is tapered distally so as to constrain the lateral motion of the optical fibers

Figure 20 depicts selected embodiments of the invention Part [A] depicts the optical delivery system of Figure 18[B], wherein the flexible balloon assembly consists of an arrangement of consecutive sections described as a "bellows balloon" which is structured to substantially maintain centering of the "scattering sheath" within the flexible balloon assembly Part [B] depicts the optical delivery system of [A], wherein the closed end of the scattering sheath includes a flexible, optically transmissive "atraumatic tip" that presents a soft, rounded shape when the assembly is inserted in a body cavity, the "atraumatic tip" includes a lumen for the passage of a medical guide-wire, over which the assembly may be guided into a body cavity The atraumatic tip also includes an optional "scattering insert" which serves to further disperse or re-direct the forward-directed light emitted by the light wand The scattering insert may provide diffuse scattering, specular reflection or partial reflection, depending upon the requirements of the intended therapy Part [C] depicts the optical delivery system of Figure 18[B], wherein the assembly, consisting of a "light wand" and an un- inflated "scattering catheter," is further contained within a flexible sheath, the "cover sheath" (also called "zip sheath" herein) being removable after the entire assembly is inserted in a body cavity, and the "light wand" and "scattering catheter" remaining within the body cavity after removal of the "cover sheath", in addition, the "cover sheath" includes a removable "guide-wire lumen" for the passage of a medical guide-wire, over which the assembly may be guided into a body cavity

Figure 21 depicts an optical irradiance pattern of the light emitting portion of the device wherein a light wand is inserted into a catheter, the catheter consists of a 4 5 cm diameter x 30 cm long transparent bellows balloon filled with clear aqueous salme solution and the light wand consists of a staggered arrangement of 13 optical fibers surrounded by clear distilled water The optical fibers of the light wand are sheathed with a clear FEP tube The inner portion of the catheter includes a scattering tube, the scattering tube is Pebax loaded with 20% by weight BaSO₄ particles

DETAILED DISCRIPTION OF THE INVENTION

One aspect of the invention relates to a surgical device which includes components for producing localized light radiation within an inflatable balloon The invention can be employed for killing or debilitating various pathogenic microorganisms The invention can be used to advantage in treating infections of the gastrointestinal system, as well as other ailments in which light radiation is to be delivered to portions of the body that are not easily accessible from the exterior or via standard surgical techniques In one aspect of the present invention, a source of light radiation, such as an array of laser diodes, is coupled to an array of optical fibers The distal end of the array of optical fibers is positioned in a body cavity (e g , the stomach) for treating H pylori infections by injuring or killing the bacterial cells carried on or within the epithelium lining the stomach The present invention can therefore be used to prevent the escalation of the infection to stomach ulcers and cancer

Certain aspects of the present invention will be described by way of example in the treatment of Helicobacter pylori infections within the stomach Various forms of radiation, including x-rays, radiation from isotopes, radio waves, microwaves, or light radiation (e g , ultraviolet light) provide an advantageous method of treating such infections A light radiation device, deployed through a catheter, for example, produces radiation that irradiates the lining of the body cavity, in this case the columnar epithelial lining of the walls of the stomach, or the epithelium of any other passage or lumen that is being treated (Figure 1) During this treatment, the light radiation injures or kills bacterial cells An important advantage of the mvention lies in the fact that many organisms, such as bacteria, are susceptible to particular wavelengths of light to a much greater degree than the surrounding human cells Accordingly, the microorganisms can be killed or debilitated with minimal destruction of host cells Figure 1 illustrates by way of example one method of use in accordance with the present invention (e g , the treatment of Helicobacter pylori infections of the stomach) In this case, an instrument is provided which includes a catheter and a light wand The catheter has a balloon at its distal end which can be filled with a liquid or a gas The light wand has a distal light emitting portion from which radiation emanates, which can be inserted into the catheter, thereby placing the distal light emitting portion inside the balloon In certain embodiments, an array of laser diodes is coupled to the proximal end of an array of optical fibers, the distal ends of the optical fibers are all disposed withm the distal end of the light wand

Catheters. Figures 2-5 illustrate embodiments of a catheter of the invention A catheter permits a physician to introduce and position a light wand (described below) at the treatment site in a body It is therefore helpful for the catheter to be flexible, to have a reduced diameter and rounded forward end, such that it can be easily introduced into the esophagus and stomach In one particular embodiment, during the insertion stage the catheter will have an outer diameter of less than or equal to about 10 mm In one particular embodiment, the catheter will have an outer diameter of less than or equal to about 4 mm In one particular embodiment, during the insertion stage the catheter will have an outer diameter of about 5 mm In one particular embodiment, during the insertion stage the catheter will have an outer diameter of about 4 mm In other applications, the properties and dimensions of the catheter may vary to meet the requirements of a particular task In certain embodiments, the catheter may be inserted into the stomach, by way of the mouth and esophagus Insertion in a body cavity may be accomplished in a variety of ways, including through a lumen of an endoscope or similar tool, over an endoscope, where the endoscope serves as a mechanical guide and as a means to visualize the insertion process, side-by-side with an endoscope or similar tool, in a side-car fashion, over a guide wire, or independently, either with or without the aid of an external visualizing means, such as X-ray fluoroscopy A guide wire can be used to aid in the introduction of the catheter Once a guide wire is positioned in the patient, the free end of the guide wire, which extends from the patient's mouth, is then "back loaded" through the catheter tip In certain embodiments a removable guide wire lumen can be used as a temporary binding cord to secure a zip- sheath, which surrounds the balloon at the end of the catheter See Figures 4 and 5 In certain embodiments, removal of the guide wire separates the zip-sheath from the catheter (which allows the zip-sheath to be opened and left in place or removed via the patient's mouth), thereby separating the zip-sheath from the catheter and allowing the balloon to be inflated In other embodiments, the zip sheath can be independently secured to the catheter and removed after the guidewire has been removed (e g , peeled away) In other embodiments, a vacuum is applied the catheter upon insertion to prevent sliding of the balloon (see below) along the catheter, this approach obviates the need for a zip-sheath

In certain embodiments, the catheter serves to disperse or direct or otherwise shape the light that is emitted by the light wand In certain embodiments, the inner portion of the catheter includes a scattering tube In certain embodiments, the scattering tube is a transmissive polymer, such as Pebax or FEP or PTFE or polyurethane or polyethylene and is loaded with scattering particles such as BaSO₄ particles In certain embodiments, the scattering tube consists of Pebax, loaded with 15% by weight BaSO4 In certain embodiments, the scattering tube consists of Pebax, loaded with 10% by weight BaSO₄ In certain embodiments, the scattering tube consists of Pebax, loaded with 20% by weight BaSO₄

In certain embodiments, the catheter balloon shape is selected to provide flexibility so as to conform to the shape of the target organ In certain embodiments, the catheter balloon shape is a bellows shape, as depicted in Figures 2 and 3 In certain embodiments, the balloon shape, when filled with fluid, serves as a light focusing or shaping element

Lamps, Laser Diodes, and other Optical Sources. For various applications, visible light can be used if desired In one form of the invention, visible blue or violet light of approximately 400 nm wavelength is employed In other applications, light composed of a multiplicity of wavelengths can be used if desired, for example, as a continuous broad band of light or as a combination of discrete emission bands, or as a combination of both broad-band and discrete-band emission In such a form of the invention, visible light ranging from 400 nm to approximately 450 nm is employed In another form of the mvention, a combination of UV-A light and visible light, ranging from approximately 350 nm to 450 nm is employed In another form of the invention, the emission lines at approximately 365 nm, 404 nm and 435 nm, such as are emitted by mercury-xenon arc lamps, are employed In another form of the invention, visible light and/or ultraviolet light selected to correspond to specific absorption bands of the photo-sensitizer is employed In another form of the invention, the selected wavelength or wavelengths of operation correspond with the absorption band or bands of endogenous photo-sensitizers (that is, photo-sensitive compounds that are naturally present within the target organisms), such as porphyrins, and more specifically, proto-porphyrm IX and Coproporphyria For those cases where a multiplicity of wavelengths is employed, the light may be supplied by any of several suitable sources In one form of the invention, the optical sources consist of one or several laser diodes, of which the laser diodes may emit at several different wavelengths In another form of the invention, the optical sources consist of broad-band lamps, for example xenon or mercury-xenon compact arc lamps, or xenon flash lamps, or metal halide lamps Light energy can be provided by one or more optical sources coupled to the proximal end of a light wand Optical sources, including but not limited to lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps and fluorescent lamps may be used The light sources may be used in continuous wave operation, or they may be pulsed or otherwise modulated Light Wands. Figure 6 illustrates one embodiment of a light wand of the invention

In certain embodiments a plurality of laser diodes are coupled to the proximal ends of a plurality of optical fibers, herein called a "fiber bundle," by means of optical connectors The optical fibers are spaced along the distal end of an elongated shaft to form a light wand The distal ends of the optical fibers are distributed or staggered in a pattern that meets the requirements of the intended therapy In certain embodiments, the optical fibers are

"potted" or fixed in relative position at a proximal location, but loosely bundled at all other locations, as depicted in Figure 6 In certain embodiments, the distal ends of the optical fibers are staggered in a uniform longitudinal pattern, as shown in Figures 7 and 8 In this way, the light that is emitted is evenly distributed over the distal end of the light wand In certain embodiments the laser diodes are distributed over an about 25 cm length In certain embodiments the spacing between optical fiber ends is about 2 cm Figures 7 and 8 show one embodiment of the spacing of the optical fiber ends In certain embodiments the sheath surrounding the optical fiber bundle is formed from transparent FEP It will be understood that in one embodiment, the distal portions of the optical fibers comprising the staggered optical fiber bundle are loosely bundled, i e , while the optical fibers are potted in a proximal region, as shown in Figure 6, the distal portion of each optical fiber remains unattached This arrangement allows the distal portions of the optical fibers to slide relative to each other, as typically occurs when the distal portion is bent Therefore, in certain embodiments, the sheath surrounding the optical fiber bundle is distally tapered so as to substantially maintain centering of the optical fibers within the sheath without constraining the longitudinal sliding motion of each fiber

In other embodiments, the distal portion of each optical fiber is fitted with one or several centering collars or similar attachments to achieve centering within the sheath, without constraining the longitudinal sliding motion of each fiber and without interfering with fluid motion within the sheath In another embodiment, the sheath surrounding the optical fiber bundle is fitted with one or several centering collars or similar attachments such that the light wand sheath remains substantially centered within the catheter in a bend and the lateral range of motion of the light wand sheath withm the catheter is minimized, without constraining the longitudinal sliding motion of the sheath and without interfering with fluid motion surrounding the light wand sheath

In certain embodiments, a fiber bundle contains 13 optical fibers (see Figure 6) In certain embodiments, a fiber bundle contains about 200 separate pure silica fibers To prevent solaπzation of the fiber optics, the core glass of the fiber bundle may consist of hydrogen-loaded or high-OH silica To increase the tensile strength of the optical fibers, these may be hermetically coated, as, for example, with an aluminum buffer One suitable optical fiber type is a UVI or UVM optical fiber manufactured by Polymicro Technologies of Phoenix, Ariz By using a fiber optic bundle of this composition, minimal attenuation of the radiation occurs within the fiber optic bundle due to solarization Solarization is an undesirable blackening of the fibers due to energy absorption

During use of a light wand, the light energy passes as a plurality of beams out of the distal end of the fiber bundle The distal end of the fiber bundle is staggered along the distal end of the light scope and bathed in fluid Fluid, such as distilled water, can be introduced to the light wand via a manifold in the light wand, as shown in Figure 6 In certain embodiments, the fluid is introduced at a rate of about 10 mL/min, about 12 mL/min, about 14 mL/min, about 16 mL/min, about 18 mL/min or about 20 mL/mm In one embodiment, the fluid is introduced at about 16 7 mL/mm This fluid passes down over the optical fibers within the FEP sheath, exits the distal end of the light wand into the inner lumen of the catheter, where the fluid is then routed back along the outside of the light wand and ultimately out of the catheter at a proximal fitting The fluid may serve as both a transmission medium for the light that issues from the optical fiber ends, and a coolant for the optical fibers and the inner lumen of the catheter In certain embodiments, the fluid serves to couple the light out of the optical fiber ends and into the catheter, as by refractive index matching In some instances, the fluid serves to scatter the emanating light

The light passes into the body cavity of the patient after passing through the fluid- filled balloon, and is directed onto the inner surface of the body cavity so as to kill or debilitate the pathogenic microorganisms that are present on the inner surface of the body cavity As already mentioned, the light can be employed in treating any of a variety of body cavities, such as the vessels of the circulatory system, any of the various parts of the digestive tract or urogenital system, peritoneal cavity, respiratory tract or sinuses, oral cavity or other body cavities

Dosage of Light. The dosage of light to be applied to the interior of a body will generally be selected based on individual conditions, such as the severity of the infection and the damage that has occurred at the site to be treated In order to treat H pylori infection, only the surface of the epithelium needs to be irradiated In certain embodiments the light will be pulsed for short or long durations In other embodiments, continuous light exposure will be used In other embodiments, a combination of pulsed and continuous light exposure will be used

In certain embodiments, the light treatment lasts no more than about 15 minutes In other embodiments, the light treatment lasts about 2 to 10 minutes, or about 3 to 5 minutes In certain embodiments, the total light dose is applied in a series of 15 minute-long periods In certain embodiments, between illumination periods the laser light is turned off and the fluid is removed from the balloon and is replaced with room temperature fluid, simultaneously, the physician may conduct a mid-treatment endoscopic exam of the stomach surface and balloon position In certain embodiments, the treatment can last longer than 15 minutes with room temperature or cooled fluid circulating through the light wand and/or catheter The light source may be repositioned by moving it from one part of the body cavity to another, either continuously or intermittently during the course of treatment, depending on the dimensions of the area requiring treatment In certain embodiments, the light can be administered at any suitable interval from about once per second to about 10 flashes per second, or about 100 flashes per second or several thousand flashes per second In certain embodiments, the light can be administered continuously

Distribution of Light. For many disorders, a uniform distribution of light through out the body cavity is preferred In order to achieve a uniform distribution, certain passages and other interior portions of the body may need to be dilated while treatment is carried out For example, the stomach is soft and, except after a meal, is in a collapsed state Rugae or folds are present on its inner walls In one embodiment of the present invention, air is used to dilate the passage of the body, such as the stomach, and thereby distend the passage (e g , stomach wall) and hence spread apart the rugae so that a uniform distribution of light can be achieved In certain embodiments, the catheter balloon may fill the entire body cavity and serve to insufflate the cavity such that no additional means of insufflation is necessary In certain embodiments the positioning of the balloon may be important in creating the uniform light distribution in the desired location, especially from a central position that is equidistant from all parts of the surrounding passage (e g , stomach wall) so as to provide the same dose of light to all portions of the passage or cavity In certain embodiments, the catheter balloon is substantially centered within the body cavity, the light passing through the balloon is distributed by the structure of the catheter to provide a uniform dosage of light to all portions of the passage or cavity (e g , stomach) In other embodiments, the catheter balloon is not centered within the body cavity, instead, the balloon is positioned asymmetrically withm the cavity, in contact with some but not all surfaces, and the desired light distribution is achieved in part through multiple reflections from the body cavity surface In certain embodiments, the distribution of light within the cavity is intentionally concentrated on infected areas, by means of selective balloon shape or size or positioning within the cavity

In certain embodiments, the balloon material may be selected to be translucent or partially scattering or partially reflecting to aid in achieving the desired distribution of light In other embodiments, the fluid used to fill the balloon may include scattering means to further distribute the light In other embodiments, the balloon material and/or the fluid used to fill the balloon may include fluorescent materials selected to achieve a desired geometric or wavelength distribution of light

While in some traditional therapies it is necessary for the tip of the light source to be moved from side to side so as to pass the beam back and forth across the area that is to be treated, it will be noted that because the source of light is at the center of the balloon all of the rays will diffuse when passing through the structure of the catheter, thereby achieving the desired exposure of light on the walls of the cavity treated Uniform radiation exposure is also aided through the flattening of the cavity wall by insufflation by air as described above In certain embodiments, e g , during a surgical procedure, the light wand is held about 20 mm to about 30 mm from the interior surface of the body cavity by means of the surrounding balloon

Fluid-Filled Balloons. In some applications excessive heat may be generated during a treatment This heat may arise from absorption of light by the organ tissue, or it may arise from absorption of light by the distal portion of the device, or some combination of the two However, if the balloon is filled with fluid, or fluid circulates through the balloon interior, it not only serves to disperse or shape the light, but further serves to cool the body cavity and the distal portion of the device and dissipate the heat produced The distal portion of the device can be cooled by recirculatmg the fluid that is used to bathe the light wand and/or the fluid that is used to fill the catheter balloon The fluid-filled balloon also serves to establish a minimum distance between the light wand and the body cavity wall, thereby establishing a maximum optical irradiance at the illuminated surface of the body cavity Heating due to tissue absorption is thus controlled and minimized In certain embodiments the fluid used to fill the balloon is isotonic saline In certain embodiments the fluid pressure is maintained at about 1 0 psig to ensure balloon inflation Balloon pressure can be monitored continuously by means of an electronic pressure gauge that is in fluid communication with the balloon fill line If necessary, additional fluid may injected into the balloon during the treatment to maintain deployment These small volumetric additions are expected because the balloon material may stretch slightly as it is warmed by the body However, a rapid decrease in pressure is an indicator that the balloon is leaking The electronic gauge may be configured to emit an audible alarm m the event that balloon pressure falls below a pre-set value During balloon filling, the electronic gauge may also be configured to stop fluid inflow if high pressures are encountered If desired, the balloon can be in fluid communication with a lumen that is disposed within the shafts of the catheter to carry fluid from outside the body to the interior of the balloon and provide a return path for the fluid In certain embodiments the fluid system of the catheter and the fluid system of the light wand are combined If desired, the fluid can circulate in the interior of the balloon, inflating the balloon, and can then be returned to the proximal portion of the catheter A circulating pump can be used to circulate the fluid and maintain the pressure required to achieve the desired balloon size The pump can be coupled to the catheter and light wand via fluid ports Other methods and devices known in the art may also be used to circulate the fluid in the balloon In certain embodiments, before the expansion of the balloon, a vacuum pump is used to remove residual air from the balloon During use, an inflation fluid is provided to expand the balloon via a lumen, inflation port and tubing, which is connected to the pump If a liquid is used instead of a gas, such as air, the liquid (e g , water or saline), can be supplied from a tank connected to the inlet of the pump In some applications, such as in the stomach, the diameter of the dilated balloon is varied with the pressure applied, so that the diameter of the balloon can be adjusted to fit the patient's stomach or other passage In certain embodiments, it may be desirable to employ an inelastic balloon with a fixed dilated diameter In certain embodiments the diameter of the balloon is about 2 cm In other embodiments, the diameter of the balloon is about 3 cm, or about 4 cm The balloon may be secured to the catheter, e g , by a suitable means such as adhesive or heat-bonding or a suture wrap (see Figure 2) The balloon is of a suitable length so that the light emitting portion of the light wand can be completely inserted into the balloon

In certain embodiments, the balloon material is porous or the catheter end is open so that fluid or other substances may be issued into the body cavity in a controlled manner This fluid or substances may serve as a coolant and/or as an adjuvant to therapy (e g , a selective photo-sensitizer or an inhibitory agent that renders the targeted pathogen more susceptible to the light therapy)

Use of Endoscopes or Laryngoscopes. According to one embodiment of the invention, the inventive device may be placed within or beside or around a standard endoscope or laryngoscope The inventive device described herein is introduced into the passage to be treated and is then guided through the passage, using techniques known in the art, until it is positioned near the area to be treated The site to be treated may be viewed through the endoscope, and the area around the device may be flushed using the endoscope, if necessary The balloon is then inflated by fluid, either liquid or gas from the fluid pump, to the desired diameter so as to distribute the light from the distribution head in the desired location as described herein The endoscope is then retracted or removed and the device is left in place

Bacterial Repopulation. Many types of bacteria proliferate in the human bowel The body, however, sometimes cross-reacts to either pathogenic or normal bacteria Occasionally, after sensing the presence of normal bowel flora, the body attacks one or more of the bowel flora species as a pathogen, setting up a chronic inflammatory state which makes the patient feel sick Other gastrointestinal infections are caused by H pylori In accordance with the present invention, microorganisms in the stomach, colon or other parts of the digestive tract are either killed or debilitated by light radiation In one preferred protocol in accordance with the invention, following treatment of the stomach, colon or other part of the bowel, the digestive tract is populated with probiotic bacteria, i e , beneficial bacteria or innocuous bacteria to which the body does not react adversely In the preferred embodiment, the probiotic bacteria are administered in sufficient numbers to displace or compete with the target pathogen, either prior to or following light treatment The administered probiotic population may be transient, but still effective at displacing or weakening the resident infection In another embodiment, the probiotic bacteria are administered with meals to reestablish a flora that approximates the flora found in the gut under normal conditions To repopulate the bowel, any suitable commercially available probiotic bacteria can be employed One preferred probiotic bacteria formulation is shown below in Table 1 The probiotic is administered either as tablets or capsules, typically taken three times a day or until the natural background flora of the digestive tract is reestablished

Table 1. Example of a commercially available probiotic bacteria formulation

Probiotic Bacteria Quantity

Lactobacillus acidophilus 5 billion/gram

Lactobacillus plantarum 5 billion/gram

Lactobacillus rhamnosus 5 billion/gram Bifidobacterium infantis 5 billion/gram

Bifidobacterium lactis 5 billion/gram

Bifidobacterium longum 5 billion/gram

Streptococcos thermophilus 5 billion/gram

Prior to using the instrument, in order to assure that the pathogenic bacteria has been eliminated, in vitro kill studies are conducted The kill studies are used to assess how much radiation may be required to achieve desired bacterial counts Then, when the instrument is used later in the stomach or intestine, the correct amount of light at the particular wavelength will be known Thus, the microbicidal effectiveness of a given light wand is determined by the kill studies conducted in vitro for the lamp that is used later in treating human patients In certain embodiments, good results may be obtained with blue light from a laser diode Light-Sensitizing Compound and Adjuvants. A light-sensitizmg medication may be administered to the patient so that the light is preferentially absorbed by the pathogen within the treatment site, rather than by human cells Any suitable light-sensitizing medicine can be used, such as any of the suitable porphyrm-promotmg or porphyrin-type compounds known to those skilled in the art for preferentially absorbing light, so as to provide a more effective bactericidal action Similarly, adjuvants that pre-dispose the pathogen to injury or death by light therapy or adjuvants that are effective at killing or displacing the pathogen prior to or following light therapy may be administered to enhance treatment Adjuvants include but are not limited to those agents that inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy

Photosensitizers. For those cases where endogenous photo-sensitizers may be present, then administered or exogenous photosensitizers may not be an essential feature of the invention Any suitable photosensitizer known to those skilled in the art can be administered, if desired, for sensitizing the microorganisms to the illumination that is applied One preferred sensitizer is amino levulinic acid, another is protoporphyrin IX, another is coproporphyrm Another suitable sensitizer comprises a psorlen, such as demethylchlortetracyclme Other suitable known sensitizers can be employed if desired The wavelength of the light provided should be matched to the photo sensitizer employed or to the natural photosensitizer that is present so that the light is absorbed by the photo sensitizer Selected Apparatus and Methods of the Invention. As mentioned above, the therapeutic methods of the present invention are suited for use in various body cavities and can also be used with various devices, fabrication methods, arrangements, systems and methods of employment which irradiate the walls of various body cavities or interior sites within the body of a patient by means of radiation in sufficient amount to debilitate or kill microorganisms lining the body cavity

One aspect of the present invention relates to an apparatus comprising a plurality of light-emitting optical fibers having proximal ends and distal ends, a first fluid, a first sheath with an open distal end, and a second sheath with a closed distal end, wherein said plurality of light-emitting optical fibers are arranged so that their distal ends are staggered, thereby forming a staggered array of optical fibers, and said first sheath is positioned over said staggered array of light-emitting optical fibers, said second sheath is placed over said first sheath, said first sheath and said second sheath are filled with said first fluid, and said first sheath and said second sheath are in fluid communication, thereby forming a fluid-filled optical diffusing section

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a catheter, with a proximal end and a distal end, which comprises a second fluid, an optional fluidic port at said proximal end, and a balloon at said distal end, wherein said balloon is placed over said fluid-filled optical diffusing section, and the introduction of said second fluid into said fluidic port inflates said balloon, while the removal of said second fluid from said fluidic port deflates said balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is less than about 10 mm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is between about 1 mm and about 10 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is between about 3 mm and about 6 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is about 5 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is about 4 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a light source coupled to said proximal ends of said plurality of optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is one or more laser diodes

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is operated in CW or pulsed mode, or a combination of both In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone, or a combination thereof

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of a fluorocarbon In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of fluormated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said proximal end of said first sheath terminates in a fiuidic port

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluormated ethylene-propylene or polyether block amides In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 10% by weight OfBaSO₄

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 20% by weight OfBaSO₄

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said proximal end of said second sheath terminates in a fluidic port

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are between about 100 optical fibers and about 1,000 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are less than or equal to about 100 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are less than or equal to about 20 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are less than or equal to about 15 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are 13 optical fibers In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are less than or equal to about 10 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers are arranged so that each distal end is at least 1 0 mm from all other distal ends In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers are arranged so that each distal end is at least 1 5 mm from all other distal ends

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers are arranged so that each distal end is at least 2 0 mm from all other distal ends

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers are arranged so that said distal ends are spaced over a length of about 25 cm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers are arranged so that said distal ends are substantially evenly distributed over a length of about 25 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of light-emitting optical fibers are connected or gathered into one or more bundles at their proximal ends

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of light-emitting optical fibers are loose, i e , not connected, at their distal ends

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said distal ends of said light-emitting optical fibers further comprise one or more centering collars, thereby keeping said light-emitting optical fibers in the center of said apparatus

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers emit light at a wavelength in the range of between about 200 nm and about 810 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers emit light at a wavelength in the range of between about 250 nm and about 600 nm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers emit light at a wavelength in the range of between about 300 nm and about 500 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers emit light at a wavelength in the range of between about 350 nm and about 450 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said optical fibers emit light at a wavelength of about 400 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is a liquid

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is distilled water, de-iomzed water, or essentially pure water

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is distilled water

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is isotonic aqueous salme solution

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamme, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is an aqueous solution that contains barium sulfate

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first second is an aqueous solution that contains adjuvants, and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein adjuvants are administered in conjunction with the light treatment (prior to, during or following light treatment), and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is a gas

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is air

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is a liquid

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is isotonic aqueous saline solution

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first and second fluids are one and the same, and wherein the fluid is circulated within all parts occupied by those fluids In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog- bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloons with tubular sidecars, and braided balloons

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is a bellows balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon, when inflated, has a diameter of between about 2 5 cm and about 5 0 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon, when inflated, has a diameter of about 3 0 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon, when inflated, has a diameter of about 3 5 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon, when inflated, has a diameter of about 4 0 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon, when inflated, has a diameter of about 4 5 cm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is less than about 30 cm long

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is between about 10 cm long and 30 cm long

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is about 25 cm long

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is about 20 cm long

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is about 15 cm long In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is porous to said second fluid

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is partially or completely transparent to the light emitted by said light-emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is comprised of polyurethane

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is comprised of white, translucent, polyethylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is comprised of a polyurethane, and said first sheath is fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is comprised of white, translucent, polyethylene, and said first sheath is fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is composed of an optically transmissive material

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of fluorescent dyes and colloidal particles

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, and colloidal gold

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is composed of an optically transmissive material which contains barium sulfate

In certain embodiments, said optically transmissive medium contains regions of refractive index mismatch, for example gel, glass or polymer doped with entrained solids, liquids or gases

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is composed of an optically transmissive material which has a metallic thm-film coating

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a third sheath capable of constraining said balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said third sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a guidewire, and a third sheath capable of constraining said balloon, wherein said third sheath comprises a guidewire lumen, thereby allowing attachment of said third sheath via a guidewire

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising an atraumatic tip disposed on the distal end of said catheter

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said atraumatic tip comprises a scattering insert

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said atraumatic tip comprises a guidewire lumen In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said first fluid

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said first fluid, wherein the temperature of said first fluid is about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said first fluid, wherein the temperature of said first fluid is about 20 ⁰C

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said first fluid, wherein the temperature of said first fluid is about 15 ⁰C

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said second fluid

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said second fluid, wherein the temperature of said second fluid is about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said second fluid, wherein the temperature of said second fluid is about 20 ⁰C In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump to circulate said second fluid, wherein the temperature of said second fluid is about 15 ⁰C

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump, and wherein said first and second fluids are one and the same, and said pump is used to circulate said fluids

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising an electronic gauge to measure the pressure of said first fluid

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising an electronic gauge to measure the pressure of said second fluid Another aspect of the invention relates to an apparatus comprising a plurality of optical fibers having proximal ends and distal ends, a first fluid, a first sheath with an open distal end, and a second sheath with an open distal end, wherein said plurality of optical fibers are arranged so that their distal ends are staggered, thereby forming a staggered array of optical fibers, and said first sheath is positioned over said staggered array of optical fibers, said second sheath is placed over said first sheath, and said first sheath and said second sheath are filled with said first fluid, thereby forming a fluid-filled optical diffusing section

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a catheter, with a proximal end and a distal end, which comprises a fluidic port at said proximal end, and a balloon at said distal end, wherein said balloon is placed over said fluid-filled optical diffusing section, and the introduction of said fluid will inflate said balloon, while the removal of said fluid will deflate said balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is less than about 10 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is between about 1 mm and about 10 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is between about 3 mm and about 6 mm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is about 5 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter is about 4 mm In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a light source coupled to said proximal ends of said plurality of optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is one or more laser diodes In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source is operated in CW or pulsed mode, or a combination of both

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone, or a combination thereof In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of a fluorocarbon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first sheath is comprised of fluormated ethylene-propylene In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said proximal end of said first sheath terminates in a fiuidic port

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluormated ethylene-propylene or polyether block amides

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is comprised of fluormated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherem said second sheath is comprised of fluormated ethylene-propylene with about 10% by weight OfBaSO₄

In certain embodiments, the present invention relates to the aforementioned apparatus, wherem said second sheath is comprised of fluormated ethylene-propylene with about 20% by weight OfBaSO₄

In certain embodiments, the present invention relates to the aforementioned apparatus, wherem said proximal end of said second sheath terminates m a fiuidic port In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of light-emitting optical fibers are loose, i e , not connected, at their distal ends In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said distal ends of said light-emitting optical fibers further comprise one or more centering collars, thereby keeping said light-emitting optical fibers in the center of said apparatus

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is a liquid In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said first fluid is distilled water, de-iomzed water, or essentially pure water

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said second fluid is an aqueous solution that contains adjuvants, and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or redistribute or flush out the pathogen withm the body cavity so as to enable or enhance light therapy In certain embodiments, the present invention relates to the aforementioned apparatus, wherein adjuvants are administered in conjunction with the light treatment (prior to, during or following light treatment), and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog- bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloons with tubular sidecars, and braided balloons

Another aspect of the invention relates to an apparatus for killing or debilitating pathological microorganisms in a body cavity of a patient, comprising a catheter body having a diameter, a length, a proximal end and a distal end, the catheter body defining therein a first lumen extending therethrough, a second lumen extending therethrough and optionally a third lumen extending therethrough, a balloon having a diameter, a length, a proximal and a distal section secured to the distal end of the catheter body so that an interior of the balloon is in fluid communication with the second lumen and optionally the third lumen, and the balloon having a non- expanded configuration and an expanded configuration, a light-emitting instrument having a diameter, a length, a proximal end and a distal end, the light-emitting instrument defining therein a fourth lumen extending therethrough, and a plurality of optical fibers emitting at a plurality of wavelengths, staggered along the distal section of said light-emitting instrument, wherein the light-emitting instrument is adapted to be delivered through the first lumen, thereby placing said plurality of optical fibers in the interior of the balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a guidewire having a proximal end and a distal end In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a zip-sheath which surrounds the balloon when it is in its non-expanded consideration

In certain embodiments, the present invention relates to the aforementioned 5 apparatus, wherein the zip-sheath is a polyethylene sheet

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a guidewire having a proximal end and a distal end, wherein the zip-sheath is connected to the catheter via the guidewire

In certain embodiments, the present invention relates to the aforementioned 10 apparatus, wherein there are between about 10 and about 15 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are 13 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there is about 1 0 mm between the distal ends of each optical fiber

15 In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 200 nm to about 810 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 250 nm to about 20 600 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 300 nm to about 500 nm

In certain embodiments, the present invention relates to the aforementioned 25 apparatus, wherein said plurality of wavelengths are in the range of about 350 nm to about 450 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 400 nm

In certain embodiments, the present invention relates to the aforementioned 30 apparatus, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog- bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloon with tubular sidecars, and braided balloons In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is a bellows balloon

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is made of polyethylene

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the length of the balloon is about 25 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter between about 1 cm and about 15 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter between about 2 cm and about 4 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter of about 2 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter of about 3 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter of about 4 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter pπor to balloon inflation is about 10 mm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter pπor to balloon inflation is between about 3 mm and about 7 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said light-emitting instrument is about 5 mm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said light-emitting instrument is between about 2 mm and about 5 mm

One aspect of the present invention relates to a method for debilitating or killing a microorganism in a body cavity of a patient, comprising the steps of providing an aforementioned apparatus, introducing the apparatus into the body cavity of a patient, and causing light to be transferred from the optical fibers of the apparatus to the body cavity of the patient In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of inflating the balloon

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of distending the body cavity with air

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of distending the body by inflating said balloon

In certain embodiments, the present invention relates to the aforementioned method, wherein the body cavity any portion of the gastro-mtestinal tract, the stomach, the mouth, the esophagus, the bowels, the lungs, the peritoneal cavity, the bladder, the womb, or the urinary tract In certain embodiments, the present invention relates to the aforementioned method, wherein the body cavity is the stomach

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of inserting a guidewire

In certain embodiments, the present invention relates to the aforementioned method, further comprising the steps of stopping light from being transferred to the body cavity of the patient, and re-causing light to be transferred to the body cavity of the patient, thereby delivering discrete pulses or intervals of light

In certain embodiments, the present invention relates to the aforementioned method, wherein said light is delivered in both a pulsed and continuous fashion In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of centering said balloon in said body cavity

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of positioning said balloon in said body cavity, thereby targeting a specific area of said body cavity

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter is less than about 10 mm

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter is between about 1 mm and about 10 mm In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter is between about 3 mm and about 6 mm

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter is about 5 mm

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter is about 4 mm

In certain embodiments, the present invention relates to the aforementioned method, further comprising a light source coupled to said proximal ends of said plurality of optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps

In certain embodiments, the present invention relates to the aforementioned method, wherein said light source is one or more laser diodes In certain embodiments, the present invention relates to the aforementioned method, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm In certain embodiments, the present invention relates to the aforementioned method, wherein said light source is operated in CW or pulsed mode, or a combination of both

In certain embodiments, the present invention relates to the aforementioned method, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein

In certain embodiments, the present invention relates to the aforementioned method, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting ofacetals, acrylics, cellulosics, chlorinated polyethers, fiuorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone, or a combination thereof In certain embodiments, the present invention relates to the aforementioned method, wherein said first sheath is comprised of a fluorocarbon

In certain embodiments, the present invention relates to the aforementioned method, wherein said first sheath is comprised of fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned method, wherein said proximal end of said first sheath terminates in a fluidic port

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting ofacetals, acrylics, cellulosics, chlorinated polyethers, fiuorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is comprised of fluormated ethylene-propylene or polyether block amides

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is comprised of fluormated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is comprised of fluormated ethylene-propylene with about 10% by weight of BaSO₄

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is comprised of fluormated ethylene-propylene with about 20% by weight of BaSO₄

In certain embodiments, the present invention relates to the aforementioned method, wherein said proximal end of said second sheath terminates in a fluidic port

In certain embodiments, the present invention relates to the aforementioned method, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon

In certain embodiments, the present invention relates to the aforementioned method, wherein there are between about 100 optical fibers and about 1,000 optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein there are less than or equal to about 100 optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein there are less than or equal to about 20 optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein there are less than or equal to about 15 optical fibers In certain embodiments, the present invention relates to the aforementioned method, wherein there are 13 optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein there are less than or equal to about 10 optical fibers In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers are arranged so that each distal end is at least 1 0 mm from all other distal ends

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers are arranged so that each distal end is at least 1 5 mm from all other distal ends

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers are arranged so that each distal end is at least 2 0 mm from all other distal ends In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers are arranged so that said distal ends are spaced over a length of about 25 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers are arranged so that said distal ends are substantially evenly distributed over a length of about 25 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of light-emitting optical fibers are connected or gathered into one or more bundles at their proximal ends

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of light-emitting optical fibers are loose, i e , not connected, at their distal ends

In certain embodiments, the present invention relates to the aforementioned method, wherein said distal ends of said light-emitting optical fibers further comprise one or more centering collars, thereby keeping said light-emitting optical fibers in the center of said apparatus

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers emit light at a wavelength in the range of between about 200 nm and about 810 nm In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers emit light at a wavelength in the range of between about 250 nm and about 600 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers emit light at a wavelength in the range of between about 300 nm and about 500 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers emit light at a wavelength in the range of between about 350 nm and about 450 nm In certain embodiments, the present invention relates to the aforementioned method, wherein said optical fibers emit light at a wavelength of about 400 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is a liquid

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is distilled water, de- ionized water, or essentially pure water

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is distilled water

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is isotonic aqueous saline solution In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride

In certain embodiments, the present invention relates to the aforementioned method, wherein said first fluid is an aqueous solution that contains barium sulfate In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is an aqueous solution that contains adjuvants, and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distπbute or flush out the pathogen within the body cavity so as to enable or enhance light therapy

In certain embodiments, the present invention relates to the aforementioned method, wherein adjuvants are administered in conjunction with the light treatment (prior to, during or following light treatment), and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is a gas

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is air

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is a liquid

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride

In certain embodiments, the present invention relates to the aforementioned method, wherein said second fluid is isotonic aqueous saline solution In certain embodiments, the present invention relates to the aforementioned method, wherein said first and second fluids are one and the same, and wherein the fluid is circulated withm all parts occupied by those fluids

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog-bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloons with tubular sidecars, and braided balloons In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is a bellows balloon

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon, when inflated, has a diameter of between about 2 5 cm and about 5 0 cm In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon, when inflated, has a diameter of about 3 0 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon, when inflated, has a diameter of about 3 5 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon, when inflated, has a diameter of about 4 0 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon, when inflated, has a diameter of about 4 5 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is less than about 30 cm long In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is between about 10 cm long and 30 cm long

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is about 25 cm long

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is about 20 cm long In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is about 15 cm long

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is porous to said second fluid In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is partially or completely transparent to the light emitted by said hght- emitting optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is comprised of a polymer or copolymer selected from the group consisting ofacetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is comprised of polyurethane

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is comprised of white, translucent, polyethylene

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is comprised of a polyurethane, and said first sheath is fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is comprised of white, translucent, polyethylene, and said first sheath is fluorinated ethylene-propylene

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is composed of an optically transmissive material

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of fluorescent dyes and colloidal particles In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, and colloidal gold

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is composed of an optically transmissive material which contains barium sulfate

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is composed of an optically transmissive material which has a metallic thin-film coating In certain embodiments, the present invention relates to the aforementioned method, further comprising a third sheath capable of constraining said balloon

In certain embodiments, the present invention relates to the aforementioned method, wherein said third sheath is comprised of a polymer or copolymer selected from the group consisting ofacetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide (Pebax), polyethylene terapthalate (PET), silicone or a combination thereof

In certain embodiments, the present invention relates to the aforementioned method, further comprising a guidewire, and a third sheath capable of constraining said balloon, wherein said third sheath comprises a guidewire lumen, thereby allowing attachment of said third sheath via a guidewire

In certain embodiments, the present invention relates to the aforementioned method, further comprising an atraumatic tip disposed on the distal end of said catheter

In certain embodiments, the present invention relates to the aforementioned method, wherein said atraumatic tip comprises a scattering insert In certain embodiments, the present invention relates to the aforementioned method, wherein said atraumatic tip comprises a guidewire lumen

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said first fluid In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said first fluid, wherein the temperature of said first fluid is about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said first fluid, wherein the temperature of said first fluid is about 20 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said first fluid, wherein the temperature of said first fluid is about 15 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said second fluid

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said second fluid, wherein the temperature of said second fluid is about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said second fluid, wherein the temperature of said second fluid is about 20 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of circulating said second fluid, wherein the temperature of said second fluid is about 15 ⁰C In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a pump, and wherein said first and second fluids are one and the same, and said pump is used to circulate said fluids

Another aspect of the invention relates to an apparatus for killing or debilitating pathological microorganisms in a body cavity of a patient, comprising a catheter body havmg a diameter, a length, a proximal end and a distal end, the catheter body defining therein a first lumen extending therethrough, a second lumen extending therethrough and optionally a third lumen extending therethrough, a balloon having a diameter, a length, a proximal and a distal section secured to the distal end of the catheter body so that an interior of the balloon is in fluid communication with the second lumen and optionally the third lumen, and the balloon having a non- expanded configuration and an expanded configuration, a light-emitting instrument having a diameter, a length, a proximal end and a distal end, the light-emitting instrument defining therein a fourth lumen extending therethrough, and a plurality of optical fibers emitting at a plurality of wavelengths, staggered along the distal section of said light-emitting instrument, wherein the light-emitting instrument is adapted to be delivered through the first lumen, thereby placing said plurality of optical fibers in the interior of the balloon In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a guidewire having a proximal end and a distal end

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a zip-sheath which surrounds the balloon when it is in its non-expanded consideration In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the zip-sheath is a polyethylene sheet

In certain embodiments, the present invention relates to the aforementioned apparatus, further comprising a guidewire having a proximal end and a distal end, wherein the zip-sheath is connected to the catheter via the guidewire In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there are between about 10 and about 15 optical fibers

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein there is about 1 0 mm between the distal ends of each optical fiber In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 200 nm to about 810 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 250 nm to about 600 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 300 nm to about 500 nm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 350 nm to about 450 nm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said plurality of wavelengths are in the range of about 400 nm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog- bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloon with tubular sidecars, and braided balloons

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein said balloon is made of polyethylene In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the length of the balloon is about 25 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter between about 1 cm and about 15 cm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter between about 2 cm and about 4 cm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the expanded configuration has a diameter of about 4 cm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter pπor to balloon inflation is about 10 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said catheter pπor to balloon inflation is between about 3 mm and about 7 mm In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said light-emitting instrument is about 5 mm

In certain embodiments, the present invention relates to the aforementioned apparatus, wherein the diameter of said light-emitting instrument is between about 2 mm and about 5 mm Another aspect of the invention relates to a method for debilitating or killing a microorganism in the body cavity of a patient, comprising the steps of providing a catheter body having a diameter, a length, a proximal end and a distal end, the catheter body defining therein a first lumen extending therethrough, a second lumen extending therethrough and an optional third lumen extending therethrough, providing a balloon having a diameter, a length, a proximal and a distal section secured to the distal end of the catheter body so that an interior of the balloon is in fluid communication with the second lumen and the optional third lumen, and the balloon having a non-expanded configuration, providing a light-emitting instrument having a diameter, a length, a proximal end and a distal end, the light-emitting instrument defining therein a fourth lumen extending therethrough, providing a plurality of optical fibers emitting at a plurality of wavelengths, staggered along the distal section of the light-emitting instrument, introducing said catheter body into the body cavity of the patient, inserting the light-emitting instrument into the first lumen, thereby placing said plurality of optical fibers in the interior of the balloon, passing a first fluid through the fourth lumen, over the optical fibers, into the distal end of the catheter, and through the first lumen, passing a second fluid through the second lumen, into the balloon, thereby expanding the balloon, and causing light to be transferred from the ends of the optical fibers to the body cavity of the patient In certain embodiments, the present invention relates to the aforementioned method, further comprising distending the body cavity with air In certain embodiments, the body cavity is the stomach

In certain embodiments, the present invention relates to the aforementioned method, further comprising providing a zip-sheath which surrounds the balloon in its non-expanded configuration

In certain embodiments, the present invention relates to the aforementioned method, further comprising using a guide wire to introduce the catheter

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of removing the guidewire, thereby separating the zip-sheath from the catheter

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of removing the zip-sheath In certain embodiments, the present invention relates to the aforementioned method, wherein said fluid is water, saline, barium sulfate particles in water, or a magnesium hydroxide solution

In certain embodiments, the present invention relates to the aforementioned method, wherein said fluid comprises particles which can scatter light

In certain embodiments, the present invention relates to the aforementioned method, wherein the second fluid is circulated through the balloon

In certain embodiments, the present invention relates to the aforementioned method, wherein the second fluid is removed from the balloon and replaced with a third fluid In certain embodiments, the present invention relates to the aforementioned method, where the second fluid is introduced at a temperature between about 5 ⁰C and about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, where the second fluid is introduced at a temperature between about 5 ⁰C and about 15 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, where the second fluid is introduced at a temperature between about 15 ⁰C and about 20 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, where the second fluid is introduced at a temperature between about 20 ⁰C and about 25 ⁰C

In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of pulsing the light In certain embodiments, the present invention relates to the aforementioned method, further comprising the step of monitoring the temperature of said body cavity

In certain embodiments, the present invention relates to the aforementioned method, wherein the body cavity is the stomach, the bowel, the lungs, the peritoneal cavity, or the urinary tract In certain embodiments, the present invention relates to the aforementioned method, wherein the body cavity is the stomach

In certain embodiments, the present invention relates to the aforementioned method, wherein the zip-sheath is a polyurethane sheet In certain embodiments, the present invention relates to the aforementioned method, wherein there are between about 10 and about 15 optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein there are 13 optical fibers In certain embodiments, the present invention relates to the aforementioned method, wherein there is about 1 0 mm between the ends of each of the optical fibers

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of wavelengths are in the range of about 200 nm to about 810 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of wavelengths are in the range of about 250 nm to about 600 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of wavelengths are in the range of about 300 nm to about 500 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of wavelengths are in the range of about 350 nm to about 450 nm In certain embodiments, the present invention relates to the aforementioned method, wherein said plurality of wavelengths are in the range of about 400 nm

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog-bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloon with tubular sidecars, and braided balloons

In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is a bellows balloon In certain embodiments, the present invention relates to the aforementioned method, wherein said balloon is made of polyethylene

In certain embodiments, the present invention relates to the aforementioned method, wherein the length of the balloon is about 25 cm In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration has a diameter between about 1 cm and about 15 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration has a diameter between about 2 cm and about 4 cm In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration has a diameter of about 2 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration has a diameter of about 3 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration has a diameter of about 4 cm

In certain embodiments, the present invention relates to the aforementioned method, wherein the expanded configuration does not engage the body cavity of the patient

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter before balloon inflation is about 10 mm In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said catheter before balloon inflation is between about 3 mm and about 7 mm

In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said light-emitting instrument is about 5 mm In certain embodiments, the present invention relates to the aforementioned method, wherein the diameter of said light-emitting instrument is between about 2 mm and about 5 mm

Selected Advantages of the Invention. Importantly, the aforementioned apparatus of the invention is designed such that it can be inserted easily and safely into a body cavity For example, the use of atraumatic surfaces, including an atraumatic tip (z e , soft, conformable and bio-compatible medical-grade materials with smooth surfaces), a flexible assembly (flexible optical fibers and soft polymers compliant with body geometry during insertion and placement), and a thm cross-section (thm optical fibers plus low-profile assembly with deflatable balloon and an optional removable cover sheath, allow insertion of the apparatus with little or no damage to soft tissue of the patient In certain embodiments the apparatus is guide-wire compatible, adding to its ease of use In addition, the method of treatment is consistent with standard medical practices and similar procedures (e g , endoscopy) wherein the patient can be kept comfortable

In certain embodiments, the instant invention can be used for selective photo- eradication In other words, preferential damage to a targeted pathogen, with little or no damage to bodily tissue, can be achieved The apparatus and method can be adjusted, as described above, to achieve the most effective optical (and adjuvant) parameters to minimize the time required for treatment In certain embodiments, the option to fractionate or pulse the light source permits optimization of both kinetic and oxygen diffusion effects, which can minimize unwanted photo-bleaching effects and allow for the control of temperature Given that photo-eradication is typically related to total dose (total dose is equal to delivered power multiplied by time), the present invention can be practiced in such a way (e g , pulsing) so that the required dose can be delivered without substantial heating to the body cavity being treated In certain embodiments, light from any external source may be launched into optical fibers allowing a wavelength bandwidth to be selected which will cause the greatest damage to pathogen (e g , for H pylori, Protoporphyrin IX and Coproporphyrm Soret absorption bands are centered at about 400 nm) In addition, the use of low absorption materials in certain embodiments permits a wide range of externally launched power, essentially independent of the structure of the device, to be used Further, the use of an externally pulsed, a cw, or a fractionated (z e , duty cycle-driven) light source, independent of the structure of the device, can allow optimization of the treatment In certain embodiments, by means of fiber stagger pattern, balloon diameter and launched power, selectable surface irradiance can be achieved

Another advantage of the instant invention is that it allows the delivery of light to, and distribution withm, a well-defined target zone For example, in certain embodiments light can be delivered to deep organs, large organ surface areas can be illuminated, irregularly shaped body cavities can be illuminated, and a selective patterning of light can be used to treat differentially infected areas In certain embodiments, the optical fibers utilized are long and thin which are well adapted for trans-luminal delivery In certain embodiments, the irradiance pattern used is diffuse (sometimes due to scattering sheath and/or selectable balloon diameter) which allows for a smooth distribution of light to large surface areas In addition, in certain embodiments, the irradiance pattern may be "shaped" for best fit to target area by means of scattering insert in tip, shape of tip, shape of fluid- filled balloon (which may act like a lens), the stagger pattern of the optical fibers, the total number of optical fibers, the adjustable power per fiber, the selection of scattering characteristics of materials used, and the overall length of assembly Yet another advantage of the instant invention is that, in certain embodiments, the temperature of the apparatus and surrounding body cavity can be controlled during illumination Control of temperature allows the avoidance thermal damage to bodily tissues and allows for the adjustment of local temperature (within tolerable limits) for optimal eradication (e g , heat damage to pathogen) Control of temperature is obtained, in certain embodiments, through the use of low absorption materials, the use of high heat capacity fluid (e g , water) in catheter balloon and light wand, the circulation of balloon fluid or successive filling/emptying of balloon, the fractionating of light to allow cool-down, and the minimization of irradiance "hot spots" by means of scattering sheath and a sufficient balloon diameter The instant invention is commercially viable In certain embodiments, the catheter and/or light wand can be made of inexpensive materials, allowing single use of each In addition, the modular design, separating the catheter from light source and pumps and monitoring equipment, allows disposal only of the catheter

Definitions. All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms

The indefinite articles "a" and "an," as used herein in the specification and m the claims, unless clearly indicated to the contrary, should be understood to mean "at least one " The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i e , elements that are conjunctively present m some cases and disjunctively present m other cases Multiple elements listed with "and/or" should be construed m the same fashion, i e , "one or more" of the elements so conjoined Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified Thus, as a non-limiting example, a reference to "A and/or B", when used in conjunction with open-ended language such as "comprising" can refer, in one embodiment, to A only (optionally including elements other than B), in another embodiment, to B only (optionally including elements other than A), in yet another embodiment, to both A and B (optionally including other elements), etc As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above For example, when separating items in a list, "or" or "and/or" shall be interpreted as being inclusive, i e , the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i e , "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of" "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law

As used herein in the specification and in the claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements

This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified Thus, as a non- hmitmg example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently "at least one of A and/or B") can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B), in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A), in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements), etc

It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited

In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i e , to mean including but not limited to Only the transitional phrases "consisting of and "consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111 03

In certain embodiments, the microorganism targeted by the instant invention is a prokaryote, including but not limited to, a member of the genus Streptococcus,

Staphylococcus, Bordetella, Corynebacteπum, Mycobacterium, Neisseria, Haemophilus, Actinomycetes, Streptomycetes, Nocardia, Enterobacter, Yersinia, Fancisella, Pasturella, Moraxella, Acinetobacter, Erysipelothrix, Branhamella, Actinobacillus, Streptobacillus, Listeria, Calymmatobacterium, Brucella, Bacillus, Clostridium, Treponema, Escherichia, Salmonella, Kleibsiella, Vibrio, Proteus, Erwima, Borreha, Leptospira, Spirillum,

Campylobacter, Shigella, Legionella, Pseudomonas, Aeromonas, Rickettsia, Chlamydia, Borrelia and Mycoplasma, and further including, but not limited to, a member of the species or group, Group A Streptococcus, Group B Streptococcus, Group C Streptococcus, Group D Streptococcus, Group G Streptococcus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus faecahs, Streptococcus faecium,

Streptococcus durans, Neisseria gonorrheae, Neisseria meningitidis, Staphylococcus aureus, Staphylococcus epidermidis, Corynebacterium diptheπae, Gardnerella vaginalis, Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium ulcerans, Mycobacterium leprae, Actmomyctes israelii, Listeria monocytogenes, Bordetella pertusis, Bordatella parapertusis, Bordetella bronchiseptica, Escherichia coll, Shigella dysenteπae, Haemophilus influenzae, Haemophilus aegyptius, Haemophilus paramfluenzae, Haemophilus ducreyi, Bordetella, Salmonella typhi, Citrobacter freundn, Proteus mirabilis, Proteus vulgaris, Yersinia pestis, Kleibsiella pneumoniae, Serratia marcessens, Serratia hquefaciens, Vibrio cholera, Shigella dysenteπi, Shigellaflexneπ, Pseudomonas aeruginosa, Franscisella tularensis, Brucella abortis, Bacillus anthracis, Bacillus cereus, Clostridium perfringens, Clostridium tetani, Clostridium botulmum, Treponema pallidum, Rickettsia πckettsu, Helicobacter pylori and Chlamydia trachomitis In certain embodiments, the microorganism targeted by this invention is Helicobacter pylori

As used herein, a "catheter" is a flexible, hollow tube that can be introduced into a patient A catheter has a distal end and proximal end As used herein, the distal end of a catheter is the furthermost end placed in the patient, the proximal end remains outside the patient

As used herein, a "fluidic port" is an opening with allows the introduction and/or removal of a fluid

As used herein, a "sheath" is a tubular, surrounding or enveloping structure A sheath can be open-ended or close-ended, as depicted below An open-ended sheath is like a drinking straw, a close-end sheath is like a test tube

"an open-ended sheath" " a closed-ended sheath"

A closed-ended sheath can be placed over an open-ended sheath, as depicted below

"a closed-ended sheath placed over an open-ended sheath"

As used herein, when two parts of an apparatus are said to be in "fluid communication," it indicates that fluid can pass through one part of the apparatus into another part of the apparatus The close-ended sheath and the open-ended sheath shown directly above are in fluid communication

As used herein, a "fluid" can be a liquid (e g , water or saline) or a gas (e g , air)

As used herein, "distilled water" is water from which all minerals and other impurities have been removed by the process of distillation, "de-iomzed water" is a form of water which lacks ions, such as those from sodium, calcium, iron, and copper, and "essentially pure" is water that is free of foreign substances that would be optically absorbing in the visible light range As used herein, "balloon" can refer to one or a plurality of balloons Examples of "balloons" are shown in the figures

As used herein, an "atraumatic tip" indicates a material shape and substance positioned at the distal end of the device that facilitates insertion of the device into a selected body cavity with a minimum of tissue trauma

As used herein, a "fluoropolymer" is a polymer that contains atoms of fluorine Polytetrafluoroethylene (PTFE) is an example of a fluoropolymer, as is fluormated ethylene-propylene (FEP)

As used herein the term "colloidal" refers to a state of subdivision, implying that the molecules or polymolecular particles dispersed in a medium have at least in one direction a dimension roughly between 1 nm and lμm, or that in a system discontinuities are found at distances of that order It is not necessary for all three dimensions to be in the colloidal range Likewise, a "colloidal dispersion" is a system in which particles of colloidal size of any nature (e g , solid, liquid or gas) are dispersed in a continuous phase of a different composition (or state) As used herein, the continuous phase is a fluid, preferably a liquid The term "colloid" may be used as a short synonym for colloidal system. The size limits given above are not rigid since they will depend to some extent on the properties under consideration This nomenclature can be applied to coarser systems, especially when a gradual transition of properties is considered Metals (e g , silver, gold or barium) and oils {e g, polyols, such as glycerol, and polyamines) can form colloidal dispersions

As used herein, "fluorescent dyes" are dyes that consists of molecules that selectively absorb light (e g , in the visible range of the spectrum) A dye is fluorescent because upon absorbing light, it instantly emits light at a longer wavelength than the light absorbed Examples of fluorescent dyes include fluorescein, tetramethylrhodamine and carboxy-x-rhodamine In certain embodiments, the fluorescent dyes of the invention are selected from the group consisting of 4-fluoro-7-aminosulfonylbenzofurazan, 6-((7-amino- 4-methylcoumarm-3-acetyl)amino)hexanoic acid, 6-((7-amino-4-methylcoumarin-3- acetyl)amino)hexanoic acid, succinimidyl ester, 4'-(aminomethyl)fluorescem, hydrochloride, 5-carboxyrhodamine 6G, hydrochloride, 5-carboxyrhodamine 6G, succinimidyl ester, 6-carboxyrhodamine 6G, hydrochloride, 6-carboxyrhodamine 6G, succinimidyl ester, 5(6)-carboxyrhodamine 6G, hydrochloride, 5(6)-carboxyrhodamine 6G, succinimidyl ester, 5-dimethylaminonaphthalene-l-(N-(5-ammopentyl))sulfonamide, 5- dimethylaminonaphthalene-1-sulfonyl chloride, 5-(4,6-dichlorotπazinyl)amino fluorescein, 6-(4,6-dichlorotπazinyl)amino fluorescein, 5-carboxyfluorescein, fluorescem-5- carboxamide cadaverine, fluorescein-5-carboxamide lysine, 5-carboxyfluorescein, succinimidyl ester, 6-(fluorescein-5-carboxamido)hexanoic acid, succinimidyl ester, 6- carboxyfluorescem, 6-carboxyfluorescein, succinimidyl ester, 5(6)-carboxyfluorescem, 5(6)-carboxyfluorescein, succinimidyl ester, fluorescein-5-isothiocyanate, 5-((5- aminopentyl)thioureidyl)fluorescein, fluorescem-6-isothiocyanate, fluorescein-5- thiosemicarbazide, fluorescamine, fluorescein-5-maleimide, 7-hydroxycoumarin-3- carboxyhc acid, 7-hydroxycoumarm-3-carboxylic acid, succinimidyl ester, 5- iodoacetamido fluorescein, 6-carboxy-4',5'-dichloro-2',7'-dimethoxyfluorescein, succinimidyl ester, 4-chloro-7-mtrobenzofurazan, 4-fluoro-7-mtrobenzofurazan, 5-carboxy- X-rhodamine, 5-carboxy-X-rhodamine, succinimidyl ester, 6-carboxy-X-rhodamme, 6- carboxy-X-rhodamine, succinimidyl ester, 5(6)-carboxy-X-rhodamine, 5(6)-carboxy-X- rhodamme, succinimidyl ester, 4-chloro-7-sulfobenzofurazan, ammonium salt, 4-fluoro-7- sulfobenzofurazan, ammonium salt, sulforhodamine, sulfonyl chloride, sulforhodamine, sulfonamide cadaverine , sulforhodamine, sulfonamide lysine, 5- carboxytetramethylrhodamine, 5-carboxytetramethylrhodamine, succinimidyl ester, 6- carboxytetramethylrhodamine, 6-carboxytetramethylrhodamine, succinimidyl ester, 5(6)- carboxytetramethylrhodamine, 5(6)-carboxytetramethylrhodamine, succinimidyl ester, 6- (tetramethylrhodamine-5(6)-carboxamido)hexanoic acid, succinimidyl ester, 5-((N-(5- aminopentyl)ammo)-carbonyl)tetramethylrhodamme, tetramethylrhodamine 5-carboxamide cadaverine, 5-((N-(5-amino-5-carboxypentyl)amino)carbonyl), tetramethylrhodamine, tetramethylrhodamine-5-carboxamide lysine, 6-((N-(5- aminopentyl)ammo)carbonyl)tetramethylrhodamine, tetramethylrhodamine 6-carboxamide cadaverine, 5(6)-((N-(5-aminopentyl)amino)carbonyl)tetramethylrhodamine, tetramethylrhodamine 5(6)-carboxamide cadaverine, tetramethylrhodamine-5- iodoacetamide dihydroiodide, and derivatives thereof

As used herein, "Milk of Magnesia" is used to describe a solution of magnesium hydroxide at about 8% weight/volume water EXEMPLIFICATION

The mvention now being generally described, it will be more readily understood by reference to the following examples, which are included merely for purposes of illustration of certain aspects and embodiments of the present invention, and are not intended to limit the invention

Example 1 Following symptoms, including stomach discomfort, "heart burn," and/or pam, a tentative diagnosis by the physician of stomach ulcers is made which is later confirmed by an endoscopic examination The diagnosis can then be further confirmed with standard enzymatic tests to detect the presence oϊH pylori Treatment using the present invention is then begun Following standard sedation, the light wand is inserted into the catheter, the catheter is inserted through the esophagus The distal or tip end of the catheter is then positioned as required under the supervision of the physician In certain embodiments the zip-sheath is removed and the balloon inflated The power supply is then turned on Fluid can be circulated through the balloon The light can be continuous or pulsed The catheter can be repositioned as necessary to provide adequate treatment to all of the affected areas, until the bacteria are either killed or incapacitated The instrument is then withdrawn

Example 2 Following a diagnosis of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, the bowel is cleansed conventionally The patient is sedated in the usual manner, and the light wand is inserted into the catheter, the catheter is then inserted through the rectum and advanced to the infected area to be treated The distal end of the instrument is then positioned where treatment is required and placed in proximity to the lesions on the lining of the colon that require treatment In certain embodiments the zip-sheath is removed and the balloon inflated Fluid can be circulated through the balloon The laser diodes are then used to produce a series of flashes that provide optimum exposure to the light radiation until the pathogenic bacteria are killed or debilitated The patient is then placed on a regimen of probiotics as already described for an indefinite period so as to reestablish the growth of innocuous flora within the bowel

Example 3. In Figure 17, the irradiance range was plotted for several measurement trials of three different catheters (a 3 cm diameter "scattering" balloon, a 3 cm diameter "clear" balloon, and a 4 cm diameter "clear" balloon) For each trial, about 30-40 irradiance measurements were made along the length of a light wand/catheter The range (MAX-MIN) was then calculated The range is expressed as a percent of the mean irradiance the top bar is (MAX-MEAN)/MEAN and the bottom bar is (MEAN- MIN)/MEAN The smaller the range the more uniform the irradiance distribution Note that a three centimeter "scattering" balloon performs like a 4 cm diameter "clear" balloon For all measurements the inventive instruments were held in a straight configuration The balloons used were bellows balloons

INCORPORATION BY REFERENCE

All of the U S patents and U S published patent applications cited herein are hereby incorporated by reference U S patent number 6,890,346 (Ganz et al ) is hereby incorporated by reference in its entirety, U S patent number 6,464,625 (Ganz et al ) is hereby incorporated by reference in its entirety, and U S patent number 6,491,618 (Ganz et al ) is hereby incorporated by reference in its entirety

EQUIVALENTS

While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present invention More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed The present invention is directed to each individual feature, system, article, material, kit, and/or method described herein In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present invention

Claims

We claim:

1. An apparatus comprising: a plurality of light-emitting optical fibers having proximal ends and distal ends; a first fluid; a first sheath with an open distal end; and a second sheath with a closed distal end; wherein said plurality of light-emitting optical fibers are arranged so that their distal ends are staggered, thereby forming a staggered array of optical fibers; and said first sheath is positioned over said staggered array of light-emitting optical fibers, said second sheath is placed over said first sheath, said first sheath and said second sheath are filled with said first fluid, and said first sheath and said second sheath are in fluid communication, thereby forming a fluid- filled optical diffusing section.

2. The apparatus of claim 1, further comprising a catheter, with a proximal end and a distal end, which comprises: a second fluid; an optional fluidic port at said proximal end; and a balloon at said distal end; wherein said balloon is placed over said fluid- filled optical diffusing section; and the introduction of said second fluid into said fluidic port inflates said balloon, while the removal of said second fluid from said fluidic port deflates said balloon.

3. The apparatus of claim 2, wherein the diameter of said catheter is less than about 10 mm.

4. The apparatus of claim 2, wherein the diameter of said catheter is between about 1 mm and about 10 mm.

5. The apparatus of claim 2, wherein the diameter of said catheter is between about 3 mm and about 6 mm.

6. The apparatus of claim 2, wherein the diameter of said catheter is about 5 mm.

7. The apparatus of claim 2, wherein the diameter of said catheter is about 4 mm.

8. The apparatus of claim 1 or 2, further comprising a light source coupled to said proximal ends of said plurality of optical fibers.

9. The apparatus of claim 8, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps.

10. The apparatus of claim 8, wherein said light source is one or more laser diodes.

11. The apparatus of claim 8, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps.

12. The apparatus of claim 8, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm.

13. The apparatus of claim 8, wherein said light source is operated in CW or pulsed mode, or a combination of both.

14. The apparatus of claim 1 or 2, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein.

15. The apparatus of claim 1 or 2, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

16. The apparatus of claim 1 or 2, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone, or a combination thereof.

17. The apparatus of claim 1 or 2, wherein said first sheath is comprised of a fluorocarbon.

18. The apparatus of claim 1 or 2, wherein said first sheath is comprised of fluorinated ethylene-propylene .

19. The apparatus of claim 1 or 2, wherein said proximal end of said first sheath terminates in a fluidic port.

20. The apparatus of claim 1 or 2, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

21. The apparatus of claim 1 or 2, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

22. The apparatus of claim 1 or 2, wherein said second sheath is comprised of fluorinated ethylene-propylene or polyether block amides.

23. The apparatus of claim 1 or 2, wherein said second sheath is comprised of fluorinated ethylene-propylene.

24. The apparatus of claim 1 or 2, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 10% by weight OfBaSO₄.

25. The apparatus of claim 1 or 2, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 20% by weight OfBaSO₄.

26. The apparatus of claim 1 or 2, wherein said proximal end of said second sheath terminates in a fluidic port.

27. The apparatus of claim 2, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon.

28. The apparatus of claim 1 or 2, wherein there are between about 100 optical fibers and about 1,000 optical fibers.

29. The apparatus of claim 1 or 2, wherein there are less than or equal to about 100 optical fibers.

30. The apparatus of claim 1 or 2, wherein there are less than or equal to about 20 optical fibers.

31. The apparatus of claim 1 or 2, wherein there are less than or equal to about 15 optical fibers.

32. The apparatus of claim 1 or 2, wherein there are 13 optical fibers.

33. The apparatus of claim 1 or 2, wherein there are less than or equal to about 10 optical fibers.

34. The apparatus of claim 1 or 2, wherein said optical fibers are arranged so that each distal end is at least 1.0 mm from all other distal ends.

35. The apparatus of claim 1 or 2, wherein said optical fibers are arranged so that each distal end is at least 1.5 mm from all other distal ends.

36. The apparatus of claim 1 or 2, wherein said optical fibers are arranged so that each distal end is at least 2.0 mm from all other distal ends.

37. The apparatus of claim 1 or 2, wherein said optical fibers are arranged so that said distal ends are spaced over a length of about 25 cm.

38. The apparatus of claim 1 or 2, wherein said optical fibers are arranged so that said distal ends are substantially evenly distributed over a length of about 25 cm.

39. The apparatus of claim 1 or 2, wherein said plurality of light-emitting optical fibers are connected or gathered into one or more bundles at their proximal ends.

40. The apparatus of claim 1 or 2, wherein said plurality of light-emitting optical fibers are loose at their distal ends.

41. The apparatus of claim 1 or 2, wherein said distal ends of said light-emitting optical fibers further comprise one or more centering collars, thereby keeping said light- emitting optical fibers in the center of said apparatus.

42. The apparatus of claim 1 or 2, wherein said optical fibers emit light at a wavelength in the range of between about 200 nm and about 810 nm.

43. The apparatus of claim 1 or 2, wherein said optical fibers emit light at a wavelength in the range of between about 250 nm and about 600 nm.

44. The apparatus of claim 1 or 2, wherein said optical fibers emit light at a wavelength in the range of between about 300 nm and about 500 nm.

45. The apparatus of claim 1 or 2, wherein said optical fibers emit light at a wavelength in the range of between about 350 nm and about 450 nm.

46. The apparatus of claim 1 or 2, wherein said optical fibers emit light at a wavelength of about 400 nm.

47. The apparatus of claim 1 or 2, wherein said first fluid is a liquid.

48. The apparatus of claim 1 or 2, wherein said first fluid is distilled water, de-ionized water, or essentially pure water.

49. The apparatus of claim 1 or 2, wherein said first fluid is distilled water.

50. The apparatus of claim 1 or 2, wherein said first fluid is isotonic aqueous saline solution.

51. The apparatus of claim 1 or 2, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts.

52. The apparatus of claim 1 or 2, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride.

53. The apparatus of claim 1 or 2, wherein said first fluid is an aqueous solution that contains barium sulfate.

54. The apparatus of claim 1 or 2, wherein said second fluid is an aqueous solution that contains adjuvants; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy.

55. The apparatus of claim 1 or 2, wherein adjuvants are administered in conjunction with the light treatment; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, render the pathogen susceptible to light therapy, localize or re-distribute or flush out the pathogen within the body cavity, or combinations thereof, so as to enable or enhance light therapy.

56. The apparatus of claim 2, wherein said second fluid is a gas.

57. The apparatus of claim 2, wherein said second fluid is air.

58. The apparatus of claim 2, wherein said second fluid is a liquid.

59. The apparatus of claim 2, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts.

60. The apparatus of claim 2, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride.

61. The apparatus of claim 2, wherein said second fluid is isotonic aqueous saline solution.

62. The apparatus of claim 2, wherein said first and second fluids are one and the same, and wherein the fluid is circulated within all parts occupied by those fluids.

63. The apparatus of claim 2, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog-bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloons with tubular sidecars, and braided balloons.

64. The apparatus of claim 2, wherein said balloon is a bellows balloon.

65. The apparatus of claim 2, wherein said balloon, when inflated, has a diameter of between about 2.5 cm and about 5.0 cm.

66. The apparatus of claim 2, wherein said balloon, when inflated, has a diameter of about 3.0 cm.

67. The apparatus of claim 2, wherein said balloon, when inflated, has a diameter of about 3.5 cm.

68. The apparatus of claim 2, wherein said balloon, when inflated, has a diameter of about 4.0 cm.

69. The apparatus of claim 2, wherein said balloon, when inflated, has a diameter of about 4.5 cm.

70. The apparatus of claim 2, wherein said balloon is less than about 30 cm long.

71. The apparatus of claim 2, wherein said balloon is between about 10 cm long and 30 cm long.

72. The apparatus of claim 2, wherein said balloon is about 25 cm long.

73. The apparatus of claim 2, wherein said balloon is about 20 cm long.

74. The apparatus of claim 2, wherein said balloon is about 15 cm long.

75. The apparatus of claim 2, wherein said balloon is porous to said second fluid.

76. The apparatus of claim 2, wherein said balloon is partially or completely transparent to the light emitted by said light-emitting optical fibers.

77. The apparatus of claim 2, wherein said balloon is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

78. The apparatus of claim 2, wherein said balloon is comprised of polyurethane.

79. The apparatus of claim 2, wherein said balloon is comprised of white, translucent, polyethylene.

80. The apparatus of claim 2, wherein said balloon is comprised of a polyurethane; and said first sheath is fluorinated ethylene-propylene.

81. The apparatus of claim 2, wherein said balloon is comprised of white, translucent, polyethylene; and said first sheath is fluorinated ethylene-propylene.

82. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material.

83. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of fluorescent dyes and colloidal particles.

84. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy- x-rhodamine, colloidal barium sulfate, and colloidal gold.

85. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material which contains barium sulfate.

86. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material containing regions of refractive index mismatch selected from the group consisting of gels, glasses, polymers doped with entrained solids, liquids and gases.

87. The apparatus of claim 2, wherein said balloon is composed of an optically transmissive material which has a metallic thin- film coating.

88. The apparatus of claim 2, further comprising a third sheath capable of constraining said balloon.

89. The apparatus of claim 88, wherein said third sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

90. The apparatus of claim 2, further comprising a guidewire; and a third sheath capable of constraining said balloon; wherein said third sheath comprises a guidewire lumen, thereby allowing attachment of said third sheath via a guidewire.

91. The apparatus of claim 2, further comprising an atraumatic tip disposed on the distal end of said catheter.

92. The apparatus of claim 91, wherein said atraumatic tip comprises a scattering insert.

93. The apparatus of claim 91, wherein said atraumatic tip comprises a guidewire lumen.

94. The apparatus of claim 1 or 2, further comprising a pump to circulate said first fluid.

95. The apparatus of claim 1 or 2, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 25 ⁰C.

96. The apparatus of claim 1 or 2, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 20 ⁰C.

97. The apparatus of claim 1 or 2, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 15 ⁰C.

98. The apparatus of claim 1 or 2, further comprising a pump to circulate said second fluid.

99. The apparatus of claim 2, further comprising a pump to circulate said second fluid; wherein the temperature of said second fluid is about 25 ⁰C.

100. The apparatus of claim 2, further comprising a pump to circulate said second fluid; wherein the temperature of said second fluid is about 20 ⁰C.

101. The apparatus of claim 2, further comprising a pump to circulate said second fluid; wherein the temperature of said second fluid is about 15 ⁰C.

102. The apparatus of claim 2, further comprising a pump; wherein said first and second fluids are one and the same; and said pump is used to circulate said fluids.

103. The apparatus of claim 1 or 2, further comprising an electronic gauge to measure the pressure of said first fluid.

104. The apparatus of claim 2, further comprising an electronic gauge to measure the pressure of said second fluid.

105. An apparatus comprising : a plurality of optical fibers having proximal ends and distal ends; a first fluid; a first sheath with an open distal end; and a second sheath with an open distal end; wherein said plurality of optical fibers are arranged so that their distal ends are staggered, thereby forming a staggered array of optical fibers; and said first sheath is positioned over said staggered array of optical fibers, said second sheath is placed over said first sheath, and said first sheath and said second sheath are filled with said first fluid, thereby forming a fluid- filled optical diffusing section.

106. The apparatus of claim 105, further comprising a catheter, with a proximal end and a distal end, which comprises: a fluidic port at said proximal end; and a balloon at said distal end; wherein said balloon is placed over said fluid- filled optical diffusing section; and the introduction of said fluid will inflate said balloon, while the removal of said fluid will deflate said balloon.

107. The apparatus of claim 106, wherein the diameter of said catheter is less than about 10 mm.

108. The apparatus of claim 106, wherein the diameter of said catheter is between about 1 mm and about 10 mm.

109. The apparatus of claim 106, wherein the diameter of said catheter is between about 3 mm and about 6 mm.

110. The apparatus of claim 106, wherein the diameter of said catheter is about 5 mm.

111. The apparatus of claim 106, wherein the diameter of said catheter is about 4 mm.

112. The apparatus of claim 105 or 106, further comprising a light source coupled to said proximal ends of said plurality of optical fibers.

113. The apparatus of claim 112, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps.

114. The apparatus of claim 112, wherein said light source is one or more laser diodes.

115. The apparatus of claim 112, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps.

116. The apparatus of claim 112, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm.

117. The apparatus of claim 112, wherein said light source is operated in CW or pulsed mode, or a combination of both.

118. The apparatus of claim 105 or 106, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein.

119. The apparatus of claim 105 or 106, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

120. The apparatus of claim 105 or 106, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone, or a combination thereof.

121. The apparatus of claim 105 or 106, wherein said first sheath is comprised of a fluoro carbon.

122. The apparatus of claim 105 or 106, wherein said first sheath is comprised of fluorinated ethylene-propylene.

123. The apparatus of claim 105 or 106, wherein said proximal end of said first sheath terminates in a fluidic port.

124. The apparatus of claim 105 or 106, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

125. The apparatus of claim 105 or 106, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

126. The apparatus of claim 105 or 106, wherein said second sheath is comprised of fluorinated ethylene-propylene or polyether block amides.

127. The apparatus of claim 105 or 106, wherein said second sheath is comprised of fluorinated ethylene-propylene.

128. The apparatus of claim 105 or 106, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 10% by weight OfBaSO₄.

129. The apparatus of claim 105 or 106, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 20% by weight OfBaSO₄.

130. The apparatus of claim 105 or 106, wherein said proximal end of said second sheath terminates in a fluidic port.

131. The apparatus of claim 105 or 106, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon.

132. The apparatus of claim 105 or 106, wherein there are between about 100 optical fibers and about 1,000 optical fibers.

133. The apparatus of claim 105 or 106, wherein there are less than or equal to about 100 optical fibers.

134. The apparatus of claim 105 or 106, wherein there are less than or equal to about 20 optical fibers.

135. The apparatus of claim 105 or 106, wherein there are less than or equal to about 15 optical fibers.

136. The apparatus of claim 105 or 106, wherein there are 13 optical fibers.

137. The apparatus of claim 105 or 106, wherein there are less than or equal to about 10 optical fibers.

138. The apparatus of claim 105 or 106, wherein said optical fibers are arranged so that each distal end is at least 1.0 mm from all other distal ends.

139. The apparatus of claim 105 or 106, wherein said optical fibers are arranged so that each distal end is at least 1.5 mm from all other distal ends.

140. The apparatus of claim 105 or 106, wherein said optical fibers are arranged so that each distal end is at least 2.0 mm from all other distal ends.

141. The apparatus of claim 105 or 106, wherein said optical fibers are arranged so that said distal ends are spaced over a length of about 25 cm.

142. The apparatus of claim 105 or 106, wherein said optical fibers are arranged so that said distal ends are substantially evenly distributed over a length of about 25 cm.

143. The apparatus of claim 105 or 106, wherein said plurality of light-emitting optical fibers are connected or gathered into one or more bundles at their proximal ends.

144. The apparatus of claim 105 or 106, wherein said plurality of light-emitting optical fibers are loose at their distal ends.

145. The apparatus of claim 105 or 106, wherein said distal ends of said light-emitting optical fibers further comprise one or more centering collars, thereby keeping said light-emitting optical fibers in the center of said apparatus.

146. The apparatus of claim 105 or 106, wherein said optical fibers emit light at a wavelength in the range of between about 200 nm and about 810 nm.

147. The apparatus of claim 105 or 106, wherein said optical fibers emit light at a wavelength in the range of between about 250 nm and about 600 nm.

148. The apparatus of claim 105 or 106, wherein said optical fibers emit light at a wavelength in the range of between about 300 nm and about 500 nm.

149. The apparatus of claim 105 or 106, wherein said optical fibers emit light at a wavelength in the range of between about 350 nm and about 450 nm.

150. The apparatus of claim 105 or 106, wherein said optical fibers emit light at a wavelength of about 400 nm.

151. The apparatus of claim 105 or 106, wherein said first fluid is a liquid.

152. The apparatus of claim 105 or 106, wherein said first fluid is distilled water, de- ionized water, or essentially pure water.

153. The apparatus of claim 105 or 106, wherein said first fluid is distilled water.

154. The apparatus of claim 105 or 106, wherein said first fluid is isotonic aqueous saline solution.

155. The apparatus of claim 105 or 106, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts.

156. The apparatus of claim 105 or 106, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride.

157. The apparatus of claim 105 or 106, wherein said first fluid is an aqueous solution that contains barium sulfate.

158. The apparatus of claim 105 or 106, wherein said first second is an aqueous solution that contains adjuvants; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy.

159. The apparatus of claim 105 or 106, wherein adjuvants are administered in conjunction with the light treatment; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, render the pathogen susceptible to light therapy, localize or re-distribute or flush out the pathogen within the body cavity, or a combination thereof, so as to enable or enhance light therapy.

160. The apparatus of claim 106, wherein said balloon is a bellows balloon.

161. The apparatus of claim 106, wherein said balloon, when inflated, has a diameter of between about 2.5 cm and about 5.0 cm.

162. The apparatus of claim 106, wherein said balloon, when inflated, has a diameter of about 3.0 cm.

163. The apparatus of claim 106, wherein said balloon, when inflated, has a diameter of about 3.5 cm.

164. The apparatus of claim 106, wherein said balloon, when inflated, has a diameter of about 4.0 cm.

165. The apparatus of claim 106, wherein said balloon, when inflated, has a diameter of about 4.5 cm.

166. The apparatus of claim 106, wherein said balloon is less than about 30 cm long.

167. The apparatus of claim 106, wherein said balloon is between about 10 cm long and 30 cm long.

168. The apparatus of claim 106, wherein said balloon is about 25 cm long.

169. The apparatus of claim 106, wherein said balloon is about 20 cm long.

170. The apparatus of claim 106, wherein said balloon is about 15 cm long.

171. The apparatus of claim 106, wherein said balloon is porous to said second fluid.

172. The apparatus of claim 106, wherein said balloon is partially or completely transparent to the light emitted by said light-emitting optical fibers.

173. The apparatus of claim 106, wherein said balloon is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

174. The apparatus of claim 106, wherein said balloon is comprised of polyurethane.

175. The apparatus of claim 106, wherein said balloon is comprised of white, translucent, polyethylene.

176. The apparatus of claim 106, wherein said balloon is comprised of a polyurethane; and said first sheath is fluorinated ethylene-propylene.

177. The apparatus of claim 106, wherein said balloon is comprised of white, translucent, polyethylene; and said first sheath is fluorinated ethylene-propylene.

178. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material.

179. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of fluorescent dyes and colloidal particles.

180. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy- x-rhodamine, colloidal barium sulfate, and colloidal gold.

181. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material which contains barium sulfate.

182. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material containing regions of refractive index mismatch selected from the group consisting of gels, glasses, polymers doped with entrained solids, liquids and gases.

183. The apparatus of claim 106, wherein said balloon is composed of an optically transmissive material which has a metallic thin- film coating.

184. The apparatus of claim 106, further comprising a third sheath capable of constraining said balloon.

185. The apparatus of claim 184, wherein said third sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

186. The apparatus of claim 106, further comprising a guidewire; and a third sheath capable of constraining said balloon; wherein said third sheath comprises a guidewire lumen, thereby allowing attachment of said third sheath via a guidewire.

187. The apparatus of claim 106, further comprising an atraumatic tip disposed on the distal end of said catheter.

188. The apparatus of claim 187, wherein said atraumatic tip comprises a scattering insert.

189. The apparatus of claim 187, wherein said atraumatic tip comprises a guidewire lumen.

190. The apparatus of claim 105 or 106, further comprising a pump to circulate said first fluid.

191. The apparatus of claim 105 or 106, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 25 ⁰C.

192. The apparatus of claim 105 or 106, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 20 ⁰C.

193. The apparatus of claim 105 or 106, further comprising a pump to circulate said first fluid; wherein the temperature of said first fluid is about 15 ⁰C.

194. A method for debilitating or killing a microorganism in a body cavity of a patient, comprising the steps of: providing an apparatus of claim 1; introducing the apparatus into the body cavity of a patient; and causing light to be transferred from the optical fibers of the apparatus to the body cavity of the patient.

195. A method for debilitating or killing a microorganism in a body cavity of a patient, comprising the steps of: providing an apparatus of claim 2; introducing the apparatus into the body cavity of a patient; and causing light to be transferred from the optical fibers of the apparatus to the body cavity of the patient.

196. A method for debilitating or killing a microorganism in a body cavity of a patient, comprising the steps of: providing an apparatus of claim 105; introducing the apparatus into the body cavity of a patient; and causing light to be transferred from the optical fibers of the apparatus to the body cavity of the patient.

197. A method for debilitating or killing a microorganism in a body cavity of a patient, comprising the steps of: providing an apparatus of claim 106; introducing the apparatus into the body cavity of a patient; and causing light to be transferred from the optical fibers of the apparatus to the body cavity of the patient.

198. The method of claim 195 or 197, further comprising the step of inflating the balloon.

199. The method of any one of claims 194-197, further comprising the step of distending the body cavity with air.

200. The method of claim 195 or 197, further comprising the step of distending the body by inflating said balloon.

201. The method of any one of claims 194- 197, wherein the body cavity any portion of the gastro-intestinal tract, the stomach, the mouth, the esophagus, the bowels, the lungs, the peritoneal cavity, the bladder, the womb, or the urinary tract.

202. The method of any one of claims 194-197, wherein the body cavity is the stomach.

203. The method of any one of claims 194-197, further comprising the step of inserting a guide wire.

204. The method of any one of claims 194-197, further comprising the steps of stopping light from being transferred to the body cavity of the patient; and re-causing light to be transferred to the body cavity of the patient; thereby delivering discrete pulses or intervals of light.

205. The method of any one of claims 194-197, wherein said light is delivered in both a pulsed and continuous fashion.

206. The method of claim 195 or 197, further comprising the step of centering said balloon in said body cavity.

207. The method of claim 195 or 197, further comprising the step of positioning said balloon in said body cavity, thereby targeting a specific area of said body cavity.

208. The method of claim 195 or 197, wherein the diameter of said catheter is less than about 10 mm.

209. The method of claim 195 or 197, wherein the diameter of said catheter is between about 1 mm and about 10 mm.

210. The method of claim 195 or 197, wherein the diameter of said catheter is between about 3 mm and about 6 mm.

211. The method of claim 195 or 197, wherein the diameter of said catheter is about 5 mm.

212. The method of claim 195 or 197, wherein the diameter of said catheter is about 4 mm.

213. The method of any one of claims 194-197, further comprising a light source coupled to said proximal ends of said plurality of optical fibers.

214. The method of claim 197, wherein said light source is selected from the group consisting of lasers, laser diodes, light emitting diodes, gas discharge lamps, flash lamps, arc lamps, incandescent lamps, and fluorescent lamps.

215. The method of claim 197, wherein said light source is one or more laser diodes.

216. The method of claim 197, wherein said light source is one or more arc lamps, flash lamps or gas discharge lamps.

217. The method of claim 197, wherein said light source emits continuously or in discrete wavelengths over a wavelength range of 350 nm to 450 nm.

218. The method of claim 197, wherein said light source is operated in CW or pulsed mode, or a combination of both.

219. The method of any one of claims 194-197, wherein said first sheath is tapered distally, thereby constraining the lateral motion of said staggered array of optical fibers placed therein.

220. The method of any one of claims 194-197, wherein said first sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

221. The method of any one of claims 194-197, wherein said first sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone, or a combination thereof.

222. The method of any one of claims 194-197, wherein said first sheath is comprised of a fluorocarbon.

223. The method of any one of claims 194-197, wherein said first sheath is comprised of fluorinated ethylene-propylene.

224. The method of any one of claims 194-197, wherein said proximal end of said first sheath terminates in a fluidic port.

225. The method of any one of claims 194-197, wherein said second sheath is partially or completely transparent to the light emitted by said light-emitting optical fibers.

226. The method of any one of claims 194-197, wherein said second sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

227. The method of any one of claims 194-197, wherein said second sheath is comprised of fluorinated ethylene-propylene or polyether block amides.

228. The method of any one of claims 194-197, wherein said second sheath is comprised of fluorinated ethylene-propylene.

229. The method of any one of claims 194-197, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 10% by weight OfBaSO₄.

230. The method of any one of claims 194-197, wherein said second sheath is comprised of fluorinated ethylene-propylene with about 20% by weight OfBaSO₄.

231. The method of any one of claims 194- 197, wherein said proximal end of said second sheath terminates in a fluidic port.

232. The method of claim 195 or 197, wherein said second sheath is perforated, thereby allowing fluid communication between said second sheath and said balloon.

233. The method of any one of claims 194-197, wherein there are between about 100 optical fibers and about 1,000 optical fibers.

234. The method of any one of claims 194-197, wherein there are less than or equal to about 100 optical fibers.

235. The method of any one of claims 194-197, wherein there are less than or equal to about 20 optical fibers.

236. The method of any one of claims 194-197, wherein there are less than or equal to about 15 optical fibers.

237. The method of any one of claims 194-197, wherein there are 13 optical fibers.

238. The method of any one of claims 194-197, wherein there are less than or equal to about 10 optical fibers.

239. The method of any one of claims 194-197, wherein said optical fibers are arranged so that each distal end is at least 1.0 mm from all other distal ends.

240. The method of any one of claims 194-197, wherein said optical fibers are arranged so that each distal end is at least 1.5 mm from all other distal ends.

241. The method of any one of claims 194-197, wherein said optical fibers are arranged so that each distal end is at least 2.0 mm from all other distal ends.

242. The method of any one of claims 194-197, wherein said optical fibers are arranged so that said distal ends are spaced over a length of about 25 cm.

243. The method of any one of claims 194-197, wherein said optical fibers are arranged so that said distal ends are substantially evenly distributed over a length of about 25 cm.

244. The method of any one of claims 194- 197, wherein said plurality of light-emitting optical fibers are connected or gathered into one or more bundles at their proximal ends.

245. The method of any one of claims 194- 197, wherein said plurality of light-emitting optical fibers are loose at their distal ends.

246. The method of any one of claims 194-197, wherein said distal ends of said light- emitting optical fibers further comprise one or more centering collars, thereby keeping said light-emitting optical fibers in the center of said apparatus.

247. The method of any one of claims 194-197, wherein said optical fibers emit light at a wavelength in the range of between about 200 nm and about 810 nm.

248. The method of any one of claims 194-197, wherein said optical fibers emit light at a wavelength in the range of between about 250 nm and about 600 nm.

249. The method of any one of claims 194-197, wherein said optical fibers emit light at a wavelength in the range of between about 300 nm and about 500 nm.

250. The method of any one of claims 194-197, wherein said optical fibers emit light at a wavelength in the range of between about 350 nm and about 450 nm.

251. The method of any one of claims 194-197, wherein said optical fibers emit light at a wavelength of about 400 nm.

252. The method of any one of claims 194-197, wherein said first fluid is a liquid.

253. The method of any one of claims 194-197, wherein said first fluid is distilled water, de-ionized water, or essentially pure water.

254. The method of any one of claims 194-197, wherein said first fluid is distilled water.

255. The method of any one of claims 194-197, wherein said first fluid is isotonic aqueous saline solution.

256. The method of any one of claims 194-197, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts.

257. The method of any one of claims 194-197, wherein said first fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride.

258. The method of any one of claims 194-197, wherein said first fluid is an aqueous solution that contains barium sulfate.

259. The method of any one of claims 194-197, wherein said second fluid is an aqueous solution that contains adjuvants; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, and/or localize or re-distribute or flush out the pathogen within the body cavity so as to enable or enhance light therapy.

260. The method of any one of claims 194-197, wherein adjuvants are administered in conjunction with the light treatment; and said adjuvants inhibit pathogen growth, inhibit colonization by the pathogen, as by inhibiting adhesion, render the pathogen susceptible to light therapy, localize or re-distribute or flush out the pathogen within the body cavity, or combinations thereof, so as to enable or enhance light therapy.

261. The method of claim 195, wherein said second fluid is a gas.

262. The method of claim 195, wherein said second fluid is air.

263. The method of claim 195, wherein said second fluid is a liquid.

264. The method of claim 195, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of fluorescent dyes, colloidal particles, colloidal oils, miscible liquids, polyols, polyamines, and soluble salts.

265. The method of claim 195, wherein said second fluid is an aqueous solution that contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy-x-rhodamine, colloidal barium sulfate, colloidal gold, glycerol, magnesium sulfate, magnesium hydroxide, titanium dioxide and sodium chloride.

266. The method of claim 195, wherein said second fluid is isotonic aqueous saline solution.

267. The method of claim 195, wherein said first and second fluids are one and the same, and wherein the fluid is circulated within all parts occupied by those fluids.

268. The method of claim 195 or 197, wherein said balloon is selected from the group consisting of bellows balloons, single balloons with centering webs, overlapping balloons, tufted balloons, alternating dog-bone balloons, closely spaced alternating balloons, construction method alternating balloons, covered individual balloons, multiple tubular balloons, single helical balloons, multiple helical balloons, quilted balloons with tubular sidecars, and braided balloons.

269. The method of claim 195 or 197, wherein said balloon is a bellows balloon.

270. The method of claim 195 or 197, wherein said balloon, when inflated, has a diameter of between about 2.5 cm and about 5.0 cm.

271. The method of claim 195 or 197, wherein said balloon, when inflated, has a diameter of about 3.0 cm.

272. The method of claim 195 or 197, wherein said balloon, when inflated, has a diameter of about 3.5 cm.

273. The method of claim 195 or 197, wherein said balloon, when inflated, has a diameter o f about 4.0 cm.

274. The method of claim 195 or 197, wherein said balloon, when inflated, has a diameter of about 4.5 cm.

275. The method of claim 195 or 197, wherein said balloon is less than about 30 cm long.

276. The method of claim 195 or 197, wherein said balloon is between about 10 cm long and 30 cm long.

277. The method of claim 195 or 197, wherein said balloon is about 25 cm long.

278. The method of claim 195 or 197, wherein said balloon is about 20 cm long.

279. The method of claim 195 or 197, wherein said balloon is about 15 cm long.

280. The method of claim 195 or 197, wherein said balloon is porous to said second fluid.

281. The method of claim 195 or 197, wherein said balloon is partially or completely transparent to the light emitted by said light-emitting optical fibers.

282. The method of claim 195 or 197, wherein said balloon is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

283. The method of claim 195 or 197, wherein said balloon is comprised of polyurethane.

284. The method of claim 195 or 197, wherein said balloon is comprised of white, translucent, polyethylene.

285. The method of claim 195 or 197, wherein said balloon is comprised of a polyurethane; and said first sheath is fluorinated ethylene-propylene.

286. The method of claim 195 or 197, wherein said balloon is comprised of white, translucent, polyethylene; and said first sheath is fluorinated ethylene-propylene.

287. The method of claim 195 or 197, wherein said balloon is composed of an optically transmissive material.

288. The method of claim 195 or 197, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of fluorescent dyes and colloidal particles.

289. The method of claim 195 or 197, wherein said balloon is composed of an optically transmissive material which contains optical modifiers selected from the group consisting of violet or blue fluorescers, fluorescein, tetramethylrhodamine, carboxy- x-rhodamine, colloidal barium sulfate, and colloidal gold.

290. The method of claim 195 or 197, wherein said balloon is composed of an optically transmissive material which contains barium sulfate.

291. The method of claim 195 or 197, wherein said balloon is composed of an optically transmissive material which has a metallic thin- film coating.

292. The method of claim 195 or 197, further comprising a third sheath capable of constraining said balloon.

293. The method of claim 195 or 197, wherein said third sheath is comprised of a polymer or copolymer selected from the group consisting of acetals, acrylics, cellulosics, chlorinated polyethers, fluorocarbons, polyamides (nylons), polycarbonates, polyethylenes, polypropylenes, polystyrenes, polyurethanes, vinyl resins, polyether block amide, polyethylene terapthalate (PET), silicone or a combination thereof.

294. The method of claim 195 or 197, further comprising a guidewire; and a third sheath capable of constraining said balloon; wherein said third sheath comprises a guidewire lumen, thereby allowing attachment of said third sheath via a guidewire.

295. The method of claim 195 or 197, further comprising an atraumatic tip disposed on the distal end of said catheter.

296. The method of claim 271, wherein said atraumatic tip comprises a scattering insert.

297. The method of claim 271, wherein said atraumatic tip comprises a guidewire lumen.

298. The method of any one of claims 194-197, further comprising the step of circulating said first fluid.

299. The method of any one of claims 194-197, further comprising the step of circulating said first fluid; wherein the temperature of said first fluid is about 25 ⁰C.

300. The method of any one of claims 194-197, further comprising the step of circulating said first fluid; wherein the temperature of said first fluid is about 20 ⁰C.

301. The method of any one of claims 194-197, further comprising the step of circulating said first fluid; wherein the temperature of said first fluid is about 15 ⁰C.

302. The method of claim 195, further comprising the step of circulating said second fluid.

303. The method of claim 195, further comprising the step of circulating said second fluid; wherein the temperature of said second fluid is about 25 ⁰C.

304. The method of claim 195, further comprising the step of circulating said second fluid; wherein the temperature of said second fluid is about 20 ⁰C.

305. The method of claim 195, further comprising the step of circulating said second fluid; wherein the temperature of said second fluid is about 15 ⁰C.