Patent Publication Number: US-10307612-B2

Title: Methods and apparatus to deliver therapeutic, non-ultraviolet electromagnetic radiation to inactivate infectious agents and/or to enhance healthy cell growth via a catheter residing in a body cavity

Description:
RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 13/801,750, filed on Mar. 13, 2013 and entitled METHODS AND APPARATUS TO INACTIVATE INFECTIOUS AGENTS ON A CATHETER RESIDING IN A BODY CAVITY and is also a continuation-in-part of U.S. application Ser. No. 15/424,732, filed Feb. 3, 2017 and entitled METHOD AND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHT THERAPEUTIC SYSTEM. This application also claims the benefit of U.S. Provisional Application No. 61/686,432 that was filed Apr. 5, 2012, for an invention titled HINS LASER LIGHT CATHETER, which is hereby incorporated by this reference as if fully set forth herein. 
    
    
     TECHNICAL FIELD 
     The present invention is a method and apparatus to provide therapeutic doses of non-ultraviolet light to inactivate infectious agents residing on, within, or generally around a catheter while the catheter is residing within a body cavity and/or to stimulate healthy cell growth causing a healing effect. In particular, the disclosure is a medical device assembly that utilizes non-ultraviolet visual therapeutic electromagnetic radiation (EMR) at a high enough intensity to stimulate healthy cell growth causing a healing effect and/or to reduce or eliminate infectious agents in, on, and around a catheter while it resides inside a body cavity. 
     Various exemplary embodiments of the present invention are described below. Use of the term “exemplary” means illustrative or by way of example only, and any reference herein to “the invention” is not intended to restrict or limit the invention to exact features or steps of any one or more of the exemplary embodiments disclosed in the present specification. References to “exemplary embodiment,” “one embodiment,” “an embodiment,” “some embodiments,” “various embodiments,” and the like, may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase “in one embodiment,” or “in an exemplary embodiment,” do not necessarily refer to the same embodiment, although they may. 
     BACKGROUND 
     Catheters are commonly used as channels to inject medications or retrieve fluid samples in a patient. Each catheter comprises a tube, usually derived from plastic or other polymers, such as silicone, polyurethane, and the like, that is inserted into an area of the body and may contain one or more separate lines in which these fluids may be delivered or retrieved. A “lumen” designates a pathway in the catheter that goes from outside the body to inside the body. Catheters are used in various applications, including intravascularly, abdominally, urologically, gastrointestinally, ophthalmically, within the respiratory tract, within cranial space, within the spinal column, and the like. In all cases, the catheter is placed inside of a space in the body where the catheter resides, herein referred to as a “body cavity”. These devices frequently give rise to infections caused by growth of infectious agents in, on, and around the catheter. Infectious agents can include bacteria, fungi, viruses, or the like that enter the body and lead to illness of a patient. Depending on the location of the catheter placement, these infections can arise in the form of urinary tract infections, blood stream infections, soft tissue infection, and the like. 
     Catheter related infections (CRIs) are a large problem in medicine, leading to high morbidity and mortality rates. Current methods of reducing or eliminating the number of infectious agents in and on a catheter are of low efficacy. Typically, catheters will be removed if they are suspected to be harboring infectious agents, increasing both the cost associated with treatment and patient discomfort. Various methods to deter or eliminate growth of infectious agents in catheters have been attempted, such as using sterile handling techniques, antibiotics, and replacing the catheter when an infection is suspected. Despite these techniques, infections resulting from catheters remain a major problem. According to the Centers for Disease Control and Prevention, over 31,000 people died specifically from catheter-related bloodstream infections in 2010. These infections, along with urinary tract infections, gastrointestinal infections, and other infections from catheters, increase both medical costs and patient discomfort. 
     Catheters come in various sizes. Those that are smaller in diameter, such as many PICC lines (peripherally inserted central catheters), have small diameter lumens. Such smaller diameter catheters may be suitable for prolonged insertion. Consequently, with smaller diameter catheters, there may be inadequate thickness to the catheter wall to carry a sterilization and/or healthy growth enhancing delivery system. 
     The use of ultraviolet (UV) light, disinfecting chemicals, catheters impregnated with drugs, to name a few, have been attempted to reduce the prevalence of infection. Many patents have attempted to utilize UV light to disinfect catheters. Unfortunately, UV light is well known to cause damage to living cells. Methods to disinfect connectors, stopcocks, and valves using sterilizing electromagnetic radiation (EMR) have also been attempted using 405 nm light to sterilize these points, but these methods neglect disinfection of the catheter body as well as the tip of the catheter. 
     The emergence of infectious agents that are resistant to current treatments, such as methicillin-resistance  staphylococcus aureus  (MRSA), further substantiate the need for another treatment of CRIs. To reduce the costs associated with having to remove and replace the catheters from the patient, there is a need for a catheter that can be sterilized while residing in the patient. Additionally, it would be advantageous to be able to stimulate healthy cell growth by providing therapeutic EMR via the indwelling catheter. 
     Immediate disinfection after placement could help prevent the growth of biofilm on the catheter. Biofilm consists of extracellular polymeric material created by microorganisms after they adhere to a surface. This biofilm facilitates the growth of infectious agents and is very difficult to break down once it has begun to grow. 
     The growth of infectious agents can result from agents outside the patient (at the point of access as the catheter crosses the skin or from the catheter hub) or from inside the patient, wherein infectious agents already in the body attach to the surface of the catheter and proliferate. Scientific literature suggests that approximately 65% of CRI&#39;s come from infectious agents residing on the skin of the patient (S. Öncü, Central Venous Catheter—Related Infections: An Overview with Special Emphasis on Diagnosis, Prevention and Management. The Internet Journal of Anesthesiology. 2003 Volume 7 Number 1). These agents travel down the outside of the catheter and colonize the catheter tip. For short term catheterization, this is believed to be the most likely mechanism of infection (Crump. Intravascular Catheter-Associated Infections. Eur J Clin Microbiol Dis (2000) 19:1-8). Thirty percent (30%) of CRIs are believed to come from a contaminated hub, in which infectious agents travel down the interior of the catheter (Öncü). This is believed to be the most likely mechanism of infection for long-term catheterization (Crump). 
     EMR in the range of 380-900 nm has been shown to be effective in killing infectious agents. Research done by a group at the University of Strathclyde shows that light in this range is effective in killing surface bacteria in burn wards without harming the patients (Environmental decontamination of a hospital isolation room using high-intensity light. J Hosp Infect. 2010 November; 76(3):247-51). Published patent application 2010/0246169, written by the members who conducted the study, utilizes ambient lighting to disinfect a large surrounding area. The mechanism proposed by the team suggests that light in this range leads to photosensitization of endogenous porphyrins within the bacteria, which causes the creation of singlet oxygen, leading to the death of the bacteria. (Inactivation of Bacterial Pathogens following Exposure to Light from a 405-Nanometer Light-Emitting Diode Array. Appl Environ Microbiol. 2009 April; 75(7): 1932-7). 
     Heretofore, however, there has never been apparatus or methods for making or using such apparatus to safely and effectively disinfect a catheter while it is still implanted in a patient. Accordingly, there exists a need for a methods and apparatus designed to deliver non-antibiotic, bactericidal therapeutics in-vivo. Such a methods and apparatus, using novel technology, may provide removable delivery of safe, effective, and reproducible disinfection and/or enhance healthy cell growth. 
     SUMMARY OF THE INVENTION 
     The exemplary embodiments of this disclosure relate to a medical device assembly for insertion into a cavity of a patient&#39;s body and for delivery and retrieval of fluids. The assembly comprises an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having intensity sufficient to inactivate one or more infectious agents and/or to enhance healthy cell growth. This catheter has an elongate catheter body with at least one internal lumen, a coupling end, and a distal end. This distal end is insertable into the cavity of the patient&#39;s body whether the cavity is venous, arterial, gastrointestinal, abdominal, urological, respiratory, cranial, spinal, or the like, wherein the indwelling catheter body directs both the fluid and the propagation of the therapeutic EMR axially relative to the catheter body for radial delivery into the patient&#39;s body and/or at the distal end. An optical element disposed within a lumen of the catheter body and/or within the catheter body acts conducive to the axial propagation of the therapeutic EMR relative to the catheter body. The optical element or another optical element also may be disposed to act conducive to propagation of therapeutic EMR through at least one coupling element to connect the EMR component to the insertable catheter component. 
     For the purposes of this disclosure the use of the term “therapeutic” should be understood to mean of or relating to the treatment of disease, including reducing or eliminating infectious agents, as well as serving or performed to maintain health, including enhancing healthy cell growth. 
     The exemplary medical device assembly comprises an EMR source, an EMR conduction system, and at least one coupling to connect the EMR source to the EMR conduction system. The EMR source provides non-ultraviolet, therapeutic EMR having intensity sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect. In at least one exemplary embodiment, the EMR conduction system may be at least partially insertable into and removable from the lumen of an indwelling catheter. 
     In some exemplary embodiments, methods and apparatuses are provided for effectively sterilizing a catheter and the surrounding area while in a body cavity. Such medical device assemblies use sterilizing EMR to reduce or eliminate the count of infectious agents in, on, or around the catheter while in a body cavity. 
     The EMR source can be from a single or group of EMR sources including, but not limited to, a light emitting diode, a semiconductor laser, a diode laser, an incandescent (filtered or unfiltered) and a fluorescent (filtered or unfiltered) light source. This EMR source provides non-ultraviolet, therapeutic EMR providing one or more wavelengths in the range of above 380 nm to about 904 nm. In order to provide sufficient inactivation of infectious species and/or stimulation of healthy cell growth, each EMR wavelength should be of a narrow spectrum and centered around one wavelength from the group. The intensity should be sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect. This group includes several wavelengths centered about: 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. 
     The EMR source may require drivers and electronic support for full functionality. Consideration should be given to accommodating the support hardware and/or software, which may encompass a significant portion of the EMR source&#39;s functionality and efficacy. It is possible that the EMR source may generate heat, which could be detrimental to the EMR source and may need to be limited. 
     This disclosure describes a catheter having an elongate catheter body with at least one internal lumen, a coupling end and a distal end, the distal end being insertable into the cavity of the patient&#39;s body. The catheter body is meant to direct both the fluid and the therapeutic EMR axially relative to the catheter body for delivery into the patient&#39;s body at the distal end. This disclosure includes an optical element disposed within the catheter body and conducive to the axial propagation of the therapeutic EMR through the catheter body. Finally, this disclosure describes at least one coupling element to connect the radiation source to the catheter body. 
     The sterilizing EMR is transmitted down a specialized path within the catheter via an optical element conducive to the axial propagation of the light. Various methods could be used to facilitate axial propagation of the light relative to the catheter, including a reflective coating within a line of the catheter, a fiber optic cable, a lens, a waveguide, or the like. The light source can be a light-emitting diode (LED), laser, fiber optic filament, or the like. 
     One exemplary embodiment of the EMR source and support components is simplified to contain only the EMR source and necessary components. In another exemplary embodiment of the EMR conduction system, a passive heat sink is required to diffuse the heat generated into the surrounding environment. In yet another exemplary embodiment of the EMR source, a heat sink may be couple to at least one fan to actively dissipate heat generated by the EMR source. 
     Of particular interest to this disclosure is the use of light between 380 nm and about 900 nm wavelengths. Additionally, the intensity and power of the light emitted bear significantly on the inactivation of infectious agents, thus a range of radiant exposures covering 0.1 J/cm 2  to 1 kJ/cm 2  and a range of powers from 0.005 mW to 1 W, and power density range covering 1 mW/cm 2  and 1 W/cm 2  are of interest for these exemplary device assemblies and methods. These ranges of wavelengths, power densities, and radiant exposures have been shown to have either antimicrobial effects or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased proliferation of fibroblasts, stimulation of collagen synthesis, angiogenesis inducement and granulation tissue formation. 
     For each exemplary embodiment described herein, the EMR conduction system and method for disinfection/healing could be utilized in an adjustable or predetermined duty cycle. If treatments begin immediately after sterile procedure was initiated, device related infections may be inhibited. This includes device related biofilm growth. 
     A treatment may include at least one wavelength of therapeutic EMR that acts as a predominant wavelength selected to sterilize one or more target organisms and selected from the group of wavelengths centered about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm. Or, a predominant wavelength selected to promote healing and healthy cell growth may be selected from the group of wavelengths centered about 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. Another treatment may include alternating the predominant wavelength between a first predominant wavelength and a second predominant wavelength (differing from the first predominant wavelength) in a selected treatment pattern. Further, sterilizing EMR and EMR that stimulates healthy cell growth may be transmitted simultaneously in tandem or alternatively. 
     A method for constructing an exemplary medical device assembly for insertion into a cavity of a patient&#39;s body and for delivery of a fluid to or retrieval from the patient&#39;s body may comprise the steps of: providing a catheter having an elongate catheter body with at least one internal lumen, a coupling end and an distal end, the distal end being insertable into the cavity of the patient&#39;s body; applying an optical element within the at least one lumen of the catheter body and/or within a wall of the catheter body, the optical element being conducive to the axial propagation of therapeutic EMR relative to the catheter body; and coupling an EMR source to the catheter body, the EMR source for providing non-ultraviolet, therapeutic EMR having an intensity sufficient to inactivate one or more infectious agent and/or to enhance healthy cell growth. 
     In one exemplary embodiment, the device uses a catheter that is inserted into a cavity of a patient&#39;s body, wherein said catheter allows both fluid and therapeutic EMR to travel axially relative to the catheter body. The catheter also contains at least one coupling lumen to connect an EMR source that will transmit the therapeutic EMR through the coupling lumen and axially relative to the catheter line. A coupling element in this context will usually refer to a typical hub on the therapeutic EMR source. 
     In at least one exemplary embodiment, a removably insertable EMR conduction system may comprise at least one optical element having an elongate body conducive to the axial propagation of the therapeutic EMR through the elongate body. This elongate body may have an exterior surface between a coupling end and a distal end. The exterior surface may have at least one radial emission portion wherein the radial emission facilitates the radial emission of therapeutic EMR from the elongate body proximate each radial emission portion. 
     At least one coupling connects the radiation source to the EMR conduction system and, in some exemplary embodiments, may comprise at least one feature that allows for the coupling to be readily removable from the EMR conduction system. The exemplary coupling may be achieved by utilizing a uniquely designed connection, a pre-manufactured coupling system, or any combination thereof that optimizes the coupling efficiency and utility. Further, such couplings couple the removably insertable EMR conduction system to the EMR source and may comprise more than one coupling with an intermediate section optimized to further the propagation of the EMR. In one exemplary embodiment, the EMR source may be coupled to a patch cable or EMR conduction extending segment, which is then coupled to the formal removably insertable EMR conduction system. 
     The optical element further may comprise at least one optical feature selected from a group of optical features such as a reflective surface, an optically transmissible material, a lens, a fiber optic filament, and any combination thereof. The optical element also may be capable of transmitting more than one wavelength or intensity EMR. Multiple wavelengths may be transmitted simultaneously, one after another or in tandem, or a combination thereof (for example, one constantly on and the other wavelength pulsed). Multiple intensities may be transmitted through the same element simultaneously. Alternating patterns of light treatments may also be transmitted. 
     The EMR conduction system may be configured to insert, at least partially, into one of any number of catheters, such as by way of example only and not to be limiting: a central venous catheter, a peripheral insertion catheter, a peripheral insertion central catheter, a midline catheter, a jugular catheter, a subclavian catheter, a femoral catheter, a cardiac catheter, a cardiovascular catheter, a urinary Foley catheter (see  FIGS. 13 and 14 ), an intermittent urinary catheter, an endotracheal tube, a dialysis catheter (whether hemodialysis or peritoneal dialysis), a gastrointestinal catheter, a nasogastric tube, a wound drainage catheter, or any similar accessing medical catheter or tube that has been inserted into a patient for the purpose of delivering or retrieving fluids or samples. 
     One exemplary embodiment of the EMR conduction system has an optical element comprising a single, insertable optical fiber. With a single optical fiber, the single fiber may allow light to transmit radially or axially at various sections along its length. For sections where light will transmit radially, the exterior surface of the optical element may be altered to facilitate the radial emission of the EMR. The alteration of the exterior surface may be achieved by chemical etching, physical etching, or electromagnetic ablation through plasma or lasers to create various radial emission portions along the length of the optical fiber. The radial emission portions permit light to emit radially from the optical fiber. 
     For purposes of this disclosure, light emitted radially means that the light has a radial component. Hence, the light emitted radially may emit perpendicularly and/or obliquely to the central axis of the optical fiber at the axial point of emission. 
     For embodiments having radial emission sections, the material comprising the optical fiber may be selected from a group of materials comprising optical fibers including plastic, silica, fluoride glass, phosphate glass, chalcogenide glass, and any other suitable material that is capable of axial light propagation and surface alteration to achieve radial emission. In addition, the optical fibers may be single mode, multi-mode, or plastic optical fibers that may have been optimized for alteration using a chemical, physical, or electromagnetic manufacturing alteration process. The optical fibers may also be optimized for alteration post-production. 
     Yet another exemplary embodiment employs a physical abrasion method of alteration to modify the EMR conduction system comprised of at least one optical fiber. This fiber would be utilized based on its optimal optical response to the physical abrasion process. This process may include, but is not limited to, sanding, media blasting, grinding, buffing, or media blasting at least one section of the optical fiber. The physical abrasion process would also necessarily be optimized in terms of the extent of physical abrasion to optimize the appropriate radial EMR emission or lack thereof. This may be accomplished by adjusting at least one of the velocity, acceleration, pressure, modification time, or abrasion material utilized in modifying the optical fiber. 
     Yet another exemplary embodiment employs microscopic porous structures suspended within the optical fiber to achieve radial transmission of light. These microscopic structures may be positioned within the core and/or core-cladding boundary of the optical fiber. The microscopic structures having a refractive index lower than the region free of microscopic structures. The microscopic structures may be a material added to the optical fiber core or the core-cladding boundary, such as a metal, rubber, glass, or plastic. The microscopic structures may also be the lack of material creating an aberration within the optical fiber core or the core-cladding boundary. For example, the presence of microscopic bubbles in the optical fiber core would create an aberration or imperfection that would alter the materials refractive index, resulting in EMR being emitted radially from the optical fiber. 
     Another exemplary embodiment may comprise at least one optical fiber with cladding altered to optimize the radial or axial propagation of EMR. For example, the cladding may be altered to at least partially remove or thin the cladding in order to achieve partial radial transmission of EMR. Another example could include an optical fiber with only certain portions containing cladding, the EMR transmitting axially in the clad portions and at least partially axially and radially in the non-clad portions. 
     Yet another exemplary embodiment achieves uniform radial transmission wherein the radial emission portion of the optical fiber has substantially equivalent intensity over the length of the radial emission portion along the optical fiber. This may be done through chemical etching, physical etching, plasma ablation, or laser ablation in a gradient pattern. By altering at least one of the velocity, acceleration, pressure gradients, flow, modification time, or modification material or process, it is possible to achieve radial transmission equivalency throughout each portion or the entire length of the modified optical fiber. During manufacturing, a gradient-provided uniformity also may be achieved through addition of microscopic structures positioned within the core and/or core-cladding boundary in a gradient pattern. Also, radial transmission uniformity achieved through gradient cladding or core features are contemplated for achieving desired radial emission, whether substantially uniform over a portion length or varying as desired. 
     Still another exemplary embodiment achieves a gradient radial transmission wherein at least one portion of the optical fiber emits EMR radially in a gradient distribution. The gradient distribution may also be accomplished through chemical etching, physical etching, plasma or laser ablation in a uniform or gradient pattern. By altering at least one of the velocity, acceleration, pressure gradients, flow, modification time, or modification material or process, it is possible to achieve a gradient radial transmission throughout a portion of the optical fiber. This may also be achieved through addition of microscopic structures positioned within the core and/or core-cladding boundary. 
     A further exemplary embodiment of a removably insertable EMR conduction system comprises an optical element such as at least one LED, its associated wiring components, and a scaffold. The LED(s) may emit EMR based on the LED&#39;s inherent distribution, or may utilize another optical element, such as a lens or mirror, to focus or diffuse the EMR in the direction of interest. In addition, more than one LED could be arranged in an array to appropriately emit EMR for maximal therapeutic benefit. The LED(s), together with associated wiring components may be permanently or removably attached to the scaffold, which allows for removable insertion of the EMR conduction system into a catheter. The scaffold may be rigid, semi-rigid, malleable, elastic, or flexible, or any combination thereof. 
     In another exemplary embodiment, a catheter with multiple lumens for fluid injection or retrieval contains a separate lumen for transmission of the therapeutic EMR. Each lumen may have a separate proximal catheter hub assembly. These internal lumens converge at a convergence chamber, where individual internal lumens consolidate into a single elongated catheter body while retaining their individual internal paths. Such exemplary device may include use of an optical method for diverting the radiation between the convergence chamber and axially through the designated catheter internal lumen. 
     Samples retrieved through the distal end are often used to characterize the type of infection. One exemplary embodiment of the disclosure focuses on maintaining axial propagation of the light relative to the catheter and delivering therapeutic light of sufficient intensity to the distal end of the catheter to reduce or eliminate the count of infectious agents residing thereon. 
     In yet another exemplary embodiment, the medical device assembly aforementioned would be used in a urological setting. The catheter (such as a Foley catheter) would be placed into the urethra and bladder of the urinary tract. 
     In yet another exemplary embodiment, the medical device assembly aforementioned would be used in a gastrointestinal setting. 
     In yet another exemplary embodiment, the medical device assembly aforementioned would be used in an intravascular setting. 
     In yet another exemplary embodiment, the medical device assembly aforementioned would be used within the cranial cavity of a patient. 
     In yet another exemplary embodiment, the medical device assembly aforementioned would be used within the spinal cavity of a patient. 
     In still another exemplary embodiment, the medical device assembly aforementioned would be used within an ophthalmic cavity of a patient. 
     In still another exemplary embodiment, the medical device assembly would be used within a dialysis catheter (whether hemodialysis or peritoneal dialysis). 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Exemplary embodiments of the invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the invention&#39;s scope, the exemplary embodiments of the present disclosure will be described with additional specificity and detail through use of the accompanying drawings in which: 
         FIG. 1  is a perspective view of an exemplary embodiment of a double lumen catheter and an EMR component with the connection in an exploded view to illustrate the connection of the EMR source to the catheter; 
         FIG. 2  is a schematic view of another exemplary embodiment of a tunneled triple lumen catheter as inserted into a body cavity through an insert incision in the patient&#39;s chest; 
         FIG. 3  is a schematic view of yet another exemplary embodiment of a tunneled triple lumen catheter, an insertable optical element, and an EMR component, showing the triple lumen catheter as inserted into a body cavity through an insert incision in the patient&#39;s arm and the connection in an exploded view to illustrate the connection of the EMR source to the catheter and the insertion of the optical element partially inserted into the catheter; 
         FIG. 4  is a perspective, partially exploded view of still another exemplary embodiment of a dual lumen catheter with the insertable optical element disposed outside the catheter and showing an intermediate coupling; 
         FIG. 5  is a perspective view of the exemplary dual lumen catheter of  FIG. 4  with the insertable component disposed partially inside the catheter; 
         FIG. 6A  is a cross sectional view along line B-B of  FIG. 5  showing an exemplary embodiment of a cladding-encased optical element as centered within a lumen of the catheter line tubing; 
         FIG. 6B  is a cross sectional view along line B-B of  FIG. 5  showing an exemplary embodiment of the cladding-encased optical element non-centered within a lumen of the catheter line tubing; 
         FIG. 6C  is a cross sectional view along line B-B of  FIG. 5  showing another exemplary embodiment of a bare fiber optical element as centered within a lumen of the catheter line tubing ( FIGS. 6A-C  are illustrative cross sectional views of alternative optical elements as disposed within a single-lumen catheter); 
         FIG. 7  is a perspective, partially exploded view of an exemplary dual lumen catheter with the insertable component disposed partially inside the catheter and showing an intermediate coupling; 
         FIGS. 8A-D  is a series of elevation views of several exemplary embodiments of an insertable optical element with varying locations, lengths, and degrees of alteration, and with an optical element connector shown as transparent to better illustrate internal features that are shown in phantom lines;  FIG. 8A  is an elevation view of an exemplary embodiment of an optical element having no radial emission portion;  FIG. 8B  is an elevation view of another exemplary embodiment of an optical element having a single radial emission portion disposed over an intermediate segment between the coupling end and the distal end of the optical element;  FIG. 8C  is an elevation view of yet another exemplary embodiment of an optical element having a single radial emission portion disposed over substantially the entire distance between the coupling end and the distal end of the optical element;  FIG. 8D  is an elevation view of still another exemplary embodiment of an optical element having multiple radial emission portions, one disposed over an intermediate segment between the coupling end and the distal end of the optical element, and another proximate the distal end. 
         FIG. 9  shows cross-sectional views of multiple portions of an exemplary insertable optical element (similar to that shown in  FIG. 8C ) with various EMR radial, gradient emission levels; 
         FIG. 10  shows the cross-sectional views of various gradient emission levels of  FIG. 9  showing the sections with EMR ray diagrams of internal reflection, and relative radial emission; 
         FIG. 11  shows cross-sectional views of various exemplary dispersals of microscopic structures (such as flecks or bubbles) within a fiber optic&#39;s core, cladding, and the core/cladding boundary; 
         FIG. 12  is a schematic view of a treatment being applied to the insertable optical elementdistal end; 
         FIG. 13  is a perspective, partially exploded view of an exemplary embodiment of a urinary catheter with the insertable optical element shown partially inserted into an input port and the ballon cuff inflated; and 
         FIG. 14  is a schematic view of another exemplary embodiment of a urinary catheter positioned to drain urine and to provide therapeutic EMR. 
     
    
    
     
       
         
           
               
             
               
                   
               
               
                 REFERENCE NUMERALS 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
            
               
                 catheter 10 
                 patient&#39;s body 12 
               
               
                 optical element 14 
                 line tubing 16 
               
               
                 EMR conduction system 18 
                 electromagnetic radiation component 20 
               
               
                 insertable catheter component 22 
                 elongate body 24 
               
               
                 electromagnetic radiation power source 26 
                 coupling element 28 
               
               
                 internal lumen 30 
                 proximal catheter hub assembly 32 
               
               
                 distal end 34 
                 aperture 35 
               
               
                 elongate catheter body 36 
                 balloon cuff 37 
               
               
                 catheter of varying lengths 38 
                 urethra 39 
               
               
                 convergence chamber 40 
                 bladder 41 
               
               
                 termination of the optical element 42 
                 input port 43 
               
               
                 flexible protection tubing 44 
                 output port 45 
               
               
                 line clamp 46 
                 transdermal area 48 
               
               
                 optical assembly 50 
                 intermediate coupling 52 
               
               
                 patch cable 54 
                 EMR conduction extending segment 56 
               
               
                 forward connector 58 
                 rearward connector 60 
               
               
                 exterior surface 62 
                 distal end 64 
               
               
                 core 66 
                 cladding 68 
               
               
                 cladding-encased fiber optic 70 
                 bare fiber optic 72 
               
               
                 inner diameter 74 
                 outer diameter 76 
               
               
                 void 78 
                 core-cladding boundary 80 
               
               
                 cladding outer boundary 82 
                 catheter wall 84 
               
               
                 connecting element 88 
                 EMR hub connector 90 
               
               
                 collimating lens 92 
                 optical element connector 94 
               
               
                 alignment shaft 98 
                 an aligning bore 99 
               
               
                 non-modified optical span 100 
                 segment-modified optical span 102 
               
               
                 radial emission portion 103 
                 fully-modified optical span 104 
               
               
                 elongated radial emission portion 105 
                 multi-modified optical span 106 
               
               
                 modified tip portion 107 
                 first section 108 
               
               
                 microscopic structures free area 109 
                 second section 110 
               
               
                 minimal concentration 111 
                 third section 112 
               
               
                 moderate concentration 113 
                 fourth section 114 
               
               
                 maximal concentration 115 
                 microscopic structures 117 
               
               
                 first dispersal 121 
                 control device 122 
               
               
                 second dispersal 123 
                 wand 124 
               
               
                 third dispersal 125 
                 acid spray 126 
               
               
                 outer region 127 
                 inner region 129 
               
               
                 boundary region 131 
                 adapter 150 
               
               
                 securing sleeve 152 
                 drain tube 154 
               
               
                 operational control features 156 
                 display 158 
               
               
                 optical jack 160 
                 fluid flow/EMR propagation 162 
               
               
                 urine flow 164 
                 insertion site A 
               
               
                   
               
            
           
         
       
     
     DETAILED DESCRIPTION 
     Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the exemplary embodiments, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the exemplary embodiments of the apparatus, system, and method of the present disclosure, as represented in  FIGS. 1 through 11 , is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments. 
     The phrases “attached to”, “secured to”, and “mounted to” refer to a form of mechanical coupling that restricts relative translation or rotation between the attached, secured, or mounted objects, respectively. The phrase “slidably attached to” refer to a form of mechanical coupling that permits relative translation, respectively, while restricting other relative motions. The phrase “attached directly to” refers to a form of securement in which the secured items are in direct contact and retained in that state of securement. 
     The term “abutting” refers to items that are in direct physical contact with each other, although the items may not be attached together. The term “grip” refers to items that are in direct physical contact with one of the items firmly holding the other. The term “integrally formed” refers to a body that is manufactured as a single piece, without requiring the assembly of constituent elements. Multiple elements may be formed integral with each other, when attached directly to each other to form a single work piece. Thus, elements that are “coupled to” each other may be formed together as a single piece. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. 
     Referring now to  FIG. 1 , a catheter  10  is insertable into a patient&#39;s body  12 . An assembly of the present disclosure comprises a non-ultraviolet, electromagnetic radiation (EMR) component  20 , and an insertable catheter component  22 . The non-ultraviolet, EMR component  20  broadly comprises an elongate body  24  used to enclose the EMR power source  26  and a coupling element  28  to couple the two components of the assembly. The EMR used manifests as visible light emitted in a range from 380 nm to 904 nm having a high intensity sufficient to create a therapeutic effect such as inactivating one or more infectious agents and/or enhancing healthy cell growth. In some embodiments, the EMR source  26  has an adjustable duty cycle length so that the EMR can be provided with appropriate desired intensity at the most effective times and for beneficial time periods. 
     The catheters  10  depicted in  FIGS. 1-5  are exemplary multiple lumen catheters  10  each of which also comprises line tubing  16 , one or more (in  FIGS. 1, 4, and 5  two are shown, in  FIGS. 2 and 3 , three are shown) proximal catheter hub assemblies  32 , an elongate catheter body  36 , a distal end  34  with one or more apertures  35  that open into internal lumens  30 , and a convergence chamber  40 . Each internal lumen  30  has an inner diameter (i.e., an interior surface dimension, for example see outer diameter  76  of  FIG. 6A ) and runs the length of the catheter  10 , from the proximal catheter hub assembly  32 , through the line tubing  16 , the convergence chamber  40 , and the elongate catheter body  36 , to the distal end  34 . Fluids may be injected into the lumen  30  and exit through the aperture  35  into the patient&#39;s body  12 , or fluids may be drawn from the patient&#39;s body  12  through the aperture  35  into the lumen  30 . Additionally, some catheters  10  may have inflatable balloon cuffs  37  (see  FIGS. 13 and 14 ) that may seal the catheter  10  against the wall of the patient&#39;s body  12  cavity into which the catheter  10  is inserted. The optical element  14  is elongate may be a reflective coating or it may be a fiber optic with an outer diameter (i.e., an exterior surface dimension, for example see outer diameter  76  of  FIG. 6A ) sufficiently small to be insertable within at least one of the internal lumens  30  and may extend at least as far into the catheter  10  as a termination of the optical element  42 , although the insertion may be less than that length if desired. 
     Catheters  10  suitable for use with an insertable optical element  14  may be of several different makes, sizes, and functions. For example, a urinary catheter  10  (see  FIGS. 13 and 14 ) inserted through a patient&#39;s urethra  39  into a patient&#39;s bladder  41  may have an input port  43 , an output port  45 , and an inflatable balloon cuff  37  to facilitate draining urine from the patient&#39;s bladder  41  while permitting fluids (or in the case of the present disclosure therapeutic EMR) to be injected into the patient&#39;s body  12 . As another example, catheters  10  that are translucent may be particularly suited to permit the passage of radially emitted EMR through the catheter wall  84  (see an exemplary catheter wall  84  in  FIGS. 6A-C ) to the tissue surrounding the catheter  10 . Catheters  10  that have an interior surface dimension (inside diameter  74 ) sufficiently larger than the exterior surface dimension (outer diameter  76 ) of the insertable optical element  14  create a void  78  or passageway (see  FIGS. 6A-C ) that may permit the injection or withdrawal of fluid (liquid or gas) simultaneously through the catheter  10  while that insertable optical element  14  resides within the catheter  10 . 
     Also, some catheters  10  have radiopacifiers embedded within the walls of the catheter  10  so that an image of where the catheter  10  is located within the patient&#39;s body  12  may be determined. However, some catheters  10  have no such radiopacifiers. In either case, it is contemplated by this disclosure that radiopacifiers may be contained in or on the insertable optical element  14  to provide detection of the location of the catheter  10  within the patient&#39;s body  12  when the catheter  10  does not have radiopacifiers, and to provide detection of the location of the insertable optical element  14  disposed within the catheter  10  whether or not the catheter  10  has radiopacifiers (this may require differing radiopacifiers in some instances so that the catheter  10  and the insertable optical element  14  may be distinguished). 
     With some exemplary embodiments, at least one of the proximal catheter hub assemblies  32  may have an optical fiber element alignment shaft  98  that aligns an optical element connector  94  and the insertable optical element  14 . 
       FIGS. 2 and 3  show the catheter  10 , in a schematic view, inserted at an insertion site A in the chest of the patient&#39;s body  12  ( FIG. 2 ) and in an arm of the patient&#39;s body  12  ( FIG. 3 ), respectively. The depiction shows how non-ultraviolet, therapeutic EMR may be delivered at the insertion site A and to other sites within the patient&#39;s body  12 . At the insertion site A, the therapeutic EMR may be delivered to a transdermal area  48  to inactivate infectious agents in that area and to enhance healing of the insert site A. Similarly, proximate the distal end  34 , in this case within the vena cava, therapeutic EMR may be delivered to inactivate infectious agents and/or to enhance healing in that proximate vicinity. 
     Referring specifically to  FIG. 2  of the present disclosure, a schematic view of another embodiment of the medical device assembly comprises a non-ultraviolet, EMR component  20 , and an insertable catheter component  22 . The embodiment shown is specifically a tunneled triple lumen central line variation of the disclosure; however it should be understood that the catheter may encompass any type of accessing catheter  10  (e.g., vascular, gastrointestinal, etc.) without departing from the scope and spirit of the invention. The non-ultraviolet EMR component  20  is coupled to the proximal catheter hub assembly  32  of the insertable catheter component  22 . The other coupling hubs  32  are available for axial propagation of fluid (whether by injection or retrieval). Each designated internal lumen  30  propagates the EMR or fluid between its proximal catheter hub assembly  32  and distal end  34 . 
     Although the triple lumen catheters  10  of  FIGS. 2 and 3  depict specific uses of the triple lumen catheter  10 , it should be understood that a triple lumen embodiment may be a desirable option in areas where multiple fluid delivery or extraction is necessary simultaneously. For example, in hemodialysis, venous and arterial blood is exchanged simultaneously. Similarly, in peritoneal dialysis, fluids and dissolved substances (electrolytes, urea, glucose, albumin, and other small molecules) are exchanged from the blood by catheter access through peritoneum in the abdomen of a patient. This exemplary triple lumen embodiment allows for the delivery of therapeutic EMR simultaneously with such dialysis function. 
     The incision site A and the proximate transcutaneous region of the insertable catheter body  36  is often a high source of infections. To reduce infections at this site and in this region, a dedicated area  48  is a region that facilitates radial emission of the therapeutic EMR from the optical element  14  within the elongate catheter body  36 . This allows the sterilizing EMR to irradiate outward and inactivate the infectious agents at the insertion site A and transcutaneous in that region. 
     Proximate the distal end  34  of the elongate catheter body  36 , the optical element  14  discontinues at termination point  42  so that the therapeutic EMR can irradiate throughout the distal end  34  of the catheter  10  and the surrounding cavity area. 
     The EMR component  20  comprises the EMR power source  26  ( FIGS. 2-5 ), a light source (not shown, such as a laser or the like), electrical circuitry (not shown), and optics (not shown, but dependent upon the light source) all housed within an elongate body  24 . A coupling element  28  connects the EMR component  20  to an optical assembly  50 . The optical assembly  50  comprises the insertable optical element  14  and the optical element connector  94 . The combination of the EMR component  20 , the coupling element  28 , and the optical assembly  50 , comprising the insertable optical element connector  94  and the insertable optical element  14 , will be referred to herein as an EMR conduction system  18 . In some embodiments, the EMR conduction system  18  is removable from its inserted disposition within the catheter  10 . When the EMR conduction system  18  is insertably removable, therapeutic EMR may be directed into an existing indwelling catheter  10  in a retrofit context. 
     Of particular interest to each of the embodiments is the use of light having wavelengths ranging from above 380 nm and about 904 nm. Additionally, the intensity and power of the light emitted server to inactivate of infectious agents and/or to promote healing. A range of radiant exposures covering 0.1 J/cm 2  to 1 kJ/cm 2  and a range of powers from 0.005 mW to 1 W, and power density range covering 1 mW/cm 2  and 1 W/cm 2  are of interest for these exemplary device assemblies and methods. These ranges of wavelengths, power densities, and radiant exposures have been shown to have either antimicrobial effects or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased proliferation of fibroblasts, stimulation of collagen synthesis, angiogenesis inducement and granulation tissue formation. 
     For each exemplary embodiment described herein, the EMR conduction system  18  and method for disinfecting/healing could be utilized in an adjustable or predetermined duty cycle. If treatments began immediately after sterile procedure has been initiated, device-related infections may be inhibited. This includes device-related biofilm growth. 
     Additionally, although a wavelength in a range from 380 nm to 904 nm with a sufficient intensity will inactivate one or more infectious agents and/or enhance healthy cell growth, more precise wavelengths may have more particular efficacy against certain infectious agents or for a desired healing purpose. It has been determined that sterilizing EMR of wavelengths including wavelengths centered about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 m, 470 nm, 475 nm, 660 nm, and 808 nm have particular efficacy. A wavelength selected to promote healing and healthy cell growth may be selected from the group of wavelengths centered about 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. 
     The insertable catheter component  22 , being capable of at least partially being inserted into a cavity of the patient&#39;s body  12  to deliver the non-ultraviolet, therapeutic EMR, comprises of at least one internal lumen  30 , a proximal catheter hub assembly  32 , and a distal end  34 . An internal lumen  30  being simply defined as the internal path by which fluid or EMR may travel. In cases of a single or multi-lumen catheter  10 , similar features in the drawings will be labeled with the same number. It should be noted that examples of multi-lumen catheters are described and depicted in the parent application (U.S. application Ser. No. 13/801,750, filed on Mar. 13, 2013) which has been incorporated into this application by a specific reference above. In multi-lumen embodiments, a dedicated single lumen may also be designated for the axial propagation of EMR and each additional lumen dedicated for the injection or retrieval of fluid axially. In this way both fluid and EMR can be axially propagated simultaneously through their individual lines and the EMR-delivering optical element  14  and fluids need not occupy the same lumen. 
     The distal end  34  being insertable into the cavity of the patient&#39;s body  12  at a determined incision site A, enables the elongate catheter body  36  to direct the delivery and/or retrieval of fluid and the therapeutic EMR axially relative to the elongate catheter body  36  for delivery into the patient&#39;s body  12 . The elongate catheter body  36  is described as being an elongated catheter  10  having at least one internal lumen  30 . Another embodiment of the present disclosure is depicted in  FIG. 4 , showing a perspective view of a dual lumen catheter  10  with the removable EMR conduction system  18  outside the catheter  10 . The catheter  10  portion of the depiction shows flexible protection tubing  44  that protects the coupling of the proximal catheter hub assembly  32  with the line tubing  16  and also protects line tubing  16  from wear imposed by line clamps  46 . 
     Therapeutic EMR will travel axially relative to the catheter  10  which may be of varying lengths  38  depending on its specific need. The fluids passing through the internal lumen  30  may be injected and contain pharmacological compounds (e.g., a drug) or may be retrieved biological fluids (e.g., blood, urine, or cerebral spinal fluid). 
     This figure depicts a multi-lumen embodiment of the disclosure. Each multi-lumen embodiment may contain a convergence chamber  40 , at the point where individual internal lumens  30  converge into a single elongated catheter body  36  while retaining their individual internal paths. At the distal end  34  of the elongate catheter body  36 , the optical element  14  discontinues at the termination point  42  so that the therapeutic EMR can irradiate throughout the distal end  34  of the catheter  10  and surrounding cavity area. 
     This embodiment also is fitted with flexible protection tubing  44  to protect the lumen at the proximal catheter hub assembly  32  and between the proximal catheter hub assembly  32  and convergence chamber  40 . If manual line occlusion is necessary it may be performed with the line clamp  46 . 
       FIG. 5  shows the dual lumen catheter  10  of  FIG. 4  with the removably insertable EMR conduction system  18  partially inserted into one of the lumens  30  of the catheter  10 . 
       FIG. 7  shows an exploded perspective view of an exemplary EMR conduction system  18  as partially inserted into the proximal catheter hub assembly  32  and an internal lumen  30 . With this exemplary embodiment, an intermediate coupling  52  is shown. Such intermediate coupling  52  may comprise a patch cable  54  or an EMR conduction extending segment  56  used to extend the distance between the EMR power source  26  and the optical element connector  94  of the insertable optical element  14 , without appreciable loss of light intensity. Each of the patch cable  54  or EMR conduction extending segment  56  may have a forward connector  58  to securely engage coupling element  28 , and a rearward connector  60  to securely engage the optical element connector  94 . Hence, by using a patch cable  54  or an EMR conduction extending segment  56 , the EMR power source  26  may be operated some desired distance from the patient to reduce noise or heat concerns and/or to position the EMR power source  26  closer to a power source (not shown) such as an electrical outlet or battery pack. 
       FIGS. 6A-C  is a series of illustrative cross sectional views of alternative optical elements  14  as disposed within an exemplary single-lumen catheter  10 . Of course, multi-lumen catheters  10  are also contemplated by this disclosure and the context of  FIGS. 6A-C  can easily be understood by those skilled in the art to apply equally to multi-lumen catheters  10  wherein one or more optical elements  14  may reside within one or more of the multiple lumens  30 . The depiction of single lumen catheter  10  cross sections is provided in the interest of brevity. However, examples of multi-lumen catheters are described and depicted in the parent application (U.S. application Ser. No. 13/801,750, filed on Mar. 13, 2013) which has been incorporated into this application by a specific reference above. 
       FIG. 6A  is a cross sectional view along line B-B of  FIG. 5  showing an exemplary embodiment of a cladding-encased fiber optic  70  as centered within a lumen  30  of the catheter line tubing  16 . However,  FIG. 6A  may also depict a cross section of a single lumen catheter  10 . The single lumen line tubing  16 /catheter  10 , depicted in cross section, has an inner diameter  74  and a catheter wall  84 . The cladding-encased fiber optic  70  is an optical element  14  and has an outer diameter  76 , a core-cladding boundary  80  and a cladding outer boundary  82 . When the cladding-encased fiber optic  70  is centered, as depicted in  FIG. 6A , an annular void  78  is created between the cladding outer boundary  82  and the catheter wall  84  when the inner diameter  74  of the catheter wall  84  is larger than the outer diameter  76  of the cladding-encased fiber optic  70 . Fluids may travel through this void  78 , whether by injection or retrieval, when the cladding-encased fiber optic  70  resides within the lumen  30  of a single lumen catheter  10  (or a EMR designated lumen  30  within a multi-lumen catheter  10 . 
       FIG. 6B  is a cross sectional view along line B-B of  FIG. 5  showing an exemplary embodiment of the cladding-encased fiber optic  70  non-centered within a lumen  30  of the catheter line tubing  16 . Similarly,  FIG. 6B  may also depict a cross section of a single lumen catheter  10 . However, the void  78  formed within the lumen  30  is not annular, and without structure to hold the cladding-encased fiber optic  70  in a centered disposition, the non-centered disposition may occur when the optical element  14  is removably inserted into the lumen  30  of the catheter  10 . Consequently, the therapeutic EMR emitted radially from the optical element  14  must pass through the void  78  before reaching and passing through the catheter wall  84 . Especially when there is fluid present within the void  78 , the intensity of the therapeutic EMR may need to be increased so that the therapeutic EMR emerging from the catheter wall  84  is sufficient to inactivate infectious agents and/or to enhance healthy cell growth in the tissue surrounding the indwelling catheter  10 . 
       FIG. 6C  is a cross sectional view along line B-B of  FIG. 5  showing another exemplary embodiment of a bare fiber optic  72  as centered within a lumen  30  of the catheter line tubing  16 . With this embodiment, the void  78  is created between the catheter wall  84  and the exterior surface  62  of the bare fiber optic  72 . 
       FIGS. 8A-D  is a series of elevation views of several exemplary embodiments of an optical assembly  50  showing various locations with gradient degrees of alteration on the exterior surface  62  of the insertable optical element  14 . Each view of the series of views shows an optical assembly  50  with an insertable optical element  14  connected to the optical element connector  94 . The optical element connector  94  (see also  FIGS. 7 and 9 ) has a connecting element  88 , an EMR hub connection  90 , a collimating lens  92 , and an alignment shaft  98 . 
     The first view (uppermost,  FIG. 8A ) of the series of views shows an unaltered optical span  100  of the insertable optical element  14  that is without any radial dispersion (i.e., the insertable optical element  14  has not been treated or altered to provide radial emission of light from the body of the insertable optical element  14 ). With this embodiment, therapeutic, non-ultra-violet EMR may be provided to a distal end  64  of the optical element  14  with no radial emission from the optical span  100  other than at the distal end  64 . 
     The second view (next view down,  FIG. 8B ) of the series of views shows an exemplary radial transmission equivalency over a radial emission portion  103  (i.e., radial emission portion  103 , as depicted, has a gradient modification such that the emitted EMR has substantially uniform intensity and power over the length of the radial emission portion  103 ) that provides radially dispersed light from a segment-modified optical span  102 . The location of the single radial emission portion  103 , in this instance, corresponds to where the catheter  10  enters the insertion site A when the insertable optical element  14  is inserted fully into the catheter  10 . With this embodiment, radially emitted visual light may sterilize and/or enhance healthy cell growth at the insertion site A and the transdermal area  48  or any other predetermined site within the patient&#39;s body  12 . 
     Each of the views in  FIGS. 8B-D  depicts a gradient modification to facilitate emitting EMR in a pattern wherein there is substantially uniform intensity and power over the length of the radial emission portion(s). It should be understood, however, that although each of the views depict EMR of uniform intensity and power, any desired pattern of EMR emission may be achieved by varying the degree of modification within the radial emission portion because less ablation will permit less radial emission of EMR and more ablation will permit more radial emission of EMR. For example, a radial emission portion with less oblation proximate each end and more ablation in the middle will emit EMR of lesser intensity and power on each end with more intensity and power emitting in the middle. Hence, any desired pattern of EMR emission may be created by adjusting the pattern of ablation within the radial emission portion. 
     The third view of the series of views ( FIG. 8C ) shows an example of a single radial emission portion  105  that provides radially dispersed EMR from optical element  14  extending along most of a fully-modified optical span  104 . The location of the single radial emission portion  105  corresponds generally to the entire length of the insertable catheter component  22  of the catheter  10 . With this embodiment, therapeutic EMR may be provided for substantially the entire length that the catheter  10  that would be inserted within the patient&#39;s body  12 . 
     The fourth view of the series of views ( FIG. 8D ) shows an example of radial transmission uniformity at multiple locations. A single radial emission portion  103  and an additional distal end region radial emission portion  107  are spaced along a multi-modified optical span  106 . The locations of the radial emission portion  103  and the distal end region radial emission portion  107  correspond to areas of the body, including for example the insertion site A, where the delivery of non-ultraviolet, therapeutic EMR may be desired for sterilization and/or healing. It should be understood that there may be more than one radial emission portion  103  disposed along the length of the multi-modified optical span  106  and/or each radial emission portion  103  may be distinct from each other radial emission portion  103  and each may have differing lengths. 
     Also, it should be understood that in each of these views the radial emission portions depicted may be of modifications other than modification of the exterior surface  62  of the insertable optical element  14 , such as for example, modifications including microscopic structures embedded within the insertable optical element  14  that allow radial transmission of light from the insertable optical element  14 . Further, such radial emission portions  103 ,  105 ,  107  may have gradient patterns that allow for an overall substantially-uniform distribution of light over the length of each radial emission portion  103 ,  105 ,  107 . 
       FIG. 9  is a schematic view of an optical assembly  50  with an insertable optical element  14  coupled to an optical element connector  94 . The insertable optical element  14  has a fully-modified optical span  104 . Multiple locations along the insertable optical element  14  are shown in enlarged cross-sectional views. These locations are axially spaced along the insertable optical element  14  to assist in describing the nature of an exemplary insertable optical element  14  at each location. As depicted, there are four section locations, a first section  108 , a second section  110 , a third section  112 , and a fourth section  114 . For brevity, the modifications on and in the insertable optical element  14  at each of the four sections are combined in the depictions of  FIG. 9 . Of course, the radial emission portions of the insertable optical element  14  may be singular or multiple, may be any length or gradient, and may be coincident, overlapping or not. 
     The first section  108  represents an internally reflected region of the insertable optical element  14 . As shown at the first section  108 , there is no ablation (or other modification) and no microscopic structure within the core  66  of the insertable optical element  14 . No therapeutic non-ultraviolet EMR will emit radially from the insertable optical element  14  at the first section  108 . 
     The second section  110  represents a minimally emissive region of the insertable optical element  14 . As shown at the second section  110 , there is minimal ablation (or other modification) to the exterior surface  62  of the insertable optical element  14  and a minimal dispersal of microscopic structures  117  within the core  66  of the insertable optical element  14 . From the second section  110 , minimal therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element  14 . However, the amount of EMR emitted should have sufficient intensity and power to inactivate infectious agents and/or promote healing proximate the second section  110 . 
     The third section  112  represents a moderately emissive region of the insertable optical element  14 . As shown at the third section  112 , there is moderate ablation (or other modification) to the exterior surface  62  of the insertable optical element  14  and moderate dispersal of microscopic structures  117  within the core  66  of the insertable optical element  14 . From the third section  112 , a moderate amount of therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element  14  proximate the third section  112 . However, prior to reaching the third section  112 , the amount of light traveling axially along the insertable optical element  14  diminishes due to the radial emission of some of the light such as at second section  110 . Consequently, the degree of the gradient of modification is selected so that the amount of EMR emitted radially at third section  112  should be substantially uniform with the radial emission at the second section  110 . Hence, the intensity and power of the EMR emitted may be substantially uniform with the intensity and power emitted at second section  110  and is of sufficient intensity and power to inactivate infectious agents and/or promote healing. 
     The fourth section  114  represents a maximally emissive region of the insertable optical element  14 . As shown at the fourth section  114 , there is maximal ablation (or other modification) to the exterior surface  62  of the insertable optical element  14  and maximal dispersal of microscopic structures  117  within the core  66  of the insertable optical element  14 . From the fourth section  114 , a maximum amount of therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element  14  proximate the fourth section  114 . Again, prior to reaching the fourth section  114 , the amount of light continuing to travel axially along the insertable optical element  14  diminishes due to the radial emission of some of the light such as at second section  110  and at third section  112 . Consequently, the degree of the gradient of modification is selected so that the amount of EMR emitted radially at fourth section  114  should be substantially uniform with the emissions at second section  110  and third section  112 . The intensity and power of the EMR emitted may be substantially uniform with the intensity and power emitted at second section  110  and third section  112  and is of sufficient intensity and power to inactivate infectious agents and/or promote healing. 
     The radial emission portions may be modified by chemical, physical or other cladding modification (e.g., ablation) to alter the critical angle enough to allow light to emit radially. Additionally or alternatively, the radial emission portions may be modified by dispersing microscopic structures  117  of varying gradient concentration inside the core  66  of the insertable element  14 . The gradient concentration of microscopic structures  117  within the core  6  shown in  FIG. 9  range from a microscopic structures free area  109 , to a minimal concentration  111  of microscopic structures  117 , to a moderate concentration  113  of microscopic structures  117 , to a maximal concentration  115  of microscopic structures  117 . 
     The concentration of microscopic structures  117  within the core  66  affects the refractive index of the core  66  and the core-cladding boundary  80 . The microscopic structures  117  (which may be, for example, reflective flakes or voids, such as bubbles) create changes in the incident angle of the light as it passes through the insertable optical element  14 . At certain incident angles, light leaves the optical element cladding  68  and emits radially from the cladding outer boundary  82 . 
       FIG. 10  is a schematic view of the cross-sectional views of  FIG. 9  depicting light rays as arrows. The same cross-sectional views of the insertable optical element  14  are shown: namely, the first section  108  (internally reflected), the second section  110  (minimally radially emissive), the third section  112  (moderately radially emissive), and the fourth section  114  (maximally radially emissive). These views also show light rays traveling axially along the core  66 , that collide with microscopic structures  117  at an incident angle causing the light ray to pass through the optical element cladding  68 . An increasing pixilated gradient is depicted on the cladding boundary  82  from the first section  108  (no pixilation), to the second section  110  (minimal pixilation), to the third section  112  (moderate pixilation), to the fourth section  114  (maximal pixilation) represents the chemical, physical or other cladding modification (e.g., ablation) at the cladding boundary  82 . Such modification of the insertable optical element  14  alters critical angles enough to allow light to emit radially. As schematically depicted, the amount of rays leaving the optical element cladding  68  are substantially equivalent at each site although the amount of rays the core  66  diminishes as the light travels from proximal to distal. The microscopic structures  117  of varying gradient concentration are also shown inside the core  66 , from the microscopic structure free area  109 , to a minimal concentration  111 , to a moderate concentration  113 , to a maximal concentration  115 . Each of the microscopic structures  117  has a refractive index that differs from that of the core  66  and the optical element cladding  68 . The microscopic structures  117  (which may be, for example, reflective flecks or voids, such as bubbles) create changes in the incident angle of the light as it passes through the insertable optical element  14 . At certain incident angles, light leaves the optical element cladding  68  and emits radially. 
       FIG. 11  shows cross-sectional views of various exemplary dispersals of microscopic structures  117  (such as flecks or bubbles) within a fiber optic&#39;s core  66 , cladding  68 , and the core/cladding boundary  80 . With each of the exemplary embodiments depicted microscopic structures  117  are dispersed within the insertable optical element  14  (in this case an optical fiber) to achieve radial transmission of light. These microscopic structures  117  may be positioned within the core  66  and/or at the core-cladding boundary  80  and/or within the cladding  68  of the optical fiber  14 . The microscopic structures  117  having a refractive index lower than the region free of microscopic structures  117 . The microscopic structures  117  may be a material added to the optical fiber core  66  or the core-cladding boundary  80 , such as a metal, rubber, glass beads, or plastic. The microscopic structures  117  may also be the lack of material creating an aberration within the optical fiber core  66  and/or the core-cladding boundary  80  and/or within the cladding  68 . For example, the presence of microscopic structures  117  (such as bubbles) in the optical fiber core  66  creates an aberration or imperfection that would alter the materials refractive index, resulting in EMR being emitted radially from the optical fiber (insertable optical element  14 ). 
     In  FIG. 11 , three exemplary dispersals, a first dispersal  121 , a second dispersal  123 , and a third dispersal  125 , are depicted. The first dispersal  121  has microscopic structures  117  (such as flecks or bubbles) dispersed within and outer region  127  of the core  66  only. The second dispersal  123  has microscopic structures  117  dispersed within an inner region  129  of the cladding  68  as well as within the outer region  127  of the core  66 . The third dispersal  125  has microscopic structures  117  dispersed proximate to the core/cladding boundary  80  and are depicted as identifying a boundary region  131  that is thinner than the outer region  127  of the core  66  and the inner region  129  of the cladding  68 . With each of these exemplary dispersals, at least some of the light traveling the length of the insertable optical element  14  (fiber optic) will not encounter any microscopic structures  117  while the remainder of the light may encounter at least one microscopic structure  117  and be deflected to emit radially from the insertable optical element  14 . 
       FIG. 12  is a schematic view of an exemplary optical element modification method for creating gradient modification on the exterior surface  62  of the insertable optical element  14 . Such modification of the core  66  or optical element cladding  68  alters the incident angle of light rays so that they differ from the critical angle needed to remain internally reflected. Depicted in  FIG. 12  is a control device  122  with a wand  124  delivering an acid spray  126  for etching the insertable optical element  14 . 
     There are several methods for achieving this gradient modification. Chemically, the insertable optical element  14  may be etched using a strong acid such as hydrofluoric acid or sulfuric acid and hydrogen-peroxide. Also, quartz powder, calcium fluoride, or an etching cream, usually carrying a fluorinated compound, may be used. Physically, heating the insertable optical element  14  or physical modification such as ablation by sanding, media blasting, grinding, or laser ablation modifications are also methods for creating gradient modification. Additionally, plasma ablation by laser modification causes the ionization of molecules and alteration of the exterior surface  62  of the insertable optical element  14 . Other known methods for creating gradient ablation are contemplated by this disclosure. Regardless of the modification or manufacturing process, whether presently known or not, the insertable optical element  14  may be modified to have substantially equivalent radially emitted light along desired lengths. This uniformity in radially emitted light allows for a more accurate treatment dose for inactivating infectious agents and/or promoting healing. 
     In  FIGS. 8A-D ,  9 , and  12  of the present disclosure, a transparent view of the optical element connector  94  is depicted, comprising a connecting element  88 , an EMR hub connection  90 , a collimating lens  92 , and an alignment shaft  98 . The insertable optical element  14  may be inserted into an aligning bore of the optical element connector  94  to collimate the light into a small diameter core  66  or one or more optical fibers. 
     The exemplary disclosure depicts an optical diversion element as a single collimating lens  92 , but other types of optical diversion elements such as multiple lenses or different types of lenses may be used to collimate the light. Depending on the optical element  14  diameter, numerical aperture, and refractive index, specific lenses will be needed as an optical diversion element to reduce light loss. 
     Turning now to  FIG. 13 , a urinary catheter assembly is depicted. The urinary catheter assembly comprises and electromagnetic radiation component  20  and an insertable catheter component  22 . The insertable catheter component comprises a proximal catheter hub assembly  32 , an elongate catheter body  36  and a distal end  34  region. The proximal catheter hub assembly  32  serves as an input port  43  (the arrow showing the direction of fluid flow and/or therapeutic EMR propagation  162 ). The elongate catheter body  36  also comprises an output port  45  for draining urine from the patient (the arrow showing the direction of urine flow  164 ), an inflatable balloon cuff  37  (shown inflated), and an aperture  35 , the balloon cuff  37  and aperture  35  are disposed within the distal end  34  region. The insertable catheter component  22  may be made in varying lengths  38  as female urinary catheters are typically shorter than male urinary catheters which are made to different lengths. 
     The electromagnetic radiation component  20  comprises an EMR power source  26 , a coupling element  28 , and an optical element  14 . As depicted, the coupling element  28  is spaced from the catheter hub assembly  32  to reveal the optical element  14  that is partially inserted into the lumen of the elongate catheter body  36 . When the coupling element  28  is connected to the catheter hub assembly  32 , the optical element will be fully inserted and the distal end of the optical element  14  will extend to the termination  42  so not to interfere with the inflatable balloon cuff  37  or the aperture  35 . In this fully inserted disposition, the optical element  14  may emit radially therapeutic EMR at the incision site A and into the transdermal area  48 . 
       FIG. 14  depicts another exemplary urinary catheter  10  as positioned within a male patient. As shown, the urinary catheter  10  has been inserted into the patient&#39;s bladder  41  through the urethra  39  and the balloon cuff  37  has been inflated to seal the bladder  41  from leaking around the urinary catheter  10 . This exemplary urinary catheter  10  comprises an elongate catheter body  36 , an adapter  150 , a securing sleeve  152 , and a drain tube  154 . The adapter  150  has an input port  43  and an output port  45 . An EMR component  20  may be utilized in conjunction with the exemplary urinary catheter  10  to provide therapeutic EMR along the urethra  39  and into the bladder  41  to inactivate infectious agents and/or to promote healthy cell growth. The EMR component  20  comprises a control device  154  that houses an EMR power source  26 , operational control features  156  and a display  158 , an optical element  14 , and an optical jack  160 . 
     When positioned as shown in in  FIG. 14 , the optical element  14  has been threaded into the adapter  150  and secured by the securing sleeve  152  and urine freely drains through the elongate body  36  into the drain tube  154  to be deposited in a urine drain bag (not shown). Frequently, urinary catheters  10  are indwelling for long periods of time and consequently are a concern for the build-up and proliferation of infectious agents in or around the urinary catheter  10 . To provide therapeutic EMR to prevent, reduce, or eliminate the proliferation of infectious agents and/or to enhance healthy cell growth, the optical jack  160  is plugged into the control device  154  connecting the optic al element  14  to the EMR power source  26  and the operational control features  156  are activated to set the frequency or frequencies, intensity, power, duty cycle, and other operational parameters, and turn on the EMR delivery into the optical element  14 . The setting of the operational features and the monitoring of the parameters may be viewed on the display  158 . 
     For exemplary methods or processes of the invention, the sequence and/or arrangement of steps described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal arrangement, the steps of any such processes or methods are not limited to being carried out in any particular sequence or arrangement, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and arrangements while still falling within the scope of the present invention. 
     Additionally, any references to advantages, benefits, unexpected results, or operability of the present invention are not intended as an affirmation that the invention has been previously reduced to practice or that any testing has been performed. Likewise, unless stated otherwise, use of verbs in the past tense (present perfect or preterit) is not intended to indicate or imply that the invention has been previously reduced to practice or that any testing has been performed. 
     Exemplary embodiments of the present invention are described above. No element, act, or instruction used in this description should be construed as important, necessary, critical, or essential to the invention unless explicitly described as such. Although several exemplary embodiments have been described in detail herein, those skilled in the art will readily appreciate that many modifications are possible in these exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims. 
     In the claims, any means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents, but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts, a nail and a screw may be equivalent structures. Unless the exact language “means for” (performing a particular function or step) is recited in the claims, a construction under Section 112, 6th paragraph is not intended. Additionally, it is not intended that the scope of patent protection afforded the present invention be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself. 
     While specific embodiments and applications of the present invention have been illustrated and described, it is to be understood that the invention is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present invention disclosed herein without departing from the spirit and scope of the invention.