Apparatus for variably delivering therapeutic non-ultraviolet electromagnetic radiation via a catheter placed in a body cavity - Patent Application 20070122999

Abstract

A device for safely and effectively disinfecting a catheter while it remains implanted in a patient's body is provided. [Solution] Methods and devices for providing therapeutic electromagnetic radiation (EMR) to inactivate infectious agents and / or enhance healthy cell growth in, on, or around a catheter (10) placed in a patient's body cavity. Non-ultraviolet therapeutic EMR is transmitted axially along the lumen of the catheter body and / or along an optical element (14) within the catheter body. Delivery of the therapeutic EMR to specific infected areas and / or areas requiring tissue healing results in inactivation of primary sources of infection in, on, and around the catheter and / or enhancement of healthy cell growth around the catheter through the use of controlled relative intensity and treatment-site-specific dose projection of the therapeutic EMR radially emitted from the optical element. Specific embodiments for urinary catheters and peritoneal dialysis catheters are also disclosed.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Patent Application No. 16 / 364,051, filed in the United States Patent and Trademark Office on March 25, 2019, the entire contents of which are incorporated by reference herein for all applicable purposes as if fully set forth below. Application No. 16 / 364,051 is a continuation-in-part of U.S. patent application Ser. No. 15 / 668,266 (hereinafter referred to as the "patent application"), entitled "Method and Apparatus for Delivering Therapeutic Non-Ultraviolet Electromagnetic Radiation to Inactivate Infectious Agents and / or Enhance the Growth of Healthy Cells via a Catheter Placed Within a Body Cavity," filed on August 3, 2017, which is a continuation-in-part of U.S. patent application Ser. No. 13 / 801,750, entitled "Method and Apparatus for Inactivating Infectious Agents to a Catheter Placed Within a Body Cavity," filed on March 13, 2013, which now issues as U.S. Patent No. 9,808,647, dated November 7, 2017, and claims the benefit of U.S. Provisional Patent Application No. 61 / 686,432, filed on April 5, 2012, entitled "HINS Laser Light Catheter." This application is also a continuation-in-part of U.S. Patent Application No. 15 / 424,732, filed February 3, 2017, entitled "Method and Apparatus for a Detachable Catheter Visible Light Therapy System." This application also claims the benefit of U.S. Provisional Patent Application No. 61 / 686,432, filed April 5, 2012, for an invention entitled "HINS Laser Light Catheter." Each of the related applications mentioned in this paragraph is incorporated herein by reference as if fully set forth below.

[0002] The present invention relates to an apparatus for variably delivering a therapeutic dose of non-ultraviolet light to inactivate infectious agents resident on, within, or around a catheter while the catheter is indwelling within a body lumen and / or to stimulate healthy cell growth to produce a therapeutic effect. Such variable delivery of therapeutic doses of non-ultraviolet light can employ controlled relative intensities and / or treatment site-specific application of the therapeutic dose. In particular, the present disclosure relates to a medical device assembly that utilizes non-ultraviolet visible therapeutic electromagnetic radiation (EMR) of sufficient intensity to stimulate healthy cell growth to produce a healing effect and / or reduce or eliminate infectious agents in, on, and around a catheter while the catheter is indwelling within a body lumen.

[0003] Various preferred embodiments of the present invention are described below. "Preferred" means exemplary or illustrative, and references to "the present invention" herein are not intended to limit or restrict the present invention to one or more particular features or steps of the preferred embodiments disclosed herein. References such as "preferred embodiment," "one embodiment," "embodiment," "some embodiments," "various embodiments," etc., indicate that the embodiments of the present invention so described may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Furthermore, repeated use of "in one embodiment" or "preferred embodiment" does not necessarily refer to the same embodiment, although they may be. [Background technology]

[0004] Catheters are widely used as channels for infusing drugs into or withdrawing fluid samples from a patient's body. Each catheter comprises a tube, usually made of plastic or other polymers such as silicone, polyurethane, and the like, that can be inserted into an area of ​​the body and contain one or more separate lines through which fluids can be delivered or withdrawn. A "lumen" refers to the passageway within the catheter that leads from outside the body to inside the body. Catheters are used for a variety of purposes, including intravascular, abdominal, urinary, gastrointestinal, ophthalmic, respiratory, cranial, spinal, and the like. In all cases, catheters are placed within the body space (hereafter referred to as a "body cavity") in which they are placed. These devices often result in infection of the tissue surrounding the catheter caused by the 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 cause illness in the patient. Depending on the location of the catheter, such infections can take the form of urinary tract infections, bloodstream infections, soft tissue infections, and the like.

[0005] Catheter-related infections (CRIs) are a major problem in healthcare, causing significant morbidity and mortality. Current methods for reducing or eliminating the number of infectious agents in, on, and around catheters have limited efficacy. Typically, catheters are removed when infectious agents are suspected, increasing both the costs associated with treatment and patient discomfort. Various methods have been attempted to prevent or eliminate the growth of infectious agents in, on, and around catheters, including the use of sterile procedures, antibiotics, and catheter replacement when infection is suspected. Despite these techniques, catheter-related infections remain a major problem. According to the U.S. Centers for Disease Control and Prevention, more than 31,000 people died from specific catheter-related bloodstream infections in 2010. Along with urinary tract infections, gastrointestinal infections, and other catheter-related infections, bloodstream infections increase both healthcare costs and patient discomfort.

[0006] Catheters come in a variety of sizes. Small diameter catheters, such as many PICC lines (peripherally inserted central catheters), have small diameter lumens. These small diameter catheters may be suitable for long-term insertion. Therefore, small diameter catheters may not have adequate catheter wall thickness to carry a sterile and / or healthy growth-promoting delivery system.

[0007] For example, the use of ultraviolet (UV) light, disinfecting chemicals, and drug-soaked catheters have been attempted to reduce the incidence of infectious diseases. Many patents have attempted to use UV light to disinfect catheters. Unfortunately, it is well known that UV light causes damage to living cells. Methods of using sterilizing electromagnetic radiation (EMR) to disinfect connectors, stopcocks, and valves have also been attempted using 405 nm light to sterilize these points, but these methods do not properly disinfect either the catheter body or the catheter tip.

[0008] The emergence of infectious agents resistant to current treatments, such as methicillin-resistant Staphylococcus aureus (MRSA), further demonstrates the need for alternative treatments for CRI. To reduce the costs associated with the need to remove and replace catheters from within the patient, catheters that can be sterilized while indwelling in the patient are needed. Furthermore, it would be advantageous to be able to stimulate healthy cells by delivering therapeutic EMR through an indwelling catheter.

[0009] Disinfection immediately after placement can help prevent the growth of biofilms on catheters. Biofilms consist of extracellular polymeric compounds produced by microorganisms after they attach to a surface. These biofilms support the growth of infectious agents and are very difficult to destroy once established.

[0010] Growth of infectious agents can originate from factors external to the patient (at the access point or from the catheter hub when the catheter crosses the skin) or from within the patient; infectious agents already present in the body can attach to and multiply on the surface of the catheter. Scientific literature suggests that approximately 65% ​​of CRIs originate from infectious agents present on the patient's skin (S. Oncu, Central Venous Catheter-Related Infections: An overview with Special Emphasis on Diagnosis, Prevention, and Management. Internet Journal of Anesthesiology. 2003 Volume 7 Number 1). These agents migrate down the outer surface of the catheter and colonize the catheter tip. In short-term catheter procedures, this is considered the most likely mechanism of infection (Crump, Intravascular Catheter-Associated Infections. Eur J Clin Microbiol Dis (2000) 19:1-8). 30% of CRIs are thought to originate from contaminated hubs, where infectious agents migrate down into the catheter (Oncu). This is considered the most likely mechanism of infection in chronic catheterization (Crump).

[0011] EMR in the 380–900 nm range has proven effective in killing infectious agents. Research by a group at the University of Strathclyde has shown that light in this range is effective in killing surface bacteria in burn wards without harming the patient (Environmental decontamination of a hospital isolation room using high-intensity light. J Hosp. Infect. 2010 Nov;76(3):Nov; 76(3):247–51). Published patent application No. 2010 / 0246169, written by members of the study, utilizes ambient light to disinfect large surrounding areas. The mechanism proposed by the team suggests that light in this range leads to the photosensitivity of endogenous porphyrins in bacteria, resulting in the production of singlet oxygen, which leads to bacterial death. (Inactivation of Bacterial Pathogens following Exposure to Light from a 405-Nanometer Light-Emitting Diode Array. Appl Environ Microbiol. 2009 Apr;75(7):1932-7).

[0012] However, to date, there has been no device for safely and effectively disinfecting a catheter while it remains implanted in a patient's body, nor a method for making or using such a device. Accordingly, there is a need for a device designed to deliver non-antibiotic bacterial therapeutics in vivo. Devices using such novel technology would enable the removable delivery of safe, effective, and reproducible disinfection and / or enhance healthy cell growth. Summary of the Invention

[0013] Preferred embodiments of the present disclosure relate to medical device assemblies for insertion into a patient's body cavity and for delivering and withdrawing fluids. Each assembly includes an electromagnetic radiation (EMR) source for providing non-ultraviolet therapeutic EMR of sufficient intensity to inactivate one or more infectious agents and / or enhance the growth of healthy cells. Each assembly includes a catheter or can be used with a catheter having an elongated catheter body with at least one internal lumen and a connecting end and a distal end. The distal end is insertable into a patient's body cavity, whether the cavity is venous, arterial, gastrointestinal, abdominal, urinary, respiratory, cranial, spinal, or similar, where the indwelling catheter body directs both the propagation of fluid and therapeutic EMR axially relative to the catheter body for delivery into the patient's body and / or radially at the distal end. Where appropriate, the therapeutic EMR can also be directed to or into an insertion location. An optical element disposed within the lumen of the catheter body and / or within the catheter body acts as a conductor of therapeutic EMR propagation axially relative to the catheter body. The optical element or another optical element can also be positioned to act as a conductor of therapeutic EMR propagation via at least one coupling element for connecting the EMR component to the insertable catheter component.

[0014] In this disclosure, "therapeutic" should be understood to mean or relate to aiding in or performed for the treatment of disease, including the reduction or elimination of infectious agents, and the maintenance of health, including the growth of healthy cells.

[0015] In this disclosure, "controlled relative intensity" should be understood as a versatile term meaning that the delivery of various desired intensities of EMR can be controlled in any of a number of ways, including: 1) by using different single fibers, 2) by using various radial gradients, 3) by using multiple different fibers, and 4) by retrofitting fiber type and / or design for custom use with existing catheters. The versatility contemplated by "controlled relative intensity" is the ability to deliver the desired / appropriate intensity of EMR to the desired site when it is most effective within a wide range of catheter types and sizes.

[0016] In this disclosure, "treatment site-specific" should also be understood as a flexible term meaning that EMR of various desired intensities can be delivered to a specific treatment site for a desired dose projection by using fibers with radial radiation capabilities that are adapted to a specific site(s) within, on the exterior of, or around a patient and / or catheter that is to be treated by the application of EMR.

[0017] A preferred medical device assembly includes an EMR source, an EMR conduction system, and at least one coupling for connecting the EMR source to the EMR conduction system. The EMR source provides non-UV therapeutic EMR with sufficient intensity to inactivate one or more infectious agents and / or stimulate the growth of healthy cells to produce a healing effect. In at least one preferred embodiment, the EMR conduction system is at least partially insertable into and removable from the lumen of an indwelling catheter. Because the EMR conduction system is removably insertable, in another preferred embodiment, a separate, second EMR conduction system (or at least the optical element of the second EMR conduction system) can also be removably insertable such that two different EMR conduction systems are interchangeably insertable into the same lumen of the catheter.

[0018] In some preferred embodiments, an apparatus is provided for effectively sterilizing a catheter and the area surrounding the catheter while the catheter is being placed within a body cavity. Such a medical device assembly uses sterile EMR to reduce or eliminate the number of infectious agents in, on or around the catheter and / or in the tissue surrounding the catheter while it is within the body cavity.

[0019] The EMR source can be a single or group of EMR sources, including, but not limited to, light-emitting diodes, semiconductor lasers, diode lasers, incandescent (filtered or unfiltered), and fluorescent (filtered or unfiltered) light sources. The EMR source provides non-ultraviolet therapeutic EMR that provides one or more wavelengths in the range of greater than 380 nm to about 904 nm. To sufficiently inactivate infectious species and / or stimulate healthy cell growth, each EMR wavelength must be narrowly spectral and centered around one wavelength from the group. The intensity must be sufficient to inactivate one or more infectious agents and / or stimulate healthy cell growth to produce a healing effect. This group includes several wavelengths centered around 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.

[0020] EMR sources may require drivers and electronic support to be fully functional. Housing the supporting hardware and / or software must be taken into consideration, which may comprise a significant portion of the functionality and effectiveness of the EMR source. EMR sources may generate heat, which may be harmful to the EMR source and need to be limited.

[0021] The present 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 is insertable into a body cavity of a patient. The catheter body is for directing both a fluid and therapeutic EMR axially at an insertion site, along the elongate catheter body, and / or at the distal end relative to the catheter body for delivery into the patient. The present disclosure includes an optical element disposed within the catheter body to guide axial propagation of the therapeutic EMR through the catheter body. The present disclosure also describes at least one coupling element for connecting a radiation source to the catheter body.

[0022] Sterile EMR is transmitted down a dedicated path within the catheter via an optical element that conducts the axial propagation of light. Various means can be used to facilitate the axial propagation of light through the catheter, including reflective coatings within the catheter line, fiber optic cables, lenses, waveguides, or the like. The light source can be a light emitting diode (LED), laser, fiber optic filament, or the like.

[0023] One preferred embodiment of the EMR source and supporting components is simplified and includes only the EMR source and necessary components. In another preferred embodiment of the EMR conduction system, a passive heat sink is required to dissipate the generated heat into the surrounding environment. In yet another preferred embodiment of the EMR source, the heat sink can be coupled to at least one fan to actively dissipate the heat generated by the EMR source. Other embodiments can employ EMR sources connected to separate, individual optical elements or a single EMR source that can be connected to separate, individual optical elements to provide EMR of different intensities and / or wavelengths to the separate optical elements.

[0024] Of particular importance in the present disclosure is the use of light with wavelengths of 380 nm to about 900 nm. Furthermore, the intensity and power of the emitted light have a significant effect on the inactivation of infectious agents, so that 0.1 J / cm 2 ~1kJ / cm 2and output power in the range of 0.005mW to 1W, and 1mW / cm 2 ~1W / cm 2 Power densities in the range of 1000 to 15000 are important for these preferred device assemblies and procedures. These wavelengths, power densities, and radiation dose ranges have been demonstrated to have antimicrobial or positive biological effects on healing tissue. Such positive biological effects include reduction of inflammatory cells, increased fibroblast proliferation, stimulation of collagen synthesis, induction of angiogenesis, and granulation tissue formation.

[0025] For each of the preferred embodiments described herein, the EMR conduction systems and means for disinfection / healing are available with adjustable or preset duty cycles. If treatment begins immediately after the sterilization procedure begins, device-associated infections can be prevented. This includes device-associated biofilm growth.

[0026] The treatment can include at least one wavelength of therapeutic EMR selected to sterilize one or more target organisms and acting as a dominant wavelength selected from a group of wavelengths centered around approximately 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm. Alternatively, the dominant wavelength selected to promote healing and healthy cell growth can be selected from a group of wavelengths centered around approximately 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 can include alternating dominant wavelengths between a first dominant wavelength and a second dominant wavelength (different from the first dominant wavelength) in a selected treatment pattern. Furthermore, the sterilizing EMR and the EMR that stimulates healthy cell growth can be delivered alternately, in conjunction, simultaneously, or alternatively.

[0027] A means for constructing a preferred medical device assembly for insertion into a body cavity of a patient and for delivering or withdrawing fluids from the body includes providing a catheter having an elongated catheter body with one or more internal lumens, a connecting end, and a distal end, the distal end being insertable into the body cavity of the patient; applying one or more optical elements within the one or more lumens of the catheter body and / or within a wall of the catheter body, the optical elements conducting therapeutic EMR propagation axially relative to the catheter body; and coupling at least one EMR source to the EMR conduction system and / or the catheter body, the EMR source for providing non-UV therapeutic EMR of sufficient intensity to inactivate one or more infectious agents and / or enhance the growth of healthy cells.

[0028] In one preferred embodiment, the device employs a catheter inserted into a patient's body cavity, the catheter allowing both fluid and therapeutic EMR to advance axially relative to the catheter body. The catheter also includes at least one coupling lumen for connecting an EMR source that delivers therapeutic EMR axially through the coupling lumen to the catheter line. A coupling element in this context generally refers to a typical hub on the therapeutic EMR source.

[0029] In at least one preferred embodiment, a removable, insertable EMR conduction system (i.e., an EMR conduction system that can be partially or completely inserted into a lumen of a catheter and partially or completely withdrawn from its location within the lumen of the catheter) can include at least one optical element having an elongate body that conducts axial propagation of therapeutic EMR through the elongate body. The elongate body can have an outer surface between a mating end and a distal end. The outer surface can have at least one radially radiating portion that facilitates radial radiation of the therapeutic EMR from the elongate body adjacent each radially radiating portion. Again, because the removable, insertable EMR conduction system can be completely withdrawn from within the lumen of the catheter, in another preferred embodiment, a different, second, removable, insertable EMR conduction system (or at least the optical element of the second conduction system) can be interchangeably inserted into the same lumen of the catheter. The second removable insertable EMR conduction system can differ in having at least one radial radiating portion that differs from the at least one radial radiating portion of the replaceable EMR conduction system.

[0030] At least one coupling connects the radiation source to the EMR conduction system and, in some preferred embodiments, can include at least one feature that allows the coupling to be easily detached from the EMR conduction system. Preferred couplings can be obtained by utilizing custom-designed connections, pre-fabricated coupling systems, or any combination thereof that optimizes coupling efficiency and usability. Furthermore, such couplings can include multiple couplings with intermediate sections optimized for coupling the removable insertable EMR conduction system to the EMR source and further propagating the EMR. In one preferred embodiment, the EMR source can be coupled to a patch cable or EMR conduction extension section, which is then coupled to the proper removable insertable EMR conduction system.

[0031] The optical element may further include at least one optical feature selected from the group of optical features, such as a reflective surface, an optically transmissive material, a lens, an optical fiber filament, and any combination thereof. The optical element may also transmit multiple wavelengths or intensities of EMR, for example, the optical element may comprise one or more elongate bodies, each elongate body transmitting a different wavelength and / or intensity of EMR. The multiple wavelengths may be transmitted alternately, simultaneously, one after the other, in tandem, or combinations thereof (e.g., one wavelength constant and the other wavelengths pulsed). The multiple intensities may be transmitted simultaneously through the same element. Alternating patterns of phototherapy may also be transmitted.

[0032] The EMR conduction system can be configured for at least partial insertion into one of any number of catheters, including, but not limited to, a central venous catheter, a peripherally inserted catheter, a peripherally inserted central catheter, a midline catheter, a jugular catheter, a subclavian catheter, a femoral catheter, a cardiac catheter, a cardiovascular catheter, a urethral Foley catheter (FIGS. 13-15), an intermittent urinary catheter, an endotracheal tube, a dialysis catheter (whether hemodialysis or peritoneal dialysis (FIGS. 16A-18B)), a gastrointestinal catheter, a nasogastric tube, a wound drainage catheter, or similar access medical catheter or tube inserted into a patient's body for the delivery or retrieval of fluids or specimens.

[0033] One preferred embodiment of the EMR delivery system has an optical element comprising a single insertable optical fiber. In the case of a single optical fiber, the single fiber allows light to be delivered radially or axially in various sections along its length. In the case of sections in which light is delivered radially, the outer surface of the optical element can be modified to facilitate radial emission of EMR. The modification of the outer surface can be achieved by chemical etching, physical etching, or electromagnetic ablation with plasma or laser to create various radially emitting sections along the length of the optical fiber. The radially emitting sections allow light to be emitted radially from the optical fiber. Of course, another preferred embodiment of the EMR delivery system can include multiple single insertable optical fibers, each of which may have the same or different lengths, or which may be partially or completely inserted into the catheter.

[0034] In this disclosure, radially emitted light means that the light has a radial component. Thus, radially emitted light can be emitted perpendicular and / or oblique to the central axis of the optical fiber at the axial point of emission.

[0035] For embodiments having a radial emitting section, the material comprising the optical fiber can be selected from the group of materials comprising optical fibers, including plastic, silica, fluoride glass, phosphate glass, chalcogenide glass, and any other suitable material that can be surface modified to provide axial light propagation and radial emission. Furthermore, the optical fiber can be single-mode, multimode, or a plastic optical fiber that has been optimized for modification using chemical, physical, or electromagnetic manufacturing modification processes. The optical fiber can also be optimized for post-production modification.

[0036] Yet another preferred embodiment employs a physical grinding modification method to modify an EMR transmission system comprising at least one optical fiber. The fiber is utilized based on its optimal optical response to a physical grinding process, which may include, but is not limited to, sanding, media blasting, polishing, buffing, or media blasting of at least one section of the optical fiber. The physical grinding process is not necessarily optimized in terms of the extent or absence of physical grinding to optimize proper radial EMR emission. This can be achieved by adjusting at least one of the speed, acceleration, pressure, modification time, or grinding material utilized in modifying the optical fiber.

[0037] Yet another embodiment employs microscopic pore structures suspended within the optical fiber to achieve radial transmission of light. Such microscopic structures can be positioned within the core and / or core-clad boundary of the optical fiber. The microscopic structures have a lower refractive index than regions without the microscopic structures. The microscopic structures can be materials such as metal, rubber, glass, or plastic added to the core or core-clad boundary of the optical fiber. The microscopic structures can also be the absence of material that causes optical aberrations within the core or core-clad boundary of the optical fiber. For example, the presence of microscopic bubbles in the core of an optical fiber creates optical aberrations or defects that alter the refractive index of the material, resulting in EMR radiating radially from the optical fiber.

[0038] Another preferred embodiment can include at least one optical fiber having a cladding modified to optimize radial or axial propagation of EMR. For example, the cladding can be modified to at least partially remove or thin the cladding to partially transmit EMR radially. Another example can include an optical fiber in which only certain portions include cladding, and EMR is transmitted axially in the cladded portion and at least partially axially and radially in the non-cladded portion.

[0039] In yet another preferred embodiment, the radially emitting portion of the optical fiber has substantially equal intensity along the length of the radially emitting portion, thereby achieving uniform radial transmission. This can be achieved by chemical etching, physical etching, plasma ablation, or laser ablation of a gradient pattern. Uniformity of radial transmission can be achieved across each portion or length of the modified optical fiber by modifying at least one of the velocity, acceleration, pressure gradient, flow rate, modification time, or modification material or process. During manufacturing, gradient uniformity can also be achieved by adding microscopic structures positioned within the core and / or core-clad boundary in a gradient pattern. It is also contemplated that the radial transmission uniformity achieved by a gradient cladding or core feature will achieve the desired radial emission, regardless of whether it is substantially uniform or varies across the length of the portion.

[0040] In yet another preferred embodiment, at least a portion of the optical fiber emits EMR radially in a gradient distribution to obtain gradient radial transmission. The gradient distribution can also be achieved by uniform or gradient pattern chemical etching, physical etching, plasma, or laser ablation. Gradient radial transmission can be obtained over an entire portion of the optical fiber by modifying at least one of the velocity, acceleration, pressure gradient, flow rate, modification time, or modification material or process. This can also be achieved by the addition of microscopic structures positioned within the core and / or core-cladding boundary. Gradient radial transmission, in another preferred embodiment, allows the optical fiber to exhibit controlled relative intensities that vary uniformly and / or non-uniformly over a portion of its length.

[0041] Further preferred embodiments of the removable, insertable EMR conduction system include at least one optical element, such as an LED, its associated wiring components, and a scaffold. The LED can emit EMR based on its inherent distribution or can utilize other optical elements, such as lenses or mirrors, to focus or diffuse the EMR in a targeted direction. Furthermore, multiple LEDs can be arranged in an array to appropriately emit EMR for maximum therapeutic effect. The LEDs, along with their associated wiring components, can be permanently or removably attached to the scaffold, allowing the EMR conduction system to be removably inserted into a catheter. The scaffold can be rigid, semi-rigid, malleable, elastic, flexible, or any combination thereof.

[0042] In another preferred embodiment, a catheter with multiple lumens for fluid infusion or withdrawal includes one or more separate lumens for delivery of therapeutic EMR. Each lumen can have a separate proximal catheter hub assembly. Such internal lumens converge at a focusing chamber, where the individual internal lumens merge into a single elongated catheter body while maintaining their individual internal pathways. Such a preferred device can include the use of optical means to shunt radiation axially passing through the catheter internal lumen designated as the focusing chamber.

[0043] Specimens retrieved through the distal tip are often used to characterize the type of infection. One preferred embodiment of the present disclosure focuses on maintaining axial light propagation through the catheter and delivering therapeutic light to the distal tip of the catheter of sufficient intensity to reduce or eliminate the number of resident infectious agents.

[0044] In yet another preferred embodiment, the medical device assembly described above is used in urology: a catheter (such as a Foley catheter) is placed in the urethra and bladder of the urinary tract.

[0045] In yet another preferred embodiment, the medical device assembly described above is for gastrointestinal use.

[0046] In yet another preferred embodiment, the medical device assembly described above is for intravascular use.

[0047] In yet another preferred embodiment, the medical device assembly described above is used within the intracranial cavity of a patient.

[0048] In yet another preferred embodiment, the medical instrument assembly described above is used within the spinal cavity of a patient.

[0049] In yet another preferred embodiment, the medical device assembly described above is used within the ocular cavity of a patient.

[0050] In yet another preferred embodiment, the medical device assembly is used within a dialysis catheter (whether hemodialysis or peritoneal dialysis).

[0051] Preferred embodiments of the present invention will become more apparent from the following description and claims taken in conjunction with the accompanying drawings, in which: Preferred embodiments of the present disclosure will be described with additional specificity and detail using the accompanying drawings, with the understanding that these drawings are merely illustrative of preferred embodiments and are not to be considered as limiting the scope of the invention. [Brief explanation of the drawings]

[0052] [Figure 1] FIG. 1 shows a perspective view of a preferred embodiment of a dual lumen catheter and EMR components in an exploded view, including connections, illustrating the connection of an EMR source to the catheter. [Figure 2] FIG. 2 is a schematic diagram of another preferred embodiment of a tunneled triple lumen catheter inserted into a body cavity through an access incision in a patient's chest. [Figure 3]FIG. 3 is a schematic diagram of yet another preferred embodiment of a tunneled triple-lumen catheter, insertable optical element, and EMR components, showing the triple-lumen catheter and connections in an exploded view inserted into a body cavity through an access incision in a patient's arm to illustrate connection of an EMR source to the catheter and insertion of an optical element partially inserted into the catheter. [Figure 4] FIG. 4 is a partially exploded perspective view of yet another preferred embodiment of a dual lumen catheter in which the insertable optical element is located external to the catheter, showing the focusing chamber. [Figure 5] FIG. 5 is a perspective view of the preferred dual lumen catheter of FIG. 4 with the insertable component partially disposed within the catheter. [Figure 6A] FIG. 6A is a cross-sectional view of a preferred embodiment of a clad coated optical element centrally located within a single lumen of a catheter line tube. [Figure 6B] FIG. 6B is a cross-sectional view of a preferred embodiment of a clad coated optical element that is off-center within a single lumen of a catheter line tube. [Figure 6C] FIG. 6C is a cross-sectional view showing another preferred embodiment of a bare fiber optic element centrally located within a single lumen of a catheter line tubing. (FIGS. 6A-C are exemplary cross-sectional views of alternative optical elements placed within a single lumen catheter.) [Figure 6D] FIG. 6D is a cross-sectional view of a preferred three-lumen catheter showing preferred clad coated optical elements each disposed within a separate lumen of the catheter line tubing. [Figure 6E] FIG. 6E is a perspective view of a portion of the three-lumen catheter of FIG. 6D cut away to show that each clad coated optical element is the same length. [Figure 6F] FIG. 6F is a cross-sectional view of a preferred four-lumen catheter with a central core, showing preferred clad coated optical elements, each disposed within a separate lumen of the catheter line tubing, and a bare optical fiber element concentrically embedded within the central core. [Figure 6G]FIG. 6G is a perspective view of a portion of the four-lumen catheter of FIG. 6G cut away to show the different lengths of each clad-coated optical element and bare optical fiber element. [Figure 7A] FIG. 7A is a partially exploded perspective view of a preferred dual lumen catheter in which the removable insertable optical element of the EMR conduction system is partially disposed within the catheter, showing an intermediate coupling that serves as an EMR conduction extension section. [Figure 7B] FIG. 7B is a partially exploded perspective view of the preferred dual-lumen catheter of FIG. 7A showing two EMR conduction systems, one in which the removable, insertable optical element of the EMR conduction system is partially disposed within the catheter and the other in which the removable, insertable optical element of the EMR conduction system is completely disposed within and surrounded by the catheter. [Figure 8A] 8A-E are a series of elevational views of several preferred embodiments of removable, insertable optical elements varying in position, length, and degree of modification, with the optical element connectors shown as transparent to better show internal features shown in shaded lines. Figure 8A is an elevational view of a preferred embodiment of an optical element that does not have a radially radiating portion. [Figure 8B] FIG. 8B is an elevation view of another preferred embodiment of an optical element having a single radial emitting portion located in the intermediate section between the coupling end and the distal end of the optical element, with a gradient designed to radiate a uniform EMR over the length of the intermediate section. [Figure 8C] FIG. 8C is an elevation view of yet another preferred embodiment of an optical element having a single radial radiating portion positioned substantially the entire distance between the coupling end and the distal end of the optical element, with a gradient designed to radiate uniform EMR over the length of the segment. [Figure 8D] FIG. 8D is an elevational view of yet another preferred embodiment of an optical element having multiple radial radiating portions, one radial radiating portion located in an intermediate section between the coupling end and the distal end of the optical element and another adjacent the proximal end. [Figure 8E]8E is an elevation view of another preferred embodiment of an optical element having multiple radial radiation portions, one radial radiation portion having two non-gradient radiation bands flanking a non-radial radiation band, another having an example of a varying gradient in the middle portion of the optical element, and another having a non-uniform gradient near the distal end of the optical element, each of which is an example of controlled relative intensity. [Figure 9A] FIG. 9A is a cross-sectional view of portions of a preferred removable insertable optical element (similar to that shown in FIG. 8C) having various EMR radial gradient radiation levels. [Figure 9B] FIG. 9B is a cross-sectional view of portions of yet another preferred removable and insertable optical element showing examples of non-gradient and gradient EMR radial radiation levels with controlled relative intensities. [Figure 10] FIG. 10 is a cross-sectional view of the various gradient radiation levels of FIG. 9A, showing the EMR ray diagram of internal reflection and the relative radial radiation cross-section. [Figure 11] FIG. 11 is a cross-sectional view of various preferred dispersions of microscopic structures (such as flecks or bubbles) within the core, cladding, and core / cladding boundary of an optical fiber. [Figure 12] FIG. 12 is a schematic illustration of an ablation process applied to a removable insertable optical element away from its distal end. [Figure 13] FIG. 13 is a partially exploded perspective view of a preferred embodiment of a urinary catheter with a removable insertable optical element partially inserted into the input port and the balloon cuff inflated. [Figure 14] FIG. 14 is a schematic diagram of another preferred embodiment of a urinary catheter positioned to drain urine from and provide EMR within the body of a male patient. [Figure 15] FIG. 15 is a schematic diagram of a urethral catheter for draining urine from and providing EMR to a male patient, showing preferred EMR delivery with increased intensity in the external urethral region of the penis and in the bladder compared to the dose inside the urethra. [Figure 15A] FIG. 15A is an enlarged view of the circle in FIG. 15 showing the radially radiating portion of the optical element near the external urethral region. [Figure 16A] 16A-C are a series of perspective views of a preferred two-cuff peritoneal catheter showing the preferred radial EMR radiation. Figure 16A is a perspective view of a preferred two-cuff peritoneal dialysis catheter showing the radial radiation extending from the connector to a point proximal to and downstream of the peritoneal cuff. [Figure 16B] FIG. 16B is a perspective view of another preferred two-cuff peritoneal dialysis catheter, illustrating the radial radiation of the EMR between a point upstream of the subcutaneous cuff and a point downstream of the peritoneal cuff. [Figure 16C] FIG. 16C is a perspective view of yet another preferred two-cuff peritoneal dialysis catheter illustrating the radial radiation of the EMR between the connector hub and a point within the peritoneal dialysate region. [Figure 17A] FIG. 17A is an elevational view of a preferred two-cuff peritoneal dialysis catheter with an extended set interface, showing radial EMR radiation of only the Y-site / transition region. [Figure 17B] FIG. 17B is an elevational view of a two-cuff peritoneal dialysis catheter 10 connected to an extension set interface, showing radial EMR radiation only outside the patient's body. [Figure 17C] FIG. 17C is an elevational view of another preferred two-cuff peritoneal dialysis catheter with an extension set interface, illustrating radial EMR radiation in the Y-section / transition region, connector hub region, tunnel section, and peritoneal dialysate region. [Figure 17D] FIG. 17D is an elevational view of yet another preferred two-cuff peritoneal dialysis catheter with an extension set interface, showing radial EMR radiation in the Y-section / transition region, connector hub region, tunnel section, and peritoneal dialysate region extending into the coiled Tenckhoff. [Figure 18A] FIG. 18A is a schematic diagram of a preferred embodiment of a single-cuff peritoneal dialysis catheter inserted into a female patient. [Figure 18B] FIG. 18B is a schematic diagram of another preferred embodiment of a single-cuff peritoneal dialysis catheter inserted into a female patient, showing radial EMR radiation from a point downstream of the EMR source to just downstream of the peritoneal cuff and into the peritoneal dialysate region. DETAILED DESCRIPTION OF THE INVENTION

[0053] Preferred embodiments of the present disclosure can be best understood by reference to the drawings, in which like parts are designated with like numerals throughout. It will be readily understood that the components of the preferred embodiments, as generally described and illustrated, could be arranged and designed in a wide variety of configurations. Thus, the following more detailed description of preferred embodiments of the devices, systems, and methods of the present disclosure, as represented in Figures 1-18B, is not intended to limit the scope of the invention, but merely represents preferred embodiments.

[0054] "Attached to," "fixed to," and "mounted to" refer to a form of mechanical connection that restricts relative translation or rotation between the attached, fixed, or mounted object. "Slidably attached to" refers to a form of mechanical connection that allows relative translation while restricting other relative movement. "Directly attached to" refers to a form of fixation in which the items being secured are maintained in their fixed state through direct contact.

[0055] "Abut" means that items are in direct physical contact with one another, although the items may not be attached together. "Grip" means that an item is in direct physical contact with one of the items to firmly hold the other. "Integrally formed" means a body that is manufactured as a single piece without the need for assembly of components. Multiple elements can be integrally formed with one another if they are directly attached to one another to form a single workpiece. Thus, elements that are "coupled" to one another can be formed together as a single piece.

[0056] "Preferred" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "preferred" is not necessarily to be construed as desirable or advantageous over other embodiments. While various forms of the embodiments are presented in drawings, the drawings are not necessarily to scale unless explicitly indicated.

[0057] Referring to FIG. 1, a catheter 10 is insertable into a patient's body 12 (FIG. 2). The medical device assembly of the present disclosure includes a non-ultraviolet electromagnetic radiation (EMR) component 20 and an insertable catheter component 22. The non-ultraviolet EMR component 20 generally includes an elongated body 24 used to enclose an EMR power source 26 and a coupling element 28 for coupling the two components of the assembly. The EMR used manifests as visible light (shown as rays extending radially from the catheter 10) emitted in the 380 nm to 904 nm range with a sufficiently high intensity to produce a therapeutic effect, such as inactivating one or more infectious agents and / or enhancing the growth of healthy cells. In some embodiments, the EMR source 26 has adjustability, such as an adjustable duty cycle length, so that the EMR can be provided at an appropriate desired intensity for a time interval advantageous for the most effective time.

[0058] The catheters 10 shown in Figures 1-5 are preferred multi-lumen catheters 10, each comprising a line tube 16, one or more (two shown in Figures 1, 4, and 5, three shown in Figures 2 and 3) proximal catheter hub assemblies 32, an elongate catheter body 36, a distal end 34 with one or more openings 35 leading to the inner lumens 30, and a focusing chamber 40. Each inner lumen 30 has an inner diameter (i.e., inside surface dimension; see, e.g., outer diameter 76 in Figure 6A) and extends the length of the catheter 10 from the proximal catheter hub assembly 32, through the line tube 16, the focusing chamber 40, and the elongate catheter body 36 to the distal end 34. Fluids can be infused into the lumens 30 and exit through the openings 35 into the patient's body 12, or fluids can be drawn from the patient's body 12 through the openings 35 into the lumens 30. Additionally, some catheters 10 may have an inflatable balloon cuff 37 (FIGS. 13 and 14) that can seal the catheter 10 against the wall of a cavity within the patient's body 12 into which the catheter 10 is inserted. The optical element 14 may be elongated, have a reflective coating, or be an optical fiber having a sufficiently small outer diameter (i.e., outer surface dimension, e.g., outer diameter 76 in FIG. 6A) so that it is insertable into at least one of the inner lumens 30 and can extend into the catheter 10 at least to the termination point 42 of the optical element (although the insertion portion may be shorter than this length if desired).

[0059] Catheters 10 suitable for use with insertable optical element 14 can be of various makes, sizes, and capabilities. For example, a urinary catheter 10 (e.g., FIGS. 13 and 14 ) that is inserted through a patient's urethra 39 and into the patient's bladder 41 can have an input port 43, an output port 45, and an inflatable balloon cuff 37 that facilitates drainage of urine from the patient's bladder 41 while allowing fluid (or, in the case of the present disclosure, therapeutic EMR) to be infused into the patient's body 12. As another example, a translucent catheter 10 is particularly well-suited to allow passage of radially radiating EMR through a catheter wall 84 (e.g., the preferred catheter wall 84 of FIGS. 6A-C ) and into the tissue surrounding the catheter 10. The catheter 10 has an inner surface dimension (inner diameter 74) that is sufficiently larger than the outer surface dimension (outer diameter 76) of the insertable optical element 14 to create a gap 78 or passageway (FIGS. 6A-C) that allows fluid (liquid or gas) to be simultaneously injected or withdrawn through the catheter 10 while the insertable optical element 14 remains within the catheter 10.

[0060] Additionally, some catheters 10 have a radiopaque agent embedded within their walls to enable imaging of the location where the catheter 10 is placed within the patient's body 12. However, some catheters 10 do not include such a radiopaque agent. In either case, the present disclosure contemplates the inclusion of a radiopaque agent within or on the exterior of the insertable optical element 14 to detect the location of the catheter 10 within the patient's body 12 when the catheter 10 does not have a radiopaque agent, and to detect the location of the insertable optical element 14 disposed within the catheter 10 regardless of whether the catheter 10 has a radiopaque agent (which may require different radiopaque agents in some cases to distinguish between the catheter 10 and the insertable optical element 14).

[0061] In some preferred embodiments, at least one of the proximal catheter hub assemblies 32 can have a fiber optic element alignment shaft 98 that aligns the optical element connector 94 with the insertable optical element 14 .

[0062] 2 and 3 are schematic diagrams of catheter 10 inserted at insertion site A in the chest (FIG. 2) and arm (FIG. 3) of patient 12, respectively. The figures illustrate how non-ultraviolet therapeutic EMR can be delivered at insertion site A and to other sites within patient body 12. At insertion site A, therapeutic EMR can be delivered to the percutaneous area 48 to inactivate infectious agents in the percutaneous area and promote healing at insertion site A. Similarly, therapeutic EMR can be delivered proximate distal end 34 (in this case, within the vena cava) to inactivate infectious agents and / or promote healing in its vicinity.

[0063] Referring to FIG. 2 of the present disclosure, a schematic diagram of another embodiment of a medical device assembly includes a non-UV EMR component 20 and an insertable catheter component 22. While the illustrated embodiment is specifically a tunneled, triple-lumen, centerline variant, it should be understood that the catheter 10 can encompass access catheters 10 (i.e., vascular, gastrointestinal catheters, etc.) without departing from the scope and spirit of the present invention. The non-UV EMR component 20 is coupled to a proximal catheter hub assembly 32 of the insertable catheter component 22. The other coupling hub 32 is available for axial transmission of fluid (for infusion or withdrawal). Each designated inner lumen 30 transmits EMR or fluid between its proximal catheter hub assembly 32 and a distal end 34.

[0064] While the triple-lumen catheter 10 of Figures 2 and 3 specifically illustrates the use of the triple-lumen catheter 10, it should be appreciated that triple-lumen embodiments are desirable in areas where multiple fluid delivery or extraction is required simultaneously. For example, in hemodialysis, venous and arterial blood are exchanged simultaneously. Similarly, in peritoneal dialysis, fluids and dissolved substances (electrolytes, urea, glucose, albumin, and other small molecules) are exchanged from the blood through catheter access through the peritoneal membrane in the patient's abdomen. Such preferred triple-lumen embodiments allow for the delivery of therapeutic EMR simultaneously with such dialysis functions.

[0065] The incision site A and the adjacent percutaneous area of ​​the insertable catheter body 36 are often high sources of infection. To reduce infection at the incision site and percutaneous area 48, a dedicated area of ​​the catheter body 36 can be provided to facilitate the radial emission of therapeutic EMR from the optical element 14 within the elongated catheter body 36. This allows the sterilizing EMR to be emitted outward to inactivate infectious agents at the insertion site A and the percutaneous area 48. By extending the length of the dedicated area toward the distal end 34, the therapeutic EMR can be emitted to percutaneous areas within the patient body 12 adjacent to the dedicated area.

[0066] Proximate the distal end 34 of the elongated catheter body 36, the optical element 14 is terminated at a termination point 42 so as to be able to irradiate the entire distal end 34 of the catheter 10 and the surrounding body cavity area with therapeutic EMR without poking or penetrating tissue beyond the distal tip of the catheter 10.

[0067] The EMR component 20 includes an EMR power supply 26 (FIGS. 2-5), a light source (not shown, such as a laser or the like), electrical circuitry (not shown), and optics (not shown, depending on the light source), all of which are housed within the elongate body 24. A coupling element 28 connects the EMR component 20 to an optical assembly 50. The optical assembly 50 includes the insertable optical element 14 and an optical element connector 94. The combination of the EMR component 20, the coupling element 28, and the optical assembly 50 including the insertable optical element connector 94 and the insertable optical element 14 is referred to herein as the EMR conduction system 18. In some embodiments, the EMR conduction system 18 is removable from its insertion position within the catheter 10. If the EMR conduction system 18 is insertably removable, therapeutic EMR can be retrofitted into an existing indwelling catheter 10. Also, if the EMR conduction system 18 is removably insertable, a different second EMR conduction system 18 (or at least the optical element 14 of the second EMR conduction system 18) may also be removably insertable so that two different EMR conduction systems 18 are interchangeably insertable into the same lumen 30 of the catheter 10.

[0068] Of particular importance to each of the embodiments is the use of light having a wavelength in the range of 380 nm to about 904 nm. Furthermore, the intensity and power of the emitted light serves to inactivate infectious agents and / or promote healing. 2 ~1kJ / cm 2 and output power in the range of 0.005mW to 1W, and 1mW / cm 2 ~1W / cm 2 Power densities in the range of are important for these preferred device assemblies and procedures. These ranges of wavelength, power density, and irradiance have been demonstrated to have antimicrobial or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased fibroblast proliferation, stimulation of collagen synthesis, induction of angiogenesis, and granulation tissue formation.

[0069] For each of the preferred embodiments described herein, the EMR conduction system 18 and disinfection / healing means are available with adjustable or preset duty cycles. If treatment begins shortly after the sterilization procedure is initiated, device-related infections may be prevented. This includes device-related biofilm growth.

[0070] Furthermore, wavelengths in the 380 nm to 904 nm range provide sufficient intensity to inactivate one or more infectious agents and / or enhance healthy cell growth, although more precise wavelengths can have more specific efficacy against specific infectious agents or for desired healing purposes. Sterilizing EMR at wavelengths including those centered around 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm have been shown to have specific efficacy. Wavelengths selected to promote healing and healthy cell growth can be selected from wavelengths centered around 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm.

[0071] The insertable catheter component 22, which can be at least partially inserted into a body cavity of a patient 12 to deliver non-ultraviolet therapeutic EMR, includes at least one internal lumen 30, a proximal catheter hub assembly 32, and a distal end 34. The internal lumen 30 is simply defined as an internal passageway through which fluid or EMR can pass. In the case of a single or multiple lumen catheter 10, like features are numbered the same in the drawings. It should be noted that an example of a multiple lumen catheter is described and illustrated in U.S. Patent Application No. 13 / 801,750, filed March 13, 2013, which was expressly incorporated herein by reference above. In a multiple lumen embodiment, a dedicated single lumen can be designated for axial propagation of EMR, and each additional lumen can be dedicated for axial injection or withdrawal of fluid. In this way, both the fluid and EMR can propagate axially simultaneously through separate lines; the EMR delivery optics 14 and the fluid do not have to occupy the same lumen.

[0072] The distal end 34, insertable into a body cavity of the patient 12 at a designated incision site A, allows the elongate catheter body 36 to direct the delivery and / or withdrawal of fluids and therapeutic EMR axially relative to the elongate catheter body 36 for delivery into the patient's body 12. The elongate catheter body 36 is described as an elongate catheter 10 having at least one inner lumen 30. Another embodiment of the present disclosure is shown in FIG. 4, which is a perspective view of a dual-lumen catheter 10 in which a detachable EMR conduction system 18 is external to the catheter 10. The illustrated catheter 10 portion shows a flexible protective tube 44 that protects the connection between the proximal catheter hub assembly 32 and the line tubing 16 and also protects the line tubing 16 from abrasion by a line clamp 46.

[0073] The therapeutic EMR passes axially through the catheter 10, which may have a length 38 that varies depending on the specific needs of the catheter. The fluid passing through the inner lumen 30 may contain a pharmaceutical compound (e.g., a drug) to be infused or may be a biological fluid (e.g., blood, urine, or cerebrospinal fluid) to be withdrawn.

[0074] Each multi-lumen embodiment may include a focusing chamber 40 at the point where the individual inner lumens 30, while maintaining their individual internal paths, converge into a single elongate catheter body 36. At the distal end 34 of the elongate catheter body 36, the optical element 14 terminates at a termination point 42 to allow therapeutic EMR to illuminate the entire distal end 34 of the catheter 10 and the surrounding body cavity area.

[0075] This embodiment may also include flexible protective tubing 44 to protect the lumens at the proximal catheter hub assembly 32 and between the proximal catheter hub assembly 32 and the focusing chamber 40. If manual line occlusion is required, this can be accomplished using a line clamp 46.

[0076] FIG. 5 shows the dual lumen catheter 10 of FIG. 4 with a removable, insertable EMR conduction system 18 partially inserted into one of the lumens 30 of the catheter 10.

[0077] 6A-G are a series of exemplary cross-sectional views of alternative optical elements 14 disposed within a preferred single-lumen catheter 10 (FIGS. 6A-C) or a preferred multi-lumen catheter 10 (FIGS. 6D-G). FIG. 6A is a cross-sectional view showing a preferred embodiment of a cladding-coated optical fiber 70 centrally located in the lumen 30 of the catheter line tube 16 of the single-lumen catheter 10. The single-lumen line tube 16 / catheter 10 shown in cross-section has an inner diameter 74 and a catheter wall 84. The cladding-coated optical fiber 70 is the optical element 14 and has an outer diameter 76, a core-cladding boundary 80, and a cladding outer boundary 82. When the cladding-coated optical fiber 70 is centrally located as shown in FIG. 6A, if the inner diameter 74 of the catheter wall 84 is larger than the outer diameter 76 of the cladding-coated optical fiber 70, an annular gap 78 is created between the cladding outer boundary 82 and the catheter wall 84. Fluid, whether infusion or withdrawal, can pass through this gap 78 when the clad optical fiber 70 is within the lumen 30 of the single lumen catheter 10 .

[0078] 6B is a cross-sectional view illustrating a preferred embodiment of a cladding optical fiber 70 that is off-centered within the lumen 30 of the catheter line tubing 16 of a single-lumen catheter 10. However, because the void 78 formed within the lumen 30 is not annular and lacks structure to center the cladding optical fiber 70, off-center placement can occur when the optical element 14 is removably inserted into the lumen 30 of the catheter 10. Thus, 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. Particularly when fluid is 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 enhance healthy cell growth in the tissue surrounding the indwelling catheter 10.

[0079] 6C is a cross-sectional view showing another preferred embodiment of a bare optical fiber 72 centrally located within the lumen 30 of the catheter line tubing 16 of a single lumen catheter 10. In this embodiment, a gap 78 is created between the catheter wall 84 and the outer surface 62 of the bare optical fiber 72.

[0080] Of course, multiple lumen catheters 10 are also contemplated in this disclosure, and one skilled in the art would recognize that the situations of Figures 6A-C are equally applicable to multiple lumen catheters 10, and that one or more optical elements 14 can be present within one or more of the multiple lumens 30. An example of a multiple lumen catheter is described and illustrated in patent application (U.S. Patent Application No. 13 / 801,750, filed March 13, 2013), which is incorporated herein by express reference above.

[0081] Figure 6D is a cross-sectional view of a preferred three-lumen catheter 10, showing preferred cladding-coated optical fibers 70 each centrally located within a separate lumen of the catheter line tube 16. The three-lumen line tube / catheter 10 shown in cross-section has a catheter wall 84 and an internal partition wall 85 separating the lumens 30 from one another. When the cladding-coated optical fibers 70 are centrally located, as shown in Figure 6D, a peripheral void 79 is created between the cladding outer boundary 82, the catheter wall 84, and the internal partition wall 85. Fluids, whether infused or withdrawn, can pass through the peripheral void 79 as needed.

[0082] 6E is a perspective view of a portion of the three-lumen catheter 10 of FIG. 6D cut away to show that each clad-coated optical fiber 70 is the same length. In this preferred embodiment, EMR doses of controlled relative intensity can be delivered simultaneously, alternately, and / or alternatively to each clad-coated optical fiber 70 for radial radiation for treatment-region-specific dose projection as described throughout this disclosure.

[0083] FIG. 6F is a cross-sectional view of a preferred four-lumen catheter 10 with a central core 86, showing preferred clad-coated optical fibers 70, each within a separate lumen 30 of the catheter line tubing 16, and a bare optical fiber 72 concentrically embedded within the central core 86.

[0084] FIG. 6G is a perspective view of a portion of the four-lumen catheter of FIG. 6F cut away to show the different lengths of each clad-coated optical element and bare optical fiber element. Again, in this preferred embodiment, an EMR dose of controlled relative intensity can be simultaneously, alternately, and / or alternatively delivered to each clad-coated optical fiber 70 and / or bare optical fiber 72 for radial radiation for treatment-region-specific dose projection as described throughout this disclosure. This embodiment also illustrates that the clad-coated optical fiber 70 and bare optical fiber 72 can have different lengths, thereby providing further versatility for controlled relative intensity and / or treatment-site-specific dose projection. FIG. 7A is an exploded perspective view of a preferred conduction system 18 partially inserted into the proximal catheter hub assembly 32 and inner lumen 30. In this preferred embodiment, an intermediate coupling 52 is shown. Such an intermediate coupling 52 can include a patch cable 54 or EMR conducting extension section 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 significant loss of light intensity. Each of the patch cables 54 or EMR conductive extension sections 56 can have a front connector 58 for fixedly engaging the coupling element 28 and a rear connector 60 for fixedly engaging the optical element connector 94. Thus, by using the patch cables 54 or EMR conductive extension sections 56, the EMR power source 26 can be operated at a desired distance from the patient to reduce noise or heat concerns and / or to position the EMR power source 26 in proximity to a power source (not shown), such as an outlet or battery pack.

[0085] 7B is a partially exploded perspective view of the preferred dual-lumen catheter 10 of FIG. 7A showing two EMR conduction systems 18: one having a removable, insertable optical element 14 of the EMR conduction system 18 partially disposed within the catheter 10, and another having a removable, insertable optical element 14 of the EMR conduction system 18 disposed completely within and surrounded by the catheter 10. In this preferred embodiment, EMR doses of controlled relative intensity can be delivered simultaneously, alternately, and / or alternatively using different EMR sources, which can be used to provide further versatility in controlled relative intensity and / or treatment site-specific dose projection.

[0086] 8A-E are a series of elevation views of several preferred embodiments of optical assembly 50, illustrating various positions of non-graded and graded modifications on outer surface 62 of insertable optical element 14. Each view in the series shows optical assembly 50 in which insertable optical element 14 is connected to optical element connector 94. Preferred optical element connector 94 (see also FIGS. 7A and 9A) includes connecting element 88, EMR hub fitting 90, collimator lens 92, and alignment shaft 98.

[0087] The first figure in the series (top figure, FIG. 8A) shows the unmodified optical span 100 of the insertable optical element 14 without radial dispersion (i.e., the insertable optical element 14 has not been treated or modified to provide radial emission of light from the body of the insertable optical element 14). In this embodiment, therapeutic non-ultraviolet EMR is provided to the distal end 64 of the optical element 14 without radial emission from the optical span 100 other than at the distal end 64.

[0088] The second figure in the series (FIG. 8B immediately below) illustrates the preferred radial transmission equivalence across the radial emission portion 103, providing radially dispersed light from the segmented modified optical span 102 (i.e., as shown, the radial emission portion 103 is gradient modified so that the emitted EMR has substantially uniform intensity and power along the length of the radial emission portion 103). The location of the single radial emission portion 103, in this example, corresponds to the position at which the catheter 10 enters the insertion site A when the insertable optical element 14 is fully inserted into the catheter 10. In this embodiment, the radially emitted visible light can sterilize and / or enhance healthy cell growth at the insertion site A, the percutaneous area 48, or any other predetermined location within the patient's body 12 by positioning one or more segmented modified optical spans 102 along the length of the insertable optical element 14.

[0089] Each of Figures 8B-E illustrates gradient modifications that allow EMR to be emitted in a substantially uniform intensity and power pattern along the length of radial emitting portions 103, 105. While each figure illustrates uniform intensity and power EMR, varying the degree of modification within radial emitting portion 103 can achieve a desired pattern of EMR emission, since less ablation results in less radial EMR emission and more ablation results in more radial EMR emission. For example, as shown in Figure 8E, a radial emitting portion 103 with less ablation near each end and more ablation in the middle will emit less EMR intensity and power at both ends and more intensity and power in the middle. Therefore, any desired EMR emission pattern can be created by adjusting the ablation pattern of radial emitting portion 103.

[0090] The third figure in the series (FIG. 8C) shows an example of a single radially radiating portion 105 that provides radially dispersed EMR from the optical element 14 extending along most of the fully modified optical span 104. The location of the single radially radiating portion 105 corresponds generally to the entire length of the insertable catheter component 22 of the catheter 10, from the insertion site A to the distal end 64. In this embodiment, therapeutic EMR is provided substantially along almost the entire length of the catheter 10 that is inserted into the patient's body 12, including the incision site A.

[0091] The fourth figure in the series (FIG. 8D) shows an example of uniformity of radial transmission at multiple locations. One radial radiating portion 103 and an additional distal radial radiating portion 107 are spaced apart along the multiple modified optical span 106. The locations of the radial radiating portion 103 and the distal radial radiating portion 107 correspond to areas of the body where delivery of non-ultraviolet therapeutic EMR is desired for sterilization and / or healing, including, for example, insertion site A. It should be appreciated that multiple radial radiating portions 103 can be positioned along the length of the multiple modified optical span 106 and / or each radial radiating portion 103 can be separate from the other radial radiating portions 103, each having a different length and gradient ablation degree.

[0092] It should also be appreciated that in each of these figures, the illustrated radial radiating portions can be modified apart from modifications to the outer surface 62 of the insertable optical element 14, such as modifications including microscopic structures embedded within the insertable optical element 14 that enable radial transmission of light from the insertable optical element 14. Furthermore, such radial radiating portions 103, 105, 107 can have a gradient pattern that allows for a substantially uniform distribution of light throughout the length of each radial radiating portion 103, 105, 107, or a non-gradient in the modified gradient pattern can result in a non-uniform distribution of light throughout the length of each radial radiating portion 103, 105, 107. It should also be appreciated that flexibility in the degree, length, and position of each radial radiating portion 103, 105, 107 facilitates controlled relative intensity and / or treatment site-specific dose projection.

[0093] FIG. 9A is a schematic diagram of an optical assembly 50 in which an insertable optical element 14 is 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 help explain the properties of the insertable optical element 14 at each location. As shown, there are four cross-sectional locations: a first cross-section 108, a second cross-section 110, a third cross-section 112, and a fourth cross-section 114. For simplicity, the modifications to the insertable optical element 14 at each of the four cross-sections are summarized in FIG. 9A. Of course, the radially radiating portions of the insertable optical element 14 may be single or multiple, may be of any length, sloped or non-sloped, and may be coincident, overlapping, or not.

[0094] The first cross-section 108 represents the internally reflective region of the insertable optical element 14. As shown in the first cross-section 108, there are no ablations (or other modifications) or microscopic structures within the core 66 of the insertable element 14. No therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14 at the first cross-section 108.

[0095] The second cross-section 110 represents the minimum emitting area of ​​the insertable optical element 14. As shown in the second cross-section 110, there is slight ablation (or other modification) on the outer surface 62 of the insertable optical element 14 and a slight dispersion of microscopic structures 117 within the core 66 of the insertable optical element 14. From the second cross-section 110, a slight amount of therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14. However, the amount of EMR emitted must have sufficient intensity and power to inactivate infectious agents and / or promote healing proximate the second cross-section 110.

[0096] The third cross-section 112 represents a moderately emitting region of the insertable optical element 14. As shown, at the third cross-section 112, there is a moderate ablation (or other modification) on the outer surface 62 of the insertable optical element 14 and a moderate distribution of microscopic structures 117 within the core 66 of the insertable optical element 14. From the third cross-section 112, a moderate amount of therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14 proximate the third cross-section 112. However, before reaching the third cross-section 112, the amount of light traveling axially along the insertable optical element 14 is reduced by the radial emission of some of the light, such as at the second cross-section 110. Therefore, the degree of modification is selected so that the amount of EMR emitted radially at the third cross-section 112 is substantially equal to the radial emission at the second cross-section 110. Thus, the intensity and power of the emitted EMR can be substantially equivalent to the intensity and power emitted at the second cross section 110 and has sufficient intensity and power to inactivate infectious agents and / or promote healing.

[0097] The fourth cross-section 114 represents the maximum emission region of the insertable optical element 14. As shown, at the fourth cross-section 114, there is maximum ablation (or other modification) on the outer surface 62 of the insertable optical element 14 and maximum dispersion of microscopic structures 117 within the core 66 of the insertable optical element 14. From the fourth cross-section 114, the maximum amount of therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14 adjacent the fourth cross-section 114. Again, the amount of light continuing axially along the insertable optical element 14 before reaching the fourth cross-section 114 is reduced by the radial emission of some of the light at the second cross-section 110, the third cross-section 112, etc. Thus, the degree of modification is selected so that the amount of EMR emitted radially at the fourth cross-section 114 is substantially equal to that at the second cross-section 110 and the third cross-section 112. The intensity and power of the emitted EMR can be substantially equal to the intensity and power emitted at the second cross section 110 and the third cross section 112, and has sufficient intensity and power to inactivate infectious agents and / or promote healing.

[0098] The radial emission portion can be modified by chemical, physical, or other cladding modifications (e.g., ablation) to alter the critical angle sufficiently to allow light to radiate radially. Additionally or alternatively, the radial emission portion can be modified by dispersing microscopic structures 117 of varying gradient concentrations within the core 66 of the insertable optical element 14. The gradient concentrations of the microscopic structures 117 within the core 66 shown in FIG. 9A range from an area 109 without microscopic structures, to a minimum concentration 111 of the microscopic structures 117, to a medium concentration 113 of the microscopic structures, to a maximum concentration 115 of the microscopic structures 117.

[0099] The concentration of microscopic structures 117 within the core 66 affects the refractive index of the core 66 and the core-clad boundary 80. The microscopic structures 117 (e.g., reflective flakes or voids such as bubbles) cause a change in the angle of incidence of light as it passes through the insertable optical element 14. At a particular angle of incidence, light leaves the cladding 68 of the optical element and radiates radially from the cladding outer boundary 82.

[0100] FIG. 9B is a cross-sectional view of portions of yet another preferred removable insertable optical element 14, again showing examples of non-gradient and gradient EMR radial radiation levels as examples of controlled relative intensity and treatment site-specific dose projection.

[0101] FIG. 10 is a schematic diagram of the cross-section of FIG. 9A , with arrows indicating light rays. The same cross-sections of the insertable optical element 14 are shown: first cross-section 108 (internal reflection), second cross-section 110 (minimum radial radiation), third cross-section 112 (moderate radial radiation), and fourth cross-section 114 (maximum radial radiation). These figures also show light rays traveling axially along the core 66 impinging on microscopic structures 117 at an angle of incidence that causes the light rays to pass through the optical element cladding 68. An increasing pixilation gradient at the cladding boundary 82 is shown, from the first cross-section 108 (no pixilation), to the second cross-section 110 (minimum pixilation), to the third cross-section 112 (moderate pixilation), to the fourth cross-section 114 (maximum pixilation), which represent chemical, physical, or other cladding modifications (e.g., ablation) at the cladding boundary 82. Such modification of the insertable optical element 14 alters the critical angle sufficiently to allow light to radiate radially. As shown schematically, the amount of light remaining within the core 66 decreases as the light passes from proximal to distal, but the number of rays leaving the optical element cladding 68 is substantially equal at each location. Microscopic structures 117 of varying gradient concentrations are also shown within the core 66, ranging from a microscopic structure-free area 109 to a minimum concentration 111, a medium concentration 113, and a maximum concentration 115. Each of the microscopic structures 117 has a different refractive index than the core 66 and the optical element cladding 68. The microscopic structures 117 (e.g., reflective flakes or voids such as bubbles) cause a change in the angle of incidence of light as it passes through the insertable optical element 14. At certain angles of incidence, light radiates radially away from the optical element cladding 68.

[0102] FIG. 11 shows cross-sectional views of various preferred distributions of microscopic structures 117 (such as flecks or bubbles) within the core 66, cladding 68, and core / cladding boundary 80 of an optical fiber. In each of the preferred embodiments shown, the microscopic structures 117 are distributed within the insertable optical element 14 (in this case, the optical fiber) to obtain radial transmission of light. The 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 have a lower refractive index than areas without the microscopic structures 117. The microscopic structures 117 may be a material added to the optical fiber core 66 or core-cladding boundary 80, such as metal, rubber, glass beads, or plastic. The microscopic structures 117 may also be the absence of a material that introduces optical aberrations within the optical fiber core 66 and / or the core-cladding boundary 80 and / or the cladding 68. For example, the presence of microscopic structures 117 (such as bubbles) in the optical fiber core 66 creates optical aberrations or defects that modify the refractive index of the material, causing EMR to be emitted radially from the optical fiber (insertable optical element 14).

[0103] 11 shows three preferred dispersions: a first dispersion 121, a second dispersion 123, and a third dispersion 125. In the first dispersion 121, the microscopic structures 117 (fluxes or bubbles) are dispersed only in an outer region 127 of the core 66. In the second dispersion 123, the microscopic structures 117 are dispersed in an inner region 129 of the cladding 68 as well as in the outer region 127 of the core 66. In the third dispersion 125, the microscopic structures 117 are dispersed close to the core / cladding boundary 80, as shown by 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. In each of the preferred dispersions, at least a portion of the light traveling the length of the insertable optical element 14 (optical fiber) does not encounter any microscopic structures 117, and the remaining light may encounter at least one microscopic structure 117 and be deflected and emitted radially from the insertable optical element 14.

[0104] Figure 12 is a schematic diagram of a preferred optical element modification means for creating a slope modification in the outer surface 62 of the insertable optical element 14. Such modifications to the core 66 or optical element cladding 68 alter the angle of incidence of a light ray so that it is different from the critical angle required for continued internal reflection. Figure 12 shows a control device 122 along with a wand 124 that delivers an acid spray 126 to etch the insertable optical element 14.

[0105] There are several means for achieving such gradient modification. Chemically, the insertable optical element 14 can be etched using strong acids, such as hydrofluoric or sulfuric acid and hydrogen peroxide. Also, etching creams containing quartz powder, calcium fluoride, or typically fluorinated compounds can be used. Physically, physical modification, such as heating the insertable optical element 14 or ablating it with a sander, media blasting, polishing, or laser ablation, are also means for creating gradient modification. Additionally, plasma ablation by laser modification results in the ionization of molecules and alteration of the outer surface 62 of the insertable optical element 14. Other known means for creating gradient ablation are also contemplated in this disclosure. Whether by modification or manufacturing process, currently known or not, the insertable optical element 14 can be modified to radially emit light substantially uniformly along a desired length. This uniformity in radially emitted light can result in a more precise therapeutic dose for inactivating infectious agents and / or promoting healing.

[0106] 8A-E, 9A, 9B, and 12 of the present disclosure show an optical element connector 94 that includes a connecting element 88, an EMR hub fitting 90, a collimator lens 92, and an alignment shaft 98. An insertable optical element 14 can be inserted into the alignment hole of the optical element connector 94 to collimate light into the small diameter core 66 or one or more optical fibers.

[0107] Although the preferred disclosure shows the optical deflection element as a single collimator lens 92, other types of optical deflection elements, such as multiple lenses or different types of lenses, can be used to collimate the light beam. Depending on the diameter, numerical aperture, and refractive index of the optical element 14, a specific lens may be required as the optical deflection element to minimize light loss.

[0108] FIG. 13 illustrates a urinary catheter assembly. The urinary catheter assembly includes an electromagnetic radiation component 20 and an insertable catheter component 22. The insertable catheter component includes a proximal catheter hub assembly 32, an elongated catheter body 36, and a distal end 34 region. The proximal catheter hub assembly 32 serves as an input port 43 (arrows indicate the direction of fluid flow and / or therapeutic EMR propagation 162). The elongated catheter body 36 includes an output port 45 for draining urine from the patient's body (arrows indicate the direction of urine flow 164), an inflatable balloon cuff 37 (shown inflated), and an opening 35, with the balloon cuff 37 and opening 35 located in the distal end 34 region. Because female urinary catheters are typically shorter than male urinary catheters, which are made in different lengths, the insertable catheter component 22 can be made in variable lengths 38.

[0109] The electromagnetic radiation component 20 includes an EMR power source 26, a coupling element 28, and an optical element 14. In the figures, the coupling element 28 is spaced from the catheter hub assembly 32 to reveal the optical element 14 partially inserted into the lumen 30 of the elongated catheter body 36. When the coupling element 28 is connected to the catheter hub assembly 32, the optical element is fully inserted, with the distal end of the optical element 14 extending to a termination point 42 so as not to interfere with the inflatable balloon cuff 37 or the opening 35. In this fully inserted configuration, the optical element 14 can radially emit therapeutic EMR at the incision site A and into the percutaneous area 48 as well as at the distal end region 34.

[0110] FIG. 14 shows another preferred urinary catheter 10 positioned within a male patient 12. In the figure, the urinary catheter 10 is inserted through the urethra 39 into the patient's bladder 41, with the balloon cuff 37 inflated to seal leakage from the bladder 41 around the urinary catheter 10. The preferred urinary catheter 10 includes an elongated catheter body 36, an adapter 150, a fixation sleeve 152, and a drain tube 154. The adapter 150 has an input port 43 and an output port 45. An EMR component 20 can be used with the preferred urinary catheter 10 to deliver therapeutic EMR along the urethra 39 into the bladder 41 to inactivate infectious agents and / or promote the growth of healthy cells. The EMR component 20 includes a control device 155 housing the EMR power supply 26, actuation control features 156, and display 158, an optical element 14, and an optical jack 160.

[0111] When positioned as shown in FIG. 14 , the optical element 14 is threaded into the adapter 150 and secured by the retaining sleeve 152, allowing urine to drain freely through the elongated body 36 into the drain tube 154 and into a urine drainage bag (not shown). Often, because the urinary catheter 10 is left indwelling for extended periods of time, the growth and proliferation of infectious agents in, on, or around the urinary catheter 10 is a concern. To provide therapeutic EMR to prevent, reduce, or eliminate the proliferation of infectious agents and / or enhance the growth of healthy cells, the optical jack 160 is plugged into a control device 155 that connects the optical element 14 to the EMR power supply 26, and the operating control features 156 are activated to set the frequency(ies), intensity, power, duty cycle, and other operating parameters to turn on the delivery of EMR to the optical element 14. Setting of the operating features and monitoring of the parameters can be viewed on the display 158.

[0112] Figure 15 is a schematic diagram of the urinary catheter 10 of Figure 14 positioned to drain urine and provide therapeutic EMR into a male patient 12, illustrating the preferred delivery of EMR using both controlled relative intensity and treatment-region-specific dose projection, with increased intensity in the external urethral region 166 of the penis 168 and the bladder 41 compared to the maintenance dose within the urethra 39. Figure 15A is an enlarged schematic diagram of the circle in Figure 15, showing the radially radiating portion of the optical element 14 near the external urethral region 166. Also, because the external urethral region 166 is more susceptible to infection, the intensity of the dose is increased, while lower intensities can be used within the urethra 39 and bladder 41 as a precaution to prevent biofilm formation or the initiation of infection.

[0113] Figures 16A-C are a series of perspective views of a preferred peritoneal dialysis catheter 10, illustrating the preferred radial EMR radiation. Peritoneal dialysis offers several advantages over hemodialysis, including quality of life, due to the potential for greater patient mobility and independence, simplicity of use, and clinical benefits of preserving residual kidney function and lower mortality during the first few years after initiating peritoneal dialysis. A disadvantage of peritoneal dialysis is the risk of peritonitis. Peritonitis often results from bacterial skin contamination, but it may also result from retrograde migration of microorganisms into the catheter. Systemic or intraperitoneal antibiotics can be administered to reduce exchange rates. While peritoneal dialysis catheter-associated peritonitis can be resolved with appropriate antibiotic therapy, EMR delivery using both controlled relative intensity and treatment-site-specific dose projections, alternating, simultaneously, or alternatively, may prove more effective in preventing and helping to treat peritonitis. If infection persists, removal of the catheter and use of hemodialysis for 4 to 6 weeks may be necessary to resolve the peritonitis. Because there is a strong association between exit site infection and subsequent peritonitis, early prophylactic EMR delivery, followed by maintenance delivery, as described herein, can reduce or eliminate exit site infections that can lead to peritonitis.

[0114] The peritoneum is the lining that surrounds a patient's abdominal organs. The lining is called the peritoneal membrane and forms a space called the peritoneal cavity, which can hold fluid. In peritoneal dialysis, a long-term or permanent catheter is inserted through the lining into the space around the patient's organs. Dialysate passes through the catheter and drains into the space. The peritoneal lining contains many blood vessels. Dialysate passes through the lining from these vessels, drawing excess fluid, chemicals, and waste products. The lining acts as a filter. The dialysate remains in place for several hours while dialysis takes place. The dialysate can then be drained through the catheter. New, clean dialysate can be immediately introduced to refill the space. This process of exchanging old dialysate for new is called exchange.

[0115] The dual-cuff peritoneal dialysis catheter 10 shown in Figures 16A-C includes a connector hub 170, a line tubing 16 connected to the connector hub 170, a peritoneal cuff 172, a subcutaneous cuff 174, and a coiled Tenckhoff 176. This preferred peritoneal dialysis catheter 10 is divided into three sections: an exterior section 178, a tunnel section 180 (extending from an exit site 181 to just inside the peritoneal membrane), and an intraperitoneal section 182. When the dual-cuff peritoneal dialysis catheter 10 is placed within a patient's body 12, the exterior section 178 is visible, protruding from the patient's body 12 at the exit site 181, the tunnel section 180 passes through the subcutaneous tissue, rectus muscle, and peritoneal membrane, and the intraperitoneal section 182 is located within the peritoneal cavity. The optical element 14 is shown positioned within the lumen 30 of the peritoneal dialysis catheter 10.

[0116] FIG. 16A is a perspective view of a preferred two-cuff peritoneal dialysis catheter 10 showing the preferred radial EMR radiation (including the radial EMR radiation in the outer section 178 and tunnel section 180) extending from the connector hub 170 to a point adjacent to and downstream of the peritoneal cuff 172 within the peritoneal membrane.

[0117] FIG. 16B is a perspective view of a preferred two-cuff peritoneal dialysis catheter 10 showing the radial radiation of EMR (radial EMR radiation within tunnel segment 180) between an exit site 181 upstream of the subcutaneous cuff 174 and a point downstream of the peritoneal cuff 172 within the peritoneal membrane.

[0118] FIG. 16C is a perspective view of the two-cuff peritoneal dialysis catheter 10 showing the radial radiation of EMR (including the radial EMR radiation within the outer section 178, tunnel section 180, and intraperitoneal section 182) extending into the peritoneal dialysate region 177 during dialysis between the connector hub 170 and a point downstream of the peritoneal cuff 172.

[0119] 17A is an elevational view of a two-cuff peritoneal dialysis catheter 10 connected to an extension set interface 184. The extension set interface 184 includes a Y-port adapter 186, extension line tubing 188, and a connecting luer 190. Radial EMR radiation is shown only at the Y-site / transition region 192.

[0120] FIG. 17B is an elevational view of a two-cuff peritoneal dialysis catheter 10 connected to an extension set interface 184, showing radial EMR radiation only outside the patient's 12 body (i.e., within the Y-site / transition region 192, along the extension line tubing 188, within the connecting luer / connector hub region 194, and within the outer section 178).

[0121] 17C is an elevational view of a two-cuff peritoneal dialysis catheter 10 connected to an extension set interface 184, showing radial EMR radiation within the Y-section / transition region 192, connecting luer / connector hub region 194, tunnel section 180, and intraperitoneal section 182. This preferred embodiment provides additional radial EMR radiation in the outer regions susceptible to infection due to contamination, i.e., the Y-section / transition region 192 and connecting luer / connector hub region 194.

[0122] Similarly, Figure 17D is an elevational view of a two-cuff peritoneal dialysis catheter 10 connected to an extension set interface 184, but showing radial EMR radiation through the Y-site / transition region 192, connecting luer / connector hub region 194, tunnel section 180, intraperitoneal section 182, and coiled Tenckhoff 176. This preferred embodiment demonstrates that radial EMR radiation can be delivered to the entire extent of the catheter 10, including outer regions and regions within the patient's body 12 that are susceptible to infection due to contamination. In combination with the other figures, Figure 17D demonstrates that radial EMR radiation can be turned on and off in any combination of regions along the length of the catheter 10 as desired to employ controlled relative intensities and / or treatment site-specific treatment doses.

[0123] Also, by extending the optical element 14 into the coiled Tenckhoff 176 as shown in FIG. 17D, the optical element 14 can prevent blockage of the holes 195 and / or tissue adhesion to the catheter 10. A smaller diameter optical element 14 may be required (at least in the region of the optical fiber that extends into the coiled Tenckhoff 176) to prevent unwinding of the coiled Tenckhoff 176.

[0124] 18A is a schematic diagram of another preferred embodiment of a peritoneal dialysis catheter 10 inserted into a female patient's body 12. This preferred embodiment shows a single-cuff peritoneal dialysis catheter 10 that does not provide radial EMR radiation.

[0125] 18B is a schematic diagram of another preferred embodiment of a single-cuff peritoneal dialysis catheter 10 inserted into a female patient's body 12. This preferred embodiment provides radial EMR radiation from a point downstream of the EMR control device 155 to a point just downstream of the peritoneal cuff 172 (i.e., through the Y-section / transition region 192, the outer section 178, and the tunnel section 180) and to the peritoneal dialysate 196 in the peritoneal dialysate region 177.

[0126] In the preferred methods or processes of the present invention, the order and / or sequence of steps described herein is exemplary and not limiting. Thus, although various process or method steps are illustrated and described in a sequential or chronological sequence, these process or method steps are not limited to being performed in any particular order or sequence unless otherwise indicated. In fact, such process or method steps can generally be performed in a variety of orders and sequences and still fall within the scope of the present invention.

[0127] Furthermore, references to advantages, benefits, unexpected results, or operability of the invention are not intended to assert that the invention has previously been put into practice or that any testing has been performed. Similarly, unless otherwise expressly stated, the use of a verb in the past tense (present perfect or past tense) is not intended to suggest or indicate that the invention has previously been put into practice or that any testing has been performed.

[0128] Although preferred embodiments of the present invention are described above, no element, act, or instruction used herein should be construed as critical, necessary, essential, or essential to the present invention unless specifically and explicitly described as such. Although several preferred embodiments are described in detail herein, those skilled in the art will recognize that many modifications to these preferred embodiments are possible without materially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to be included within the scope of the present invention as defined in the claims.

[0129] In utility model claims, means-plus-function clauses are intended to encompass structures described herein as performing the recited function, not only structural equivalents but also equivalent structures. Thus, while nails and screws are not structurally equivalent in that nails employ cylindrical surfaces and screws employ helical surfaces to fasten wood parts together, in the context of fastening wood parts, nails and screws may be equivalent structures. Unless the precise phrase "means for" (means for performing a particular function or step) is recited in a claim, no interpretation under Section 112, paragraph 6, is intended. Moreover, the scope of patent protection afforded to this invention is not intended to be determined by reading into the claims any limitations herein that are not expressly apparent in the claims themselves.

[0130] While specific embodiments and applications of the present invention have been illustrated and described, it should be understood that the present invention is not limited to the precise configuration and components disclosed herein. Various modifications, changes and variations apparent to those skilled in the art can be made in the arrangement, operation and details of the inventive systems disclosed herein without departing from the spirit and scope of the present invention. The following are some examples of embodiments of the present invention. [Aspect 1] 1. A medical device assembly for insertion into a body cavity of a patient and for delivering and / or withdrawing fluids from said patient, comprising: 0.1J / cm 2 ~1.0kJ / cm 2 an electromagnetic radiation (EMR) source for providing non-UV therapeutic EMR having an irradiance of 0.005 mW to 1 watt and an intensity comprising a power output of 0.005 mW to 1 watt, said intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing the growth of healthy cells; a catheter having an elongated catheter body with at least one internal lumen, a connecting end, and a distal end, the distal end being insertable into the body cavity of the patient, the catheter body directing both the fluid and the therapeutic EMR axially relative to the catheter body, the axial flow of the fluid within the catheter body facilitating at least one of delivery of fluid into and withdrawal of fluid from the patient; an optical element that conducts axial propagation of the therapeutic EMR relative to the catheter body, the optical element having a position relative to the catheter body that is within at least one internal lumen of the catheter body, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber conducting axial propagation of the therapeutic EMR within the core, the optical fiber further comprising at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling radiation of the therapeutic EMR radially from the fiber body into the internal lumen of the catheter; at least one coupling for connecting the EMR source to the catheter body; Equipped with the medical device assembly delivering, via the at least one radially radiating portion, the therapeutic EMR of a controlled relative intensity into, on an exterior surface of, or about the elongated catheter body to produce a desired therapeutic effect while the catheter is positioned within the patient; Medical device assemblies. [Aspect 2] A medical device assembly as described in aspect 1, wherein the at least one radially radiating portion of the fiber body is positioned such that radial radiation of the therapeutic EMR from the fiber body is directed to a location for treatment area-specific dose projection of the therapeutic EMR. [Aspect 3] 2. The medical device assembly of claim 1, wherein the optical element is removably insertable into the catheter. [Aspect 4] 4. The medical device assembly of claim 3, wherein the medical device assembly further comprises a second optical element, the second optical element conducting axial propagation of the therapeutic EMR relative to the catheter body, the second optical element having a position relative to the catheter body within at least one internal lumen of the catheter body, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber conducting axial propagation of the therapeutic EMR within the core, the optical fiber further comprising at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling radiation of the therapeutic EMR radially from the fiber body into the internal lumen of the catheter, and the second optical element having at least one radial radiating portion different from the at least one radial radiating portion of the optical element. [Aspect 5] 5. The medical device assembly of claim 4, wherein the second optical element is removably insertable into the catheter and the second optical element is replaceably insertable into the same lumen of the catheter. [Aspect 6] 2. The medical device assembly of claim 1, wherein the radial EMR radiation from the at least one radial radiation portion has uniform intensity. [Aspect 7] 2. The medical device assembly of claim 1, wherein the radial EMR radiation from the at least one radial radiating portion has a non-uniform intensity. [Aspect 8] 2. The medical device assembly of claim 1, wherein the catheter is a urinary catheter. [Aspect 9] 2. The medical device assembly of claim 1, wherein the catheter is a peritoneal dialysis catheter. [Aspect 10] 1. A medical device assembly for insertion into a body cavity of a patient and for delivering and / or withdrawing fluids from said patient, comprising: 0.1J / cm 2 ~1.0kJ / cm 2 an electromagnetic radiation (EMR) source for providing non-UV therapeutic EMR having an irradiance of 0.005 mW to 1 watt and an intensity comprising a power output of 0.005 mW to 1 watt, said intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing the growth of healthy cells; a catheter having an elongated catheter body with at least one internal lumen, a connecting end, and a distal end, the distal end being insertable into the body cavity of the patient, the catheter body directing both the fluid and the therapeutic EMR axially relative to the catheter body, the axial flow of the fluid within the catheter body facilitating at least one of delivery of fluid into and withdrawal of fluid from the patient; an optical element that conducts axial propagation of the therapeutic EMR relative to the catheter body, the optical element having a position relative to the catheter body that is within at least one internal lumen of the catheter body, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber conducting axial propagation of the therapeutic EMR within the core, the optical fiber further comprising at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling radiation of the therapeutic EMR radially from the fiber body into the internal lumen of the catheter; at least one coupling for connecting the EMR source to the catheter body; Equipped with At least one radially emitting portion of the fiber body is positioned such that the radiation of the therapeutic EMR radially from the fiber body is directed to a location for treatment site-specific dose projection of the therapeutic EMR. Medical device assemblies. [Aspect 11] 11. The medical device assembly of claim 10, wherein the optical element is removably insertable into the catheter. [Aspect 12] 1. A medical device assembly for insertion into a peritoneal cavity of a patient's body and for delivering fluids to and / or withdrawing fluids from said patient's body, comprising: 0.1J / cm 2 ~1.0kJ / cm 2 an electromagnetic radiation (EMR) source for providing non-ultraviolet therapeutic EMR having an intensity comprising an irradiance of 0.005 mW to 1 watt and a power output of 0.005 mW to 1 watt, said intensity being sufficient to produce a therapeutic effect that inactivates one or more infectious agents; a peritoneal dialysis catheter having an elongated catheter body with at least one internal lumen, a connecting end, and a distal end, the distal end being insertable into the peritoneal cavity of the patient's body, the catheter body directing both the fluid and the therapeutic EMR axially relative to the catheter body, the axial flow of the fluid within the catheter body facilitating delivery of the fluid into the patient's body and withdrawal of the fluid from the patient's body; an optical element that conducts axial propagation of the therapeutic EMR relative to the catheter body, the optical element having a position relative to the catheter body that is within at least one internal lumen of the catheter body, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber conducting axial propagation of the therapeutic EMR within the core, the optical fiber further comprising at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling radiation of the therapeutic EMR radially from the fiber body into the internal lumen of the catheter; at least one coupling for connecting the EMR source to the catheter body; Equipped with At least one radially emitting portion of the fiber body is positioned such that the radiation of the therapeutic EMR radially from the fiber body is directed to a location for treatment site-specific dose projection of the therapeutic EMR. Medical device assemblies. [Aspect 13] 13. The medical device assembly of claim 12, wherein at least a portion of the optical element is removably insertable into the inner lumen. [Aspect 14] 13. The medical device assembly of aspect 12, wherein the peritoneal dialysis catheter further comprises at least one cuff and a connector hub, and has an external section, a tunnel section, and an intraperitoneal section. [Aspect 15] A medical device assembly as described in aspect 14, wherein radial radiation of the therapeutic EMR from the fiber body is directed to at least one radial radiation portion within at least one of the external section, the tunnel section, and the intraperitoneal section. [Aspect 16] The medical device assembly of aspect 14, wherein the peritoneal dialysis catheter further comprises an extension set interface, the extension set interface comprising a Y adapter, an extension line tubing, and a connection luer for connecting to the connection hub, and the peritoneal dialysis catheter further has a Y portion / transition region and a connection luer / connector hub region. [Aspect 17] 17. The medical device assembly of claim 16, wherein the therapeutic EMR radiation radially from the fiber body is directed to the Y-section / transition region. [Aspect 18] A medical device assembly as described in aspect 16, wherein radial radiation of the therapeutic EMR from the fiber body is directed to at least one of the Y-section / transition region, the connection luer / connector hub region, the external section, the tunnel section, and the intraperitoneal section. [Aspect 19] A medical device assembly as described in aspect 12, wherein the medical device assembly delivers the therapeutic EMR of controlled relative intensity via the at least one radially radiating portion to produce a desired therapeutic effect in, on an outer surface of, or around the peritoneal dialysis catheter while at least a portion of the peritoneal dialysis catheter is positioned within the patient's body. [Aspect 20] A medical device assembly as described in aspect 18, wherein the medical device assembly delivers the therapeutic EMR of controlled relative intensity via the at least one radially radiating portion to produce a desired therapeutic effect within, on an outer surface of, or around the peritoneal dialysis catheter while at least a portion of the peritoneal dialysis catheter is positioned within the patient's body. [Explanation of symbols]

[0131] 10 Catheter 12 Patient body (or inside the body) 14 Optical Elements 16 Line Tube 18 EMR Conduction System 20 Electromagnetic Radiation Components 22 Insertable Catheter Components 24 Elongated body 26 Electromagnetic Radiation Source 28 Bonding Elements 30 internal lumens 32 Proximal catheter hub assembly 34 distal end 35 Aperture 36 Long, thin catheter body 37 Balloon Cuff 38 Variable Length Catheter 39 Urethra 40 Focusing chamber 41 Bladder 42 Optical element termination point 43 Input port 44 Flexible protective tube 45 output ports 46 Line clamp 48 Transdermal Area 50 Optical assembly 52 Intermediate coupling 54 patch cables 56 EMR Conduction Extension Section 56 58 Front Connector 60 Rear Connector 62 Exterior 64 distal end 66 cores 68 Clad 70 Clad coated optical fiber 72 Bare Optical Fiber 74 Inner diameter 76 outer diameter 78 void 79 Surrounding Void 80 Core-clad boundary 82 Cladding outer boundary 84 Catheter wall 85 Interior Partition Wall 88 Connecting Elements 90 EMR Hub Connector 92 Collimator Lens 94 Optical Element Connector 98 Alignment Shaft 99 Alignment holes 100 uncorrected optical span 102 Section Corrected Optical Span 103 Radial radiation part 104 Fully Corrected Optical Span 105 Elongated radial radial section 106 Multiple Correction Optical Span 107 Modified tip part 108 1st cross section 109 Areas without microscopic structures 110 Second section 111 Minimum concentration 112 Third section 113 Moderate concentration 114 4th section 115 Maximum concentration 117 Microscopic structures 121 1st variance 122 Control equipment 123 2nd dispersion 124 Wand 125 3rd dispersion 126 Acid spray 127 Outer area 129 Inner area 131 Boundary area 150 adapter 152 Fixed sleeve 154 Drain pipe 155 Control Equipment 156 Actuation Control Features 158 Display 160 optical jack 162 Fluid Flow / EMR Propagation 164 Urine flow 166 External urethral region 168 Penis 170 Connector Hub 172 Peritoneal Cuff 174 Subcutaneous Cuff 176 Coiled Tenckhoff 177 Peritoneal dialysis fluid area 178 External classification 180 Tunnel Section 181 Exit site 182 Intraperitoneal division 184 Extension Set Interface 186 Y-port adapter 188 Extension line tube 190 Connection Lua 192 Y site / transition region 194 Connection Luer / Connector Hub Area 195 holes 196 Peritoneal dialysis fluid A. Insertion site

Claims

1. 1. A medical equipment assembly for a dialysis system, at least a portion of which is insertable into a patient's body for delivering and / or withdrawing fluids from the patient's body, the medical equipment assembly comprising: 0.1 J / cm 2 ~1.0 kJ / cm 2 an electromagnetic radiation (EMR) source for providing non-ultraviolet therapeutic EMR having an irradiance of 0.005 mW to 1 watt and an intensity comprising a power output of 0.005 mW to 1 watt, said intensity being sufficient to produce a therapeutic effect of at least one of inactivating one or more infectious agents and enhancing the growth of healthy cells; a dialysis access having an elongate body with at least one internal lumen, a connecting end, and a distal end, the distal end being insertable into the patient's body, the elongate body directing both the fluid and the therapeutic EMR axially relative to the dialysis access, axial flow of the fluid within the dialysis access facilitating at least one of delivery of fluid into and withdrawal of fluid from the patient's body, the dialysis access comprising a peritoneal dialysis catheter; an optical element that maintains axial propagation of the therapeutic EMR relative to the elongate body of the dialysis access, the optical element having a position relative to the dialysis access that is within at least one internal lumen of the dialysis access, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber maintaining axial propagation of the therapeutic EMR within the core, the optical fiber further comprising at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling radiation of the therapeutic EMR radially from the fiber body into the internal lumen of the dialysis access; at least one coupling for connecting the EMR source to the dialysis access; Equipped with the elongate body comprises a coiled Tenckhoff catheter having side holes for delivery and withdrawal of the fluid, the optical fiber having a portion that extends into a coiled portion of the coiled Tenckhoff catheter, the portion that extends into the coiled portion having a length that reaches the side holes and a diameter that does not cause the coiled portion to unwind; at least one radially radiating portion of the fiber body is positioned such that radiation of the therapeutic EMR radially from the fiber body is directed to a location for treatment-site specific dose projection of the therapeutic EMR; Medical device assemblies.

2. The medical device assembly of claim 1 , wherein the optical element is removably insertable into the dialysis access.

3. The medical device assembly further comprises a second optical element, the second optical element maintaining axial propagation of the therapeutic EMR relative to the dialysis access, the second optical element having a position relative to the dialysis access within at least one internal lumen of the dialysis access, at least a portion of the optical element comprising an optical fiber for placement within the at least one internal lumen, the optical fiber comprising a fiber body having an outer surface, a coupling end, a distal end, and a core, the optical fiber maintaining axial propagation of the therapeutic EMR within the core, the optical fiber the fiber body further comprises at least one radial radiating portion disposed between the coupling end of the fiber body and the distal end of the fiber body, the radial radiating portion enabling the therapeutic EMR to radiate radially from the fiber body into the internal lumen of the dialysis access; the second optical element has at least one radial radiating portion different from the at least one radial radiating portion of the optical element, the second optical element being removably insertable into the dialysis access, and the second optical element being replaceable with the optical element; 2. The medical device assembly of claim 1, wherein the internal lumen of the dialysis access into which the optical element is inserted is the same as the internal lumen of the dialysis access into which the second optical element is inserted.

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