Remote eradication of pathogens

Abstract

A method and apparatus for remote eradication of pathogens, comprising a light source for emitting UV light within a pathogen-killing wavelength range, and a tangible transmission medium that is at least initially resistant to degradation by the UV light. An optical interface between the UV light source and the tangible transmission medium is provided, whereby emitted UV light is collected from the light source and transmitted through the tangible transmission medium, whereby UV light emitted from the tangible transmission medium and directed toward pathogens in its vicinity is at a power level sufficient to be substantially effective in killing the pathogens within a reasonable period of time. The apparatus is used for disinfection of endoscopic biopsy channels and for treatment of pathogens in humans and animals.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the following provisional patent applications, which are: 63 / 017407, filed on April 29, 2020; 63 / 044641, filed on June 26, 2020; 63 / 077003, filed on September 11, 2020; 63 / 118638, filed on November 25, 2020; 63 / 139294, filed on January 19, 2021; 63 / 149611, filed on February 15, 2021 and 63 / 115484, filed on November 18, 2020, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates to remote destruction or eradication of pathogens, such as viruses, bacteria, cancer, etc., where direct destruction is difficult or completely blocked, and in particular to pathogen eradicators, such as irradiation, which directly contacts the pathogen eradication in vivo from outside the body. The term eradication as used herein is equivalent to inactivation and does not necessarily mean complete destruction. The present invention particularly relates to ultraviolet (UV) light transmitted in the DNA / RNA destruction wavelength range through a tangible transmission medium, which has sufficient energy to effectively kill pathogens that are usually inaccessible, and in particular to such transmission into the human body, killing pathogens in the body, and killing pathogens in inaccessible or difficult-to-access infection sites during disinfection or killing pathogens in application scenarios that require strict control and centralized application. The present invention relates to maximizing the transmission intensity of light from a wide-angle light source such as an LED to an irradiation target through a transmission medium, such as an optical cable, and in particular to the transmission power intensity of deep UV (UV-C to UV-B range) light with minimal attenuation and maximum transmittable UV light power. Background Art

[0004] Pathogens, such as viruses, are easily eradicated when exposed to the outside (e.g., on surfaces) by various means, such as using soap and water that destroys the protective envelope of the virus, or using alcohol of sufficient strength (usually above 70%) as common hand sanitizers. For more than a hundred years, it has been known that ultraviolet light, especially in the deep ultraviolet range of UV-C (effective wavelength of 200-280nm), is a very effective pathogen eradicator and a large number of products use ultraviolet light for disinfection. However, a common feature of the effectiveness of such pathogen eradicators is the need for direct access. Once the pathogen is able to "hide" and become partially or completely inaccessible, the effectiveness is greatly reduced and depends on the degree of direct access necessary to which the pathogen eradicator can safely enter. UV-B (280-315nm) and the part of the UV-A range 315-340 in the 315-400 range) also show pathogen eradication effects, but to a much lesser extent.

[0005] Pathogens such as viruses, bacteria, and even cancers usually have a safe haven within the body or host organism where they can replicate and cause considerable damage, including death of the host organism, unless the interior is destroyed by chemical and biological components (e.g., drugs), removal of the pathogen from the infected area (surgery), or by radiation therapy.

[0006] Directly applied UV disinfection (although often attenuated by distance) has widely accepted uses, such as short-wave UV lamps used effectively in settings such as hospitals. However, the transmission of disinfecting UV light or even its use in the human body has recently been widely derided.

[0007] U.S. Patent Publication No. 2016 / 0114185 (Lacey Mankin)

[0008] There is a large amount of literature and patent literature related to the use of ultraviolet light to treat various viral and bacterial infections in animals or humans, especially in holes and cavities in the body. The vast majority of such literature describes the introduction of ultraviolet light sources such as LEDs directly into the body. Michael Gertner's U.S. patent application with publication number 2006 / 0195165 on August 31, 2006 (later abandoned) illustrates this emergency treatment method. It is known that there is no literature that illustrates an actual working device or the actual successful transmission of ultraviolet light that can be remotely positioned outside the body and effectively treat ultraviolet light, especially in highly restricted or difficult to access areas.

[0009] U.S. Patent Application Publication No. 2016 / 0114185, published on April 28, 2016 by Lacey Mankin (later abandoned), describes the use of ultraviolet light to kill viral pathogens in humans or animals by transmitting ultraviolet light through optical fibers of an endoscope. However, there is no teaching or example of actual light ultraviolet light collected from an ultraviolet light source or the transmission of ultraviolet light and application to a viral or bacterial target, nor is there any teaching or example of any structure or method that can utilize any degree of power to transmit such ultraviolet light through optical fibers to effectively kill pathogens in one go or within a reasonable time period, wherein such method can overcome any tendency of pathogens to spread faster than they can be eliminated by minimal ultraviolet application. Optical fibers used in endoscopes are generally very susceptible to degradation by deep ultraviolet light through a process called "solarization", which effectively prevents any deep ultraviolet light from being transmitted through the optical fiber. Instead, the deep ultraviolet light is completely absorbed by the optical fiber. In addition, although the patent application mentions that the ultraviolet light is effective in killing at 1.2 mW / cm 2 level, but this is when the UV light is applied directly without transmission, which would result in a significant, if not complete, loss of the UV light that would normally be output by the UV light source even when the fiber is not exposed.

[0010] Despite the suggestions of Lacey Mankin in the aforementioned abandoned patent application, it is now generally accepted, even among optical engineers, that deep UV light cannot be successfully transmitted through a transmission medium such as fiber optic cable with any useful pathogenic therapeutic power output. Prior art research has in fact experimentally demonstrated that the amount of UV power required to damage or kill pathogens such as viruses and bacteria is far greater than the powers and application methods mentioned in the aforementioned patent application, even without the substantial power losses encountered with UV transmission. The following is a description and table of prior art claims for direct viral and bacterial UV treatment, particularly for exposed wound treatment (for purposes of this application, mW / cm 2 Basically equivalent to mJoule or mJ / cm 2 ):

[0011] UV treatment of wounds, pathogens with power requirements:

[0012] Table 1. Potential applications of UV phototherapy in wound care and skin diseases

[0013]

[0014] UV Dose Required to Achieve Incremental Log Inactivation of Bacteria, Protozoa and Viruses, by Gabriel Chevrefils, B.Ing. Caron, B.Sc., revised and expanded by Harold Wright3 and Gail Sakamoto3, with earlier contributions (1999), and peer reviewed by Pierre Payment, Benoit Barbeau, and Bill Cairns, provides the UV dose effects for specific bacteria and viruses using low-pressure (LP) and medium-pressure (MP) mercury arc lamps as follows:

[0015] Note:

[0016] Table 2 – Escherichia coli C LP (Low Pressure Mercury Lamp)

[0017] This most common bacteria is extremely sensitive to UV doses ranging from 2mJ / cm 2 Change to 10.7mJ / cm 2 , that is, an increase of 8mJ in UV dose can reduce the bacterial concentration from 1Log to 7Log, a change of 6log. This is 1,000,000 times less than E. coli.

[0018] Table 4 – Rotaviruses with LP

[0019] This virus is much more powerful. 20mJ / cm 2 The first 10-fold reduction was achieved.

[0020] Then another 1,000 times (3log) reduction would require an additional 180 mJ / cm 2 .

[0021] Table 1

[0022]

[0023] Table 2 UV doses required for multiple log reduction of various bacteria

[0024]

[0025] Table 2 (continued)

[0026]

[0027] Table 3. UV doses for multiple log reductions of various protozoa

[0028]

[0029] Table 4. UV doses for multiple log reductions of various viruses

[0030]

[0031] Table 4. (Continued)

[0032]

[0033] Table 4. (Continued)

[0034]

[0035] Therefore, the biggest problem with effectively applying transmitted UV light is being able to apply high enough power, more specifically UV-C light, to kill pathogens at a meaningful rate in a reasonable amount of time. Deep UV light in the DNA / RNA damaging range is extremely susceptible to attenuation during transmission and will seek every opportunity to be absorbed by the transmission medium or be severely restricted from absorption for transmission. The transmission losses for the application disclosed in the patent application can be on the order of more than 95% of the light entering the endoscope fiber (much less than the amount of light emitted from the light source to be described) or even completely lost, with the far-end power output of existing UV light sources being measured in the low microwatts per square centimeter (if any at all). As shown in the table above, this is generally ineffective for UV exposure to pathogens in a reasonable amount of time, and is likely lower than the rate at which the human body (even if the immune response is overwhelmed) is able to kill pathogens.

[0036] UV-C light is usually too attenuated by its directional transmission to be used effectively, and in fact, it often corrosively attacks the medium through which it is transmitted, even the optical fibers commonly used in endoscopes, in a destructive process called solarization. To make the use of UV-C light for disinfection in, for example, the human body even more untenable, sources of pure emission UV-C light in the ideal and optimal 265nm range for DNA / RNA destruction are limited to pulsed xenon and mercury bulbs (with total UV power output of no more than about 4mW / cm2 for a particular wavelength). 2 ). Even currently produced UV-emitting LEDs and lasers themselves have very low efficiencies and very low direct output powers, which are measured in the low milliwatt range.

[0037] As a result, it is difficult to provide UV-C light with sufficient transmitted power (the applied power to kill pathogens is measured in millijoules rather than microjoules or microwatts per square centimeter of area) to effectively kill pathogens unless the pathogens are exposed for a long period of time (if that is possible), where the time here is usually measured in hours or even days (depending on various common factors, such as the extent of the area to be disinfected). This is particularly problematic in applications that require limited time parameters, such as in vivo treatments such as endoscopy, and where immediate effective treatment is critical.

[0038] Another problem with UV light transmission is the need to efficiently collect the UV light from the source (usually widely dispersed) into the transmission medium at first, and then into the appropriate acceptance angle to allow transmission rather than absorption into the walls or cladding of the transmission medium. A further problem is that the size of the inaccessible or difficult to access place is usually the smallest, and the widely collected light needs to be focused to such a minimum size. However, light, especially UV light, is not easily compressed, and further power losses are inevitably continued before any lighting application.

[0039] It should also be understood that the size of UV light sources such as LEDs, and certainly xenon and mercury lamp sources, are generally too large to be effective in direct access to inaccessible or difficult to access locations or areas such as the interior of the human body. Therefore, much of the literature and patent literature requires that the UV light source be inserted directly into the body and is therefore limited to accessible orifices and relatively large cavities within the body.

[0040] Furthermore, UV light sources are very inefficient (e.g., the maximum efficiency of currently available 265 nm LEDs does not exceed 1.5%). As a result, they generate a lot of heat, which can be very harmful to surrounding organisms or other delicate materials adjacent to them. Some literature recognizes this problem and provides measures to dissipate the heat. However, an effective heat sink only increases the bulk, making it more difficult to place such UV light sources directly near the infected site, especially those with limited access and small size.

[0041] The xenon arc lamps and mercury bulbs traditionally used as UV-C light sources are not limited to a single spectrum, but instead emit light over a wide spectral range, with the actual power in each portion of the spectrum being as low or lower than single-spectrum LEDs and lasers in the pathogen-killing range, such as at 265nm. The available power output of newly introduced LEDs (with efficiencies in the 1-1.5% range) typically does not effectively exceed the 40mW range for a 4W input, and lasers have lower power outputs, with larger and more expensive equipment. Standard light transmission media, such as optical fiber, even when formulated to resist environmental UV degradation, typically lose 95% or more of their output power within a 1-2 meter length, depending on length (which is the minimum requirement for endoscopic transmission), immediately de-energizing. As a result, there is usually not enough power available for one to treat internal pathogens with UV light in a reasonable amount of time (measured in seconds or even less than a minute, with a maximum of several minutes to half an hour per exposure site to avoid extreme patient discomfort or possible UV-C cell damage). From prior art studies it can be seen that effective reasonable duration of pathogen treatment generally requires an effective minimum power of about 2-20 mW per square centimeter, and for most viral pathogens, a distance of up to 35-50 mm.

[0042] Tech Talk Semiconductors Optoelectronics IEEE presented a recent study and presentation on the effects of deep UV light on pathogens on April 16, 2020. The study, titled "Ultraviolet-LED Maker Demonstrates 30Second Coronavirus Kill," was presented by Seoul Viosys and written by Samuel K. Moore, which provides a rough basis for determining the UV parameters (wavelength, application distance, application power, and duration) required to have a destructive effect on pathogens. The study provides results of direct (non-transmitted) output of a non-optimal 275nm LED on a viral cell (coronavirus), concluding that the virus was effectively killed within 30 seconds with an output power of approximately 20mW / cm 2 The distance is 1.5cm. According to the inverse square law, the power applied will increase greatly with closer distance.

[0043] It should also be noted that 275nm UV light is approximately 25% less effective at killing viral pathogens than 265nm UV light. Furthermore, the controlling factor for viral or other pathogen destruction is the power applied by the actual pathogen rather than the power initially generated, and these powers often vary widely due to losses that occur during transmission.

[0044] U.S. Patent Publication No. 2019 / 0175938 (Cedar Sinai)

[0045] Given these deficiencies and the need for extended exposure periods, trends such as those described in current published studies also include the prolonged use of UV-A light introduced into the patient via a fixed-place catheter device containing a UV-emitting LED (the UV light is not transmitted through a transmission medium) to safely kill viruses within the patient. Cedar Sinai Hospital is using this placed device to kill internal pathogens with light sources at the higher end of the UV spectrum, such as UV-B (280nm-315nm) and UV-A (315nm-400nm, wavelengths above 340nm, effectively have little or no pathogen killing effect), which are generally considered to be less harmful to healthy cells. These light sources, while potentially having greater output power, are much less efficient at pathogen destruction, often require unacceptably long exposure times, and, contrary to popular belief, may actually be more harmful due to greater tissue penetration. Cedar Sinai treatment requires multiple dosing over several days to extend the duration of each dosing and full and continuous anesthesia of the patient.

[0046] A system is described in U.S. Patent Publication No. 2019 / 0175938, assigned to Cedar-Sinai Hospital, that involves the use of UV-A and UV-B light delivered inside the body through a tube equipped with a string of UV-emitting LEDs. However, internal placement of electronic components, such as motorized LEDs, is undesirable, and UV-A and UV-B light, while relatively safer than UV-C light, are much less effective in eradicating pathogens and require longer application times.

[0047] Ultraviolet extracorporeal treatment of infected blood is also used for sterilization, but the treatment is performed outside the patient's body, with the sterilized blood returned to the human patient.

[0048] UV light scattering, absorption and collection:

[0049] With the exception of highly coherent and focused lasers, most visible light sources emit in a conical penumbra of about 120-130° (LEDs) or an emission range greater than 180° (bulbs). The latter is desirable in areas where a wider area of ​​illumination is required. For more focused uses such as flashlights, the lighting element bulb is located in a roughly conical reflector that roughly collimates the light within a narrower angular emission range. Special lenses are used to refract or focus the light as required. Visible light can easily achieve this lighting operation. If a specific purpose requires dynamically focused light, coherent visible lasers with significant power output can be easily obtained. Even with common collimation methods, a large amount of white light is lost when the light is transmitted through optical transmission media (such as optical fibers), which have specific angles at which they can only accept a portion of the light introduced into the end of the optical fiber. This disadvantage is usually overcome to some extent by increasing the lumen output of the light source, so that even if the input light has severe losses, the final output can provide sufficient illumination.

[0050] Invisible light, especially in the ultraviolet spectrum, and more specifically in the UV-C and UV-B ranges (deep UV), is not easily controlled in terms of emission range and power output, and the input power is not easily increased. This light is widely scattered, much greater than white visible light, and is more easily absorbed, with even greater transmission losses. To exacerbate the problem of deep UV light transmission, only deep UV light sources with low microwatt and low milliwatt power levels are currently available. Even laser diode sources can only provide outputs of no more than milliwatts, but the equipment is bulky and costly. Mercury and xenon bulbs, which have broad spectrum emissions and are common sources of deep UV light, need to be pulsed for such uses and provide similar low power levels at specific ultraviolet wavelengths. UV LEDs are currently available, but the output is in the low milliwatt range (usually no more than about 40mW).

[0051] Since deep UV light is invisible, its useful applications are generally limited to power applications, such as direct area disinfection, and instrument spectral detection. The transmission of UV light through a transmission medium inevitably results in almost complete losses (if not total losses) in the effective capture of the emitted UV light at the beginning, and then attenuation transmission losses caused by the transmission medium and / or collimating or focusing lenses and reflectors, as well as the minimum light entering the transmission medium. The loss of transmitted power of about 95% or more makes moderately transmitted deep UV light, already at low input power levels, relatively useless for disinfection, which requires higher output power levels for practical use. Although low UV attenuation fiber optic cables are available, their practical application is hindered by their UV absorption limiting angle that cannot actually accept enough UV light from the power source initially. However, fiber optic cables with higher UV light absorption rates are composed of materials that degrade rapidly when exposed to deep UV light, which either degrade immediately or have very short service lives with high attenuation. To the best of our knowledge, deep UV light in the DNA / RNA wavelength range has never been accomplished using any usefully emitted UV light with effective power levels. Therefore, UV light disinfection applications almost exclusively involve applying disinfecting UV light directly to air, water, and other materials and surfaces. Ultraviolet light delivery for non-disinfecting purposes such as borescopes is only readily transmittable non-deep UV-A light wavelengths with little or no power requirements.

[0052] Pathogen Sterilization:

[0053] Medical devices absolutely require strict sanitation and sterilization in sterilization and pathogen removal applications to prevent dangerous infections when reusing medical devices with strict FDA requirements. Common sterilization methods include autoclaving with hot steam and using sterilizing fluids that are often irritating and toxic. Each of these methods has significant disadvantages. Studies have shown that, except for very limited applications, UV-based disinfection is very harmful to common polymer medical devices, especially endoscopes.

[0054] Autoclaving with steam is time consuming and limits the time that medical devices can be used continuously, and is often limited to use with UV-resistant metal instruments. Conventional UV sterilization in a sterilization chamber bathed in UV light is limited by the compatibility of materials with UV light and the inability of the light to penetrate internal sites. Disinfectant liquids, while effective, require rigorous and lengthy procedures and are often unable to reliably access internal sites of highly susceptible materials, such as biopsy and endoscope suction channels, and also require rigorous and thorough removal of liquid chemicals, as even slight residues can have toxic effects.

[0055] Common instruments that require rigorous sterilization are flexible endoscopes used for pulmonary examinations, such as bronchoscopes. The actual endoscope that enters the body can be a major source of infection, and inadequate sterilization has recently been the source of a number of infection outbreaks due to inadequate removal of resistant microorganisms.

[0056] In addition to limiting the time of use (sterilization times typically exceed 30 minutes), autoclaving can affect the polymers that make up the structure of the endoscope as it generates heat and steam, and can cause the device to deform and degrade. These same polymers are also susceptible to UV damage and turn yellow and brittle. As a result, endoscopes are most often sterilized using disinfecting chemicals such as ethylene oxide or a series of chemical treatments. While the chemicals are easily and effectively removed from the outside of the endoscope in a bath, the internal portions of the endoscope often present challenges for complete sterilization and chemical removal after disinfection is completed. As a result, toxic residues may inadvertently remain, and resistant organisms may linger in the internal areas of the endoscope.

[0057] The primary internal areas of an endoscope with limited access and high sensitivity to microbial containment are the biopsy / aspiration or instrument channels through which biopsy specimens are extracted during endoscopic examinations. The dimensions of the biopsy / aspiration or instrument insertion channels of an endoscope are typically approximately 2.2-3.7 mm ID by 500 mm long. The very narrow cross-section and relatively long length present unique challenges for sterilization, which are further exacerbated by incomplete sterilization due to limited fluid access, possible air occlusion areas, and surface tension resistance to cleaning fluids such as removal of chemical liquids. Other limited access areas in endoscopes include narrower water and air introduction channels with an ID of approximately 1 mm.

[0058] Implanted medical devices, such as pacemakers and drug infusion sets, must be surgically removed, sterilized, and then re-implanted, with attendant medical complications and costs.

[0059] On a related non-medical level, certain non-medical applications, such as fluid transport pipes and ducts, cracks and crevices, particularly in moist environments such as bathrooms, are a breeding ground for various harmful growths and pathogens. However, since the area with the growths and pathogens cannot be accessed (which is often why the growths are so prevalent), cleaning is required, which is usually done with a mechanically propelled pig (with a cleaning element) inserted into the pipe size and thin tools such as brushes that cannot be truly sterilized. Flushing disinfecting chemicals are often very expensive to use over a large area in sufficient disinfecting quantities, and the chemicals are difficult to completely remove, especially from long pipes or ducts. Summary of the invention

[0060] It is an object of the present invention to provide a method and apparatus that enables pathogen-killing UV light, particularly UV-C light, to be delivered through a controllably positionable delivery medium with a power output sufficient to kill inaccessible or difficult-to-reach pathogens within a reasonable (application dependent) period of time, or with a high degree of direct focus.

[0061] It is another object of the present invention to provide a method and apparatus for collecting UV light from a UV light emitting source coupled with collimating and focusing elements to provide transmitted UV light with sufficient output power to kill pathogens within a reasonable period of time.

[0062] Another object of the present invention is to provide such emitted pathogen-killing ultraviolet light for use in sterilizing medical instruments such as endoscopes.

[0063] It is another object of the present invention to provide a method and apparatus for delivering pathogen-killing UV light for use in eliminating mold or other harmful biological organisms.

[0064] Another object of the present invention is to provide a method and apparatus for directing pathogen-killing UV light through a controllably positioned tangible transmission element, such as an optical fiber, carried by a standard endoscope, EBUS or similar aspiration needle (e.g., EUS), or other medically acceptable body insertion device, wherein the other medically acceptable body insertion device is capable of carrying and bringing the UV light transmission element in close proximity to or even at the site of pathogen infection, and transmitting UV light directly to an organ or pathogen-infected area of ​​the human body with sufficient power to kill pathogens, including viruses, bacteria, and cancer cells. Implanted medical devices can also be sterilized in situ if they are resistant to UV degradation.

[0065] Another object is to provide a method and apparatus for safely targeting and delivering pathogenicidal UV light into the nose, ears, throat, and genitals of a human to treat the pathogens contained therein.

[0066] Another object is to provide a device for disinfecting or sterilizing air and water, such as in a swimming pool or an enclosed vehicle, by transmitting UV light therethrough.

[0067] In several co-pending applications, and as described below, various structures, devices and methods are described for introducing UV light, particularly UV-C light in the wavelength range, and most particularly UV-C light in the 265nm (260-270nm) wavelength range, which is the most effective light for destroying the DNA / RNA of pathogens, such as viruses, bacteria, cancers, etc., safely and directly into the human body, i.e., in the area of ​​the body immediately adjacent to the pathogen infection (or potential infection). Other co-pending applications describe introducing UV light into inaccessible or difficult to access sites or areas to kill pathogens for disinfection purposes. Pathogens as defined for the purposes of this application include all DNA / RNA containing unhealthy items, such as viruses, bacteria, cancers, mold, mildew, etc., which are susceptible to damage by ultraviolet rays, and the areas containing these pathogens are referred to herein as infection sites or areas.

[0068] Another object of the present invention is to provide a light transmission method and device structure that significantly reduces optical power loss, especially reducing the optical power loss of white light LED light with a wide emission angle, and more particularly LED light emitted in the deep ultraviolet wavelength range.

[0069] Another object of the present invention is to provide a method and apparatus that significantly increases deep UV angular absorption from a UV emitting LED into a UV light transmitting medium having increased UV power output and useful UV light disinfection capabilities in UV treatment areas that are not normally easily accessible.

[0070] The "reasonable time" parameter usually depends on the emergency situation, such as life-threatening serious infection, inconvenience to patients and medical staff, and the need for rapid turnover and reuse of medical equipment and the need to reduce incomplete disinfection events. Generally, for each UV light application site in an application requiring multiple areas to be treated, the reasonable time for a specific application is ideally within a few seconds, and no more than a few minutes to about half an hour. For application, factors such as the need for fixed positioning, duration of anesthetic effect, degree of infection, available application power and distance are factors in determining a medically reasonable reasonable time. Unless the situation is very serious, the application time (or repeated operation) should not exceed the time that causes damage to healthy cells greater than the reasonable removal of pathogens.

[0071] Generally, in embodiments of the present invention, methods and apparatus for implementing the method include collecting and efficiently transmitting pathogen-killing UV light from a UV light source, such as a high-power 75mW or higher-power LED, through a tangible transmission medium, such as a low-UV attenuation optical cable (no more than about 3 dB loss per meter of length) that is at least initially resistant to degradation by UV light. The interface between the UV light source and the tangible transmission medium is sufficiently effective so that the UV light collected and transmitted has an initial sufficiently high power level so that, under attenuation and loss conditions, the UV light emitted from the transmission medium remains at a power level that is sufficient to substantially effectively kill pathogens near the output portion of the transmission medium within a reasonable period of time. Different target pathogens require different power levels, with the minimum power required to kill bacteria and the maximum power required to kill cancer cells. Through efficient collection and transmission, UV light sources with less power emission can also be effectively utilized.

[0072] Depending on the application and accessibility to the pathogen site, the transport medium can be operably positioned with or without a steerable carrier. For example, a steering device, such as an endoscope or hollow EBUS needle, can be carried, such as with video or other associated mapping steering for visual positioning, for positioning within a human or animal organ, and the sterilization process can be achieved by simply manually manipulating the transport medium without a separate carrier or positioning steering controls.

[0073] disinfect:

[0074] Generally speaking, one embodiment of the present invention comprises a method and apparatus for rapidly sterilizing structural elements and devices, including interior and normally inaccessible areas, from pathogens without chemicals and any heat-generating attendant residues.

[0075] The method requires that the structural elements and areas of the device being disinfected are generally inert to UV light ("inert" is defined herein as being minimally or unaffected by or not degradable by UV light), and comprises the following steps:

[0076] a) providing an elongated light transmission member, such as a fiber optic cable, having a UV light input at a first end thereof and a UV light output at a second end thereof. The cross-sectional dimensions of the elongated light transmission member are configured to enable the light transmission member to be inserted (generally without the need for a carrier or steering control) into an area of ​​a structural element or device until light transmitted through the transmission member is able to effectively reach most or all or substantially all of the portions of the area that may contain pathogens. The wavelength and power intensity of the UV light output are sufficient to disinfect the area of ​​the structural element or device containing pathogens at a desired distance and within a desired reasonable period of time. (UV-C light output is more desirable due to its faster speed and better disinfection effect on growth and pathogens, but UV-B and UV-A light having wavelengths that are effective in killing pathogens may similarly be used to compensate for the increased time and lower efficiency of the disinfection procedure). As the light output and the infected area are inserted and in close proximity, the power requirements are reduced due to the short distance and the inverse square law applied to the disinfection output;

[0077] b) inserting the light transmission member into or near the UV-inert area of ​​the structural element or device that may be infected with pathogens, so that the light transmission member can be moved close to the UV-inert area within a desired distance; and

[0078] c) moving the light transmission member and the UV-inert area relative to each other while the disinfecting UV light is transmitted through the light transmission member so that the UV light impinges on the UV-inert area to be disinfected at a desired distance and for a desired time sufficient to acceptably disinfect the UV-inert area.

[0079] An apparatus suitable for implementing the disinfection method includes an optical cable having a cross-sectional size suitable for insertion into an area to be disinfected and having sufficient flexibility to conform to the nonlinear interface of the area, as well as the relative disinfection movement for the method. A UV light source of sufficient power to achieve disinfection is provided at the optical input first end of the optical cable, and is optically connected thereto, for example, by a conventional LED to optical cable, butt coupling, or optical lens. The optical cable has sufficiently low UV attenuation (typically 3db / meter or less) so that the power of the UV light emitted from the second end output is sufficient to kill pathogens to a degree that is considered to be properly disinfected within a reasonable period of time required. The details of appropriate power, UV LED power output and attenuation, and UV output sufficient to kill pathogens are apparent from prior art studies, such as those presented above. Ideally, the UV application time for a single site is less than one second, and may be several seconds or even minutes, but should not exceed the time required for common but less reliable sterilization procedures.

[0080] In one embodiment, the normally opaque cladding (the term "cladding, as used herein, includes protective and optical layers on the optical fiber, such as buffers and light-retaining materials") of the optical cable is given UV transmittance, for example, by removing or replacing at least a portion of its length, which is usually about 1 cm, with a transparent or light-diffusing portion (as a non-limiting parameter). The disinfecting UV light is thereby radially transmitted to the proximal region of the structural element or instrument to be disinfected by relative motion. In another embodiment or combination of embodiments, during the relative motion, the distal emitting end emits disinfecting UV light in a backward or forward directional cone form, which irradiates the peripheral area to be disinfected.

[0081] The biopsy / aspiration or instrument channel in a typical endoscope is one of the most difficult parts of the endoscope to sterilize or disinfect because of its small diameter (typically about 2.2 to 3.7 mm inner diameter and about 500 to 600 mm in length) and relative inaccessibility. The most common method of disinfection is the use of disinfecting chemicals in a disinfecting bath. However, this presents a number of problems as failure to completely remove the chemicals can result in toxic residues. In addition, it is difficult to ensure complete contact with the chemicals or that the chemicals have sufficient time or extent to fully achieve disinfection. Other cleaning workarounds, such as the use of brushes, are not satisfactory in terms of use and the ability to ensure complete disinfection. Other small diameter areas of the endoscope include water and air introduction channels with inner diameters of approximately 1 mm, which present additional challenges for effective disinfection.

[0082] According to the effective disinfection method, a low UV attenuation optical cable of about 2 mm outer diameter (larger diameter cables can also be used for larger diameter channels) optically connected to an LED UV light source is inserted into the biopsy / suction or instrument channel of an endoscope with a standard diameter range of 2.2 to 3.7 mm. Once the UV light transmitted by the optical cable is inserted into the channel, it will irradiate the pathogen infection site and kill the pathogen within a determined time, which depends on the UV wavelength, transmission power and transmission distance. Generally, due to the close proximity of the infected site and the applied UV light, and depending on the output power, the disinfection time may be less than one second, a few seconds or even a few minutes. Longer time schemes may be suitable to ensure complete disinfection. The incident light is in front of the distal end of the optical fiber, or is arranged laterally or radially in the case where the optical fiber cable is removed from or inserted into the channel, and the end of the optical cable has been given lateral UV transmission or diffusion. The optical cable can be provided with a distal diffuser, etc. (usually about 10 mm in length). Similarly, optical cables of appropriate size can be inserted into other endoscope channels, such as endoscope channels of water and air, to disinfect them with UV light.

[0083] This ultraviolet treatment fiber can be used as part of an endoscopic treatment through a biopsy channel, as described therein, or as a separate tool for reliably, quickly, completely and safely sterilizing or disinfecting a biopsy or instrument channel of an endoscope at a rate that is the same as or less than the time required for normal extraction or insertion. If used as part of an endoscopic examination procedure, the UV light exposure is maintained during the removal of the optical cable from the biopsy channel for disinfection. The rate of removal of the optical cable is such that the UV light can fully irradiate the adjacent walls of the biopsy channel peripherally. The close distance between the optical cable and the inner wall of the biopsy channel ensures the effectiveness of the UV disinfection within a fraction of a second even with the small amount of mW of ultraviolet light output by the optically connected UV LED. As a double check that the biopsy channel is disinfected before operation, the UV light can be turned on and kept on before the optical cable is inserted into the biopsy channel. Alternatively, the device is provided with a pressure contact switch (on the front end or distal end of the cable) that maintains the UV light emission during the entire time the optical cable is in the biopsy channel. Other controls include sensors that monitor the presence of the optical fiber cable in the biopsy channel to control the ultraviolet light output. Since continued application of UV light to the device has no adverse effects, there is no maximum length of time that UV light may be continued, other than for convenience.

[0084] As a separate disinfection tool for often hard-to-reach parts of medical devices (with UV-resistant inner walls), a fiber optic cable carrying UV light can be easily inserted into these hard-to-reach parts, and the UV light can be turned on during insertion or removal. For optimal disinfection, the UV light is turned on during both insertion and removal. UV light during removal alone is more ideal than UV light during insertion alone because it also affects the disinfection of any pathogens originally carried by the initial insertion of the fiber optic cable. To protect personnel performing such disinfection, the open end of the biopsy channel may be capped to prevent external UV light leakage.

[0085] The biopsy / aspiration channel is uniquely suited for such disinfection because its interior surface needs to be chemically inert and reduce friction. Therefore, a material such as polytetrafluoroethylene (PTFE) or Teflon Materials are used to completely or substantially line the interior surface of the biopsy channel. As mentioned above, such materials are also inert to degradation by UV light, and the integrity of the endoscope is not compromised by the use of UV light for disinfection. Other endoscope channels are also commonly lined with Teflon and other inert materials, and can also be sterilized quickly and easily.

[0086] Since other accessible or external parts of the endoscope are easily degraded by UV light, disinfection of the endoscope includes disinfecting the easily accessible external parts of the endoscope with a chemical bath, and separately disinfecting the inaccessible parts of the endoscope by highly disinfecting UV light, especially the biopsy / aspiration channel.

[0087] Implanted medical devices, such as pacemakers, medical infusion sets, etc., can similarly be sterilized in situ with UV light, for example by placing the fiber optic cable end in place through a simple skin incision (e.g., laparoscopic surgery) and appropriately placed sterilizing UV light.

[0088] Equipment such as borescopes with fiber optic cables are likewise used to inspect or otherwise operate on structural elements such as metal, concrete, clay, and other types of materials that are also resistant to UV damage. Thus, mold, mildew, fungus, and pathogenic growth that is normally difficult to access can be eradicated by inserting a fiber optic cable carrying UV light. Due to minimized size constraints and no UV / human contact issues, in these applications, a UV light source, such as an electrically powered UV LED (suitably environmentally friendly), can be inserted directly into the structural element for disinfection, either as a single LED or as a projected array, with projected arrays being more ideal for larger diameter areas and greater distances of UV emission light propagation. In such applications, light is not actually transmitted, but rather can be carried by an elongated member that transmits power. A simple cable with a UV LED structure can be used as an insertable household cleaning tool to remove harmful growth in hard-to-reach areas such as ceilings or tile cracks that are normally not suitable for disinfectant formulations.

[0089] In another embodiment, the UV transmission cable is equipped with a distal focusing element, such as a lens, whereby the emitted UV light is focused on the pathogen or growth, such as mold, to ensure that the pathogen or growth is completely eradicated while preventing any return growth. In this embodiment with focused UV light, the UV transmission cable can be used for both inaccessible and accessible growth.

[0090] With the development of high power UV LEDs at 265nm (peak disinfection), with powers such as 40mW, 75mW; 95mW and 400mw, a sterilization box with one or more high power LEDs can be provided, which can be used directly during the surgical procedure, with the ability to instantly and completely disinfect surgical tools that are resistant to UV light, such as metal instruments, without having to spend half an hour waiting for autoclave sterilization to complete the disinfection. The box is equipped with a switch that activates when closed and closes when opened to prevent the emitted UV light. Even the most resistant viruses or bacteria can be eradicated immediately by this level of UV light and short-range exposure.

[0091] In vivo pathogenicity treatment:

[0092] Another disinfection embodiment for killing pathogens within a host such as a human or animal includes a method and apparatus for transmitting pathogen-killing UV light from a UV light source and through a UV-resistant transmission medium outside the body of a human or animal. The transmission medium is operably connected to a body insertion device, such as an endoscope or insertion needle, and is directed or guided (if necessary) into and through a human or animal into a position in close proximity with respect to the pathogen to apply the pathogen-killing light thereto.

[0093] The device includes a light source that emits UV light in the DNA / RNA destroying range, and in the most useful embodiments, in the UV-C range in the range of about 250 to 280 nm, with a peak at 265 nm. The light source, ideally a single high power UV-C LED, is optically connected to a UV-resistant, low attenuation light transmission medium, such as a fiber optic cable having a distal operative end having an OD suitable for insertion into a carrying instrument, such as an endoscope, and in further embodiments insertably positioned within the ducts and passages of an organ to position the distal UV emitting application end up to a few centimeters from the site of pathogen infection. For example, in the case of a carrying bronchoscope, the OD is typically 2 to 3.7 mm, and less than 1 mm in embodiments for reaching small, infected bronchi and bronchioles in the lungs. Even for access rather than insertion, such as in very narrow bronchioles, the emitted light can enter these small areas to disinfect pathogens contained in the colonoscope because the physiological size allows for a larger diameter. Other types of endoscopes are sized accordingly based on utilization and access parameters.

[0094] In all embodiments, specific parameters of the methods and apparatus for effectively and safely utilizing ultraviolet light to treat pathogenic cancer cells and tumors in vivo include applying UV light in close proximity directly to cancer cells and tumors, with highly controlled, focused and diffused ultraviolet light, particularly UV-C LED lamps of normally harmful intensity but with controlled timing and other parameters. As an adjunct, bacterial and viral pathogens can be similarly treated at lower time levels, power levels, and optionally with some deviation from the optimal wavelength.

[0095] It will be appreciated that reference to humans is for convenience and that the corresponding devices and methods are equally applicable to animals infected with pathogens.

[0096] The light source device provides deep UV light in the DNA / RNA destroying range, particularly a UV-C light generating element, particularly a UV-emitting LED with an effective power output. Other optional and desirable supplemental light generating elements may also be optionally provided, such as white light (for normal endoscopic operation), indicator lights, ablation lights for removal of inactivated pathogens, etc., to assist in locating and observing the site of infection or as operational feedback for the normally invisible application of ultraviolet light (which may similarly include other types of tactile feedback). If removal of killed pathogens, etc. is required or desired, an ablation lamp such as UV-A may be included. IR spectrum lamps may also be included to provide Raman spectral feedback related to the presence and degree of removal of pathogens.

[0097] Due to the potential toxic effects of internally applied UV-C light (although toxicity is minimal due to minimal penetration), one or both of the light source and the endoscope are optionally provided with controls to limit the extent of UV-C light application (i.e., the power applied). These controls, for example, limit duration, intensity (e.g., number of LEDs activated), power applied to individual LEDs, general power application, calculated application distance, etc., specific wavelength of UV-C light applied, focus, degree of pathogen infection (whether visible or merely indicated and assumed to be present), etc.

[0098] Existing commonly available UV-generating LEDs operating at a wavelength with maximum RNA / DNA damaging capabilities (265 nm) have essentially power outputs (20 mW or less, with LEDs of approximately 40 mW being difficult to obtain) that make them inadequate for direct combating pathogens such as viruses, fungi, or bacteria on surfaces or open wounds. Transmission of UV light through transmission media such as optical fibers is believed to completely or nearly completely reduce the output power to negligible and ineffective pathogen combating levels.

[0099] On the surface, high-power mercury arc and xenon bulb-generated UV lamps have been used for direct application UV disinfection purposes. However, such sources emit a wide range of wavelengths, require constant pulses and specific wavelengths (after filtering), and have lower specific power than single-wavelength LEDs. The aforementioned Mankin patent application discloses a directly usable power output of 1.2 mW. This generally makes them unsuitable for transmission in vivo in an unmodified form for inactivation of pathogens with losses exceeding 95% or even complete loss.

[0100] LEDs emitting ultraviolet light in the UV-A and UV-B wavelength ranges have been used (e.g., as in the above-mentioned patent application of Cedar Sinai Hospital), but at the expense of greatly reduced efficiency in destroying the RNA / DNA of pathogens and increased treatment times. UV-C is a complicating factor, as having sufficient power to be effective against pathogens presents the risk of UV-C-induced side effects and / or toxicity to healthy tissues, cells, and blood vessels. Therefore, it is considered important to control UV-C light.

[0101] UV LEDs developed for applicants embody the necessary characteristics of DNA / RNA damaging capabilities at the most effective wavelength levels (generally between 260 and 270 nm, peaking at 265 nm, which is the center of the RNA / DNA damaging sweet spot) as power levels increase, coupled with a power intensity of at least 40 milliwatts per LED for enhanced interference. Other effective long-lasting UV-C LEDs with emission powers of approximately 75mW, 90mW, and 360mW have also been developed specifically for the purpose of this application and are generally available from applicants. These LEDs in the 265nm range have been developed for the present invention with high stability despite enhanced thermal issues, housing and chip expanded size (with improved heat dissipation) and a judicious combination of heat resistant materials and glues for the construction of higher power 265nm UV-C LEDs.

[0102] Blood processing for pathogen removal, currently typically accomplished by ex vivo removal and processing of blood and return, could be accomplished by simply placing a portion of the distal end of an optical fiber into a blood vessel and emitting pathogen-killing ultraviolet light into the circulating blood stream without the need for blood removal.

[0103] UV light source:

[0104] UV LEDs are described and used in the invention of the present application, and their available characteristics of specifically defined UV emission wavelengths and controllability are desirable. Other newer alternative UV light sources (e.g., LED-based lasers or coherent light emitting LEDs) are being developed in accordance with the present invention, which can replace LEDs as UV light sources and are included herein.

[0105] The next generation of UV light generating devices is thought to be OLEDs (organic light emitting diodes), but the original UV LED remains unchanged and is still at the forefront in terms of applicability. The new generation of UV light sources can be called "solid-state light emitting devices" and include but are not limited to LEDs, OLEDs, pLEDs (polymer light emitting diodes), and the newest LEDs, quantum dots. Quantum dots actually emit UV-B light and may soon evolve to include high-power UV-C (265nm). As with diodes, using component materials other than silicon can result in large differences in performance, some of which may be smaller wavelengths. (Including lasers)

[0106] Future devices might not be diodes, but rather conduct more evenly in both directions. "Solid-state light-emitting devices" would encompass all of these, but might not include vacuum tubes, particle accelerators, or forms of radioisotopes.

[0107] Although a single LED with acceptable power output is most desirable in terms of simplicity and control, and is best suited for UV light collection, an array of LEDs with a combination of light delivery can also improve power output and may provide other desirable characteristics as defined herein. However, light collection and delivery and focusing of light arrays can be problematic and difficult to control to achieve effective output.

[0108] Internally directed UV-C light does not cause cancer, but will inactivate rapidly growing cancers using tumor DNA exposed to it in mitosis. The conclusion is that internal UV-C should be as high power as possible, increasing the power increases the desirability of cancer cell penetration, unlike X-rays which may cause normal tissue burns. In addition, the ability of healthy cells to repair the low to moderate DNA damage they may receive from UV-C light is likely to be very strong, especially when compared to the negligible repair capacity of cancer cells.

[0109] The LEDs in the array embodiments may also include UV-A and UV-B LEDs, but in smaller numbers, as these may actually be of higher power and are primarily used for ablation purposes. Each LED type array may have its own input / output switch and pulse generator and timer settings (such as UV-C) with integrated duty cycle and exposure time control. The microcontroller version does not need to (but may) have a physical switch to enable a combination of UV A, B, and / or C. Red emitting LEDs or any other color or shade are optionally included in any LED array and operably connected to the UV-C light generation as a clear real-time visual indicator of UV-C light generation.

[0110] The relatively safer but more penetrating UV-A light is not normally effective even at moderate exposures, but can be made effective by being very close to the UV light source for only a few seconds. Endoscopes of similar nature can be used in the same modified form to treat different organs or body parts attacked by bacterial, cancerous or viral pathogens. Applicants are currently developing UV-C emitting LED diode devices with highly focusable coherent light output, similar to lasers, with higher output power levels.

[0111] Operation feedback:

[0112] In further embodiments, the endoscope or, for example, a bronchoscope may be equipped with a photodetector that detects specific fluorescent pathogens to more effectively direct the UV light. Fluorescence of cancer cells is generally applied to other pathogens with similar applicability. Furthermore, in other embodiments, the endoscope or bronchoscope is equipped with a DNA fragmentation detector in order to determine the extent and scope of pathogen destruction by UV treatment. As organisms grow and replicate their DNA, their DNA is more exposed and particularly susceptible to external radiation. Therefore, this selective effect, i.e., a faster detrimental effect on viral DNA proliferation within virus-infected cells compared to lung cells, is likely to serve to increase the differential effect of close-range UV light in destroying viruses and viral cells and cells that are not invaded by viruses.

[0113] White light illumination from conventional LEDs and red or other colored aiming light from colored LEDs can be combined or bundled with UV-C light in a single beam. Criteria for UV-C light effectiveness include adequate power and optimized wavelengths as well as safety, control of power through any or all timed releases or bursts, and control of the number of LEDs activated and their power emissions. LEDs or various powers and wavelengths can be combined and appropriately controlled as needed to achieve effectiveness while minimizing peripheral damage to healthy tissue.

[0114] IR or Raman spectroscopy (IR radiation applied with a section of optical fiber inserted) can be used to identify the position of characteristic peaks of the virus present, with the height of the peak indicating the degree of infection.

[0115] UV light collection and transmission processing:

[0116] Regarding in vivo UV delivery, this is primarily a therapy, not a cure, one that works in concert with other methods or alone at first, then with a lightning-fast assault on human tissues with unforgivably blunt and more powerful X-rays. Hundreds of billions of dollars have been spent on cancer research and treatment. This therapeutic device and protocol essentially destroys localized tissues infected with bacteria and viruses (i.e., by disrupting RNA structures to eliminate replication of viral or bacterial pathogens on tissues), as well as selectively killing cancer and tumor cells (also damaging DNA), with minimal impact on adjacent healthy cell tissues.

[0117] Effective transmission media for introducing therapeutic UV light into the body, particularly those carried by existing endoscopes, generally require the following criteria for optimal performance:

[0118] a) UV light sources with UV light output in the DNA / RNA damaging wavelengths and ideally at or near 265 nm wavelength have the greatest DNA / RNA damaging effect.

[0119] b) To compensate for the inevitable power losses inherent in the transmissive emission of UV light from the UV light source, the power output is preferably greater than 20 mW, ideally 75 mW or more, the greater the output, the greater the inherent flexibility of the system.

[0120] c) The optical interface between the UV light source and the transmission medium should be as complete as possible, and the transmission medium end, such as the optical cable end, should be able to completely cover the light source, such as the bare chip of an LED, for physical docking connection (by proper alignment, for example, using an xy plane alignment device) or insertion of a light guiding interface that collects light from the light source, collimates it and focuses it to the near end of the transmission medium.

[0121] d) The emitted UV light should be maximally collectible with minimal scattering and maximum transmission by the transmission medium. For UV-compatible fiber optic transmission cables, this is the transmission toward the end of the cable, less than the absorption acceptance angle of approximately 20 to 27 degrees (light above the acceptance angle is absorbed and converted to heat).

[0122] e) A transmission medium is required that is resistant to the effects of UV light, flexible as required, and sized to collect and transmit light with appropriate cladding, diffusers, and dimensional parameters for collecting light and fitting into the operating area and channel. Flexible optical fibers, especially those with low UV attenuation components, have very small diameters, typically less than 600 microns, and if the fiber is to accept LEDs effectively, it should have a larger diameter, typically several millimeters, or a fiber bundle with a large spacing gap and light intake loss. Fusion-ended fibers provide good intake, minimize gap losses, and are still flexible, and the distal operating portion of the fiber is a separate fiber bundle and has the necessary flexibility.

[0123] f) Light collection is optimal, with larger diameter transmission media being better at accepting light, while light output transmission media require a minimum diameter for flexibility (typically about 1 cm bend radius for bronchoscopic applications) and a small diameter (1 mm or less) to enable the transmission media or such as optical fibers to be inserted into the small diameter channels of a bronchoscope or EBUS or EUS aspiration needle and used to access small organ regions such as lung bronchi. Focusing media such as lenses or tapered fiber sections can be used for optical transmission, but with significant losses in UV transmission and power.

[0124] g) Taking into account all power losses of the UV light source, including attenuation losses in the transmission medium, failure to fully capture or properly transmit the light, and transition losses, the output optical power should be at least 2 mW / cm 2 , more preferably at least 20 mW / cm 2 It should be emitted from the far end of the transmission medium to the pathogen for effective and reasonably timed eradication of the pathogen. A power loss of greater than 95% is not unexpected.

[0125] The following is a description of structures and methods for efficient UV light transmission, which increase the light transmission power level to effective values.

[0126] DNA / RNA destroying UV light is similar to, and may even be better than, a non-systemic therapeutic adjunct to localized conventional X-ray radiation therapy for the afflicted body. Another embodiment includes an efficient light delivery device and light delivery method for focused light application and actual UV disinfection in hard to reach areas, such as within the body or within narrow passages, such as endoscopes.

[0127] One embodiment of the method comprises the following steps:

[0128] a. emitting light from a widely scattered incoherent light source, such as an LED;

[0129] b. collimating the emitted light to a diameter that effectively captures and collimates substantially all of the incoherent light emitted by the light source;

[0130] c. introducing substantially all of the collimated light into a low attenuation light transmission medium having a diameter at least substantially equal to the diameter of the collimated light (it will be understood that the collimation need not be perfect, but may be sufficient to introduce the light at an angle less than the angular absorption angle);

[0131] d. focusing the collimated light to a focal point into a transmission medium of a smaller diameter of the desired size; and

[0132] e. Light is emitted from a smaller diameter transmission medium with enhanced power and intensity.

[0133] Alternatively, steps b), c) and d) may be combined with a single or combined element that achieves collimation and focusing while using transmission media of substantially equal diameter.

[0134] In a specific embodiment, a device for implementing the method includes a light source, such as an LED, which is surrounded by a reflective collimating member such as a cone or parabola (symmetrical or asymmetrical or off-axis), the bottom portion of which allows the light source to enter, allowing collimated reflection of substantially all (or at least most) of the light emitted from the light source. The device also includes a short transition light collection and transmission element, which has a relatively high light acceptance angle and matches the open end of the collimating member to maximize the diameter of the collimated light collected. The short transition light collection and transmission element is in turn coupled to a short first optical cable of similar diameter through a low attenuation coupler and is transmitted to the optical cable with maximum light. The first optical cable of similar diameter is then coupled to a longer second optical cable of reduced diameter with a low attenuation focusing input lens, the second optical cable being used for the far-end output of light, wherein the longer second optical cable is inserted into a difficult-to-reach area where light output is required.

[0135] Components that can be used to output deep UV emitting LEDs include a light collection and transmission element that is a usable light pipe or liquid light guide that has an acceptance angle for UV light that is more than twice that of available low attenuation UV cables. Light pipes and liquid light guides are comparable in absorption angle to UV degradable plastic cables, but without the degradation. Further reductions in UV light losses can be obtained by removing the attenuating air (particularly the nitrogen component of air) from the reflective collimating member, such as by drawing a vacuum or partial vacuum therein or by integrating the reflective collimating member with a short liquid light guide and filling it with the same liquid.

[0136] Another embodiment of a method of maximizing remote end deep UV light output in a UV light delivery system comprises the following steps:

[0137] 1. Collimating all UV light output by integrating the UV light source with a collimating member, the output diameter of the collimating member being larger than the diameter of the UV light source and at least the diameter of the collimated light;

[0138] 2. Collecting substantially all of the collimated UV light with light collector and emitter elements having low UV light attenuation transmission, wherein the diameters of the light collector and emitter are optically matched to the output diameter of the collimating member; and

[0139] 3. Transmit and focus the collected collimated light onto a UV light delivery cable with a remote output.

[0140] Modifications of the above configurations include coupling a short light pipe or liquid light guide directly to a long fiber optic cable through a lens focusing coupler, utilizing light pipes or liquid light guides of different diameters with appropriate collimating or focusing lens couplers.

[0141] LEDs with unique 120° or greater hemispherical emission are difficult to focus using ordinary optics. A parabolic mirror reflector is a good match for LEDs because it can collimate (reflect to parallel rays) such widely divergent light. Traditionally, such large collimated beams are usually focused to a point or smaller area by lenses. However, according to the present invention, transition elements can be used to enhance the collection of light that is usually lost due to limited light absorption (especially UV light). The transition elements include liquid light guides filled with higher refractive index substances. They have larger numerical apertures and can be made with larger core diameters, making them very suitable for coupling. A section of similar size optical cable is coupled by the known method of coupling two optical cables and matching numerical apertures, and the light leaving the transition liquid light guide is moved to small or difficult to access places. For interconnection with smaller diameter optical cables, fiber-to-fiber couplers can also be used. The above process is more important for smaller wavelengths than for longer wavelengths. Therefore, for ultraviolet use, especially the smaller UV-C wavelengths, this series of components may be particularly useful, which can achieve greater overall transmission efficiency than if these initial optical mirrors and light guides were not used. However, liquid light guides have difficulties with flexibility compared to optical fibers and are generally more effective for endoscopy or other applications where little or no flexibility is required.

[0142] To further aid light collection, in one embodiment, the UV LED is provided with an integrated lens which, while introducing some losses, also reduces the normal 120° emission output angle to more closely match the absorption angle of the connected optical fiber, e.g., 27°, thereby increasing the amount of light directed into the optical fiber for transmission. It will be appreciated that this lens and any other lens used in coupling or UV light transmission must be resistant to degradation by ultraviolet light. In general, quartz is an ideal resistant material, although it is more difficult to process and produce than plastic lenses and is more expensive.

[0143] In another embodiment, the collimation entering the liquid light guide is replaced by a lens system such as a TIR (total illumination preservation) lens, which is configured to collimate light collected from a light source such as an LED and then focus the collimated light to a focal area or plane equal to or smaller than the diameter of the optical fiber.

[0144] Aspheric lenses, especially when used in pairs, provide similar collimation functions, focusing into narrow diameter fibers.

[0145] Light from a source mounted in a notch at the bottom of the lens is collimated by the parabolic portion of the lens, and the collimated light is then immediately focused by the concave portion of the lens into a first fiber bundle at a focal region or plane, shown as 11 mm from the far end of the lens. The first fiber bundle is, for example, 8 to 12 mm in diameter, and is an intermediate to a second, smaller fiber bundle (1 to 2 mm) via a second demagnifying focusing element between the first and second fiber bundles. To avoid light loss, the TIR lens is preferably configured to focus the collimated light to fit the diameter of the smaller fiber bundle.

[0146] A typical example of a TIR lens that can be used has a diameter of about 20 mm, with an inserted 3.9 x 3.9 LED having a light emitting die of about 1.2 x 1.2 mm and with a focus distance of about 16 mm.

[0147] The aluminum ferrule end of the cable secures the cable in position relative to the TIR lens, focusing light onto the 2mm cable end at the focal point of the lens. The cable can be easily removed and replaced by releasing the ferrule clamp as needed for sterilization purposes or wear.

[0148] To reduce the overall distance to the focus, which is a light loss factor for UV light, another embodiment has a separate parabolic collimating element connected to the focusing convex lens, such as a Fresnel type lens with significantly smaller folds and thickness, but similar focal length.

[0149] Matching different numerical apertures to a spherical lens provides better coupling. One way to match optics to different sized entrance and exit light cones is to use a spherical (ball) lens. An example is coupling light from a larger angle emitter, such as an LED, into a fiber optic cable with a lower entry angle. Side-emitting LEDs have a smaller emission angle than top-emitting LEDs, but still larger than a fiber optic cable.

[0150] In a further embodiment, the focus distance volume is closed and the volume containing air (including the parabolic collimator) is provided with a partial vacuum or an inert gas. By using the former, the parabolic structure is strengthened to prevent gas pressure collapse.

[0151] It is worth noting that commercially available TIR and Fresnel lenses are composed of plastics such as polycarbonate that are susceptible to UV degradation. Therefore, for use in collimation and focusing, lenses are constructed of UV inert materials such as quartz with the same or similar effective configuration and structure. However, degradable lenses can be used with disposable elements and can be used multiple times before unacceptable performance occurs due to degradation. Other lenses include aspherical lenses for selective focusing as needed.

[0152] The present application is used in a similar manner to current radiation therapy, except that relatively weak UV-C light is used instead of X-rays, and it is delivered directly inside the body, very close (usually no more than 25mm) to the desired area, rather than the usual external radiation therapy. The X-rays used in radiation therapy are essentially a similar type of light, or more accurately electromagnetic radiation, but at a higher frequency and therefore higher energy level. The RNA / DNA sensitivity peak common to bacteria, viruses, and tumors is 254nm-275nm, which means the maximum peak of UV-C light is about 265nm.

[0153] Borescopes for transmitting UV light are configured entirely to transmit UV light in the visible wavelength spectrum, for example, in the 365 nm range, which has little effect on pathogens or their destruction. Borescope UV transmission is used for mechanical effects, such as detection of metal fatigue or defects, curing of glue, etc. Therefore, these devices and uses of UV light outside of pathogen-affecting wavelengths are not within the scope of this application.

[0154] Security Question:

[0155] As mentioned above, due to safety concerns, the latest practical developments in UV pathogen therapy (almost exclusively viral and bacterial treatments, which are less invasive than cancer treatments) have focused entirely on UV-A light, although it is less effective and requires longer exposures.

[0156] Even at low power relative to X-rays, UV-C light can be too powerful and potentially harmful to healthy tissue or blood vessels, although this has not been clinically proven or even explored to any significant degree. To avoid this unproven degree of harm, precisely focused or more widely focused and controllable emission, controllable UV emitting LEDs with precise wavelengths, pulse circuits, and precise short duration exposures are provided and adjusted so that appropriate exposures are typically only a few seconds and at most a few minutes. The precise emission distance is typically obtained through physiological factors and experienced medical personnel, or even with the help of LIDAR or similar type circuit distance feedback.

[0157] Stretching the exposure with pauses between more intense UV pulses, with the same total energy, is known to greatly reduce damage to normal cells, which is often attributed to normal cells having better working DNA repair mechanisms that can correct DNA damage if given enough time compared to pathogen-infected cells.

[0158] Light source operating parameters regarding the level of pathogen inactivation and the level at which healthy cells and tissues are adversely affected are measured in terms of the UV-C light power level that actually reaches the pathogen or healthy cells or tissue. These are typically measured based on the area affected in units of millijoules per square centimeter (mJ / cm 2 and their size changes). The baseline measurement is calibrated to UV-C application at 265nm (ideal wavelength for RNA / DNA destruction), the variables are the power level generated, application time and generation distance from the application site, and changes in focus. An operational table with variables and inactivation effects determines the proper, effective and safe UV-C light application. Inactivation of pathogens such as viruses and bacteria requires seconds or at most minutes of UV-C light applied directly to the pathogen at milliwatt power levels.

[0159] Tuberculosis, pneumonia, and bronchitis are all pathogens (bacteria and viruses) that enter the body through the respiratory system and end up in the lungs. Therefore, they are surface-initiated pathogens that infiltrate the lung tissue. UV-C light does not have a penetration problem when applied to these surface-initiated pathogens. A full bronchoscopy lasts about 30 to 60 minutes to view the different bronchi and airways, as well as about 20 major areas of a typical lung. Therefore, a full lung treatment takes a little longer.

[0160] Since the above pathogens are more easily destroyed than human tissue, determining the differences between the various destructions as defined above provides a basis for selecting the targeting power level to be used.

[0161] The effects of UV light, especially UV-C, have been studied and measured in terms of mJ / cm 2 The power level at the damaging wavelength (ideally 26nm wavelength) determines a number of baseline pathogen destruction. These have been exemplified in the tables reproduced above for specific pathogens.

[0162] One of the issues regarding the detection of pathogens (i.e. viruses and bacteria) is that the only real basis for locating bacterial and viral sites is the location of visible physical damage caused by the pathogen.

[0163] Therefore, using an endoscope such as a bronchoscope to target the damaged site with UV-C light, with a higher confirmed differential value and more focused UV-C light, since the virus or bacteria is definitely present and has taken up residence in the cells. The entire remaining lung may be covered with lower power UV-C light as a precaution against possible presence of viruses or bacteria. In the latter regard, using a wider focal spread may be useful. Depending on the minimum time per site determined, the normal bronchoscopic procedure time should be adjusted appropriately.

[0164] It is well known that distance has a large effect on effective intensity and energy transfer, with an inverse square relationship. Therefore, specific distances are included in the definitions used for various distance settings. The peak DNA sensitivity curve is broad enough that a wavelength range of 10nm can be safely used, as 90% of the power of known LED UV-C devices is within 265nm + / - 5nm. Therefore, the power that can be utilized is the UV-C device with 90% of its emitted power within the 265nm ideal range.

[0165] In addition to the classic bronchoscope, the UV light described in this article can be used for all types of endoscopes, such as those specialized for different organs, either inserted into body orifices or through small incisions. These include endoscopy, which is used to study many systems in the human body, such as:

[0166] Gastrointestinal tract: esophagus, stomach, and duodenum (esophagogastroduodenoscopy), small intestine (enteroscopy), large intestine / colon (colonoscopy, sigmoidoscopy), bile duct, rectum (proctoscopy), and anus (anoscopy).

[0167] Respiratory tract: nose (rhinoscopy), lower respiratory tract (bronchoscopy).

[0168] Ears: Otoscopy

[0169] Urinary tract: Cystoscopy

[0170] Female reproductive tract (gynecological examination): cervix (colposcopy), uterus (hysteroscopy), fallopian tubes (salpingoscopy).

[0171] Through small incisions: into the abdomen or pelvis (laparoscopy), inside a joint (arthroscopy), or into the chest organs (thoracoscopy and mediastinoscopy).

[0172] Capsule endoscopes that are not physically connected to external controls but are controlled (internal body movement and operation) or with magnetic, RF, Bluetooth, etc., and disposable endoscopes are also included herein. It will be appreciated that while organ treatment is the primary consideration, other body parts, such as blood and bone of the skeletal structure are also suitable for similar treatment of leukemia or other pathogen-based blood or bone diseases.

[0173] As used in this application, "endoscope" includes any structure that can be inserted into the human or animal body and is capable of carrying and transmitting UV light into the human or animal body through its own transmission elements or through a carried transmission element. The classical definition of endoscope is further expanded to not require viewing capabilities, but only its use in conjunction with positioning guidance devices, such as computer-linked X-ray guidance maps or even with experienced manual operation.

[0174] As described herein, the UV light source is located outside the human or animal body, and only the UV light emitted therefrom is transmitted into the body. In classic endoscopic devices, an external light box contains visible light emitting elements that are transmitted through the endoscope for illuminating and viewing internal body parts, such as organs. For example, as previously described, bronchoscopic endoscopes are used to visually inspect lung parts to detect abnormalities. In disposable endoscopes such as those sold under the GlideScope trademark, the light source or "box" is located in the handle control of the endoscope.

[0175] Battery packs, particularly those of the cartridge and replaceable type, can be used to enable endoscopes to have a fully portable configuration, such as the disposable endoscopes described above.

[0176] There is already a type of illumination cancer therapy that uses electromagnetic radiation of a higher frequency (smaller wavelength) than UV-C or even far-UVC. The X-rays used in radiation therapy are usually delivered externally and have a wavelength of 0.01-10nm. These are high-frequency and therefore high-energy electromagnetic radiation. Their wavelengths range from 0.01 to 10 nanometers, so the frequency range is 3×10 19 Up to 3×10 16 Hz. Higher frequencies have more energy (Planck's law). If UV-C degrades RNA and DNA links, X-rays will completely remove them! Brachytherapy for radiation therapy is tolerated because the alternative is more lethal. Using precisely delivered UV-C is much less lethal than X-rays, and it delivers more locally, internally, and with greater precision and guidance.

[0177] There are several characteristics of cancer cells that can be exploited in a more effective way. Cancer cells can be easily labeled, such as with fluorescent dyes, which makes them easily distinguishable from healthy normal cells. With this visible marker, a UV-C device can be programmed to detect cancer cells and determine through AI evaluation when to trigger UV light treatment at the optimal focused distance with the optimal pulsed or timed UV intensity while avoiding the effects of UV light on neighboring healthy normal cells. Stage 4 cancer patients with metastatic cancer sites can be treated more effectively as a result of this fine-tuning of treatment. Often, the broadly applied therapies required to treat metastatic cancer tend to also affect normal cells to a large extent, with accompanying lethal effects. Highly focused UV light can eliminate this lethal effect by minimizing the range of normal healthy cells that are treated along with the cancer cells.

[0178] One factor in determining the required UV light intensity is determining how well the light penetrates thick tissue layers and whether the cancer cells are blocked in deeper pockets where more cancer cells are present. Specifically, using high-powered LEDs with wavelengths all in the DNA / RNA peak sensitivity region will yield the greatest effectiveness and shortest exposure time.

[0179] There are clear differences between normal cells and viruses and bacteria. This difference can be easily exploited for safe UV treatment. Regarding cancer cells versus healthy cells, the difference in the effect of UV light on cancer cells relative to healthy cells is established.

[0180] The DNA of cells that divide (replicate, such as in mitosis) rapidly involves frequent and prolonged unwinding of their DNA so that it can be copied, translated, and used to make proteins used to make another cell. Harmful cancer cells, by definition, grow much faster than the body can sustain and much faster than normal cells. Normal cell DNA is much more protected from the effects of DNA-damaging UV-C photons than the DNA of rapidly growing tumor cells, which frequently and regularly expose themselves to radiation.

[0181] The second relative weakness of cancer cells is that they do not have a functioning DNA error repair system like healthy normal cells do. Normal cells have enzymes that correct single letter errors and open links. This works in tandem with the first mechanism. Not only are cancer cells more susceptible to radiation-based DNA damage, but this damage is not repaired as quickly as it is in normal cells.

[0182] A third and additional difference between normal cells and tumor cells is that this rapid growth of cancer cells requires more and rapidly available energy. Cancer has altered the ATP-->ADP cycle (releasing available energy). These modifications made by the cells and their ability to operate in a low oxygen environment (hypoxia). Prior art literature provides evidence that such hypoxia can make tumor cells "resistant to radiation and chemotherapy". If so, it has further synergy with UV-C radiation therapy, where the treatment regimen of the virus produces a large amount of RNA fragments, which the body interprets as foreign. This leads to antibody production, but no residual pathogen. This could lead to a powerful mechanism to prevent reinfection by the pathogen. This is similar to vaccine regimens using weakened viruses.

[0183] When extended external transmitted UV radiation for cancer treatment is needed for several hours, such as at night, the periodic exposure as described above may be suspended and an endoscope or a dedicated small UV-C source with adjustable duty cycle and exposure time is connected to the outside of the remaining optical "organ window". After removing the cancerous tumor, such as by dissolution, the surgeon removes the connector and fiber segment and reseals the skin. This may be suitable for deep brain UV delivery because there is no copper or other contaminating materials left inside except for the glass (silicon dioxide) transmission member. A stage 4 cancer situation would be an appropriate condition where several hours of radiation that is harmless to normal tissue is needed at each of the multiple points, preferably delivered simultaneously and quickly.

[0184] Antibody activation or production may be a "side effect" of UV RNA / DNA destruction therapy. "Fluorescence" of viral or antibody cells or organ area tissues can help to demonstrate the affected areas.

[0185] According to one embodiment of the present invention, a method for treating humans or animals against viral and / or bacterial pathogens comprises the following steps:

[0186] 1) Inserting an endoscope equipped with fiber-optic light transmission into a human organ or body part infected with a pathogen,

[0187] 2) Guide the endoscope close to the pathogen,

[0188] 3) directing, via fiber optic light delivery, UV light of sufficient intensity and duration to destructively interrupt the replicating DNA of the pathogen with minimal adverse effects on the tissue of a human or animal organ or body part, and

[0189] 4) Provide sufficient disruptive disruption to effectively treat humans or animals.

[0190] A system is described by which the exposure time required to destroy a specific identified pathogen is determined and then used to effectively control the appropriate UV light delivery. For example, for the same power level and spectrum, if a coronavirus in the throat and upper trachea requires 35 seconds of treatment, influenza requires 15 seconds of treatment, and bacterial infections require 5 seconds of treatment. Using an insertion tube similar to the structure of a penlight or otoscope, UV-C light can be directly close to the pathogen (such as a cold virus) for the shortest possible time. The penlight or otoscope is a useful implementation example because it has no external wires, which minimizes power transmission leakage. The use of high power output UV-C LEDs operationally facilitates the use of higher powers to shorten exposure times. Fortunately, by leveraging today's rechargeable battery packs and their high power density technology, safe wireless and convenient power delivery has also been developed. The oral cavity is another easily accessible place to insert and treat pathogens such as strep throat, and since the common cold is viral, treatment may be effective in improving or even curing the common cold. Even dental treatment can be facilitated, since tooth decay is caused by bacteria that are easily eliminated by UV light.

[0191] If distance measurement is required in a non-visible area, a distance measurement device such as LIDAR can be included in the fiber bundle, where one fiber in the bundle provides the laser signal and the other fiber receives the laser signal to activate the echo distance measurement. Ultimately, it may be better to protect the data without relying on distance. Bathing the area with UV light and killing viruses but not healthy tissue avoids the distance problem regardless of distance. When targeting bacteria or viruses, penetration at long distances is minimal and will hardly affect deeper tissue. Even if it kills a thin layer, it will probably die and be replaced. With tumors, in order to obtain penetration, high power is needed to be pointed directly at the tumor, so distance is no longer an issue. Distance issues arise when trying to penetrate a tumor and cannot get the endoscope pointed directly at it.

[0192] A push button / foot switch trigger can be used to precisely emit a light pulse of calibrated duration (exposure) in a manner that does not interfere with the endoscope user's use of both hands. For convenience, these controls may be Bluetooth or other wireless connection mechanisms.

[0193] An optional preliminary step is a step of pre-localizing the pathogen, for example using X-rays, fluorescence or other known localization procedures. An optional final step is detection of DNA fragmentation to determine the effectiveness of the UV light treatment and the direction of further steps, if necessary.

[0194] Even in the deep UV range of 265nm, fiber optic cables such as those provided by Molex have minimal attenuation. In one embodiment of the present invention, such low attenuation fiber optic cables are used to replace existing endoscope optical fibers (with standard endoscope retrofits) in order to allow UV-C light from a UV-C light source such as an LED array described in the co-pending application to enter organs such as the lungs to quickly kill pathogens such as viruses and bacteria in a time frame before the UV-C light has an adverse effect on healthy cells and tissues. Low attenuation fiber optic cables allow smaller LED arrays or other UV-C light sources with lower power to be used in an equivalent manner because the attenuation power transmission losses are minimized. In fact, testing has shown that optical fibers commonly used in endoscopes are not suitable for any deep UV transmission.

[0195] As mentioned above, prior art has shown that UV-C modules can kill Covid-19 tissue cultures in 30 seconds, achieving a 99.9% kill rate with direct application of light with a UV wavelength of 275nm. The 18mw used for 30 seconds is approximately 600mJ of energy.

[0196] Replacing the original optical fiber in the endoscope with a special low-attenuation optical cable requires special processing and repair of the existing endoscope. Therefore, in another embodiment, no modification of the existing endoscope is required.

[0197] In this embodiment, the device includes a separate low UV-C attenuation optical cable suitable for insertion into an endoscope insertion tube (typically used for insertion into a biopsy tool) or a biopsy / aspiration channel having a length suitable for a particular type of endoscope. The optical cable is further configured with a UV-C light transmitting end and the other end is low-attenuation coupled to a collimating or focusing lens or coupled to an optically bundled UV-C output from an array of UV-C emitting sources, where the UV-C emitting sources are, for example, LEDs or lasers (collectively referred to herein as LEDs), such coupling being achieved, for example, directly or with a "pigtail" connector commonly used with white light LEDs. In such an embodiment, particularly for a coupled single high-power LED, the LED-to-fiber coupling can be included in the manipulation handle of the optical fiber.

[0198] Alternatively, focusing lenses enable the output from a larger diameter fiber optic cable, laser beam, LED or other collimated light to be fully focused at a focal area into a smaller fiber optic cable without significant loss of light or power.

[0199] Although existing 40mW UV-C LEDs provide nominally sufficient power for in vivo pathogen treatment, higher power LEDs of 75mW, 95mW, and 360mW have been developed for the present invention. The problem of existing low-power UV-C light sources and high attenuation of UV-C to effectively kill pathogens transmitted into the human body has been improved with the specific development of high-power UV-C LEDs.

[0200] Alternatively, a broad array (7-50) of 265nm LEDs powered at high input power (with various heat sinks) provides a total output that, even with attenuation, is sufficient to treat pathogens at each treatment site in a few seconds or even in less than a second. LED arrays such as those used with white LEDs, and even in some UV applications, are typically simple spaced placements of LEDs with individual outputs within the source without any concentrated power on top of the individual LED power outputs. These are completely unsuitable for efficiently transmitted UV-C light. The LED arrays of the co-pending application and the present application are arranged to have a combined transmittable output to provide multiple power outputs in an enhanced pathogen killing ray. In addition, the combination provides a minimum size focused output that can be fully incorporated into small diameter optical fibers that are smaller than the size of a single LED.

[0201] As described in the co-pending application, the output power of the array in one embodiment herein is in the 265nm range (260-270nm), sufficient to kill pathogens within a few seconds, ideally within one second, with a launch distance of about 50mm. The optical cable in the second embodiment can have a single integral length or have an optical coupling portion. In the first embodiment, the endoscope optical cable is optically coupled to a connector optical cable extending from a light source. In the second embodiment, the long optical cable can include a connector portion and an insertion portion, or can be composed of a coupling portion.

[0202] At the UV-C light source, the output from each LED is collimated by a collimating lens to focus at the coupling end of the fiber optic cable with no or minimal loss of UV-C light. Alternatively, each LED is directly coupled to a short (e.g., about 7 inches) low attenuation fiber optic cable, such as by an LED coupling pigtail connector or coupling to a short fiber optic cable directly adjacent to the LED die emitting the light. In the latter embodiment, the optical fiber extends into a perforated protective cover of the LED with an anchored butt connection. The other ends of the optical fibers connecting the LEDs are gathered into a single line for direct optical connection (using a focusing lens or direct base station) to a long fiber optic cable, which can be an exchanged endoscope cable or an endoscope insertion cable.

[0203] In another embodiment, the end of the fiber optic cable is "butt-coupled" directly to the light source, or to a lens on top of the light source. This is the most direct form of connection, but the most difficult to achieve correctly. To our knowledge, this type of optical connection has not been used with deep UV light sources, and is typically only used with visible light sources.

[0204] While butt coupling is not susceptible to losses due to transmission through solid bodies (e.g., lenses), various criteria must be followed to maximize the collection and transmission of UV light. If the optical fiber is not sized to completely cover the light source, such as the die of an LED, a significant amount of light will be lost in the non-optical coverage area. Increasing the diameter of the optical fiber, while effectively increasing the absorption of UV light, presents problems in transmitting the light to the smaller working fiber diameter of the cable. Focusing lenses and tapered fiber sections result in major losses in transmitted light and power. Increasing the power of a UV light source typically requires increasing the size of the light source with a concomitant increase in the fiber optic cable diameter and increased losses due to focusing down to the working fiber diameter.

[0205] Alignment problems occur when the fiber size is not sufficient to completely cover the UV light source. A slight deviation in alignment can cause a significant loss of UV light, even if it does not completely lose the transmittable UV light. Devices such as SMA connectors and fiber end ferrules can be used to reduce or minimize alignment problems.

[0206] All types of UV light delivery fiber bundles are different from single core fibers, which have problems with light loss in the gap spacing between fibers. However, single core fibers have flexibility issues in terms of proper handling locations. It has been found that the ends of the fiber bundle can be fused (e.g., hexagonally mated) with the gap spacing of the short-distance fibers at the light absorption location minimized, while the rest of the fibers remain in a flexible fiber bundle configuration.

[0207] Endoscope holder:

[0208] Flexible endoscopes such as lung bronchoscopes have an insertion tube portion that is adapted for insertion into a passage of an organ such as a bronchus of the lung and that is typically about 5 mm in diameter for a typical bronchoscope. The diameter of the insertion tube portion in other endoscopes varies depending on the size parameters of the organ in which the particular endoscope is to be used. A long fiber optic cable is inserted through the instrument channel ("biopsy channel") and the insertion tube, where it extends in a controlled manner to the distal tip and beyond:

[0209] Bronchoscopes and other endoscopes are provided with various channels, such as air / water nozzles, water jets, white illumination and viewing channels (CCD units) and biopsy channels. While the various channels in an endoscope have elements that are fixed in place or fixed end caps, the biopsy channel or instrument insertion channel is necessarily a hollow channel through which instruments such as biopsy tools are inserted and removed (the biopsy tool must be removable for retrieval of the biopsy sample) and which allows the biopsy tool to extend from the end of the endoscope. In order to allow insertion and removal without binding, and to accommodate mechanically operable tools, the "biopsy channel" is relatively large, ranging from about 2.2 mm to about 3.7 mm in diameter, depending on the model and type of endoscope.

[0210] According to this embodiment, the relatively long UV-C transmitting, low attenuation optical cable is sized (including the cladding) to have a diameter that is less than the diameter of the biopsy channel so that it can be inserted into the biopsy channel in place of the biopsy tool. In one embodiment of the bronchoscope, the length of the optical cable is approximately two meters, with one meter extending between the UV-C light source and the bronchoscope and the other meter of the cable contained within the biopsy channel when used to treat internal pathogen sites. As with the biopsy tool, the optical fiber can extend from the end of the bronchoscope, with the smaller thickness of the optical cable (approximately 1-2 mm) enabling access to smaller organ channels than the 5 mm endoscope diameter allows. Control of this extension is achieved by plunger mechanisms similar to those that have been used to extract biopsy samples with distance markings

[0211] A low attenuation loss UV-C transmission optical cable, measuring 1.0m x 0.4-0.6mm diameter (suitable for endoscope biopsy channels), with cladding and optical connectors on both ends, suitable for low attenuation loss coupling to a UV-C light source such as a light source with a "pigtail" connector, and inserted into the biopsy channel of an endoscope. Butt coupling of the fiber end to the LED tube core provides another type of optical connection, just as the various types of lenses mentioned above do. Motion control is control of the endoscope, controlling the movement of the optical cable beyond the distal tip and peripheral control of any optical needle on the distal end of the optical cable by simple extension and retraction.

[0212] In a further embodiment, a common handheld instrument called an otoscope is modified to include a UV-C LED in place of or in addition to a white LED, with a short, low-attenuation optical cable for use in treating more accessible live parts of the ear, nose, throat, and genitals (e.g., for treating HPV), the speculum carrying an optical cable for applying UV-C light to those parts. For applications such as treating middle ear infections, the otoscope-like device includes an extendable optical cable extension for accessing the Eustachian tube leading to the middle ear.

[0213] In embodiments where there is a single path for insertion, where only the extent of insertion is required, the "endoscope" can be rigid (physiologically permitted), and the definition of "endoscope" as used herein is an in vivo UV-C light introduction device and includes site viewing and non-viewing functions. The latter application device does not require white light.

[0214] In an embodiment with an extendable optical cable, the cladding surrounding the ends of the optical cable can be made transmissive to UV-C light, and the corresponding optical fiber ends can be treated to allow lateral light emission, whereby, as the cable extends, the UV-C light can extend 360 degrees, similar to the circumferential direction of a lantern, and the UV-C light has a greater impact on the emission of pathogens in organs, such as the lungs.

[0215] Flush end positioning of the fiber optic cable in the biopsy channel may be achieved by any number of means, such as positioning detents, positioning external collars, etc. Different endoscopic devices require fiber optic cables with different dimensional parameters, and the size of the fiber optic cable is adjusted accordingly.

[0216] Single lengths of fiber optic cable or even completely contiguous lengths of fiber optic cable are used to minimize the effects of UV-C light attenuation. Thus, a 5x5 array (25 LEDS) of UV-C 265nm LEDs with a power output of 40mW per LED would provide a total output power of 1 Watt (minus any nominal attenuation power). Similarly, a 7x7 array (49 LEDS) of LEDs would provide approximately 2 Watts or nominal output power. Since the output power per square centimeter is approximately 200mW (200mJ / cm 2 Energy of 500 watts) can actually inactivate or destroy viral and bacterial pathogens in under a second and ensure pathogen destruction by effectively turning down the power. At this power level, pathogen elimination in under a second provides effective treatment in a time span that is less than the time span that causes damage to any more resistant and self-healing healthy cells and tissues near the pathogen infection site. Such a short exposure time also facilitates the treatment of multiple infection sites in a fairly short treatment time. LEDs with other power levels reduce or even eliminate the need for arrays and their accompanying connection and optical coupling complexity.

[0217] In otoscope type devices and where they are closer distances between the optical cable and the treatment site, a 3x3 (9 LEDs) or even 2x2 (4 LEDs) array is effective and requires less power with a suitable battery supply.

[0218] For all embodiments herein, it is generally understood that the number of LEDs is described as a symmetrical array and the number is not limited thereto. In addition, it is the output power that is considered, not the actual number of LEDs. A single high-power LED is preferred because of less complexity and ease in light collection and transmission as well as equipment maintenance.

[0219] Because of the ability to increase the output power of the optimized DNA / RNA destruction specific 265nm LED, more resistant cancer cells can be targeted for effective removal. In addition to surgical removal of tumors in the tissue wall, which is an effective method for treating cancer tumors, UV-C light is able to treat areas that surgical treatment cannot reach, such as the tissue wall of the cancer site, to kill residual cancer cells or prevent recurrence. In addition, in a second embodiment, the "lantern" portion of the fiber optic cable extending from the endoscope can actually be dragged to directly contact the cancer site, thereby maximizing the destruction of cancer cells in a very targeted manner.

[0220] To further enhance the penetration of UV-C light into cancerous tissue, the "lantern" portion can be integrated with an array of UV light-conducting fiber optic needles in a toggle rotation structure (allowing the structure to be inserted into a 2.2mm to 3.7mm biopsy channel and then unfolded in a direction perpendicular to the cable after the "lantern" portion is cleared from the end of the endoscope). Alternatively, the needle is retained around the "lantern portion", whereby the needles in both embodiments penetrate and treat deeper portions of the cancerous site in sequence. To prevent obstruction of the biopsy channel wall during cable insertion, the needle retracts and extends when properly positioned. A simple push / pull mechanism enables the needle to be flattened or extended appropriately. The term "needle" is general and refers primarily to the overall shape of the end of the dispersed optical fiber. The end of the needle should not be sharp enough to pierce tissue or organs unless such piercing is required. Hollow E-BUS and similar types of aspiration needles are typically used for biopsy examinations of areas that are normally inaccessible (with a hollow core of approximately 1 mm in diameter), and if the diameter is small, it can be used as a steering carrier for optical fibers carrying ultraviolet light for direct and close application of pathogen-killing UV light within the tumor. Multiple penetrations during treatment can significantly inactivate otherwise inoperable malignancies. Brain tumors with highly restricted access can also be effectively treated using the smallest size optical fibers carrying UV light.

[0221] To further promote cancer cell penetration, higher power UV-A light LEDs can be incorporated into the LED array and the LEDs operatively activated after each UV-C application to ablate and remove the dead cancer cell layer. Water jets and suction from the endoscope can be used to further promote the removal of dead cancer cells. The white light of the endoscope is appropriately used to illuminate the treatment sight. Alternatively, white light LEDs can be incorporated into the LED array and the white light transmitted along a multi-channel optical fiber. This may be useful for rigid endoscopes, which essentially have one illumination channel for everything.

[0222] Once the UV-C treatment is completed site by site or in a sequential surgical procedure, the fiber optic cable can be removed and the biopsy tool can be inserted into the biopsy channel for normal operation. The optical fiber or lens can include additional treatments, such as AR coatings, to further enhance light transmission.

[0223] The following is a tabular list of different embodiment fiber optic assemblies. These are illustrative only, and other assemblies including structural and assembly variations are possible:

[0224] Components Table

[0225] Fiber Optic Component 1:

[0226] The LED is butt-coupled to a 1mm or 2mm diameter optical fiber and tapers to 500um. The taper is further coupled to an external 500um or 600um optical fiber and may include a terminal treatment at the distal end of the fiber.

[0227] Fiber Optic Component 2:

[0228] The LED is butt-coupled to a fiber diameter (single or bundle) that matches the die / LED size and tapers to a narrower point, ideally 500um. The taper is further coupled to an external 500um or 600um fiber and may include end treatment at the distal end of the fiber.

[0229] Fiber Optic Components 3:

[0230] The LED is butt-coupled to the fused-core fiber bundle.

[0231] This allows for a bend radius of up to 1 cm for fiber bundle thicknesses.

[0232] Another benefit of fused-core fiber bundles is that there are no coupled interruptions to the individual fiber lengths.

[0233] Many fibers in a bundle allow for additional opportunities for light absorption, increasing the chances of outputting power through the fibers.

[0234] This may include terminal treatment at the far end of the fiber.

[0235] Fiber Optic Components 4:

[0236] A length (single core or bundle) of 600um fiber optic cable is butt-coupled to the LED and may include terminal treatment at the distal end of the fiber.

[0237] Fiber Optic Components 5:

[0238] The LED is coupled to the fiber using an optical lens such as TIR and further focused into a 500um cone and then coupled into an external fiber of 500um or 600um and may include end treatment at the far end of the fiber.

[0239] Fiber Optic Components 6:

[0240] The LED is coupled to the fiber using an optical lens such as TIR, and is further focused and coupled into a 500um or 600um external fiber, where the proximal end of the external fiber includes a focusing lens to bring the beam to a narrower spot of 500um, and may include end processing at the distal end of the fiber.

[0241] Fiber Optic Components 7:

[0242] The LED is coupled to the optical fiber using an optical lens, such as an aspheric lens, focused at 500um-800um, and further coupled to an external optical fiber, wherein the proximal end of the external optical fiber includes a focusing lens to bring the beam to a narrower spot of 500um and may include terminal processing at the distal end of the optical fiber.

[0243] Fiber Optic Components 8:

[0244] The LED is coupled to an optical fiber with a 30° lens covering the LED and a secondary optical TIR lens at the focal length, such as a pair of aspheric lenses, to collimate and further focus the light into a single length of external optical cable of 600um and possibly including end treatment at the distal end of the fiber.

[0245] Fiber Optic Components 9:

[0246] A 500um or 600um fiber is coupled directly to a laser or coherent LED (an LED with laser-like focusing properties) and may include terminal processing at the far end of the fiber.

[0247] Fiber Optic Components 10:

[0248] Use a reflector such as an off-axis parabolic mirror or an ellipsoidal mirror to focus the LED into the narrow diameter of the optical fiber.

[0249] Fiber Optic Components 11:

[0250] The LED is coupled to the fiber using an optical lens, such as a 4-in-1 lens (for large LED sizes), with a 30° or fiber acceptance angle, and focused into the fiber by a butt coupler or lens with the appropriate focal length. The fiber can be further thinned or include additional optical couplings to bring the beam diameter to an acceptable diameter size for each application.

[0251] The four-in-one lens allows the individual beams from the various dies to be collimated into a single beam.

[0252] This allows light that enters the fiber to exit mostly intact, thereby avoiding striking the fiber walls at unacceptable angles.

[0253] Fiber Optic Components 12:

[0254] The LED is coupled to the fiber using an optical lens, for example at a 30 degree or fiber acceptance angle, and focused into the fiber by butt coupling or a lens or series of lenses of appropriate focal length. The fiber can be further tapered or include additional optical couplings to bring the beam diameter to an acceptable diameter size for each application.

[0255] This allows light that enters the fiber to exit nearly intact, thereby avoiding striking the fiber walls at unacceptable angles.

[0256] Fiber Optic Components 13:

[0257] One or more LEDs, each coupled to an optical fiber or optical fiber end of a multi-fiber combination assembly. The coupling method can be butt coupling, lenses or other optical components. The outputs of these components are configured to be combined into a single optical fiber using a method including a split-pigtail fiber combiner / splitter assembly so that the power of the LED is greater than the power of a single LED.

[0258] The above and other objects, features and advantages of the present invention will become more apparent from the following discussion and accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0259] Figure 1 describes the effects of UV light on DNA, where helical support bonds are disrupted;

[0260] Figure 2 is a graph showing the effect of UV light sterilization as a function of light wavelength;

[0261] Figure 3 The survival fraction of bacteria and keratinocytes is shown as mJ / cm 2 Table of UV-C power dose variation at measured power rates;

[0262] Figure 4 A prior art bronchoscope endoscope is depicted with parts labeled, showing an internal insertion end and an external endoscope connection end;

[0263] Figure 5 A prior art endoscope connection end is shown with its output electrically connected to a light source and a fiber optic light guide for incident light from the light source;

[0264] Figure 6 A prior art extended multi-stage light source and controller for a bronchoscope is shown;

[0265] Figure 7is a right side cutaway view of the endoscope with the biopsy / aspiration channel accessed through the biopsy valve;

[0266] Figure 8 and 8 A is Figure 7 An end view and a cross-sectional side end view of an endoscope;

[0267] Fig. 9 It is a side section view of the otoscope;

[0268] Fig.10 yes Fig. 9 A magnified view of the insertion portion of the otoscope;

[0269] Fig.11 is a schematic diagram of a UV emitting LED having an embodiment of a light collecting optical coupling structure and a liquid light having an air filled parabolic mirror light collimator;

[0270] Fig.11 A is Fig.11 Schematic diagram of , but with a parabolic mirror filled with liquid;

[0271] Fig.12 is used Fig.11 Schematic diagrams of embodiments of UV light collection structures of or 11A and UV light collection, transmission and emission structures of transmission optical fibers of various sizes;

[0272] Fig.13 is a perspective view of a TIR (total internal reflection) lens with combined light collimating and focusing elements;

[0273] Fig.14 Schematically shows the coupling to Fig.16 a TIR lens LED having a focal point for emitting light;

[0274] Fig.15 The collimation of light waves by the TIR lens and the focusing direction of the collimated light entering the optical cable are schematically shown;

[0275] Fig.16 It uses a TIR lens Fig.15 Schematic diagram of an embodiment of a UV light collection, transmission and emission structure of a UV light collection structure, wherein the TIR lens has transmission optical fibers of various sizes;

[0276] Fig.17 Instead, a Fresnel lens is used as a collimator and focusing element. Fig.16 Schematic diagram of an embodiment of a UV light collection, transmission and emission structure of a parabolic mirror of a TIR lens;

[0277] Fig.18A high-index spherical lens is shown that collimates and focuses light into an optical fiber;

[0278] Fig.19 An elongated UV light transmission optical cable inserted into a biopsy channel is shown with a portion of the cladding removed at the distal end of the cable to allow radial UV disinfecting light to be transmitted to the inner wall of the biopsy / aspiration channel during withdrawal or insertion movements;

[0279] Fig. 20 A UV light transmission cable with full cladding is shown, and during a withdrawal or insertion motion, the UV disinfecting light is transmitted distally toward the inner wall of the biopsy / aspiration channel, where the cone impinges upon the channel;

[0280] Fig.21 and 22 Is has Fig.19 and 20 Cross-sectional view of a water pipe (approximately 4-inch ID) with a UV light transmission fiber optic cable that sterilizes the pipe from mold, fungal growth, and possible pathogens. Greater impact distances require longer dwell times or less than medical-grade sterilization.

[0281] Fig.23 An electrical transmission cable with an extended distal end having an array of powered UVLED lamps closer to the inner wall of a pipe is shown;

[0282] Fig.24 shows one end of a bronchoscope inserted into a branch of a main bronchus of the lung, with optical fibers extending into smaller bronchi;

[0283] Fig.25 DNA fragments generated by ultraviolet light inactivation of pathogens are described.

[0284] Fig.26 A 40mW UV 265nm LED with a 30 degree lens and related property graphs are shown.

[0285] Fig. 27 ; 28; 29; shows 75, 95 and 360mW 265nm UV emitting LEDs and their respective radiation diagrams manufactured for the methods and apparatus herein;

[0286] Fig.30 and 30A shows a cross-sectional and stereoscopic view of a tapered section of a UV light carrying optical fiber, wherein light transmission is switched from D1 to D2 and from D2 to D1, depending on the direction of UV light flow;

[0287] Fig.31 depicts a fused core bundle having a hexagonal interfitting shape;

[0288] Fig.32A and32B These are illustrations of 37 1000um core fiber bundles and single core fibers;

[0289] Fig.33A and 33B yes Fig.32A and 32B A side view of a fiber bundle having alignment ferrules at both ends;

[0290] Fig.34 shows the butt coupling of a fiber bundle to an LED with the end ferrule held in an alignment fixture;

[0291] Fig.35 It is a UV light collection and delivery system that uses a butt-coupled connection to an LED and a fiber taper element to achieve the transition between fibers of different diameters;

[0292] Fig.36 shows the butt coupling of a fiber bundle to an LED, with the end ferrule held in an alignment fixture with xy plane adjustability;

[0293] Fig.37 This is the virtual simulation output of a 75mW 265nm LED butt-coupled to a 1mm optical fiber;

[0294] Fig.38 The efficiency of a 2 mm fiber bundle butt-coupled to a 75 mW LED is shown;

[0295] Fig.39 Shows Fig.35 and 36 The radiation pattern of the LED;

[0296] Fig.40 Figure 1 is a sensitivity graph of a ThorLabs S142C integrating sphere sensor at 350nm for use with a Thor PM320E radiometer.

[0297] Fig.41 shows a fiber bundle butt-coupled to an LED with an SMA connector;

[0298] Fig.41 AD shows Fig.41 The configurations of the fiber bundles are single core, three fibers, seven fibers, and 19 fibers, respectively;

[0299] Fig.42 The EBUS-guided aspiration needle inserted into the tumor and containing a UV-delivering fiber is depicted;

[0300] Fig.43 Shows UV light output from an LED with a 30 degree lens entering a pair of aspheric lenses with a highly focused spot output;

[0301] Fig.44 Shows Fig.43 The light output enters the optical fiber ray trajectory;

[0302] Fig.45 yes Fig.43 and 44 Dimensional output of medium light;

[0303] Fig.46 A joystick having an extended fiber optic cable is shown, the handle including a fiber optic assembly system; and

[0304] Fig.47 Shows Fig.46 The optical fiber is inserted into a biopsy channel of an endoscope having an extended control handle. DETAILED DESCRIPTION

[0305] With reference to the accompanying drawings, Figure 1 Schematically shows how UV light inactivates and unravels the structure of the DNA 1 of a pathogen such as a virus. The UV 3 breaks the phosphorus bonds 2 that maintain the helical structure of the DNA (and RNA), effectively killing or destroying it.

[0306] Figure 2 It is a graph showing the bactericidal effect of UV light of different wavelengths, among which the bactericidal effect 4 at a wavelength of 265nm reaches the strongest. Expert Rev Anti Infect Ther.2012Feb;10(2):185–195. Ultraviolet Cirradiation: an alternative antimicrobial approach to localized infections? By Tianhong Dai,1,2 Mark S Vrahas,3 Clinton K Murray,4 and Michael RHamblin's Figure 3 is a chart illustrating the relative safety of UV-C doses for bacteria 6 and keratinocytes (skin) 5 relative to colony survival and the effects of UV-C light on pathogen killing and skin cells. Even at 10 mJ / cm 2 A direct dose of UV-C can also kill almost all bacteria and has relatively little effect on skin cells.

[0307] Figure 4-8 FIG. 4 shows a typical bronchoscope endoscope 7 used in an embodiment of the present invention for carrying a light transmission optical fiber and which is difficult to sterilize. Figure 6 Light from a light source box 13 (usually using a xenon light source) shown in FIG. 1 is input through the insertion tube 10 of the endoscope 7 . Figure 5 The endoscope connector 15 shown is connected to the Figure 4 Endoscope 7 is shown with cable connection 11 connected to the endoscope and connection 14 connected to light box 13. In order for the cable connection to be usable for UV transmission, it must be replaced with a flexible cable of low UV attenuation that is sunlight resistant and optically connected to the light transmission system as described above.

[0308] Figure 7 is a cross-sectional view of the endoscope 7 showing the water and air channels 16 and 17, the biopsy insertion valve 12a with the biopsy / aspiration channel 12. The biopsy / aspiration channel 12 is configured for removable insertion of various instruments, such as ultrasound and biopsy sampling tools. Figure 8 and 8 A is an end view and a side view of the distal end 18 of the insertion tube 7a (typically about 5 mm in diameter) having a biopsy channel 12 exit, a light-guiding lens through which light is transmitted for illumination via an illumination fiber 25 (which is flexible and typically made of a flexible polymer or silica that is not resistant to UV light degradation), an objective lens with CCD image acquisition for observation, and air and water jet channels 16 and 17.

[0309] Fig. 9 and 10 is a cross-sectional view of the otoscope 30, Fig.10 is a cross-sectional view of a speculum 35 being inserted. An LED 33 powered by a battery 34 in the handle of the otoscope is coupled to a fiber optic bundle 31 which extends through the speculum 35 for insertion into the patient's nose, throat or ear. The extension of the optical fiber placed into the patient's nose enables the optical fiber to pass through the Eustachian tube at the back of the nose and into the inner ear for ultraviolet light treatment of inner ear infections. The extension of the optical fibers also enables them to be brought closer to possible infection areas in the throat and nose.

[0310] Fig.11 and 12 An embodiment is depicted where the broad light from the die 40a of a UV emitting LED 40 is collimated with a collimating parabolic mirror 42 (aluminum) into a liquid light guide 41 for UV light transmission. Fig.11 In the embodiment, the collimating parabolic mirror 42 is filled with air and the liquid light guide 41 has a closed end. Fig.12 In the embodiment, the liquid light guide 41' is open ended and the parabolic mirror 42 contains the same liquid 43 as in the liquid light guide 41'. The LEDs 40 in both embodiments are mounted in shaped recesses 42a in the parabolic mirror 42. By collimating, almost all of the emitted light is collected to increase the final output.

[0311] Fig.13 Is has Fig.12The embodiment of the UV light generation and transmission device 200 with embedded UV LED 40 emits UV light into a relatively large diameter (6-8 mm) liquid light guide portion 41, which is coupled to a UV silica fiber portion 45 of similar size (minimal coupling loss) and low attenuation through a fiber coupler 44. The UV silica fiber portion 45 is then coupled and focused into a slender fiber operation portion 47 with low UV attenuation fiber and smaller diameter (2 mm as shown). The slender fiber operation portion 47 is sized to match the biopsy channel of an endoscope for disinfection or sterilization thereof, or for use in endoscopic examination to kill pathogens in situ within body organs. The distal end of the operation portion is shown to have a distal diffuser treatment 47A to facilitate the generation of ultraviolet light over a wider and closer area. The operation portion 47 can be directly coupled to the liquid light guide through a focusing element 44. In addition, the operation portion 47 can be detachably connected and disposable based on its UV resistant structure to take into account sterilization and loss of flexibility. Wider optical fibers or light guides can collect more UV light, while smaller diameter optical fibers are required to effectively localize the UV emission at or near a size-constrained infection site. In fact, due to the flexibility necessary for proper fiber positioning, the optical fiber should be able to have a radius of curvature of 1 cm to match the radius of curvature of the endoscope into which it is inserted. Fiber bundles of 600 microns (0.6 mm) or less provide this flexible curvature, and it is most desirable to focus into a fiber bundle of this diameter to avoid further loss of UV light and power.

[0312] Fig.14 A conical TIR lens 50 is depicted having an integrated collimating lens shape configuration 50a and a focusing surface 50b for combining efficient collection of direct light from, for example, Fig.11 , 12 And 13 LEDs 40 are widely scattered light sources, and subsequently focused. Fig.15 The path of light 51 through the TIR lens is schematically depicted, with collimation and focusing 52 to a focal plane 51a into a relatively large fiber optic bundle 53 (8 to 12 mm). Fig.16 A TIR lens 50 is depicted with an aligned UV LED 40 and emitting light 51 into a cable ferrule 52 and then into the operating fiber section 47. Note that all TIR lenses currently available are made of plastic components and are degradable but not suitable for use with UV light refraction. Therefore, an effective TIR lens with a similar refractive shape is constructed of a UV light resistant polished quartz crystal.

[0313] Fig.16 and 17 In the output structure Fig.12 Similar, but the LED output is collected by TIR lens 50 ( Fig.16) and with a pair of Fresnel lenses 61 ( Fig.17 ) parabolic mirror 60 collects, collimates and focuses onto the fiber ferrule 52, and then focuses the fiber ferrule 52 onto a small diameter operating fiber optic cable section.

[0314] Fig.18 An alternative lens configuration of a high refractive index spherical lens 70 is shown for collecting, collimating and focusing the output UV light 71 from the LED 40 into the operating optical fiber 47 .

[0315] Fig.19 The schematic depicts the disinfection of the small diameter (2.2mm to 3.7mm) biopsy / aspiration channel 12 of an endoscope, which is a highly infectious area in the endoscope due to its function, and is also the most difficult and time-consuming area to disinfect due to its difficult to access size (2.2.mm to 3.7mm inner diameter x 400-600mm length). Fig.13 , 17 The operating fiber portion 47 of and 18 is shown inserted into the biopsy / aspiration channel 12 (similar to the air and water channels, but with a smaller ID size), wherein the distance of the fiber 12 from the inner wall of the biopsy channel 12 is exaggerated for clarity. The diffusion treated distal end of the fiber 47A (with the portion of the cladding 47b removed) allows UV light to be directly irradiated on the adjacent channel wall 12, while rapidly disinfecting the inner channel perimeter as the fiber 47 is moved in the removal or insertion direction.

[0316] akin Fig. 20 The disinfection of the biopsy / aspiration channel 12 is schematically depicted, wherein UV light is emitted from the distal end of the operating fiber portion 47 but the distal end is not diffusely treated (having full cladding 47b). The irradiation of UV light on the inner wall of the biopsy / aspiration channel 12 is a cone-shaped irradiation.

[0317] Fig.21 yes Fig. 20 An equivalent schematic diagram of a UV transmission optical cable 47 is placed, without diffusion end treatment, inserted into a water pipe 112 for disinfection, wherein the optical fiber emitting UV light is in an inclined cone shape, resting against the inner wall of the pipe 112, and moving with the cable. Since the pipe is larger than the endoscope channel, the optical fiber 47 is close to the bottom of the pipe and emits UV light, close to the bottom of the pipe 112 and emitting UV light at a greater power farther up the pipe 112. Timed mobile disinfection is based on the upper disinfection rate. However, it is worth noting that gravity tends to direct pathogenic infection sites to the base or bottom of the pipe, which tends to eliminate differences in travel time.

[0318] Fig. 22 Similar to the disinfection of the biopsy / aspiration channel of an endoscope, where the optical fiber 47 has a diffuse end treatment 47A and Fig.19Different considerations for disinfection of the upper and lower parts of the pipe interior Fig.21 Similar to pipeline disinfection in .

[0319] Since the dimensions of the water pipe are much larger than those of the biopsy / aspiration channel, the UV-emitting LED can be placed directly on the Fig.23 In the cylindrical structure 82 shown, the water pipe 112 is sterilized at maximum sterilization power without the attendant problems associated with biohazards. Power is transmitted to the LED 40 via the electrical connector 81 and the structure 82 is moved through the pipe 112 by a lever or pulled by a rope 80.

[0320] Fig.24 The use of a bronchoscope 7 is shown with a biopsy tool of its optical fiber 47 extending from the biopsy channel 12 and its bronchoscope end 8 and into a bronchus 10 of a lung 100. The optical fiber 47, which is 1 mm in diameter, is able to extend into a 1 mm diameter bronchiole, where a 5 mm bronchoscope 7 cannot fit. With such close proximity, even a relatively small amount of UV power is effective in killing pathogens in a large portion (about 80%) of a typical lung. Bronchioles, which are less than 1 mm in diameter, allow UV light to enter a short distance from the extended optical fiber located at their mouth.

[0321] Fig.25 The types of DNA fragments with apoptotic and necrotic properties are shown, as shown, because the DNA of the pathogen is unraveled, for example, by ultraviolet light.

[0322] Fig.26 Depicted is a 40 mW UV emitting LED 40 at 265 nm with a 30 degree lens 420 placed, along with graphical details of the radiation pattern 400 and wavelength 401, normalized output power, forward current vs. forward voltage 403, soldering conditions, and physical / electrical characteristics 405

[0323] Fig. 27 , 28 29 show 265 nm UV emitting LEDs made by the methods and apparatus herein for 75 mW 75; 95 mW 95 and 360 mW 360, and their respective radiation patterns 75', 95' and 360'. UV light falling outside the acceptance angle of about 27° in the radiation is not transmitted and is lost from any UV light emission pattern. As the radiation pattern of each LED is concentrated toward the center, lenses that reduce the angled emission, such as Fig.26 The 30° lens with a 40mW LED 40 increases the amount of light that can be absorbed for transmission below the absorption angle limit of the delivery fiber. Despite the estimated 20% loss from using the lens, there is a net increase in the UV light that can be transmitted.

[0324] Figures 30 to 33B Embodiments are directed to the structure and configuration of optical fibers for use in UV light delivery devices.

[0325] Fig.30 and 30A A cross section and external view of a tapered section 120 of a UV light carrying optical fiber is shown, where light transmission is switched from D1 to D2 and from D2 to D1, depending on the direction of the UV light flow. Light that strikes the tapered section 120a beyond the acceptance angle is lost, but the taper effectively transmits light that falls within the acceptance angle through the smaller diameter 120b. The tapered section is used to transmit light concentrated in a larger diameter fiber or fiber section to a smaller diameter fiber or fiber section for emission in a confined area. However, light losses can be considerable.

[0326] Fig.31 Depicted is a fiber optic cable 47 having a fused core fiber bundle 48 having hexagonal ends of individual optical fibers that minimizes light loss caused by the gap spacing in FIG32 by approximately 30% by reducing such spacing. Only a small section needs to be fused to facilitate light input, and the remainder of the fiber bundle should not be fused to maintain the desired flexibility of the fiber bundle.

[0327] Fig.32A depicts an end view of a bundle 48 of 37 1000um core fibers having a cladding 49 with an overall diameter of the bundle of 6000um, and Fig.32B is a view of a single core optical fiber 48' of the same size, having a cladding 49 and relatively higher stiffness and greater light absorption.

[0328] Fig.33A and 33B Depicted is a fiber optic bundle 48 and 48'. Fig.32A and 32B 4. A side view of a fiber optic cable 47, wherein fiber bundles 48 and 48' each have an alignment ferrule 490 at both ends of each optical fiber.

[0329] Fig.34 The fiber bundle 47 is shown butt-coupled against the die 41 of the LED 40, with the end ferrule 490 held in an alignment fixture 49'. Alignment is important to ensure that the initial maximum UV light is collected from the LED. For the most efficient light collection, the fiber core 48 should have a diameter or size that completely covers the LED die 41. Light that does not reach the fiber core is not collected and is lost. However, even light that reaches the core will be lost in actual transmission if it exceeds the acceptance angle of the core.

[0330] Fig.35A transmission system is shown in which UV light passes from the core 41 of the LED 40 through the fused fiber bundle 48 of the fiber optic cable 47, the cable having a diameter of 1800um, the light is focused by the tapered portion 120 at a taper of 3.6 to 1 to a beam having a diameter of 500um, and enters the ring 49 connected to the fiber bundle 48 of the fiber optic cable 47 having a diameter of 2mm or 1mm and a diameter of 600um.

[0331] Fig.36 The alignment butt coupling fixture 200 is used to align and butt-couple the optical fiber cable 47 with the ferrule 49 to the LED 40 with adjustable alignment accuracy in the xy plane by adjusting pins.

[0332] Example

[0333] Embodiment 1:

[0334] Fig.28 The 75mW 265nm LED is connected to the Olympus BF40 bronchoscope endoscope through its optical connector. Figure 4 and Figure 7 The light was transmitted through an endoscope fiber similar to those shown in FIG. The total transmitted UV light output at the distal end of the endoscope measured by a 265 nm measurement radiometer was 0.0000 Watt. The same LED was butt-coupled to a 600 micron diameter, 1 meter long, low UV attenuation optical fiber as a calibration. This resulted in an output of approximately 14.4 mW or 0.014 Watts.

[0335] Embodiment 2:

[0336] like Fig.37 As shown in the virtual simulation, a 75mW 265nm LED is butt-coupled with a 1mm optical fiber, with an NA (attenuation) of 0.37, a receiving half angle of 21.5 degrees, a coupling efficiency of 6.1%, and a UV output power of 6.1529D-02 watts. (0.0615W or 6.15mW)

[0337] Embodiment 3:

[0338] same, Fig.38 The efficiency of a 2mm fiber bundle butt-coupled with a 75mW LED is shown to be 13.9%, and the UV output power is 1.3922E-01w. (13.9mW)

[0339] With respect to the process described in Examples 2 and 3 and Fig.37 and 38 The process shown in Fig.39 The radiation diagram realizes the ray tracing process:

[0340] The ray tracing is based on the following and the radiation pattern simulation is performed using the non-sequential Zemax simulation software:

[0341] 1.Reference Fig.39 , light is emitted from a 1.2mm x 1.2mm square virtual 1 Watt LED die, which is placed vertically in the left part of the figure and emits its light to the right.

[0342] 2. The wavelength of the emitted light is 265nm, and the light is traced outward from each point on the top surface of the LED at an angle of 120°, that is, from a single direction perpendicular to the surface of the tube core, all light rays forming an angle of 60 degrees or less in any direction to see which light and how much light passes through the virtual aperture of the LED, which is positioned 0.25mm from the LED window through a vertical aperture 10mm from the tube core surface.

[0343] 3. The aperture represents the surface of the fiber and is arranged to pass only light within the fiber acceptance angle, specifically light that is 21.5° or less from the vertical.

[0344] 4.20 million random light rays start and follow from every point on the surface of the LED die with a certain granularity, and are emitted at every angle in any direction with a certain granularity, forming an angle less than 60° with the vertical line.

[0345] 5. All rays passing through each incremental area of ​​the virtual aperture are summed. Based on 20 million rays at 1 watt, the sum for all incremental areas represents:

[0346] a. The peak value of "power per unit area" in the area where the light is most concentrated is 0.173 watts per square centimeter;

[0347] Process of LED and fiber butt coupling - analysis, simulation and measurement:

[0348] The delivery of UV light through a medium, in this case, starting with an LED source and delivering the light into a fiber optic cable, begins with the coupling of the LED’s die to the optical fiber. The simple and straightforward way to accomplish this is to use a “butt coupling” method, which is probably not the best or most efficient. In this process, the near end of the optical fiber is brought into contact with the LED’s die as closely as possible, since actual contact would compromise the integrity of the die (which is usually protectively covered in any case). Since LED light typically diffuses widely from the die assembly inside the LED at an angle of 120° to 130°, it is effective to make angular expansion less likely to occur by making the coupling as close to the die as possible before the light has a chance to diffuse. This article evaluates the emission and effectiveness of the coupling in three ways that are very consistent with each other:

[0349] 1. Ray Tracing Simulation – Simulates a light source as a source of typically millions of rays shooting from all possible directions and streaming the rays to see how and if they enter the simulated fiber aperture.

[0350] 2. Actual measurements of known LED and fiber configurations - LED die come in various sizes (square) and powers (emission), and fiber optic cables come in various core sizes. The optical fiber used is very short and has low attenuation for the UV light used. The power output of the original LED and the power of the optical fiber coupled to the LED are measured using an "integrating sphere" type radiometer, similar to how manufacturers specify LED power. This produces the highest value, but takes into account all radiant output in any direction. Conclusions drawn from these tests are only for relative coupling efficiency percentages (100x power out / power in). Due to the difficulty in obtaining special UV versions of such radiometers, a much less sensitive visible light version is used on a related basis, as the efficiency (ratio or relative calculation) is considered correct regardless of the absolute power reported.

[0351] To support this, the sensitivity graph of the ThorLabs S142C integrating sphere sensor of the Thor PM320E radiometer used is shown in Fig.40 At 350nm, and possibly also at the lower 265nm, the sensitivity is 0.75 / 0.05 or 15 times lower. The ratio for power measurement is considered valid.

[0352] 3. A simple calculation based on the proportion of the die area covered by the butt-jointed fiber cable end and its area can be considered. Thus, a fiber covering only 1 / 2 of the LED die 2D area will have approximately or at least 1 / 2 of the total coupled power, since the covered center portion has equal or greater radiant intensity.

[0353] The following is an analysis and comparison of LEDs and cables using Examples 4-10:

[0354] Example 4: Ray tracing simulation of a 1 Watt 120° LED into a 1 mm optical fiber with a large aperture was used to determine the coupling efficiency of LED power out / fiber power in.

[0355] Example 5: Ray tracing simulation of a 1 Watt 120° LED into a 2 mm optical fiber with a large aperture was used to determine the coupling efficiency of LED power out / fiber power in.

[0356] Example 6: Two different numerical apertures of 2000um, 3000um and 4000um optical fibers were measured using the method described above to measure relative efficiency (ratio of power output / power input), and these three lights were butt-coupled with a UV-C LED.

[0357] Example 7: A 4mm x 4mm 360mW LED die butt coupled to a 1mm fiber was analyzed using area coverage to determine the additional losses due to uncovered light.

[0358] Example 8: A 360 mW LED die, 3 mm x 3 mm, butt-coupled to a 1 mm optical fiber was analyzed using area coverage to determine the additional losses due to uncovered light.

[0359] Example 9: A 75mW LED die, 1.2mm x 1.2mm, butt-coupled to a 1mm optical fiber was analyzed using area coverage to determine the additional losses due to uncovered light.

[0360] Example 10: A 90 mW LED die, 1.38 mm x 1.38 mm, butt-coupled to a 1 mm optical fiber was analyzed using area coverage to determine the additional losses due to uncovered light.

[0361] result:

[0362] Example 4- Fig.37 This ray tracing shows that the efficiency of the LED coupled to the 1mm fiber is 6.15%.

[0363] Example 5- Fig.38 This ray tracing shows that the efficiency of the LED coupled to the 2mm fiber is 13.9%.

[0364] Example 6 - The measured efficiency of the 3000um NA 0.28 cable is 23%.

[0365] The measured efficiency of 4000um NA 0.22 cable is 32%. (largest diameter cable)

[0366] The measured efficiency of 2000um NA 0.28 cable is 22%.

[0367] The measured efficiency of the 2000um NA 0.22 cable is 24%.

[0368] Based on these measurements made with an integrating sphere radiometer, the value of 22% can be used as a guide as to how much of the total radiation from the LED is passed through the optical fiber butt-coupled to the LED.

[0369] Example 7 - 360mW LED die, 4mm x 4mm butt coupled to 1mm fiber area ratio analysis:

[0370] The area of ​​a 4mm square die is 16mm 2 (square millimeters). The area of ​​a 1mm optical fiber with a radius of 0.5mm is PI*(0.5)2=0.785mm2 The area is 16mm 2 22% of 4.91% = 1.1% coupling efficiency.

[0371] Example 8 - 1% output of 360 mW is 3.89 mW.

[0372] Relative size of a 1mm diameter round fiber on a 4mm square LED die.

[0373] Example 9 - 360mW LED die, 3mm x 3mm butt coupled to 1mm fiber area ratio analysis:

[0374] The area of ​​a 3mm square mold is 9mm 2 .

[0375] The area of ​​a 1mm optical fiber with a radius of 0.5mm is PI*(0.5)2=0.785mm 2 .

[0376] The area is 9mm 2 8.72%.

[0377] 22% of 8.72% = 1.92% coupling efficiency

[0378] 1.92% of 360mW gives an output of 6.91mW.

[0379] Relative size of a 1mm diameter round fiber on a 3mm square LED die.

[0380] Example 10 - 75mW LED die, 1.2mm x 1.2mm butt coupled to 1mm fiber area ratio analysis:

[0381] The area of ​​a 1.2mm square die is 1.44mm 2 (square millimeters).

[0382] The area of ​​a 1mm core fiber with a radius of 0.5mm is PI*(0.5)2=0.785mm 2 .

[0383] The area is 1.44mm 2 54.5%.

[0384] 22% of 54.5% = 12.0% coupling efficiency

[0385] 12.0% of 75mW is 8.99mW outside the fiber.

[0386] Relative size of a 1mm diameter round fiber on a 1.2mm square LED die.

[0387] The IEEE study cited above used a single 18mW 275nm LED at a distance of 3cm, delivering a maximum of 600mJ of energy in 30 seconds, reducing the Covid virus by 99.9%.

[0388] At a distance of 3 cm from the illuminated surface, the 120° wide emitted light covers a circular area with a radius of 2.6 cm (diameter 5.2 cm), so the illuminated area (Pi r2) is 21.2 cm2.

[0389] A 75mW LED at 265nm is about 25% more effective than at 275nm, so the LED is considered to provide 11.2mW.At a distance of 3cm, 600mJ of energy requires 600mJ / (11.2mJ / sec) = 53.6 seconds and is able to sterilize a spot 5.2cm in diameter.

[0390] At a distance of 2 cm, 2 / 3 times closer, the time would be (2 / 3)2, shortened by 0.44 times = 23.6 seconds, and a point with a diameter of 3.5 cm could be sterilized.

[0391] At a distance of 1 cm, 1 / 3 times closer, the time would be (1 / 3)2, shortened by 0.109 times = 5.84 seconds, and a point with a diameter of 1.73 cm could be sterilized.

[0392] At a distance of 2 mm, 1 / 15 times closer, the time would be (1 / 15)2, shortened by 0.0044 times = 0.238 seconds, and a point with a diameter of 0.35 cm (3.5 mm) would be sterilized.

[0393] Example 11 - 90mW LED die, 1.38mm x 1.38mm butt coupled to 1mm fiber Area Analysis:

[0394] The area of ​​a 1.38 mm square mold is 1.90 mm2 (square millimeters). The area of ​​a 1 mm optical fiber with a radius of 0.5 mm is PI*(0.5)2=0.785 mm2. This area is 1.90 mm 2 41.3%.

[0395] 41.3% of 22% = 9.10% coupling efficiency, 9.10% of 90mW is 8.12mW output.

[0396] Relative size of a 1mm diameter round fiber on a 1mm square LED die.

[0397] Example 12 - 75mW LED die, 1.2mm x 1.2mm butt coupled to 500um fiber - Area ratio analysis:

[0398] The area of ​​a 1.2mm square core is 1.44mm2 (square millimeters). The area of ​​a 500um core fiber with a diameter of 0.250mm is PI*(0.25)2=0.196mm2. This area is 1.44mm 2 13.6% of 22% = 3.0% coupling efficiency, 3.0% of 75mW is 2.25mW output of the fiber.

[0399] Relative size of a 0.5mm diameter round fiber core on a 1.2mm square LED die.

[0400] A 75mW LED is about 25% more efficient at 265nm than at 275nm, and this LED is considered to be 2.81mW. At a distance of 3cm, 600mJ of energy requires 600mJ / (2.81mJ / sec) = 213.5 seconds, and can sterilize a spot of 5.2cm in diameter. At a distance of 2cm, 2 / 3 times closer, the time would be (2 / 3)2, 0.44 times shorter = 94.0 seconds, and can sterilize a spot of 3.5cm in diameter. At a distance of 1cm, 1 / 3 times closer, the time would be (1 / 3)2, 0.109 times shorter = 40.6 seconds, and can sterilize a spot of 1.73cm in diameter. At a distance of 2mm, 1 / 15 times closer, the time would be (1 / 15)2, 0.0044 times shorter = 0.949 seconds, and can sterilize a spot of 3.5mm in diameter.

[0401] Calculations for sterilizing a 2mm diameter biopsy channel with a length of 660mm using the 1mm OD sterilized cable version

[0402] According to IEEE research, a 275nm, 120° emission, 20mW LED used at a distance of 3cm for 30 seconds can inactivate a culture of the Covid 19Sars virus by 99.9%.

[0403] A distance of 3cm from 120° diffuse light will produce 21.2cm 2 The radius at this distance is 2.6 cm. The area obtained by squaring Pi R is 2,123 square millimeters.

[0404] (Note - units are in brackets, power mW is the same as mJ / second)

[0405] Energy (mJ) = Intensity (mW / cm2 or mJ / sec / cm2) x (Time (sec) x Area (cm2))

[0406] I) For the IEEE study, to find the intensity used, we solve for the intensity and use:

[0407] Intensity = energy / (time x area), in the study:

[0408] Intensity = 600mJ / (30sec x 21.2cm 2 )=0.94mW / cm 2 or about 1mW / cm 2

[0409] The IEEE study used about 1mW of power per square centimeter for 30 seconds.

[0410] II) The UV light of the present invention enters the biopsy channel through an optical fiber.

[0411] The surface area within a 2 mm diameter biopsy channel is calculated as follows:

[0412] To calculate the area, the cylindrical tube surface is "cut" along the longitudinal imaginary line and unfolded into a flat rectangle, like a can label. The length and width of the rectangle are the length and circumference of the tube, respectively, as shown in the figure below.

[0413] The length of the rectangle is 660 mm (26 inches) and the width is the perimeter of the biopsy channel.

[0414] The radius of the channel is 1 mm, so the circumference (2Pi r) is 6.3 mm.

[0415] Therefore, the area of ​​the rectangle is 660x6.3=4,158mm 2 , which is 41.58 cm 2 .

[0416] Measurement of light from a 1.2mm square 75mW LED emitter, butt coupled into a 600um core fiber optic cable, shows 14.4mW / cm 2 Compared with 275nm, 265nm has an advantage of more than 25%, that is, effective 18.0mW / cm 2 .

[0417] If the same amount of Covid 19 virus in the study was inside the biopsy channel, a 99.9% reduction would take 0.8 seconds, using the following calculation:

[0418] Definition of intensity, converted to energy: (units in brackets)

[0419] Energy (mJ) = Intensity (mJ / sec / cm 2 )) x time (sec) x area (cm 2 )

[0420] Resolution time,

[0421] Time (seconds) = Energy / (Intensity x Area)

[0422] In our case, the details are as follows:

[0423] Time = 600mJ / (18mW / cm 2 x 41.58cm 2 )=0.80 sec

[0424] At these levels, especially with higher powered LEDs, it is possible to deliver enough UV-C light to kill malignant lymph nodes in a reasonable amount of time at similar close ranges. These nodules have been found and catalogued and repeatedly located using the proven EBUS (endobronchial ultrasound) technique and a UV-C delivery fiber optic cable inserted within a 1mm ID aspiration needle, which itself has been inserted through an endoscopic biopsy channel and guided by ultrasound to exactly where the UV-C delivery is needed, right within the malignant lymph node, entering from within the lung bronchus.

[0425] Fig.41 An additional butt coupling assembly is shown in FIG. 4 , where an SMA 490 secures and holds the fiber bundler 47 for butt engagement with the aligned LED dies 41 . Fig.41 AD show fiber optic cables 47 optionally having a single core 48a, 3 fibers 48b, 7 fibers 48c, and 19 fibers 48d, respectively. Cables with a greater fiber count have less gap spacing and greater optical pick-up.

[0426] Fig.42 A structure is described that enables focused cancer treatment even in normally inaccessible areas of the body. An EBUS aspiration needle 300 is typically used for biopsy sample collection of cancerous tissue (EBUS is dedicated to lung biopsies, but equivalent EUS aspiration needles can be used for other parts of the body, even for normally inaccessible parts, such as the pancreas). The aspiration needle 300 typically has an OD of approximately 1 mm and an ID of 0.97 mm for biopsy sample extraction without any significant damage. The UV light transmission fiber 347 has a diameter of less than 1 mm and can be inserted into the aspiration needle shown and can extend from there. Through this structure, the optical fiber 347 is carried and guided to parts of the body that are normally inaccessible even to endoscopes, and is carried in cancerous lesions, tumors and tissues, where the optical fiber can emit UV light at the cancerous site to achieve DNA deconstruction of the cancer directly from within. This provides a less aggressive radiation-type treatment that targets only the cancer site, with enhanced safety and higher efficacy. The short range and limited penetration of UV-C enhance the safety of its use, although it may require continued penetration and targeting of the carried UV-C into different parts of the cancerous site for maximum effect.

[0427] Fig.43 An effective fiber optic assembly is shown in which a UV emitting LED 500 is provided with a lens such as Fig.26 30 degree lens for a 40mW LED shown in FIG. The lens directs and partially collimates the emitted UV light 512 to an aspheric lens 501 at or below the acceptance angle for full reception. The light is then transmitted to a second, oppositely positioned aspheric lens 502 where it can be focused into a very small spot of approximately 500um, directly into a flexible 600um optical fiber.

[0428] The simulated transmission calculations show that the total emission of the LED's initial emitted light is 75%. This is simulated as coming from Fig.28 95mW LED 75mW, and from Fig.29 The 360mW LED extrapolated to the fiber at 503 is about 270mW. The amount of light entering the acceptance angle is estimated to be about 10 to 12% of the final optical transmission power of about 27 to 40mW. Fig.44 The ray trace is shown as 100% for light 512 entering fiber optic cable 47. However, a portion of the light will fall outside the acceptance angle of the optical fiber. Fig.45 The optical fiber is shown with a small focused spot of the light beam 512 at approximately 500 um.

[0429] Fig.46 A handle 600 for controlling the fiber optic cable 47 is shown. Fig.47 The optical cable 47 is shown inserted into the endoscope 7 through the biopsy channel valve inlet 12A and into the biopsy channel 12 with an extended control handle 600. The handle has a button 601 that controls the cable 47 to extend out of the end 8 of the endoscope (see FIG. Figure 4 , 8 and 9) to expose the diffuser portion 47A and emit UV therefrom. Graduation 602 indicates the extent of the extension position of the optical cable extending from the endoscope end 8. The optical connection of the LED UV light source and the fiber optic cable 47 is contained within the handle 600.

[0430] It should be understood that the above description, drawings and embodiments are only for illustrating the present invention, and changes in the structure, composition and components of the device, and the steps and requirements of the method are only illustrative and may be changed without departing from the scope of the present invention as defined in the following claims.

Claims

1. A device for remotely eradicating pathogens, including harmful or potentially harmful entities having RNA and / or DNA susceptible to destruction by UV light, comprising: a) a UV light source, including a laser or LED, each having a power output of at least 2 mW, having a UV light output at a wavelength level that inactivates pathogens by RNA and / or DNA destruction, b) a tangible transmission medium having a proximal end and a distal end, said transmission medium comprising a lens and / or a low UV attenuation optical cable at least initially resistant to degradation by UV light to transmit UV light emitted by said UV light source, and said transmission medium having an acceptance angle for said UV light, and an optical interface between said laser or LED UV light source and said transmission medium, whereby UV light emitted by said UV light source is directed within said acceptance angle to said proximal end of said transmission medium, whereby said directed UV light is transmitted through said transmission medium, wherein said optical interface provides fixed optical alignment for the direction of UV light emitted by said UV light source within said acceptance angle of said transmission medium, and c) a device having a structure that maintains and sustains a fixed relative distance and position between the proximal end of the transmission medium and the UV light source in the optical interface by optical alignment so that the UV light direction and optical alignment are not disrupted with movement of the distal end of the transmission medium, The UV light emitted from the distal end of the transport medium is at an ultraviolet power or energy level sufficient to substantially effectively inactivate the RNA and / or DNA of the pathogen within a reasonable period of time, wherein the distal end of the transport medium is placed in proximity to the pathogen and the UV light is directed to a location proximate to the pathogen.

2. The device according to claim 1, characterized in that The UV light source for emitting UV light comprises at least one UV LED, the UV LED comprising a light emitting die, wherein the tangible transmission medium comprises an optical cable, the optical cable comprising at least one segment, and wherein the optical interface comprises an acceptance angle aligned optical connection between the light emitting die and the optical cable, the optical connection being selected from at least one of a direct butt coupling between the optical cable and the light emitting die, and a light guiding and light collimating lens system, the light guiding and light collimating lens system guiding and collimating light from the light emitting die to transmit and direct it to the proximal end of the optical cable within the UV light acceptance angle.

3. The device according to claim 1, characterized in that The UV light source provides a UV light emission output having a wavelength between 250 nm and 285 nm, has a power output of at least 40 mW, and wherein the level of UV light emitted by the transmission medium and directed toward the pathogens in its vicinity is at least 2 mW.

4. The device according to claim 2, characterized in that The UV light emitted from the distal end of the optical cable and directed toward pathogens in the vicinity thereof is configured to be at a power level of at least 2 mW or a corresponding energy level.

5. The device according to claim 1, characterized in that The UV light emitted by the UV light source is guided to one end of a collimating lens optically connected to the UV light source; and a collimated UV light output is provided from the other end of the collimating lens.

6. The device according to claim 1, characterized in that The transmission medium includes a UV light transmitting lens.

7. A method for eradicating pathogens from an area infected or potentially infected by pathogens for use in a medical device, the pathogens including harmful or potentially harmful entities having RNA and / or DNA susceptible to destruction by UV light, and the method comprising the steps of: i) combining a UV light source having a power output of at least 2 mW and having a UV light output at a wavelength level that inactivates pathogens by RNA and / or DNA destruction with a proximal end of a tangible transmission medium, said tangible transmission medium having a proximal end and a distal end and having an acceptance angle at said proximal end for UV light at said UV wavelength level, such optical combination being achieved by an optically aligned optical interface between said UV light source and said proximal end of said tangible transmission medium, whereby UV light emitted by said light source is guided within the acceptance angle and transmitted through said tangible transmission medium and emitted from the distal end of said tangible transmission medium, ii) providing the tangible transmission medium with a UV light guiding structure for guiding UV light emitted by a light source at a proximal end thereof into a receiving angle and emitting UV light output at a distal end thereof, iii) providing a structure for said UV light source and said tangible transmission medium that holds and maintains a fixed relative distance and position between a proximal end of said tangible transmission medium and said UV light source in said optical interface by optical alignment, iv) configuring and dimensioning at least a portion of the distal end of the tangible transmission medium so that it can be placed adjacent to an area infected by or likely to be infected by the pathogen, so that light transmitted through the tangible transmission medium and emitted from the distal end can effectively reach the area infected by or likely to be infected by the pathogen; v) providing the remotely emitted UV light with an energy or power intensity sufficient to effectively inactivate RNA and / or DNA of pathogens in the area infected or potentially infected by the pathogens at a desired proximity distance and within a desired reasonable period of time; vi) placing said distal end of said tangible transmission medium adjacent to an area infected or potentially infected by a pathogen and providing UV light having sufficient energy or power level intensity thereto at a desired proximity; and vii) directing the emitted UV light onto the pathogen-infected or pathogen-potentially-infected area, at least for a reasonable time required, to substantially and effectively inactivate RNA and / or DNA of the pathogen in the pathogen-infected or pathogen-potentially-infected area.

8. The method according to claim 7; a further step is to place the distal end of the tangible transmission medium close to at least one pathogen-infected or pathogen-potentially-infected area, and transmit disinfecting UV light through the tangible transmission medium, so that the UV light is irradiated on at least one pathogen-infected or pathogen-potentially-infected area, which is a required distance from the distal end, and the UV light irradiation lasts for a required time to effectively inactivate the RNA and / or DNA of the pathogen sufficiently to eradicate the pathogen in the at least one pathogen-infected or pathogen-potentially-infected area in an acceptable manner.

9. The method according to claim 7, characterized in that: The area infected by pathogens or the area that may be infected by pathogens is at least one of an instrument channel, a suction channel, a water channel and an air channel of the endoscope.

10. The method according to claim 7, characterized in that The pathogen-infected area is infected or may be infected by at least one of a virus, a bacterium, a cancer or a fungus.

11. The method according to claim 7, characterized in that The pathogen-infected area is infected or may be infected by at least one pathogen including mold.

12. The method according to claim 7, characterized in that The tangible transmission medium consists of a fiber optic cable, the distal end of which is provided with integral treatment for radial UV light diffusion.

13. A remote pathogen eradication device in combination with an endoscope, the pathogens comprising harmful or potentially harmful entities having RNA and / or DNA susceptible to destruction by UV light, the device comprising a UV light source optically coupled to a tangible UV light transmission medium capable of transmitting UV light emitted from the UV light source, The tangible UV light transmission medium has a proximal end and a distal end, wherein the distal end is movable and configured to be carried and guided through an endoscope to a pathogen-infected area or a pathogen-likely area in a human body or an animal, wherein the endoscope optionally has an instrument insertion channel and the tangible UV light transmission medium is flexible enough to guide and position the endoscope by carrying the endoscope, wherein the tangible UV light transmission medium is configured as a part of the endoscope or can be separately inserted into the instrument insertion channel and movably retained therein, The device is used to position the UV light emitted from the distal end to the pathogen-infected area or the potentially pathogen-infected area in the human or animal body to eradicate the pathogens at the infected area, and wherein the tangible UV light transmission medium is retractable in an insertion channel when inserted into the insertion channel to more closely position the UV light emitted from the distal end to the infected area, wherein the device comprises: a) a UV light source having a UV light output at a wavelength level to inactivate pathogens by RNA and / or DNA destruction, b) a tangible UV light transmitting medium having an acceptance angle for UV light at the wavelength level, and c) an optical interface having an optical alignment between the UV light source and the proximal end of the tangible UV light transmission medium, whereby UV light emitted by the light source is directed to the proximal end within the acceptance angle, whereby the directed UV light is transmitted through the tangible UV light transmission medium, wherein the optical interface provides a fixed optical alignment for the direction of UV light emitted from the UV light source within the acceptance angle of the tangible UV light transmission medium, and d) a device having structure that maintains and sustains a fixed relative distance and position between the proximal end of the tangible UV light transmitting medium and the UV light source in the optical interface through optical alignment so that UV light direction and optical alignment are not disrupted with movement of the distal end of the tangible UV light transmitting medium, The UV light emitted from the distal end of the tangible UV light transmission medium disposed proximately and directed toward the pathogen is at a UV light power or energy level sufficient to substantially effectively inactivate the RNA and / or DNA of the pathogen within a reasonable period of time.

14. The device according to claim 13, characterized in that The UV light source for emitting UV light comprises a UV laser or at least one light emitting diode (LED), and wherein the tangible transmission medium comprises a UV light transmission cable, the cable consisting of at least one section.

15. The device according to claim 14, characterized in that The optical cable is configured to be carried in an aspiration needle in a human or animal body and guided to a cancer infection site therein, the aspiration needle having a hollow portion, and the aspiration needle being configured for positioning and directly inserting into the cancer infection site, wherein a portion of the optical cable is sized to be inserted into the hollow portion of the aspiration needle and movably retained therein, whereby a distal end portion of the optical cable is retractable within the hollow portion of the aspiration needle, the aspiration needle having been inserted into the cancer infection site, whereby the optical cable is positionable, extending from the aspiration needle, for emitting UV light directly to the cancer infection site to inactivate cancer cells at the cancer infection site.

16. A sterilization box for medical devices, comprising a series of devices as claimed in claim 1, including UV diodes, wherein the UV diodes are configured to be placed in the sterilization box to sterilize medical devices.

Images