Remote pathogen eradication

Abstract

A method and device for the remote eradication of pathogens comprising a light source for emitting UV light in the pathogen killing wave length range, and a tangible transmission medium, which 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 the 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 against a pathogen in proximity thereto is at a power level sufficient to substantially effectively kill the pathogen within a reasonable period of time. The device is used for sanitization of biopsy channels of endoscopes and for treating of pathogens within humans and animals.

Claims

1. A method for disinfecting pathogens from pathogen infected areas inaccessible to direct UV light, comprising the steps of: i) optically combining UV light source, with a power output of at least 2 mW, with a UV light output at a wave length level which provides pathogen deactivation by RNA and/or DNA disruption, with a proximal end of a tangible transmission medium, capable of transmitting UV light emitted from the UV light source and having a proximal and distal end, and fiber having an acceptance angle at the proximal end, for the UV light at the UV wave length level between, the optical combining being effected by means of an optically aligned optical interface between the UV light source and the proximal end of the tangible transmission medium, whereby emitted UV light from the light source is directed within the acceptance angle and transmitted through the fiber optic cable tangible transmission medium and emitted out of the second distal end thereof, ii) providing the tangible transmission medium with a UV light collection structure for collecting the UV light emitted from the light source at the proximal end thereof into the acceptance angle and for emitting collected UV light output at a movable distal end thereof, to which output UV light is transmitted, iii) providing the UV light source and the tangible transmission medium with a jig structure which holds and maintains a fixed relative distance and position, with optical alignment, between the proximal end of the tangible transmission medium and the UV light source in the optical interface, with the distal end being movable, and wherein UV light direction and optical alignment are not disrupted with movement of the distal end of the tangible transmission medium, wherein the jig structure comprises: a) a holding element which is fixedly engaged with the proximal end of the tangible transmission medium, b) a support element for the UV light source and c) a position fixed spacer structure between the UV light source and the proximal end of the tangible transmission medium, iv) configuring and dimensioning at least a portion of the distal end of the tangible transmission medium to be capable of being inserted into or adjacent an otherwise inaccessible pathogen infected or possibly pathogen infected area, to an extent that light transmitted through the tangible transmission medium and emitted out of the distal end is able to effectively reach pathogens of the pathogen infected or possibly infected area; v) providing the emitted UV light from the distal end with a power intensity sufficient to disinfect the pathogen infected or possibly infected area from pathogens at a desired proximate distance and within a desired reasonable time period; and vi) inserting the distal end of the tangible transmission medium into or directly adjacent to the pathogen infected or possibly infected area and providing UV light thereto with the sufficient power level intensity at the desired proximate distance.

2. The method of claim 1, wherein the pathogen infected area or possibly pathogen infected area is human or animal blood, within the human or animal, and the distal end of the tangible transmission medium is inserted within a blood vessel of the human or animal and wherein blood circulation brings infecting pathogens into proximity to UV light emitted from the distal end of the tangible transmission medium.

3. The method of claim 1; with the further steps of the distal end of the tangible transmission medium being moved to at least one other pathogen infected or possibly pathogen infected area and transmitting disinfecting UV light through the tangible transmission medium whereby the UV light impinges on the at least one other pathogen infected or possibly pathogen infected area at a desired distance from the distal end and for the desired time sufficient to acceptably disinfect the at least one other pathogen infected or possibly pathogen infected area.

4. The method of claim 1, wherein the pathogen infected or possibly pathogen infected area is at least one of an instrument channel, suction channel, combined instrument and suction channel, water channel and air channel of an endoscope.

5. The method of claim 1, wherein the UV light collection structure is configured to provide the steps of: i) collecting and collimating scattered UV light emitted from a widely scattering non-coherent light source LED to a diameter effective to permit capture by the tangible transmission medium which is comprised of a fiber optic cable of a substantial portion of non-coherent light emitted by the LED light source; ii) introducing the collimated light into the low UV attenuation light transmitting fiber optic cable of a diameter at least substantially equal to that of the collimated light; iii) focusing the collimated light to a focal point into a smaller diameter fiber optic cable of desired size; and iv) emitting light from the smaller diameter fiber optic cable for pathogen deactivation.

6. A method of increasing pathogen eradicating distal UV light output in the method of claim 1, comprising the steps of: a. collimating a substantial portion of UV light output from the LED by optically integrating the LED with a collimating member having a light output diameter greater than that of a die of the LED; b. collecting a substantial portion of the collimated UV light with a light collector and transmitter element having a low UV light attenuation transmission, with the light collector and transmitter having a diameter optically matched to the light output diameter of the collimating member; c. and transmitting and focusing the collected collimated light into the proximal end of the fiber optic transmission cable with a distal end light output of UV against a pathogen in proximity thereto.

7. The method of claim 1, wherein the pathogen infected area is infected with mold, fungus or mildew.

8. A method for the remote eradication of pathogens within a human or animal in accordance with the method of claim 1 wherein the tangible transmission medium comprises a fiber optic cable having been provided with an integral treatment for radial UV light diffusion, comprising the steps of: i) inserting the fiber optic cable into an endoscope; ii) steering the endoscope within the human or animal to a site possibly infected with a pathogen; iii) extending the distal end of the fiber optic cable out of a distal end of the endoscope; iv) radially emitting the UV light against a proximate pathogen infected or possibly pathogen infected area.

9. The method of claim 1 wherein the tangible transmission medium is comprised of a fiber optic cable with the distal end of the fiber optic cable being provided with an integral treatment for radial UV light diffusion.

10. A device for the remote eradication of pathogens comprising: a) a UV light source, comprising a laser, or an LED, each with a power output of at least 2 mW, with a UV light output at a wave length level which provides pathogen deactivation by RNA and/or DNA disruption, b) a tangible solid or liquid transmission medium, having a proximal end and a distal end, which tangible transmission medium is capable of transmitting UV light emitted from the UV light source, and the transmission medium having an acceptance angle for the UV light, and an optical interface between the laser or LED UV light source and the tangible transmission medium whereby emitted UV light from the UV light source is directed to the proximal end of the transmission medium within the acceptance angle, whereby the directed UV light is transmitted through the tangible transmission medium, wherein the optical interface provides a fixed, optical alignment for the direction of emitted UV light from the UV light source within the acceptance angle of the transmission medium, and c) the device having a jig structure which holds and maintains a fixed relative distance and position, with optical alignment, between the proximal end of the transmission medium and the UV light source in the optical interface, with the distal end being movable and wherein UV light direction and optical alignment are not disrupted with movement of the distal end of the transmission medium, wherein the jig structure comprises: i) a holding element which is fixedly engaged with the proximal end of the transmission medium, ii) a support element for the UV light source and iii) a position fixed spacer structure between the UV light source and the proximal end of the transmission medium, wherein UV light emitted from the distal end of the tangible transmission medium, which distal end is movable and moved and directed against pathogens in proximity thereto, is at a UV power level sufficient to substantially effectively deactivate RNA and/or DNA of the pathogens within a reasonable period of time.

11. The device of claim 10, wherein the light source for emitting UV light comprises at least one UV light emitting diode (LED) comprising a light emitting die, wherein the tangible transmission medium comprises a low UV attenuation, solarization resistant, fiber optic cable comprised of at least one segment, and wherein the optical interface comprises an acceptance angle aligned optical connection between the UV light emitting die and the fiber optic cable selected from at least one of a direct butt coupling between the fiber optic cable and the light emitting die; and a light collecting and light collimating lens system which collects light from the light emitting die and collimates it for transmission and directs it to the proximal end of the fiber optic cable within the UV light acceptance angle.

12. The device of claim 11, wherein the light emitting diode provides a UV light emission output at a wave length level between 250 nm and 285 nm, with a power output of at least 40 mW and wherein UV light emitted from the fiber optic cable and directed against the pathogen, in proximity thereto, is at a level of at least 2 mW/cm.sup.2.

13. The device of claim 11, wherein UV light emitted from the LED is captured, collimated and focused into the proximal end of the light transmission fiber with a TIR lens optically connected with the LED.

14. The device of claim 11, wherein UV light emitted from the distal end of the fiber optic cable, and directed against a pathogen in proximity thereto, is configured to be at a power level of at least 2 mW/cm.sup.2.

15. The device for eradication of pathogens of claim 10, wherein the tangible UV light transmission medium is comprised of a UV light transmitting lens.

16. A remote pathogen eradication device in combination with an endoscope, with the device comprising a UV light source optically coupled to a tangible UV light transmission medium capable of transmitting a UV light emitted from the light source, the tangible UV light transmission medium having a proximal and distal end, with the distal end being movable and configured to be carried and steered within a human body or animal to a pathogen infected area or possibly infected area therein by the endoscope having an instrument insertion channel therein and with the tangible UV light transmission medium having sufficient flexibility for steered positioning thereof by the carrying endoscope, wherein the tangible UV light transmission medium is configured to be insertable into the instrument insertion channel and movably retained therein, for positioning emitted UV light emission from the distal end to the pathogen infected area or possibly pathogen infected area within the human or animal for pathogen eradication at the infected site and wherein the tangible UV light transmission medium is extendible and retractable within the insertion channel for closer positioning of UV light emission from the distal end to the infected site, wherein the device comprises: a) a UV light source, with a UV light output at a wave length level providing pathogen deactivation by RNA and/or DNA disruption, b) a tangible solid or liquid UV light transmission medium, capable of transmitting UV light emitted from the UV light source, which has an acceptance angle for the UV light at the wave length level, and c) an optical interface between the UV light source and the proximal end of the tangible UV light transmission medium whereby emitted UV light from 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 emitted UV light from the UV light source within the acceptance angle of the tangible UV light transmission medium, and d) the device having a jig structure which holds and maintains a fixed relative distance and position, with optical alignment, between the proximal end of the tangible UV light transmission medium and the UV light source in the optical interface, whereby UV light direction and optical alignment are not disrupted with movement of the distal end of the tangible UV light transmission medium within the instrument insertion channel, wherein the jig structure comprises: i) a holding element which is fixedly engaged with the proximal end of the tangible UV light transmission medium, ii) a support element for the UV light source and iii) a position fixed spacer structure between the UV light source and the proximal end of the tangible UV light transmission medium, wherein UV light emitted from the movable distal end of the tangible UV light transmission medium which is moved into proximity and directed against pathogens is at a UV light power level sufficient to substantially effectively deactivate RNA and/or DNA of the pathogens within a reasonable period of time.

17. The device of claim 16, wherein the light source for emitting UV light comprises at least one light emitting diode (LED) comprising a light emitting die, and wherein the tangible transmission medium comprises a low UV attenuation fiber optic cable comprised of at least one segment.

18. The device of claim 17, wherein the fiber optic cable is configured to be carried and steered within a human or animal to a cancer infected site therein within an aspiration needle having a hollow therein and the needle being configured for positioning and insertion directly into a cancer infected site, wherein a portion of the fiber optic cable is dimensioned to be insertable into the hollow of the needle and movably retained therein, whereby a distal section of the fiber optic cable is extendible and retractable from within the hollow of the needle, with the needle having been inserted into a cancer infected site, whereby the fiber optic cable is positionable, with extension from the needle, for emitting UV light directly into the cancer infected site for inactivation of cancer cells at the cancer infected site.

Description

SHORT DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 depicts the effect of UV light on DNA with disruption of spiral supporting bonds;

(2) FIG. 2 is a graph showing germicidal effectiveness of UV light aa a function of light wave length;

(3) FIG. 3 is a graph showing survival fraction of bacteria and keratinocytes as a function of UV-C power dose at power rates measured in mJ/cm.sup.2;

(4) FIG. 4 depicts a prior art bronchoscope endoscope with parts labeled, showing internal insertion end and the external endoscope connection end;

(5) FIG. 5 shows the prior art endoscope connection end with its outgoing electrical connections to the light source and the fiber optic light guide for the incoming light from the light source;

(6) FIG. 6 shows a prior art extended multi-level light source and controller for the bronchoscope.

(7) FIG. 7 is a right side sectioned view of an endoscope with a biopsy/suction channel accessed by a biopsy valve;

(8) FIGS. 8 and 9 are end and section side end views of the endoscope of FIG. 7;

(9) FIG. 10 is a side sectioned view of an otoscope;

(10) FIG. 10a is an enlarged view of the insertion section of the otoscope of FIG. 10;

(11) FIG. 11 is a schematic depiction of a UV emitting LED with a light collection optically coupled structure embodiment to a liquid light with an air-filled parabolic mirror light collimator;

(12) FIG. 11a is the schematic depiction of FIG. 11 but with a liquid filled parabolic mirror;

(13) FIG. 12 is a schematic depiction of an embodiment of a UV light collection, transmission and emission structure using the UV light collection structure of FIG. 11 or 11A and transmission fibers of various dimensions;

(14) FIG. 13 is a perspective view of a TIR (total internal (illumination) reflection) lens having combined light collimating and focusing elements;

(15) FIG. 14 schematically shows an LED coupled to the TIR lens of FIG. 16 with a focal focus of emitted light;

(16) FIG. 15 schematically shows the collimation of light waves by the TIR lens and focusing direction of the collimated light into a fiber optic cable;

(17) FIG. 16 is a schematic depiction of an embodiment of a UV light collection, transmission and emission structure using the UV light collection structure of FIG. 15 with TIR lens with transmission fibers of various dimensions;

(18) FIG. 17 is a schematic depiction of an embodiment of a UV light collection, transmission and emission structure using the UV light collection structure of a parabolic mirror with a Fresnel lens as collimator and focusing elements in place of a TIR lens of FIG. 16;

(19) FIG. 18 shows a high refractive index spherical lens collimating and focusing light into a fiber;

(20) FIG. 19 shows an elongated UV light transmission fiber optic cable as inserted into a biopsy channel, with the fiber optic cable having a section of cladding removed at a distal end to permit radial UV disinfection light transmission to the interior walls of the biopsy/suction channel, during a withdrawal or insertion movement;

(21) FIG. 20 showing the UV light transmission fiber optic cable with full cladding and with UV disinfection light being distally transmitted to the interior walls of the biopsy/suction channel as a conical impingement thereon, during a withdrawal or insertion movement;

(22) FIGS. 21 and 22 are cross sectional views of a water pipe (about 4″ ID) with the UV transmission fiber optic cable of FIGS. 19 and 20 effecting disinfection of the pipe from mildew, mold, fungus growth and pathogens which may have been generated with the greater impingement distance requiring longer dwell times or less than medical grade disinfection;

(23) FIG. 23 shows an electrical transmission cable with an expanded distal end having an array of powered UV LED lights in closer proximity to the inner walls of the pipe;

(24) FIG. 24 shows the end of a bronchoscope inserted into a main bronchial branch of a lung with a fiber optic extension into smaller bronchia;

(25) FIG. 25 depicts DNA fragments resulting from UV deactivation of pathogens.

(26) FIG. 26 shows a 40 mW UV 265 nm LED with 30 degree lens and related property charts.

(27) FIGS. 27; 28; and 29; show the 265 nm UV emitting LEDs of 75, 95 and 360 mW made for the method and devices herein with their respective radiation patterns;

(28) FIGS. 30 and 30A shows cross sectioned and solid views of a tapered section of a UV light carrying fiber with light transmission conversion from D1 to D2 and from D2 to D1, depending on the direction of UV light flow;

(29) FIG. 31 depicts a fuse core bundle with hexagonal inter-fitting shapes;

(30) FIGS. 32A and 32B are illustration of a 37 1000 um core fiber bundle and a single core fiber respectively;

(31) FIGS. 33A and 33B are side views of the fiber bundles of FIGS. 32A and 32B with alignment ferrules at both ends;

(32) FIG. 34 shows a butt coupling of a fiber bundle against an LED with an end ferrule held in an alignment jig;

(33) FIG. 35 is a UV light collection and transmission system using a butt coupling connection to an LED and a fiber taper element to effect transition between different diameter fibers;

(34) FIG. 36 shows a butt coupling of a fiber bundle against an LED with an end ferrule held in an alignment jig with x-y plane adjustability;

(35) FIG. 37 is a virtual simulation output of a 75 mW 265 nm LED butt coupled to a 1 mm fiber;

(36) FIG. 38 shows the efficiency of a 2 mm fiber bundle butt coupled to the 75 mW LED;

(37) FIG. 39 shows the radiation pattern of the LED of FIGS. 35 and 36;

(38) FIG. 40 is a sensitivity graph of a ThorLabs S142C integrating sphere sensor for the Thor PM320E radiometer at 350 nm.

(39) FIG. 41 shows a fiber bundle butt coupled to an LED with an SMA connector;

(40) FIG. 41 a-d show configurations of the fiber bundle of FIG. 41 with single core, three fibers, 7 fibers and 19 fibers respectively;

(41) FIG. 42 depicts an EBUS guide aspiration needle inserted into a tumor and containing a UV transmitting fiber;

(42) FIG. 43 shows a UV light output from an LED with a 30 degree lens into a pair of aspherical lenses with a highly focused spot output;

(43) FIG. 44 shows a ray trace of the light output of FIG. 43 into an optical fiber;

(44) FIG. 45 is the dimensional output of the light in FIGS. 43 and 44;

(45) FIG. 46 shows a manipulation handle with extending fiber optic fiber cable with contained fiber assembly system in the handle; and

(46) FIG. 47 shows the fiber of FIG. 46 inserted into the biopsy channel of an endoscope with extending control handle.

DETAILED DESCRIPTION AND DESCRIPTION OF THE DRAWINGS

(47) With reference to the drawings, FIG. 1 schematically indicates the mode in which UV light deactivates and unravels the structure of DNA 1 of pathogens such as viruses. The UV 3 breaks the phosphorous bonding 2 which maintains the spiral structure of DNA (and RNA) thereby effectively killing it or destroying it.

(48) FIG. 2 is a graph showing germicidal effect of UV light at various wavelengths with a peak germicidal effectiveness 4 at the 265 nm wavelength. FIG. 3 taken from Expert Rev Anti Infect Ther. 2012 February; 10(2): 185-195. Ultraviolet C irradiation: an alternative antimicrobial approach to localized infections? By Tianhong Dai,1,2 Mark S Vrahas,3 Clinton K Murray,4 and Michael R Hamblin is a graph illustrating the effect of UV-C dosing of bacteria 6 and keratinocytes (skin) 5 relative to colony survival fraction and the relative safety of UV-C light with respect to pathogen kill and effect on skin cells. Even direct dose of UV-C at 10 mJ/cm.sup.2 which kills substantially all of the bacteria has relative minimal effect on skin cells.

(49) A typical bronchoscope endoscope 7 used in embodiments of the invention for carrying light transmitting fibers and which is difficult to sterilize is shown in FIGS. 4-8 having a light input through its insertion tube 10 with light from a light source box 13 shown in FIG. 6 (most typically with a xenon light source). An endoscope connector 15 shown in FIG. 5 is attached to the endoscope 7 shown in FIG. 4 with a light cable connection 11 to the endoscope and connection 14 to the light box 13. In order for the light cable connection to be utilizable for transmission of UV light it must be replaced with a flexible fiber optic cable of low UV attenuation with solarization resistance and optically connected to a light transmission system as described above.

(50) FIG. 7 is a cross sectional view of the endoscope 7 showing water and air channels 16 and 17, a biopsy insertion valve 12 a with biopsy/suction channel 12. The biopsy/suction channel 12 is configured for removable insertion of various instruments such as ultrasound and biopsy sampling tools. FIGS. 8 and 8A are end and side views of the distal end 18 of the insertion tube 7a (generally about 5 mm diameter) with biopsy channel 12 outlet, light guide lens through which light is transmitted for illumination via illumination fibers 25 (which are flexible and usually of flexible polymers or silica not resistant to UV light degradation), an objective lens with ccd image takeup for viewing, and air and water jet channels 16 and 17.

(51) FIGS. 10 and 10a are cross section views of an otoscope 30 with FIG. 10a being the cross-sectional view of the insertion speculum 35. An LED 33, powered by a battery 34 in a handle of the otoscope is coupled to a fiber bundle 31 which extends through the speculum 35 for insertion into a patient's nose, throat or ears. Extension of the fiber, when positioned into a patient's nose enables the fiber to pass the Eustachian tube in the rear of the nose into the inner ear, for UV treatment of inner ear infections. Fiber extension also enable them to be more closely positioned to possible infected areas in the throat and nose.

(52) FIGS. 11 and 12 depict embodiments of collimation of widespread light from the die 40a of UV emitting LED 40 with a collimating parabolic mirror 42 (aluminum) into a liquid light guide 41 for UV light transmission. In FIG. 11, the collimator parabolic mirror 42 is filled with air and the liquid light guide 41 has a closed end. In FIG. 12, the liquid light guide 41′ is open ended with the parabolic mirror 42 containing the same liquid 43 as in the liquid light guide 41′. The LED 40 in both embodiments is fitted into a shaped recess 42a in the parabolic mirror 42. With the collimation, nearly all of the emitted light is gathered for increased eventual output.

(53) FIG. 13 is an embodiment of a UV light generation and transmission device 200 with the embedded UV LED 40 of FIG. 12, emitting UV light into a liquid light guide section 41 of relatively large diameter (6-8 mm) which is coupled to a UV silica fiber section 45 of low attenuation and of like size (with minimal coupling losses) via fiber coupler 44. The UV silica fiber section 45 is in turn coupled and focused into an elongated fiber optic operation section 47 of low UV attenuation fiber and of smaller diameter (2 mm as shown). This latter section is sized to fit into a biopsy channel of endoscope for either sanitization or disinfection thereof or for use in an endoscopic procedure to kill pathogens in situ within an organ of the body. The distal end of the operation section is shown with a distal end diffusor treatment 47A to facilitate UV generation over a wider and closer area. The operation section 47 may be directly coupled with a focusing element 44 to the liquid light guide. In addition, the operation section 47 may be removably coupled and disposable with considerations of disinfection and loss of flexibility as a function of its UV resistant structure. A wider fiber or light guide provides for greater UV light collection whereas a smaller diameter fiber is needed to enable effective positioning of UV emission at or near size restricted infection sites. In fact, for flexibility considerations, necessary for proper fiber positioning, the fibers should be able to have a 1 cm radius of curvature to match that of the endoscope through which it is inserted. A fiber bundle of 600 microns (0.6 mm) or less provides such flexibility curvature and focusing into a fiber bundle of such diameter is most desirable to avoid further losses of UV light and power.

(54) FIG. 14 depicts a conical shaped TIR lens 50 having an integrated collimating lens shape configuration 50a together with a focusing surface 50b for the combined efficient collection of light directly from a widely scattering light source such as LED 40 of FIGS. 11, 12 and 13 and the subsequent focusing. FIG. 15 schematically depicts the paths of light 51 passing through the TIR lens with the collimating and focusing 52 to a focusing plane 51a into a relatively large fiber bundle 53 (8 to 12 mm). FIG. 16 depicts the TIR lens 50 with aligned UV light emitting diode 40 and emitted light 51 into cable ferrule 52 and then into operation fiber section 47. It is noted that all TIR lenses currently available are of plastic composition and are degradable and unsuitable for use with UV light refraction. Accordingly, effective TIR lenses of similar refractive shape are constructed of UV light resistant polished quartz crystal.

(55) FIGS. 16 and 17 are similar in output structure to that of FIG. 12 but with the LED output collection being collected, collimated and focused by a TIR lens 50 (FIG. 16) and a parabolic mirror 60 with paired Fresnel lens 61 (FIG. 17) into a fiber ferrule 52 which is then focused into the small diameter operation fiber cable section.

(56) FIG. 18 shows an alternative lens structure of a high refractive index spherical lens 70 for collecting, collimating and focusing output UV light 71 from the LED 40 into operation fiber 47.

(57) FIG. 19 schematically depicts the sterilization of a small diameter (2.2 mm to 3.7 mm) biopsy/suction channel 12 of an endoscope which, because of its function, is a highly infectable region of the endoscope and at the same time, because of its difficult to access dimensions (2.2 mm to 3.7 mm ID×400-600 mm length), the most difficult and most time-consuming area to disinfect. The operation fiber section 47 of FIGS. 13, 17 and 18 is shown as inserted into the biopsy/suction channel 12 (the air and water channels are similar but are of even smaller ID dimension) with distance of the fiber 12 from the inner wall of the biopsy channel 12 exaggerated for clarity. The diffusion treated distal end of the fiber 47A (with removed section of cladding 47b) enables UV light to directly impinge on the adjacent channel walls 12 with rapid disinfection of the inner channel circumference, as the fiber 47 is moved in either a removal or insertion direction.

(58) Similar FIG. 20 schematically depicts the sterilization of the biopsy/suction channel 12 with UV light emanating from the distal end of the operation fiber section 47 but without a diffusion treated distal end (with full cladding 47b). Impingement of the UV light on the inner walls of the biopsy/suction channel 12 is with a conical impingement.

(59) FIG. 21 is a schematic equivalent of FIG. 20 with positioning of a UV transmitting fiber cable 47, without diffusion end treatment, inserted into a water pipe 112 for sanitization with the fiber emitting UV light in an angled cone against the inner walls of the pipe 112 with movement of the cable. Since the pipe is larger than an endoscope channel, the fiber 47 rests close to the bottom of the pipe and emits UV light closer to and with more power to the bottom of the pipe 112 and with lesser power to the more distant upper portion of the pipe. Timed movement sanitization is based on the upper portion sanitization rate. It is however noted that gravitational forces tend to direct pathogenic infected sites to the base or bottom of the pipe and that tends to even out the differential in movement time.

(60) FIG. 22 is similar to that of the sanitization of the biopsy/suction channel of an endoscope with a fiber 47 having a diffusion end treatment 47A and a radially directed sanitization UV light impingement as in FIG. 19. Differential considerations of sanitization of upper and lower portion of the pipe interior are similar to those with respect to the sanitization of the pipe in FIG. 21.

(61) Since water pipes are of much larger dimensions than those of biopsy/suction channels, UV emitting LEDs are able to be directly placed in a circular cylindrical structure 82 as shown in FIG. 23 for disinfection of a water pipe 112 with maximum disinfection power, without any attendant problems of biological harm. Electrical power is transmitted to the LEDs 40 via electrical connectors 81 and the structure 82 is moved through the pipe 112 via a controlling rod or pulled by a cord 80.

(62) FIG. 24 illustrates the use of a bronchoscope 7 with a biopsy tool of optical fiber 47 extending out of the biopsy channel 12 and bronchoscope end 8 thereof and into the bronchia 10 of a lung 100. An optical fiber 47 used with a diameter of 1 mm is capable of being extended into bronchioles of 1 mm diameter where the 5 mm bronchoscope 7 is incapable of being positioned. With such proximity even relatively small amounts of UV power are able to effectively kill pathogens in a large portion (about 80%) of a typical lung. Bronchiole of less than 1 mm diameter are capable of having the UV light enter for short distances from extended fiber positioned at the mouth thereof.

(63) FIG. 25 shows the types of DNA fragments of apoptotic and necrotic nature, indicated, as the DNA of a pathogen is unraveled, such as by UV light.

(64) FIG. 26 depicts a 40 mW UV emitting LED at 265 nm 40 with positioned 30 degree lens 420, together with radiation pattern 400 and graphical details of wavelength 401, normalized output power, forward current vs. forward voltage 403, soldering conditions and physical/electrical properties 405

(65) FIGS. 27, 28, and 29 show the 265 nm UV emitting LEDs made for the method and devices herein of 75 mW 75; 95 mW 95 and 360 mW 360, together with their respective radiation patterns 75′, 95′ and 360′. UV light falling outside an acceptance angle of about 27° in the radiation is not transmitted and is lost from any UV light emission patterns. With the radiation patterns of the respective LEDs being concentrated toward the center, lenses which reduce the angled emissions, such as the 30° lens with the 40 mW LED 40 of FIG. 26, increase the amount of light capable of being taken for transmission below the uptake angle limit of the transmission fiber. Despite estimated 20% losses with use of the lenses there is a net increase of transmittable UV light.

(66) FIGS. 30 through 33B relate to embodiments of the structures and configurations of optical fibers used in the UV light transmission device.

(67) FIGS. 30 and 30A show cross section and outside views of a tapered section 120 of a UV light carrying fiber with light transmission conversion from D1 to D2 and from D2 to D1 depending on the direction of UV light flow. Light striking the tapered section 120a which exceeds the acceptance angle is lost but the taper is effective in transmitting light which falls within the acceptance angle through smaller diameter 120b. The tapered section is utilized to transmit light gathered in a larger diameter fiber or fiber section to a smaller diameter fiber or fiber section for emission in restricted areas. However, light loss can be considerable.

(68) FIG. 31 depicts a fiber cable 47 with fused core fiber bundle 48 with hexagonal ends of individual fibers which minimizes light loss resulting from interstitial spacing in FIG. 32 of about 30% by reducing such spacing. Only a short section needs the fused core for facilitated light input and the remainder of the fiber bundle should not be fused to enable the fiber bundles to retain required flexibility.

(69) FIG. 32A depicts an end view of a 37 1000 um core fiber bundle 48 with an overall 6000 um diameter of the bundle with cladding 49 and FIG. 32B is a view of a single core fiber 48′ of the same dimensions with cladding 49 and a relatively higher degree of rigidity but with a greater light uptake.

(70) FIGS. 33A and 33B depict side views of the fiber cables 47 of FIGS. 32A and 32B with fiber bundles 48 and 48′ respectively with alignment ferrules 490 at both ends of each of the fibers.

(71) FIG. 34 shows a butt coupling of a fiber bundle 47 against the die 41 of an LED 40 with an end ferrule 490 held in an alignment jig 49′. Alignment is important to insure initial maximum UV light gathering from the LED. For greater effectiveness in light gathering the fiber core 48 should have a diameter or dimension to completely cover the LED die 41. Light that does not reach the fiber core is not collected and lost. However, even light that reaches the core, if it exceeds the acceptance angle of the core, it too will be lost from actual transmission.

(72) FIG. 35 shows a transmission system with UV light from the die 41 from LED 40 through fused fiber bundle 48 of fiber cable 47 and a cable diameter of 1800 um with the light being focused through taper section 120 with a 3.6 to 1 taper to a light beam of 500 um diameter and into a ferrule 49 connection to fiber bundle 48 of a fiber cable 47 of 2 mm or 1 mm diameter with a 600 um diameter.

(73) FIG. 36 is an alignment butt coupling jig 200 for aligning and butt coupling fiber cable 47 with ferrule 49 to LED 40 with adjustable alignment precision in an x-y plane via adjustment pins

EXAMPLES

Example 1

(74) The 75 mW 265 nm LED of FIG. 28 was butt coupled to an Olympus BF40 bronchoscope endoscope, similar to the ones shown in FIGS. 4 and 7, through its light connector and light was transmitted through the endoscope fiber. Total transmitted UV light output from the distal end of the endoscope, as measured by a 265 nm measuring radiometer was 0.0000 watts. The same LED was butt-coupled to a 600 um diameter low UV attenuation fiber of 1 meter length as a calibration. This resulted in an output of about 14.4 mW or 0.014 watts.

Example 2

(75) As shown in a virtual simulation in FIG. 37, the 75 mW 265 nm LED was butt coupled to a 1 mm fiber with NA (attenuation) of 0.37 and a 21.5 degree half angle of acceptance, with a 6.1% coupling efficiency and with a UV output power of 6.1529D-02 watts. (0.0615 Watts or 6.15 mW)

Example 3

(76) Similarly, FIG. 38 shows the efficiency of a 2 mm fiber bundle butt coupled to the 75 mW LED as 13.9% with a UV output power of 1.3922E-01 watts. (13.9 mW)

(77) A ray tracing procedure was effected with respect to the procedure described in Examples 2 and 3 and as illustrated in FIGS. 37 and 38 and with the radiation pattern of FIG. 39:

(78) The ray tracing is a simulation of radiation pattern based on the following and as performed with non sequential Zemax simulation software: 1. With reference to FIG. 39, light is emitted from a virtual 1 Watt LED die that is 1.2 mm by 1.2 mm square positioned vertically on the left part of the diagram and emitting its light to the right. 2. The light emitted has a wavelength of 265 nm and is being emitted from every point on the top surface of the LED in a 120° side to side angle, i.e., from the single direction perpendicular to the die surface, all rays that form an angle of 60° or less in any direction are traced outward light to see which and how many make it through the virtual aperture of the LED, positioned 0.25 mm from the LED window through a vertical aperture 10 mm away from the die surface. 3. That aperture represents the surface of an optical fiber and is set so that it passes through only rays that are within the acceptance angle of the fiber, specifically rays that form an angle with the perpendicular of 21.5° or less. 4. 20 million random rays are started and followed, with a certain granularity from each and every point on the LED die surface and exiting with a certain granularity of every angle in any direction forming less than a 60° angle with the vertical. 5. The rays making it through are totaled within each incremental area of the virtual aperture. Based on the 20 million rays having a power of 1 Watt, the totals of all the incremental areas indicate: a. That the area with the most concentrated number of rays has a peak “power per unit area” of 0.173 Watts per square centimeter;

(79) Procedure of Butt Coupling a LED and a Fiber—Analysis, Simulation, and Measurement:

(80) Delivering UV light through a medium, in this case starting from an LED source and transmitting the light into a fiber optic cable, begins with the coupling of a die of an LED and the fiber. A simple and straightforward method of implementing this, though not necessarily the best or most efficient is by using the method of “butt coupling”. In this procedure a proximal end of the fiber is brought into close contact with the die of the LED as closely as possible since actual touching is detrimental to the integrity of the die (which is normally protectively covered in any event). Since LED light spreads out widely from the die component inside the LED, typically at a 120° to 130° angle, it is efficacious to allow as little of angular expansion to occur as possible by starting the coupling close to the die before the light has a chance to spread. Emissions and effectiveness of the coupling are evaluated herein in three ways, which are in close agreement with each other: 1. Ray tracing simulation—involving the simulation of the light source as a source of typically millions of rays coming out in all possible directions and flowing them to see how and if they enter the simulated fiber aperture. 2. Actual measurements of known LEDs and fiber configurations—The LED dies have a variety of sizes (square) and power (emitted) and the fiber optic cables have a variety of core sizes. The fibers used are short and have low attenuation for the UV light used. The power out of the raw LED as well as the out of the fiber(s) coupled to the LED were measured with an “integrating sphere” type of radiometer, which is similar to how the power of LEDs is specified by their manufacturer. This produces the highest values, but takes into account all the radiated output, regardless of direction. The conclusions derived from these tests are used only for relative coupling efficiency percent (100×Power Out/Power In). Since difficult to obtain special UV versions of such a radiometer was not available, a much less sensitive visible light version was used on a correlative basis since, regardless of the absolute power reported, the efficiency (a ratio, or relative calculation) is regarded as correct.
As support for this, the sensitivity graph of the ThorLabs S142C integrating sphere sensor for the Thor PM320E radiometer used is shown as FIG. 40. At 350 nm, and presumably also at the lower 265 nm, the sensitivity is 0.75/0.05 or 15 times lower sensitivity. Ratios of power measurements are considered valid. 3. Simple calculations based on the proportion of die area covered by the abutting fiber cable end and its area can be taken into account. Thus, a fiber that covers only ½ of the 2D area of LED die will have about, or at least, ½ of the total power coupled, since the central portion covered has equal or greater radiant strength.
The following are analyses and comparisons of the LEDs and cables as Examples 4-10:

Example 4

(81) A Ray tracing simulation of a 1 Watt 120° LED into a 1 mm fiber with large aperture was used to determine coupling efficiency LED Power out/Fiber Power in.

Example 5

(82) A Ray tracing simulation of a 1 Watt 120° LED into a 2 mm fiber with large aperture was used to determine coupling efficiency LED Power out/Fiber Power in.

Example 6

(83) 2000 um, 3000 um and 4000 um fibers, of two different Numeric Apertures were measured, butt coupled to a UV-C LED, with methods sufficient for measuring relative efficiency (ratio of Power out/Power in), as previously mentioned.

Example 7

(84) A 360 mW LED die that is 4 mm×4 mm butt coupled to a 1 mm fiber is analyzed using area covering ratios to determine additional losses due to non-covered light.

Example 8

(85) A 360 mW LED die that is 3 mm×3 mm butt coupled to a 1 mm fiber is analyzed using area covering ratios to determine additional losses due to non-covered light.

Example 9

(86) A 75 mW LED die that is 1.2 mm×1.2 mm butt coupled to a 1 mm fiber is analyzed using area covering ratios to determine additional losses due to non-covered light.

Example 10

(87) A 90 mW LED die that is 1.38 mm×1.38 mm butt coupled to a 1 mm fiber is analyzed using area covering ratios to determine additional losses due to non-covered light.

(88) Results:

(89) Example 4—This ray tracing, FIG. 37, showed an efficiency of LED to 1 mm fiber coupling of 6.15%.

(90) Example 5—This ray tracing, FIG. 38, showed an efficiency of LED to 2 mm fiber coupling of 13.9%.

(91) Example 6—A 3000 um NA 0.28 cable had a measured efficiency of 23%.

(92) A 4000 um NA 0.22 cable had a measured efficiency of 32%. (the largest diam. cable)

(93) A 2000 um NA 0.28 cable had a measured efficiency of 22%.

(94) A 2000 um NA 0.22 cable had a measured efficiency of 24%.

(95) From these measurements, made with an integrating sphere radiometer, the value 22% can be used as a guide for how much of the total LED irradiation comes through a fiber, butt-coupled to an LED.

(96) Example 7—360 mW LED die that is 4 mm×4 mm butt coupled to a 1 mm fiber area ratio analysis: The 4 mm square die has an area of 16 mm2 (square millimeters). The 1 mm fiber, having a radius of 0.5 mm has an area of PI*(0.5)2=0.785 mm2 That area is 4.91% of 16 mm2. 4.91% of 22%=1.1% coupling efficiency.
Example 8—1% of 360 mW is 3.89 mW out.
Relative size of the round 1 mm diameter fiber over a 4 mm square LED die.
Example 9—360 mW LED die that is 3 mm×3 mm butt coupled to a 1 mm fiber area ratio analysis:
The 3 mm square die has an area of 9 mm2 (square millimeters).
The 1 mm fiber, having a radius of 0.5 mm has an area of PI*(0.5)2=0.785 mm2.
That area is 8.72% of 9 mm2.
8.72% of 22%=1.92% coupling efficiency
1.92% of 360 mW is 6.91 mW out.
Relative size of the round 1 mm diameter fiber over a 3 mm square LED die.
Example 10—75 mW LED die that is 1.2 mm×1.2 mm butt coupled to a 1 mm fiber area ratio analysis:
The 1.2 mm square die has an area of 1.44 mm2 (square millimeters).
The 1 mm core fiber, having a radius of 0.5 mm has an area of PI*(0.5)2=0.785 mm2.
That area is 54.5% of the 1.44 mm2.
54.5% of 22%=12.0% coupling efficiency
12.0% of 75 mW is 8.99 mW out of the fiber.
Relative size of the round 1 mm diameter fiber over a 1.2 mm square LED die.
The above cited IEEE study used a single 18 mW 275 nm LED at a distance of 3 cm, releasing 600 mJ max of energy in 30 seconds to reduce Covid virus by 99.9%.
At the distance of 3 cm from the irradiated surface, the 120° wide emitted light covers a circular area of radius 2.6 cm (diameter 5.2 cm), thus having an illuminated area (Pi r2) of 21.2 cm2.
The 75 mW LED is at 265 nm has about 25% more efficacy than 275 nm, thus this LED is to be considered as providing 11.2 mW. At 3 cm distance, 600 mJ of energy would take 600 mJ/(11.2 mJ/sec)=53.6 seconds and able to sanitize a spot 5.2 cm in diameter.
At 2 cm distance, ⅔ times as close, the time would be (⅔)2, 0.44 times shorter=23.6 s and able to sanitize a spot 3.5 cm in diameter.
At 1 cm distance, ⅓ times as close, the time would be (⅓)2, 0.109 times shorter=5.84 s and able to sanitize a spot 1.73 cm in diameter.
At 2 mm distance, 1/15 times as close, the time would be ( 1/15)2, 0.0044 times shorter=0.238 s and able to sanitize a spot 0.35 cm (3.5 mm) in diameter.
Example 11-90 mW LED die that is 1.38 mm×1.38 mm butt coupled to a 1 mm fiber area analysis:
The 1.38 mm square die has an area of 1.90 mm2 (square millimeters). The 1 mm fiber, having a radius of 0.5 mm has an area of PI*(0.5)2=0.785 mm2 That area is 41.3% of 1.90 mm2.
41.3% of 22%=9.10% coupling efficiency and 9.10% of 90 mW is 8.12 mW out.
Relative size of the round 1 mm diameter fiber over a 1 mm square LED die.
Example 12—75 mW LED die that is 1.2 mm×1.2 mm butt coupled to a 500 um fiber—area ratio analysis: The 1.2 mm square die has an area of 1.44 mm2 (square millimeters). The 500 um core fiber, having a radius of 0.250 mm, has an area of PI*(0.25)2=0.196 mm2. That area is 13.6% of the 1.44 mm2. 13.6% of 22%=3.0% coupling efficiency with 3.0% of 75 mW is 2.25 mW out of the fiber.

(97) Relative size of the round 0.5 mm diameter fiber core over a 1.2 mm square LED die. The 75 mW LED is at 265 nm which has about 25% more efficacy than 275 nm this LED is to be considered as 2.81 mW. At 3 cm distance, 600 mJ of energy would take 600 mJ/(2.81 mJ/sec)=213.5 seconds and is able to sanitize a spot 5.2 cm in diameter. At 2 cm distance, ⅔ times as close, the time would be (⅔)2, 0.44 times shorter=94.0 s and able to sanitize a spot 3.5 cm in diameter. At 1 cm distance, ⅓ times as close, the time would be (⅓)2, 0.109 times shorter=40.6 s and able to sanitize a spot 1.73 cm in diameter. At 2 mm distance, 1/15 times as close, the time would be ( 1/15)2, 0.00444 times shorter=0.949 s and able to sanitize a spot 3.5 mm in diameter.

Calculation for Disinfection of a 2 mm Diameter Biopsy Channel 660 mm Long Using a 1 mm O.D. Version of the Sanitizing Cable

(98) From the IEEE study, a 275 nm, 120° emitting, 20 mW LED, used for 30 sec at a distance of 3 cm, deactivated a culture of Covid 19 Sars virus by 99.9%.

(99) A distance of 3 cm from a 120° spreading light produces a circular irradiation area of 21.2 cm.sup.2. The radius at that distance is 2.6 cm. The area, Pi R squared, is 2,123 square mm.

(100) (Note—Units are in parenthesis and a mW of power is the same as a mJ/second)
Energy(mJ)=Intensity(mW/cm.sup.2or mJ/sec/cm.sup.2)×(Time(sec)×Area(cm.sup.2))
I) For the IEEE study, to find the Intensity used, we solve for Intensity and use:
Intensity=Energy/(Time×Area),which in the study is:
Intensity=600mJ/(30 sec×21.2 cm.sup.2)=0.94 mW/cm.sup.2or about1 mW/cm.sup.2
The IEEE study used about 1 mW per square centimeter for 30 seconds.
II) The invention's UV light through a fiber into a biopsy channel.
Calculating the surface area inside the 2 mm diameter biopsy channel is done as follows:
For calculations of area, a cylindrical tube surface is “cut” along a longitudinal dotted line and unrolled into a flat rectangle like a label of a can. That rectangle's length and width are, respectively, the length of the tube and the circumference of the tube, illustrated below.
That rectangle has a length of 660 mm (26 inches) and a width which is the biopsy channel circumference.
The radius of the channel is 1 mm, so the circumference, (2 Pi r), is 6.3 mm.
That rectangle area is therefore 660×6.3=4,158 mm.sup.2, or 41.58 cm.sup.2.
Measurements were made of the light from a 1.2 mm square 75 mW LED emitter, butt-coupled into a 600 um core fiber optic cable, which showed an emerging intensity of 14.4 mW/cm.sup.2. Accounting for the 265 nm 25% benefit over 275 nm, that is an effective 18.0 mW/cm.sup.2.
If the same amount of Covid 19 virus in the study were inside the biopsy channel, 99.9% reduction would take 0.8 seconds by the following calculation:
Definition of Intensity, Converted to Energy: (Units in Parenthesis)
Energy(mJ)=Intensity(mJ/sec/cm.sup.2))×Time(sec)×Area(cm.sup.2)
Solving for time,
Time(sec)=Energy/(Intensity×Area)
In our case, the specifics are:
Time=600mJ/(18 mW/cm.sup.2×41.58 cm2)=0.80 seconds
At these levels and especially with higher power LEDs, at similar close range, delivery of sufficient UV-C light in reasonable time to kill a malignant lymph node becomes possible. These nodes are already discovered, categorized, and repeatably located, using mature EBUS (EndoBronchial UltraSound) technology and UV-C delivery fiber cables inserted inside the 1 mm I.D. aspirating needles, which themselves have been inserted through an endoscope biopsy channel and guided precisely via ultrasound to where UV-C delivery is needed, right inside a malignant lymph node, accessed from within pulmonary bronchi.

(101) An additional butt coupling assembly is shown in FIG. 41 wherein an SMA 490 hold and retains a fiber bunder 47 for butt engagement with aligned LED die 41. FIGS. 41A-D show the fiber cable 47 as respectively alternatively having a single core 48a, 3 fibers 48b, 7 fibers 48c and 19 fibers 48d. Fiber cable with greater number of fibers have lesser amounts of interstitial gaps and with greater light pick up.

(102) FIG. 42 is illustrative of a structure capable of focused cancer treatment even in normally non accessible areas of the body. An EBUS aspiration needle 300 normally utilized for biopsy sample taking of cancerous tissue (EBUS is specific to lung biopsy but equivalent EUS aspiration needles are utilizable in other parts of the body and even in normally inaccessible sites such as the pancreas). The aspiration needle 300 generally has about a 1 mm OD and an 0.97 mm ID for biopsy sample extraction without any significant damage. The UV light transmitting fiber 347 is of a diameter under 1 mm and capable of being inserted into the aspiration needle as shown and extensible therefrom. With this structure, the optical fiber 347 is carried and steered into parts of the body normally inaccessible even by endoscopes and is carried within cancerous lesions, tumors and tissue where it is able to emit UV light within cancerous sites to effect DNA deconstruction of the cancer directly from within the cancer. This provides a much less radical radiation type treatment specifically directed only at a cancer site with enhanced safety and increased efficacy. The short range and limited penetration of UV-C enhances its safe utilization though it may necessitate continued penetration and positioning of the UV-C carrying into different parts of the cancerous site for maximum effect.

(103) FIG. 43 illustrates an efficacious fiber optic assembly wherein a UV emitting LED 500 is provided with a lens such as the 30 degree lens of the 40 mW LED shown in FIG. 26. The lens directs and partially collimates emitted UV light 512 into aspherical lens 501 at or below the acceptance angle for full acceptance. The light is then transmitted into a second reverse positioned aspherical lens 502 where it focuses the light 512 into a very small spot of about 500 um directly into a flexible 600 um fiber. Simulated transmission calculations show an overall 75% emission of the initially emitted light from the LED. This was simulated as being 75 mW from the 95 mW LED of FIG. 28 and is extrapolated to be about 270 mW from the 360 mW LED of FIG. 29 to the fiber at 503. The amount of light going into the angle of acceptance is estimated to be about 10 to 12% of the light of about 27 to 40 mW of final light transmission power. FIG. 44, shows the ray tracing of the light 512 into fiber cable 47 as being 100%. However, a portion of the light rays fall out of the acceptance angle of the fiber. FIG. 45 shows the small focused spot of the light beam 512 of the fiber at about 500 um.

(104) FIG. 46 shows a handle 600 for control of the light fiber cable 47. FIG. 47 shows the fiber cable 47 as inserted into endoscope 7 through biopsy channel valve entry 12A into biopsy channel 12 with extending control handle 600. The handle has a pushbutton 601 which controls extension of the cable 47 out of the end 8 (seen in FIGS. 4, 8 and 9) of the endoscope to expose diffusion section 47A with UV emission therefrom. Scale 602 indicates degree of extension position of the extended fiber cable from endoscope end 8. The LED UV light source and optical connection to the fiber cable 47 are contained within handle 600.

(105) It is understood that the above descriptions, figures, and examples are only illustrative of the invention and that changes in structure, composition and components of the device and steps and requirements of the method are only illustrative and that changes may be made without departing from the scope of the invention as defined in the following claims.