Electromagnetic radiation delivery and monitoring system and method for preventing, reducing and / or eliminating catheter-related infections during in-facility use or home use

Abstract

An electromagnetic radiation (EMR) delivery system for delivering EMR at wavelengths, intensities, exposure amounts, and durations that can prevent, reduce, and / or eliminate infectious agents within, on, and around a catheter and / or catheter extension portion to internal and / or external locations within and / or on the patient's body. A smart light engine box generates therapeutic EMR, controls the treatment, and monitors the integrity of the system. Disposable optical fiber supplies enable home use of the EMR delivery device. Specific embodiments of the EMR delivery device for use with peritoneal dialysis catheters, dialysis accesses, and hemodialysis accesses are also disclosed.

Description

Technical Field

[0001] The present invention provides a method and apparatus for multi-purpose delivery and monitoring of non-ultraviolet therapeutic doses to inactivate infectious agents present on, inside, or generally around a catheter while the catheter is inside a body cavity, or on, inside, or around an external extension catheter and connector along a fluid path of fluids such as dialysate and waste dialysate, blood, urine, therapeutic dose fluids, etc., and to stimulate the growth of healthy cells at the body and entry / exit sites to induce a healing effect.

[0002] Such multi-purpose delivery of non-ultraviolet therapeutic doses may use controlled relative intensities of therapeutic doses and / or region-specific application of the treatment area. The present disclosure relates to a medical device assembly that uses non-ultraviolet visible therapeutic electromagnetic radiation (EMR) at a sufficient intensity to stimulate the growth of healthy cells and induce a healing effect within and around a catheter while the catheter is present inside a body cavity, and / or within and around an external extension catheter and connector along a fluid path of fluids such as dialysate and waste dialysate, and to reduce or eliminate infectious agents, and particularly relates to a light energy source and delivery components (including a disposable fiber optic introducer in some cases).

[0003] Various exemplary embodiments of the present invention are described below. The use of the term "exemplary" has the meaning of being illustrative or merely an example, and any reference in this specification to "the invention" is not intended to limit or restrict the invention to the exact features or steps of any one or more of the exemplary embodiments disclosed herein. References to "exemplary embodiment", "one embodiment", "an embodiment", "some embodiments", "various embodiments", etc. may imply that the embodiments of the invention so described may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Further, repeated use of the phrase "in one embodiment" or "in an exemplary embodiment" may or may not mean the same embodiment, although it may. BACKGROUND OF THE INVENTION

[0004] Catheters are commonly used as channels for injecting drugs into a patient's body or collecting fluid samples from a patient. Each catheter typically includes a tube derived from plastic or other polymers, such as silicone, polyurethane, etc., and at least a portion of this tube may be inserted into a region of the body and may store one or more separate lines through which these fluids can be delivered or collected. "Lumen" refers to the path within the catheter that proceeds from outside the body into the body. Catheters are used in a variety of fields of use, including within blood vessels, within the abdomen, within the urinary system, within the gastrointestinal tract, within the ophthalmic system, within the airways, within the cranial space, within the spine, during dialysis, etc. In all cases, the catheter extends from outside the body and is placed inside a space within the body where a portion of the catheter or catheter assembly, referred to herein as the "body cavity", is present. These devices frequently cause infections induced by the growth of infectious agents in, on, and around the catheter and the tissue surrounding the catheter. Infectious agents can include bacteria, fungi, viruses, etc. that enter the body and lead to the patient's illness. Depending on the location of catheter placement, these infections can occur in the form of urinary tract infections, bloodstream infections, soft tissue infections, etc.

[0005] Catheter-related infections (CRIs) are a major medical problem leading to high morbidity and mortality. Current methods for reducing or eliminating the number of infectious agents in, on, and around catheters are of low effectiveness. Typically, a catheter will be removed if there is suspicion that it is harboring infectious agents, increasing both the cost associated with treatment and the patient's discomfort. Various methods have been attempted to inhibit or eliminate the growth of infectious agents in, on, or around catheters, such as the use of aseptic handling techniques, antibiotics, and catheter replacement in cases of suspected infection. Despite these techniques, catheter-derived infections continue to be an important problem. According to the Centers for Disease Control and Prevention, in 2010, more than 31,000 people died clearly as a result of catheter-related bloodstream infections. These infections, along with urinary tract infections, gastrointestinal infections, dialysis-related infections, and other infections due to catheters, are increasing medical costs, insurance costs, and patient discomfort.

[0006] Catheters come in a variety of sizes. Many catheters with relatively small diameters, such as many peripherally inserted central catheters (PICCs), have small-diameter lumens. Such catheters with relatively small diameters may be suitable for long-term insertion. As a result, in catheters with relatively small diameters, there may be insufficient thickness with respect to the catheter wall to carry a delivery system that enhances sterilization and / or healthy cell growth.

[0007] To name just a few, the use of ultraviolet (UV) light, disinfecting chemicals, drug-impregnated catheters, etc. has been attempted for the purpose of reducing the spread of infection. Many patients have attempted the use of UV light to disinfect catheters. Unfortunately, UV light is well known to cause damage to living cells. Similarly, methods of disinfecting connectors, stoppers, and valves using the projection of electromagnetic radiation (EMR) for sterilization have also been attempted using 405 nm light for their sterilization, but in these methods, the disinfection of the catheter body as well as the tip of the catheter has been overlooked.

[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 removal and replacement of catheters from a patient's body, there is a need to sterilize the entire catheter or catheter assembly while at least a portion of the catheter is present within the patient's body. Furthermore, it would seem advantageous if therapeutic EMR could be provided through such indwelling catheters to stimulate the growth of healthy cells.

[0009] Immediate post-placement disinfection would seem to be able to help prevent the growth of unwanted biofilms on catheters. Biofilms contain extracellular polymeric materials created by microorganisms after adhering to a surface. This biofilm promotes the growth of infectious agents and is very difficult to destroy once growth has begun.

[0010] The growth of infectious agents can be the result of agents acting outside the patient's body (contamination during handling at the access point when the catheter penetrates or traverses the skin, contamination from the catheter hub, or contamination from other external sources), or the result of infectious agents already present in the body attaching to and growing on the surface of the catheter. Scientific literature suggests that approximately 65% of CRIs are due to infectious agents present on the patient's skin (Non-Patent Document 1). These agents travel down the outside of the catheter and colonize the catheter tip. For short-term catheterization, this is considered the most likely infection mechanism (Non-Patent Document 2). Thirty percent (30%) of CRIs are thought to be due to contaminated hubs where infectious agents travel down the inside of the catheter (Non-Patent Document 1). This is considered the most likely infection mechanism for long-term catheterization (Non-Patent Document 2).

[0011] EMR in the range of 380 to 900 nm has been shown to be effective in killing infectious agents. Research conducted by a group at the University of Strathclyde has shown that light in this range is effective in killing surface bacteria in a burns unit without harming the patient (Non-Patent Document 3). U.S. Patent Application Publication No. 2010 / 0246169 (Patent Document 1), created by the members who conducted this research, uses ambient lighting to disinfect a large surrounding area. The mechanism proposed by the team suggests that light in this range induces photosensitization of endogenous porphyrins inside the bacteria, which causes the creation of singlet oxygen and leads to the death and withering of the bacteria (Non-Patent Document 4).

[0012] However, heretofore, there has been no instrument for safely and effectively disinfecting a catheter that remains implanted in a patient's body, or a method for manufacturing or using such an instrument. Accordingly, there is a need for methods and instruments designed to deliver non-antibiotic bactericidal therapies in vivo. Such methods and instruments can provide safe, effective, and reproducible removal of disinfection using novel technologies and / or enhance the growth of healthy cells.

Prior Art Documents

Patent Documents

[0013]

Patent Document 1

Non-Patent Documents

[0014]

Non-Patent Document 1

Non-Patent Document 2

Non-Patent Document 3

Non-Patent Document 4

Summary of the Invention

[0015] Exemplary embodiments of the present disclosure relate to a medical device assembly for insertion into a cavity of a patient's body and for delivery and retrieval of fluids from outside the body to inside the body and from inside the body to outside the body. Each assembly includes an electromagnetic radiation (EMR) source for inactivating one or more infectious agents and / or enhancing the growth of healthy cells. Each assembly may include a catheter or a catheter extension, or may be used with a catheter having an elongated catheter body with at least one internal lumen, a coupling end, and a distal end. The distal end is insertable into a cavity of the patient's body, whether the cavity is a venous, arterial, gastrointestinal, abdominal, urinary, respiratory, cranial, or spinal cavity, where the indwelling catheter body is capable of directing fluid and / or inducing the axial propagation of therapeutic EMR for radial delivery into the patient's body and / or at the distal end, with respect to the catheter body. Similarly, where applicable, the therapeutic EMR may be directed in the catheter extension and connector outside the body, in the insertion region, or into it. An optical element disposed within the lumen interior of the catheter body and / or within the catheter body acts to direct the axial propagation of therapeutic EMR with respect to the catheter body. An optical element or another optical element may similarly be disposed to act to direct the propagation of therapeutic EMR through at least one coupling element for connecting the EMR component to the catheter component into which it is insertable.

[0016] For the purposes of the present disclosure, the use of the term "therapeutic" is to be understood as meaning related to or for the treatment of a disease, including the reduction or elimination of infectious agents, and for maintaining health, including enhancing the growth of healthy cells.

[0017] For the purposes of the present disclosure, the phrase "controlled relative intensity" is a multi-purpose term that means that the delivery of EMR at various desired intensities can be controlled in any of a number of ways, such as 1) by using different single fibers, 2) by using different radial emission positions and / or gradients, 3) by using multiple different fibers, and 4) by improving the type and / or design of the fiber for use in conjunction with an existing catheter or catheter extension. The multi-purpose nature contemplated by the phrase "controlled relative intensity" is the ability to deliver EMR of the desired / appropriate intensity to the desired position when it is most effective within a wide range of catheter types and sizes.

[0018] For the purposes of the present disclosure, the term "treatment region specific" is likewise a multi-purpose term that means that, for a particular treatment region, EMR at various desired intensities for a desired dose can be delivered by utilizing a fiber with a radial emission capability that is compatible with a particular single or multiple regions within and / or in or around the catheter or catheter extension and connector to be treated by the application of EMR.

[0019] An exemplary medical device assembly includes an EMR source, an EMR conduction system, and at least one coupler for coupling the EMR source to the EMR conduction system. The EMR source provides non-ultraviolet therapeutic EMR having an intensity sufficient to inactivate one or more infectious agents and / or stimulate the growth of healthy cells to induce a healing effect. In at least one exemplary embodiment, the EMR conduction system may be at least partially insertable into and removable from the lumen of an indwelling catheter or catheter extension. Since the EMR conduction system is insertable in a removable form, in yet another exemplary embodiment, a different second EMR conduction system (or at least an optical element of the second EMR conduction system) may also be insertable in a removable form, such that two different EMR conduction systems may be interchangeably insertable into the same lumen of the catheter or into the extended lumen of the catheter and within the catheter extension.

[0020] In some exemplary embodiments, methods and apparatus are provided for effectively sterilizing a catheter and the area surrounding the catheter while the catheter is disposed within a body cavity. Such a medical device assembly uses sterilizing EMR to reduce or eliminate the total number of infectious agents in or on the tissue within, on, or around the catheter and / or in or on the tissue surrounding the catheter while the catheter is within the body cavity. In other exemplary embodiments, a system (such as a dialysis system) may have a catheter extension (such as a fluid extension line) and a connector disposed outside the body, and by effectively sterilizing these, prevention, reduction, and elimination of infectious agents throughout the system, including within, on, or around the catheter, within, on, or around the catheter extension, and / or in or on the tissue surrounding the catheter while the catheter is within the body cavity, is enhanced.

[0021] The EMR source(s) can be from a single, multiple, or group of EMR sources including, without limitation, light-emitting diodes, semiconductor lasers, diode lasers, incandescent lamps (filtered or unfiltered), and fluorescent lamps (filtered or unfiltered). This EMR source (or sources) provides non-ultraviolet therapeutic EMR providing one or more wavelengths within the range of greater than 380 nm to about 904 nm. To provide sufficient inactivation of infectious species and / or stimulation of healthy cell growth, each EMR wavelength should be of a narrow spectrum centered around one wavelength in the group. The intensity should be sufficient to inactivate one or more infectious agents and / or stimulate healthy cell growth to induce a healing effect. This group includes several wavelengths centered around approximately 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.

[0022] The EMR source(s) may require a driver and electronic support for full functionality. Consideration should be given to accommodating support hardware and / or software that may include a significant portion of the functionality and effectiveness of the EMR source(s). The EMR source(s) may also generate heat, which may be harmful to the EMR source(s), and thus may need to be limited or attenuated.

[0023] The present disclosure describes a catheter (or catheter assembly) having an elongate catheter body with at least one internal lumen, a proximal end, and a distal end, the distal end being insertable into a cavity of a patient's body. The catheter body is intended to direct both fluid and therapeutic EMR axially with respect to the catheter body for delivery into the patient's body at the insertion site, along the elongate catheter body, and / or at the distal end. The present disclosure includes an optical element disposed within the catheter body that guides the axial propagation of therapeutic EMR through the catheter body. Finally, the present disclosure describes at least one coupling element for coupling a radiation source to the catheter body. Additionally, the catheter may be coupled to one or more extension catheters (e.g., fluid extension lines) and connectors through which fluid is supplied or withdrawn. It may be advantageous to make such extension catheters and connectors also guide the axial propagation of therapeutic EMR therethrough, thereby enhancing the prevention, reduction, and elimination of infectious agents within the entire system during delivery of therapeutic EMR.

[0024] Sterilizing EMR is transmitted down a dedicated path within the catheter via an optical element that guides the axial propagation of light. It is contemplated that various methods can be used to facilitate the axial propagation of light with respect to the catheter, including reflective coatings, fiber optic cables, lenses, waveguides, etc. within the lines of the catheter. The light source can be a light emitting diode (LED), a laser, a fiber optic filament, etc.

[0025] One exemplary embodiment of the EMR source and support components is simplified to store only the EMR source and necessary components. In another exemplary embodiment of the EMR conduction system, a passive heat sink is required to dissipate the generated heat into the ambient environment. In yet another exemplary embodiment of the EMR source, the heat sink may be coupled to at least one fan to actively dissipate the heat generated by the EMR source. In other embodiments, multiple EMR sources coupled to separate individual optical elements or a single EMR source having the ability to couple to separate individual optical elements and provide EMR of distinctly different intensities and / or wavelengths to separate the optical elements may be utilized.

[0026] Particularly advantageous for the present disclosure is the use of light having a wavelength in the range of 380 nm to about 900 nm. Further, the intensity and output of the emitted light significantly affect the inactivation of infectious agents and thus, 0.1 J / cm 2 to 5 kJ / cm 2 (or up to 10 kJ / cm in some cases 2 ) covering the radiant exposure range, and an output range of 0.005 mW to 5 W (or up to 10 W in some cases), and an output density range covering 1 mW / cm 2 and 2 W / cm 2 (or up to 5 W / cm in some cases 2 ) are advantageous for these exemplary device assemblies and methods. These ranges of wavelength, output density, and radiant exposure have been shown to have either an antibacterial effect or a positive biological effect on the tissue being treated. These positive biological effects include a reduction in inflammatory cells, an increase in fibroblasts, stimulation of collagen synthesis, induction of angiogenesis, and granulation tissue formation.

[0027] For each of the exemplary embodiments described herein, the EMR conduction system and method for disinfection / curing are believed to be available in a manually or CPU-controlled adjustable or predetermined duty cycle. If the treatment starts immediately after the aseptic procedure is initiated, device-related infections can be inhibited or prevented. This includes device-related biofilm growth.

[0028] The treatment may include at least one wavelength of therapeutic EMR that acts as a main 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, which is selected to sterilize one or more target organisms, or the main wavelength selected to promote the growth of healing and healthy cells may 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 may include changing the main wavelength between a first main wavelength and a second main wavelength (different from the first main wavelength) in a selected treatment pattern. Further, the bactericidal EMR and the EMR that stimulates the growth of healthy cells may be transmitted alternately, simultaneously, in tandem, or alternatively.

[0029] A method for constructing an exemplary medical device assembly for insertion into a cavity of a patient's body, for delivery of a fluid (e.g., dialysis fluid, saline, or blood purified by hemodialysis) to the patient's body, or for recovery of a fluid (e.g., waste dialysis fluid or unpurified blood) from the patient's body may include providing a catheter having an indwelling catheter positioned or an elongate catheter body with one or more internal lumens, a coupling end, and a distal end, the distal end of which is pre-inserted / insertable into a cavity of the patient's body; applying one or more optical elements within one or more lumens of the catheter body (or extension catheter) and / or within the wall of the catheter body, the optical element being one that guides the axial propagation of therapeutic EMR with respect to the catheter body; and coupling at least one EMR source to the EMR conduction system and / or the catheter body (or extension catheter), the EMR source being for providing non-ultraviolet light and having an intensity sufficient for the therapeutic EMR to inactivate one or more infectious agents and / or enhance the growth of healthy cells.

[0030] In an exemplary embodiment, the device uses a catheter inserted into a cavity of the patient's body, where the catheter allows both fluid and therapeutic EMR to travel axially with respect to the catheter body. The catheter also houses at least one coupling lumen for connecting an EMR source that transmits therapeutic EMR axially with respect to the catheter line through the coupling lumen. In this regard, the coupling element means a typical hub on the therapeutic EMR source.

[0031] In at least one exemplary embodiment, an EMR conduction system that is removably insertable (i.e., may be partially or fully inserted into the lumen of a catheter and may also be partially or fully withdrawn from an arrangement inside the lumen of the catheter) may include at least one optical element having an elongate body that guides the axial propagation of therapeutic EMR through the elongate body. The elongate body may have an outer surface between a proximal end and a distal end. The outer surface has at least one radially emitting portion, where the radial emission facilitates the radial emission of therapeutic EMR from the elongate body proximate to each radially emitting portion. Also here, since the removably insertable EMR conduction system can be fully withdrawn from inside the lumen of the catheter, in another exemplary embodiment, a different second removably insertable EMR conduction system (or at least the optical element of the second EMR conduction system) may be compatibly inserted into the same lumen of the catheter. The second removably insertable EMR conduction system may differ in that it may have at least one radially emitting portion that is different from at least one radially emitting portion of the compatible EMR conduction system.

[0032] At least one coupler may include at least one feature that couples a radiation source to the EMR conduction system and, in some exemplary embodiments, enables immediate removal of the coupler from the EMR conduction system. Exemplary couplers may be achieved by utilizing uniquely designed couplings, pre-manufactured coupling systems, or any combination thereof that optimize the efficiency and utility of the coupler. Further, such a coupler may couple a removably insertable EMR conduction system to an EMR source and may include two or more couplers with intermediate sections optimized to facilitate the propagation of EMR. In one exemplary embodiment, the EMR source may be coupled to a patch cable or an EMR conduction extension segment, which is then coupled to a removably insertable formal EMR conduction system.

[0033] 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 similarly have the ability to transmit two or more wavelengths or intensities of EMR. For example, the optical element may include one or more elongated bodies that each transmit EMR of a different wavelength and / or intensity. Multiple wavelengths may be transmitted alternately, simultaneously, alternatively, tandemly, or in any combination thereof (e.g., one is always on and the other wavelength is pulsed). Multiple intensities may be transmitted simultaneously through the same element. Alternating patterns of light treatment may also be transmitted.

[0034] The EMR conduction system may be, for example, but not limited to, a central venous catheter, a peripherally inserted catheter, a peripherally inserted central catheter, a midline catheter, a neck catheter, a subclavian catheter, a femoral catheter, a cardiac catheter, a cardiovascular catheter, a Foley catheter, an intermittent catheter, an endotracheal tube, a dialysis catheter (with or without an attached extension catheter, regardless of hemodialysis or peritoneal dialysis (see FIGS. 14A - 22A)), a gastrointestinal catheter, a nasogastric tube, a wound drainage catheter, or any similar access medical catheter or tube that is inserted into the patient's body or connected to a catheter or tube for the purpose of delivering or retrieving a fluid or sample through an inserted catheter, and may be configured to be at least partially inserted into one of any number of catheters.

[0035] One exemplary embodiment of the EMR conduction system has an optical element that includes a single insertable optical fiber. In the case of a single optical fiber, the single fiber can enable light to be transmitted radially or axially in various sections along its length. For the sections where the light is to be transmitted radially, the outer surface of the optical element may be modified to facilitate the radial emission of the EMR. The modification of the outer surface may be achieved by chemical etching, physical etching, or electromagnetic ablation through plasma or laser to create various radially emitting portions along the length of the optical fiber. The radially emitting portions enable light to be emitted radially from the optical fiber. Of course, another exemplary embodiment of the EMR conduction system may include a plurality of single insertable optical fibers that each have the same length or different lengths, or are partially or fully inserted into a catheter or a catheter extension portion.

[0036] For the purposes of the present disclosure, radially emitted light means that the light has a radial component. Thus, the radially emitted light can be emitted orthogonally and / or obliquely to the central axis of the optical fiber at the axial emission point.

[0037] For embodiments having a radially emitting section, the material constituting the optical fiber may be selected from the group of optical fiber constituent materials, including plastics, silica, fluoride glass, phosphate glass, chalcogenide glass, and any other suitable material having the ability of axial light propagation and surface modification to achieve radial emission. Further, the optical fiber may be a single-mode, multi-mode, or plastic optical fiber that may be optimized for modification using chemical, physical, or electromagnetic manufacturing modification processes. The optical fiber may similarly be optimized for post-production modification.

[0038] Yet another exemplary embodiment utilizes a physical ablation modification method to modify an EMR conduction system composed of at least one optical fiber. This fiber is thought to be utilized based on its optimal optical response to the physical ablation process. This process may include, without limitation, sanding, media blasting, polishing, or buffing at least one section of the optical fiber. The physical ablation process is also thought to necessarily be optimized in terms of the degree of physical ablation to optimize proper radial EMR emission or its absence. This may be achieved by adjusting at least one of the speed, acceleration, pressure, modification time, or ablation material utilized in modifying the optical fiber.

[0039] Yet another exemplary embodiment utilizes a fine porous structure floating inside an optical fiber to achieve radial transmission of light. These fine structures may be positioned inside the core and / or the core-cladding boundary of the optical fiber. The fine structure has a lower refractive index than the region without the fine structure. The fine structure may be a material added to the optical fiber core or the core-cladding boundary such as metal, rubber, glass, or plastic. The fine structure may similarly be the absence of a material that creates aberration inside the optical fiber core or the core-cladding boundary. For example, the presence of fine air bubbles in the optical fiber core is thought to create an aberration or defect that changes the refractive index of the material and results in EMR being emitted radially from the optical fiber.

[0040] Another exemplary embodiment may include at least one optical fiber with cladding modified to optimize the radial or axial propagation of EMR. For example, the cladding may be modified to at least partially remove or thin the cladding to achieve partial radial emission of the EMR. Another example may include an optical fiber such that only some portions include cladding and the EMR is transmitted axially within the clad portions and at least partially axially and radially within the non-clad portions.

[0041] Yet another exemplary embodiment achieves uniform radial transmission by having the radial emission portion of the optical fiber have substantially equivalent intensity over the length of the radial emission portion along the optical fiber. This may be done through chemical etching, physical etching, plasma ablation, or laser ablation in a gradient pattern. By varying at least one of speed, acceleration, pressure gradient, flow rate, modification time, or modification material or process, it is possible to achieve radial transmission equivalence over each portion or the entire length of the modified optical fiber. During manufacturing, the uniformity provided by the gradient may also be achieved through the addition of microstructures positioned within the core and / or at the core-cladding boundary in a gradient pattern. Similarly, the uniformity of radial transmission achieved through gradient cladding or core features is also contemplated to achieve the desired radial emission, whether substantially uniform over the length of the portion or varying as desired.

[0042] Yet another embodiment achieves gradient radial transmission where at least one portion of the optical fiber emits EMR radially in a gradient distribution. The gradient distribution may likewise be achieved through chemical etching, physical etching, plasma, or laser ablation in a uniform or gradient pattern. It is possible to achieve gradient radial transmission throughout a portion of the optical fiber by changing at least one of speed, acceleration, pressure gradient, flow rate, modification time, or modified material or process. This may likewise be achieved through the addition of microstructures positioned within the core and / or at the core-cladding boundary. Gradient radial transmission enables another exemplary embodiment to exhibit a controlled relative intensity that may be uniform and / or non-uniform and vary as desired over a portion of the length.

[0043] A further exemplary embodiment of a removable insertable EMR conduction system includes an optical element such as at least one LED, its associated wiring components, and a scaffold. The LED may emit EMR based on the LED's inherent distribution or may utilize another optical element such as a lens or mirror to focus or diffuse the EMR in a favorable direction. Further, it is contemplated that arranging two or more LEDs in an array enables appropriate EMR emission and maximizes the therapeutic benefit. The LED, along with its associated wiring components, may be permanently or removably attached to the scaffold, thus enabling the removable insertion of the EMR conduction system into a catheter. The scaffold may be rigid, semi-rigid, malleable, elastic, or flexible, or any combination thereof.

[0044] In another exemplary embodiment, a catheter with multiple lumens for fluid injection or retrieval houses one or more separate lumens for the transmission of therapeutic EMR. Each lumen may have a separate proximal catheter hub assembly. These internal lumens converge in a convergence chamber where the individual internal lumens integrate into a single elongated catheter body while maintaining their individual internal paths. Such an exemplary device may include the use of an optical method to deflect radiation through axially designated catheter internal lumens between the convergence chamber and the distal end of the catheter.

[0045] Samples retrieved through the distal end are often used to characterize the type of infection. One exemplary embodiment of the present disclosure focuses on maintaining the axial transmission of light through the catheter and delivering therapeutic light of sufficient intensity to the distal end of the catheter to prevent, reduce, or eliminate the total number of infectious agents resident on the catheter.

[0046] In yet another exemplary embodiment, the medical device assembly is to be used in a urinary environment. A catheter (e.g., a Foley catheter) is to be placed within the urethra and bladder of the urinary tract.

[0047] In yet another exemplary embodiment, the medical device assembly is to be used in a gastrointestinal environment.

[0048] In yet another exemplary embodiment, the medical device assembly is to be used in an intravascular environment.

[0049] In yet another exemplary embodiment, the medical device assembly is to be used inside the patient's cranial cavity.

[0050] In yet another exemplary embodiment, the medical device assembly is to be used inside the patient's spinal cavity.

[0051] In yet another exemplary embodiment, the medical device assembly is to be used inside the patient's ocular cavity.

[0052] In yet another exemplary embodiment, the medical device assembly may be used inside the dialysis catheter, with or without an extension catheter and / or a connector (either hemodialysis or peritoneal dialysis).

[0053] Exemplary embodiments of the present invention will become more fully apparent from the following description and the appended claims, taken in conjunction with the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments and are not to be considered as limiting the scope of the invention. The exemplary embodiments of the present disclosure will be described with additional particularity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0054]

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[0055] Exemplary embodiments of the present disclosure are best understood by reference to the drawings, in which like parts are designated by like numerals throughout. It will be readily understood that the components of the exemplary embodiments described herein and illustrated in the figures can be arranged and designed in a wide variety of different configurations. Accordingly, the following detailed description of the exemplary embodiments of the apparatus, systems, and methods of the present disclosure represented in FIGS. 1 - 22A is not intended to limit the scope of the claimed invention, but is merely representative of exemplary embodiments.

[0056] The phrases "attached to", "secured to", and "mounted to" each mean a form of mechanical coupling that restricts relative translation or rotation between the attached, secured, or mounted objects. The phrase "slidably attached to" means a form of mechanical coupling that allows relative translation while restricting other relative movements. The phrase "attached directly to" means one form of attachment where the item being secured is in direct contact and retained in this fixed state.

[0057] The term "abutting" means that the items are in direct physical contact with each other, but do not necessarily have to be attached together. The term "grip" means that one of the items is holding the other firmly and the items are in direct physical contact. The term "integrally formed" means that the object is manufactured as a single unit without the need for assembly of components. When multiple elements are attached directly to each other to form a single workpiece, these elements may be integrally formed with each other.

[0058] The term "exemplary" is used in this specification to mean "serving as an example, instance, or illustration". Any embodiment described as "exemplary" in this specification should not necessarily be considered to be preferred or advantageous over other embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless expressly indicated.

[0059] Figures 1-5 are directed to the optical engine system 10 (in this case, the smart optical engine system 10). FIG. 1 is a perspective front view of an exemplary embodiment of the smart optical engine system 10 including the optical engine box 12, showing various features accessible from the front panel overlay 14 of the optical engine box 12, including the laser aperture 16, battery output indicator 18, RFID feature 20, optical test aperture 22, treatment on / off actuator 24, and alarm feature 26. FIG. 2 is a perspective rear view of the optical engine box 12 of FIG. 1, showing various features accessible from the rear panel 28 of the optical engine box 12, including the on / off switch 30 and output port 32. FIG. 3 is an exploded perspective view of the smart optical engine system 10 of FIG. 1, showing various components including the laser assembly 34, central processing unit (CPU) 35, battery assembly 36, side port test module 38 having a photodiode (not shown), front panel 40 with front overlay 14 and dust cover 42. Other components are referred to and described below.

[0060] FIG. 4 is a perspective front view of an alternative exemplary embodiment of the optical engine box 12, where the optical engine box 12 has an on / off switch 30 on the front panel overlay 14 and an exemplary umbilical optical transmission cable 44 that is connected to the optical engine box 12 through the laser aperture 16 and is ready for use at any time. The umbilical optical transmission cable 44 is referred to and described below.

[0061] FIG. 5 is a perspective front view of the optical engine box 12 of FIGS. 1 and 4, where the optical engine box 12 has an umbilical optical transmission cable 44 connected to the optical engine box through the laser aperture, and the umbilical optical transmission cable 44 is shown to be in an optical test mode by engagement through the optical test aperture 22. The details of the connection and the optical test mode are referred to and described below.

[0062] For each of the contemplated embodiments of the present invention, advantageously, the light (EMR) may have a wavelength in the range of from about 380 nm to about 904 nm. Further, the intensity and output of the emitted light serve to inactivate infectious agents and / or promote healing. 0.1 J / cm 2 ~5 kJ / cm 2 (or in some cases up to 10 kJ / cm 2 ) covering the radiant exposure, and an output range of 0.005 mW to 5 W (or in some cases up to 10 W), and 1 mW / cm 2 and 2 W / cm 2 (or in some cases up to 5 W / cm 2 ) covering the output density range are advantageous for these exemplary device assemblies and methods. These ranges of wavelength, output density, and radiant exposure have been shown to have either an antibacterial effect or a positive biological effect on the tissue during healing. These positive biological effects include a decrease in inflammatory cells, an increase in fibroblast proliferation, stimulation of collagen synthesis, induction of angiogenesis, and formation of granulation tissue.

[0063] For each of the exemplary embodiments described herein, each laser assembly 34 for disinfection / curing, its delivery system, and delivery method may be utilized and controlled manually or by a CPU 35 to provide an adjustable or predetermined duty cycle. When the treatment begins immediately after the start of the aseptic procedure, or in some cases when the treatment is continued throughout the aseptic procedure, device-related infections can be prevented, inhibited, or eliminated. This includes the growth of device-related biofilms. For example, the EMR delivery system can provide one duty cycle to prevent device-related infections prior to the start of dialysis and another different duty cycle for during the dialysis process, or one duty cycle can be adjusted for females and another different duty cycle for males. When using a pre-programmed or programmable CPU 35, many different types of duty cycles may be stored in the CPU's memory and called and used at the appropriate time. Such different types of duty cycles may differ by different parameters such as wavelength, intensity, and duration having different values within the scope disclosed herein, or by having different dose delivery technique parameters (e.g., the HISD technique discussed below differs from a steady, unchanging dose over a given duration).

[0064] Furthermore, while wavelengths in the range of 380 nm to 904 nm with sufficient intensity will inactivate one or more infectious agents and / or enhance the growth of healthy cells, more precise wavelengths may counter certain infectious agents or enhance the efficacy for a desired therapeutic purpose. EMR for sterilization having wavelengths including wavelengths centered around approximately 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 m, 470 nm, 475 nm, 660 nm, and 808 nm has been determined to be effective. The wavelengths selected to promote healing and the growth of healthy cells can be selected from the 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.

[0065] Since the dose delivery technique can vary depending on the different intended uses, the invention of the present disclosure provides versatility that can accommodate different uses and different dose delivery techniques, particularly when it is programmable within the internal CPU 35 and controlled by the internal CPU 35. For example, if the intended use is to deliver EMR to sterilize an extension set or fitting disposed outside the patient's body, the output and exposure amount of the EMR can be more aggressive compared to when the delivered EMR is intended to prevent, inhibit, or eliminate infectious agents within the patient's body and gentler EMR may be used. Further, the invention of the present disclosure is particularly suitable when there are time constraints that can be met or optimized by high-intensity short-duration (HISD) techniques and can be advantageous for the user / patient. On the other hand, relatively low output administered over a longer period can also be administered using the invention of the present disclosure.

[0066] The HISD technique can be effective, particularly in preventing, inhibiting, and eliminating stubborn infectious agents. For example, a 35-minute treatment using two 1W laser diodes, at approximately 270 mW / cm 2 corresponding to 570 J / cm 2It may be administered up to the radiation exposure dose of this type. This type of treatment may be used outside the patient's body before starting dialysis, while the same light engine box 12 may be used for a relatively less aggressive 4-hour treatment that delivers EMR inside the patient's body. A 20-minute treatment, which is slightly more aggressive than the 35-minute treatment, may also be used in some cases, which has the great advantage for dialysis patients of reducing the total connection time to the dialysis system and increasing convenience and comfort at home.

[0067] In short, the invention of the present disclosure can provide a way for thousands of dialysis patients to receive an effective and safe treatment at home at a cost and time that are a fraction of the cost of the comfort and convenience of dialysis administered at outpatient clinics and / or hospitals. Of course, the invention of the present disclosure may be used in some outpatient clinic and hospital environments and is not limited to dialysis applications.

[0068] Referring now to FIG. 1, with respect to the smart light engine system 10, which is particularly housed inside and presented by the light engine box 12, the light engine box 12 is shown as a substantially rectangular box with a soft and rounded edge for comfortable handling, and has a ventilation feature 46 to assist in dissipating the heat generated by the smart light engine system 10. The front panel 40 has a front panel overlay 14 connected to this panel so as to present a user interface 48 that enables a user / patient to utilize various features and connections in the operation of the smart light engine system 10. The front panel overlay 14 may present a warning icon 50, a laser aperture 16, a battery output indicator 18, an RFID feature 20 indicator, a light test aperture 22, a treatment on / off actuator 24, and an alarm feature 26 to the user / patient.

[0069] Although the drawings and descriptions in this specification are directed to a smart light engine system, it is of course equally contemplated that a light engine system that does not have any of the multi-purpose features illustrated and discussed in this specification. For example, the laser assembly 34 may be pre-set at the factory to a particular wavelength and intensity that provides a duty cycle regulated by an on / off switch that determines the duration of use.

[0070] The laser aperture 16 provides direct connection access to the laser assembly 34 through the dust cover 42 at the proximal end of the umbilical optical transmission cable 44. The dust cover 42 handles the connection environment between the umbilical optical transmission cable 44 and the laser assembly 34 (shown in FIG. 3) and prevents dust contamination to maximize the efficiency of the light (EMR) transmitted from the EMR source into the umbilical optical transmission cable 44.

[0071] Best shown in FIG. 3 is a schematic depiction of a central processing unit (CPU) 35 that controls features provided by a smart light engine box, such as those displayed on the front panel overlay 14, namely, for example, a battery output indicator 18, an RFID feature 20, a treatment on / off actuator 24, and an alarm feature 26. The CPU 35 is connected to a power source (battery and / or outlet), pre-programmed, and / or programmable. The operation of the CPU 35 for controlling the features disclosed in this specification can be understood by one of ordinary skill in the art within the scope of their experience and knowledge once the disclosure and teachings of this specification are provided. Accordingly, specific circuitry and wiring are not shown so as not to unnecessarily obscure the components of the EMR delivery system.

[0072] The battery output indicator 18 may provide a visual indication to the user / patient regarding the status of the battery charging capacity of the battery assembly 36. The battery assembly 36, best shown in FIG. 3, is provided to maintain the operability of the smart light engine system 10 in the event that the output from the facility power source (e.g., outlet or generator) is interrupted, lost, or otherwise unavailable. Thus, the battery assembly 36 can serve as a safety backup feature, and if not, a rechargeable battery provides the main power, and when recharge is required for use, the battery output indicator 18 may issue an alert. The battery output indicator 18 provides the user / patient with output-related information and a sense of peace of mind and assurance that the smart light engine system 10 will operate properly throughout a complete treatment cycle even if the power supply is interrupted, lost, or otherwise rendered inoperable for any reason.

[0073] The RFID feature 20 indicator is an interface used to monitor and track the use of disposable components (to be referenced and described below), facilitating the sterile connection of the umbilical optical transmission cable 44 by the user / patient to a catheter, such as a peritoneal dialysis catheter (“PD catheter”), and preventing the overuse of disposable components. The RFID feature 20 has an RFID reader with a built-in antenna (not shown) that enables the reading of RFID tags when placed near the RFID feature 20 indicator. The CPU 35 communicates with the RFID reader to facilitate the approval of disposable components, monitor the use of disposable components, and activate an alert, suggesting, for example, that the disposable component cannot complete another treatment before the expiration of its predetermined useful life.

[0074] The optical test aperture 22 provides direct connection access to the side port test module 38 through the dust cover 42 at the distal end of the umbilical optical transmission cable 44. The dust cover 42 handles the connection environment between the umbilical optical transmission cable 44 and the side port test module 38 (shown in FIG. 3) and prevents dust contamination, thereby enabling the ability to test the light emitted from the umbilical optical transmission cable 44 to confirm that it is the desired EMR (wavelength and intensity) for the intended treatment, and the ability to determine the soundness of the laser diode inside the laser assembly 34 and any degradation of the optical transmission of the umbilical optical transmission cable 44 and suggest that either or both of them should be replaced. The CPU 35 communicates with the test module to facilitate the EMR test. The test module 38 sends the test results to the CPU 35 and analyzes this test result against the predetermined EMR parameters by comparing the tested EMR parameters with the desired EMR parameters. Thereby, the CPU 35 can determine the soundness of the laser diode inside the laser assembly 34, and when there is any degradation in the optical transmission of the umbilical optical transmission cable 44, an alert is activated, for example, suggesting that the umbilical optical transmission cable 44 is degraded and replacement is recommended or that the useful life of the laser diode has been exhausted.

[0075] The treatment on / off actuator 24 can be a push-button interface for activation by the user / patient, and when activated, it starts the duty cycle of the pre-programmed or program-selected EMR at the specified wavelength, intensity, and duration or interval as stored in the CPU 35. The duty cycle may end automatically by programming or may be terminated manually (e.g., by pressing the button interface) when there is a legitimate need to terminate. Again, if the CPU 35 is pre-programmed or programmable, many different types of duty cycles are stored in the CPU's memory and can be called and used at the appropriate time. Such different types of duty cycles may differ by different parameters such as wavelength, intensity, and duration having different values within the scope disclosed herein, or by having different dose delivery technique parameters (e.g., the HISD technique discussed below differs from a steady, unchanging dose over a given duration).

[0076] The alarm feature unit 26 may include an alarm alert 52 and an alarm on / off actuator 54 that may be audible and / or visible. The alarm alert 52 may emit an audible sound (such as a buzzer sound, a calling sound, a voice, etc.) and / or provide a visual alert (such as a red / green light, a flashing light, a readout, etc.). The alarm feature unit 26 may provide feedback regarding various aspects of the treatment experience. For example, when a test of the light emitted from the umbilical optical transmission cable 44 indicates that the light is available for use at any time in the intended treatment, the alarm alert 52 may display a green light or play "Ready for use", or when a test of the light emitted from the umbilical optical transmission cable 44 indicates that the light is defective or not ready for use in the intended treatment, the alarm alert 52 may display a red light or play an error message. The alarm on / off actuator 54 can be used to switch on a visual alert to test that it is operable, or can be used to switch off an audible and / or visual alert triggered to alert the user / patient. Further, the alarm feature unit 26 can be used to enhance the user's / patient's awareness of any operating aspect of the smart light engine system 10. For example, by activating the alarm on / off actuator 54 during treatment, an alarm alert can be triggered to audibly provide the remaining time (e.g., the remaining radiation exposure or time amount that can be used before replacement for the current disposable item) in the treatment or some other operating aspect that the system 10 is monitoring or tracking. The alarm feature units 26 discussed within this paragraph and throughout the present disclosure can each be controlled by the CPU 35, which is in communication with the alarm alert 52 and various components that can trigger the alarm alert 52. Again, the design and operation of the CPU 35 for controlling the alarm feature units disclosed herein can be understood by those skilled in the art within the scope of their experience and knowledge once the present disclosure and teachings are provided.

[0077] As shown in FIG. 1, the ventilation feature 46 may include a series of holes on one of the side panels, but such a ventilation feature may be a slot or vent and may be positioned at any location outside the light engine box 12 that promotes dissipation of heat within the smart light engine system 10. For example, although several are not shown in the figure, the ventilation feature 46 may be positioned on the rear panel 28, side panel, top panel, or bottom panel.

[0078] The warning icon 50 may be of any type that provides information to the user / patient. The smart light engine system 10 is a medical device having operating elements that can be harmful to people or the environment if misused. The warning icon 50 can provide cautions, instructions, and / or warnings regarding product use to the user / patient. Exemplary warning icons 50 are generally shown as decals and labels on the front panel overlay 14 of FIG. 1 and on the rear panel 28 of FIG. 2.

[0079] The rear panel 28 of the light engine box 12, best shown in FIG. 2, may present a second user interface 48 that makes various features and connections available to the user / patient in the operation of the smart light engine system 10. The rear panel 28 may present, for example, the warning icon 50, the on / off switch 30, and the output port 32 to the user / patient. The on / off switch 30 may be a general on / off section that controls the output supplied from the facility power source to the light engine box 12 and / or the output drawn from the battery assembly 36. In FIG. 2, the on / off switch 30 is disposed on the rear panel 28, but the on / off switch 30 may be disposed at any other conveniently accessible location on the exterior of the light engine box 12. For example, it may be as shown in FIG. 4, or it may be on either the side panel or the top panel.

[0080] The output port 32 can be of any type. In FIG. 2, two such output ports 32 are shown as female adapters for receiving complementary output codes, which indicates, for example, that the system 10 can achieve higher versatility by including multiple types of output ports 32. Of course, it is also contemplated that output can be provided to the optical engine box 12 using only a single output port 32 and / or a wired power cord.

[0081] Since FIG. 3 is an exploded view of an exemplary smart optical engine system 10, various exemplary internal components are shown. The exemplary smart optical engine system 10 includes, as depicted, a front panel overlay 14, a front panel 40 with a dust cover 42, a laser assembly 34, a CPU 35, a battery assembly 36, a side port test module 38, a side port test adapter 56, as well as various other components used in the alignment and assembly of the cable adapter 58 and the components of the optical engine box 12.

[0082] Although one laser assembly 34 is shown in FIG. 3, multiple laser assemblies 34 may be used to achieve various capabilities of the optical engine box 12. For example, one laser assembly 34 may provide a constant wavelength at a constant intensity, and a second identical laser assembly 34 may be configured to operate in tandem with the other laser assembly to provide EMR with the same wavelength and approximately twice the intensity. For instance, two NovaLum lasers (manufactured by Ushio America, Cypress, California) operating at 1W each at a given wavelength can generate EMR that emits at approximately 2W at the given wavelength. Further, the multiple laser assemblies 34 may provide the same wavelength and intensity to multiple unidirectional optical transmission cables 44, or may provide different wavelengths and intensities to single or multiple unidirectional optical transmission cables 44.

[0083] The laser assembly 34 may have other operating capabilities. Such operating capabilities are known in the art, but have not been used for disinfection and / or healing in an EMR delivery system as disclosed herein. For example, the laser assembly 34 may operate at a single wavelength for a dedicated purpose, or the wavelength may be adjustable and tunable from one wavelength to another, or tunable within a predetermined wavelength range (e.g., the blue light range or the range of 380 nm to 904 nm disclosed herein). Also, a single laser assembly 34 may operate to provide multiple wavelengths simultaneously, for example, to provide one disinfection wavelength simultaneously with different disinfection wavelengths and / or healing wavelengths.

[0084] One embodiment of the light engine box 12 has a laser assembly 34 disposed proximate to or in contact with the front panel 40, whereby the umbilical light transmission cable 44 is directly coupled into the laser assembly 34 via an SMA adapter 58 (a subminiature version A optical fiber connector) and, as described below, can be directly coupled into the side port test module 38 via the SMA adapter 58. This direct coupling eliminates unwanted light leakage or loss, such that the light generated by the laser assembly 34 and entering the umbilical light transmission cable 44 is the same or substantially the same as the light emitted from the distal end of the umbilical light transmission cable 44 for use in therapeutic dosing or for testing by a photodiode when coupled to the side port test module 38. In this way, since the umbilical light transmission cable 44 is repeatedly used during treatment and periodically tested prior to each treatment, as recommended, the integrity of the laser diode within the laser assembly 34 and the degradation of the umbilical light transmission cable 44 over time are accurately sensed and measured by a significant difference between the generated light and the light being tested. The user / patient can confidently maximize the useful life of the umbilical light transmission cable 44 and accurately know when to replace it so as not to compromise the dosing treatment.

[0085] Figures 4 and 5 show an exemplary light engine box 12 in the "ready to use" mode and the "test" mode, respectively. By connecting an umbilical optical transmission cable 44 to the laser assembly 34 through the laser aperture 16, EMR (light) is transmitted from the laser assembly 34 to a wide range of remote locations that facilitate the use of the light engine system 10 within the facility (such as a hospital, outpatient clinic, etc.) and in the home use environment. The light engine system 10 allows for a certain range of mobility during sterilization and / or treatment, making the home treatment experience, which was previously impossible, much more comfortable and effective, thereby providing convenience and comfort to the patient receiving treatment while dramatically reducing catheter-related infections (CRIs), medical costs, and insurance costs.

[0086] Figures 6 - 8 are directed to the components and operation of an exemplary umbilical optical transmission cable 44. The exemplary umbilical optical transmission cable 44 depicted has several features in addition to the axial delivery of EMR. Of course, those skilled in the art given this disclosure can make and use an umbilical optical transmission cable 44 with more or fewer features without departing from the scope and spirit of the invention disclosed within this application, or can achieve the axial delivery of EMR.

[0087] FIG. 6 is an exploded perspective view of an exemplary embodiment of an umbilical optical transmission cable 44 showing various components including a distal connector 60, a proximal connector 62, and a cable 64 therebetween. Cable 64 includes an optical fiber 66, a wire 68, and a cable sleeve 70. Proximal connector 62 includes a first optical interlock 72 with an optical interlock connector 74, a proximal SMA 76, a fixed magnet 78, and a proximal connector shell 80 with a forwardly extending edge 81 (best shown in FIG. 8 below). Distal connector 60 includes an SMA adapter 82 with a second optical interlock 84 with a press-fit ball joint 86, a distal SMA 88, a distal connector shell 90, and a front cover 92. These interlock features provide a secure and fixed connection to prevent unwanted disconnection that could allow randomly directed laser light, unwanted light scattering, or light that is insufficient for disinfection.

[0088] Cable 64 of umbilical optical transmission cable 44 may be of any suitable length and may be manufactured in various standard lengths suitable for different applications. For example, the length of cable 64 for use within a hospital may be shorter than that of cable 64 designed for home use where the patient is more likely to be mobile. Optical fiber 66 may be a single fiber or a fiber bundle as required and may have negligible or minimal attenuation to minimize or virtually eliminate light loss as it propagates axially through the optical fiber 66. Wire 68 may be a transmission wire used for data or electrical transmission and may, if necessary, facilitate the smart features of the smart optical engine system 10 or provide a downstream electrical output.

[0089] FIG. 7 depicts a vertical cross-section of the distal connector 60 of the umbilical optical transmission cable of FIG. 6, fully assembled with a wire 68 having its tip cut off so as not to obstruct the visibility of other internal components. The optical fiber 66 is firmly nested within the SMA adapter 82 and locked in place by a second optical interlock 84 to be firmly connected to and aligned with a distal SMA 88 such that proper connection and alignment are maintained and optical loss at the connection point is minimized or eliminated, and is shown in an aligned state. These internal components are housed within the distal connector shell 90 and the front cover 92 and kept free of contaminants such as dust and moisture. As depicted, the distal connector 60 can be connected to a side port test module 38 or other downstream appliances, such as disposable articles, connectors or catheters, to facilitate further transmission of EMR. Examples of such downstream appliances are described below.

[0090] FIG. 8 depicts a vertical cross-section of the proximal connector 62 of the exemplary umbilical optical transmission cable 44 of FIG. 6, with the wire 68, having its tip cut off so as not to obstruct the visibility of other internal components, reassembled completely. The proximal connector 62 has a forwardly extending edge 81 that engages and opens the door (which swings back and forth inwardly) of the dust cover 42 to protect the polished optical fiber 66. The optical fiber 66 is firmly connected and aligned with the proximal SMA 76 that is firmly positioned and locked in place by the first optical interlock 72 so that proper connection and alignment are maintained and optical loss at the connection point is minimized or eliminated. The wire 68 (shown with its tip cut off) is attached to the pin 94 for further transmission downstream of the umbilical optical transmission cable 44 and can facilitate the transmission of data and / or electrical output from the optical engine box 12 to the umbilical optical transmission cable 44. The fixed magnet 78 provides magnetic resistance against the removal of the connection between the optical engine box 12 and the proximal connector 62 so that alignment and connection are not inadvertently impaired. To disengage the proximal connector from the optical engine box 12, a pulling force exceeding both frictional resistance and magnetic resistance is required. These internal components are housed inside the proximal connector shell 80 and the optical interlock connector 74 to keep these internal components free from contaminants such as dust and moisture.

[0091] FIGS. 9 - 11D are directed to the components and operation of an exemplary disposable optical fiber article 96, which is notable for maintaining the sterility of the system while being easy to use. The exemplary disposable optical fiber article 96 has an elongated structure that includes an optical fiber 98, which is enclosed within a foldable / storable sleeve 100 and is disposed between a proximal end 102 and a distal end 104. The disposable optical fiber article 96 may be configured in various overall lengths to correspond to the desired length of the optical fiber 98 that is advanced to the sterilization position.

[0092] FIG. 9 depicts an exemplary single-use optical fiber article 96 in its unused or fully stowed mode, disconnected from connection to the umbilical optical transmission cable 44 and any downstream connections. As depicted, the optical fiber 98 is enclosed within a foldable / stowable sleeve 100, thereby providing a sterile environment within the foldable / stowable sleeve 100 between the proximal end 102 and the distal end 104, which serves to seal the ends of the foldable / stowable sleeve 100 to enclose and preserve the sterile environment. In an exemplary embodiment of the single-use optical fiber article 96, the foldable / stowable sleeve 100 may be formed of a flexible and gas-impermeable polyethylene (PE) plastic, and / or the optical fiber 98 may be plastic.

[0093] FIG. 10 is a plan view of an exemplary embodiment of the packaging 106 for the single-use optical fiber article 96 of FIG. 9, showing the single-use optical fiber article 96 disposed within the packaging and a PFID adhesive tag 108 (shown in dashed lines) attached to the outer surface of the packaging 106. The packaging 106 may be of any suitable type that maintains the sterility of the single-use optical fiber article during transport and storage. The exemplary packaging 106 depicted is a face-seal blister packaging 110 that includes a see-through lister face 112 and an opaque backing 114. FIGS. 9 and 10 show the single-use optical fiber article in its stowed mode.

[0094] By installing the RFID adhesive tag 108 within the readable proximity range of the RFID feature 20 indicator on the front panel overlay 14 of the optical engine box 12, the disposable optical fiber item 96 inside the packaging 106 having the RFID adhesive tag 108 can be registered in the smart optical engine system 10, enabling the monitoring of the use of that specific disposable optical fiber item 96. Such monitoring helps prevent the use of a disposable optical fiber item 96 impaired by fluid outflow onto the fiber or degradation of the optical fiber 98. Each disposable optical fiber item 96 may have a predetermined service life for safe and effective use, and thus by tracking the age and cumulative usage time of the optical fiber 98, the undesirable use of an optical fiber 98 impaired by time and use can be prevented. For example, depending on the nature of the use, the service life may be determined to be within one week to ten days and / or ten uses and / or a total of 25 hours (similar to the recommended oil change interval for a vehicle being every three months or 3000 miles). The monitoring and tracking performed by the smart optical engine system 10 determines what period of time, number of uses and / or total usage duration is acceptable for the proper use of the disposable optical fiber item, and when the disposable optical fiber item 96 in use fails and needs to be replaced with a new disposable optical fiber item 96, the notification to the user / patient can be activated. The activated notification may take any suitable form. For example, through the scanning of the RFID adhesive tag 108 in the RFID feature 20 of the optical engine box 12, an alarm alert 52 may provide an audible and / or visual alert in case a new replacement disposable optical fiber item 96 has not been registered yet, or the treatment on / off actuator may be deactivated, and / or the laser assembly 34 may be deactivated.

[0095] These registration, monitoring, and exchange notification capabilities are the "smart" features of the Smart Light Engine System 10. Although any given light engine box 12 may or may not have any or each of these "smart" features, it may have one or more other "smart" features (e.g., the "smart" feature described above that determines the fatigue of the laser diode and / or the degradation of the umbilical optical transmission cable 44 and provides notification thereof). In fact, the light engine box 12 does not necessarily have to have any of the smart features disclosed herein as long as it has the ability to deliver EMR for use in preventing, reducing, or eliminating infectious agents within the catheter or within the catheter extension or within the catheter connection. However, by having one or more of the "smart" features operating within the Smart Light Engine System 10, the efficiency and effectiveness of preventing, reducing, or eliminating infectious agents are enhanced.

[0096] Figures 11 through 11D best illustrate the components and operation of the disposable fiber optic article 96. FIG. 11 is an exploded view of the disposable fiber optic article 96 of FIG. 9 showing the various components and the relative placement of each component. The proximal end 102 includes a barrel 116 with a female luer adapter 118 that serves as a coupling adapter (in FIG. 9, a male luer plug 120 closes off the female luer adapter 118 for transport and storage), a check valve 122, and a capture ring 124. The check valve 122 captures the proximal end of the collapsible / storable sleeve 100 and securely fixes it against the inner wall of the barrel 116. The check valve 122 (also depicted in an exploded view in FIG. 11A) further includes a check valve body 126, a check valve disk 128, a check valve cap 130, and a central bore 132 that is aligned through each component of the check valve 120, through which the collapsible / storable sleeve 100 is nested inside the barrel 116 when the disposable fiber optic article 96 is in its collapsed mode and through which the optical fiber 98 passes when the disposable fiber optic article 96 is in its collapsed mode. The check valve 122 allows the sterile environment inside the collapsible / storable sleeve 100 between the proximal end 102 and the distal end 104 to move / escape through the check valve 122 as the disposable fiber optic article 96 is advanced from its stored mode to its collapsed mode.

[0097] The distal end 104 (also shown in FIGS. 11B - 11D) further includes a barrel plug 134 with a barrel plug cap 136, a ferrule 138, a magnetic washer 140, a ferrule cap 142, and an optical fiber receiving bore 144 that is centered and aligned through each component of the barrel plug 134. The ferrule cap surrounds and protects the ferrule 138 during transportation and storage. The barrel plug 134 seats within and seals the barrel 116 to snugly capture the foldable / storable sleeve 100 within the interior of the barrel 116. The proximal end of the foldable / storable sleeve 100 is securely fixed in an airtight manner about the barrel plug cap 136 to maintain the sterility within the foldable / storable sleeve 100. The optical fiber 98 has a reinforced end 146 that is disposed within the optical fiber receiving bore 144 and arranged to pass through this bore for aligned connection to the distal connector 60 of the umbilical optical transmission cable 44. FIG. 11B is a perspective view of the fully assembled distal end 104 that is ready for connection at any time to the distal connector 60 of the umbilical optical transmission cable 44, while FIG. 11C is an exploded perspective view of the distal end 104 separated from the foldable / storable sleeve 100, as well as the ferrule 138 and magnetic washer 140 disassembled from the barrel plug 134. FIG. 11D is a perspective end view of the ferrule cap 142 engaged to surround and protect the ferrule 138 during transportation and storage.

[0098] FIG. 12 is a plan view of an exemplary fiber optic introducer 148 that appears to be during transport or storage, with protective caps sealing each accessible port. The illustrated fiber optic introducer 148 is particularly suitable for use with a dialysis catheter having an extension subset disposed between the dialysis catheter and a dialysis fluid source or waste receptacle. As depicted, the exemplary fiber optic introducer 148 is a Y - connector having a main line 150 between an inlet port 152 and an outlet port 154, and a branch line 156 between the main line 150 and a side port 158. Also depicted are various accessories for the fiber optic introducer 148, namely a clamp 160 for selectively opening and closing the branch line 156, and different types of sealing caps 162 for sealing the inlet port 152, outlet port 154, and side port 158. Generally, Y - connectors are well - known, but the illustrated exemplary fiber optic introducer 148 is particularly suitable for use with a dialysis catheter. As a result, the type of connection at the ports may differ from other Y - connectors so as to correspond to the connection to the extension subset, dialysis catheter, and umbilical optical transmission cable 44 (as shown in FIG. 13).

[0099] Although the depicted exemplary fiber optic introducer 148 is particularly suitable for use with a dialysis catheter, it should be understood that the scope of the invention disclosed herein is not limited to use with a dialysis catheter. Rather, the use of the invention in a dialysis catheter is intended as an example of one of many contemplated uses, and the applicant has chosen to depict the use in a dialysis catheter as representative and informative of other contemplated uses. One of ordinary skill in the art given this disclosure would be able to readily modify the configuration of the exemplary fiber optic introducer 148 to accommodate different uses of the invention without departing from the intended scope and spirit of the invention.

[0100] Figure 13 depicts a representative use of the fiber optic introducer 148 in a representative peritoneal dialysis (PD) catheter environment. The fiber optic introducer 148 is shown in its folded mode, connected to the extension set 164, the single cuff PD catheter 166, and the umbilical optical transmission cable 44 via the fully folded fiber optic disposable article 96, with the fiber optic 98 being advanced through the fiber optic introducer 148 and into the extension set 164. As depicted, the fiber optic introducer 148 facilitates the flow of fluids such as fresh dialysis fluid and / or spent dialysis fluid, and the delivery of EMR for radial emission. According to the depicted configuration, by folding the foldable / storable sleeve 100 (not shown) into the barrel 116 of the fiber optic disposable article 96 into the folded mode, the fiber optic 98 is advanced through the main line 150 of the fiber optic introducer 148 and into the extension set 164 (the extension of the PD catheter 166 located outside the patient's body). As it extends, the fiber optic 98 is positioned to deliver and emit germicidal EMR upwardly and circumferentially within the fiber optic introducer 148 and the extension set 164 (as depicted by the exemplary rays extending radially therefrom). In this way, the fiber optic introducer 148 and the extension set 164 can be sterilized prior to the initiation of dialysis treatment to prevent the colonization of infectious agents. However, if desired, the radial emission of germicidal EMR may be similarly delivered and emitted even when dialysis fluid (fresh or spent) is present inside the fiber optic introducer 148 and / or the extension set 164.

[0101] The set of FIGS. 14A - C are a series of perspective views of an exemplary PD catheter 166 that illustrate exemplary radial EMR emission. Although both peritoneal dialysis and hemodialysis require access to the patient's body via some type of dialysis access (in this case, PD catheter 166), peritoneal dialysis has several advantages, including quality of life due to its ability to provide greater mobility and independence to the patient compared to hemodialysis, simplicity of dialysis access, and maintenance of residual renal function after initiation of peritoneal dialysis and relatively low mortality within the first few years. A disadvantage of peritoneal dialysis is the risk of peritonitis. Peritonitis is often the result of contamination by skin bacteria but can also be due to retrograde migration of microorganisms on the catheter. Systemic or intraperitoneal antibiotics can be administered, and the exchange volume may decrease. PC catheter - related peritonitis may resolve with appropriate antibiotic therapy, but alternatively, delivery of EMR using both controlled relative intensity and treatment area - specific dosing, used either simultaneously or alternately, may prove more effective in the prevention and treatment support of peritonitis. If the infection persists, removal of the catheter and use of hemodialysis for 4 - 6 weeks may be required to resolve the peritonitis. Since there is a strong association between exit - site infection and subsequent peritonitis, the early prophylactic delivery and subsequent maintenance delivery of EMR as described herein can prevent, inhibit, or eliminate exit - site infections that can lead to peritonitis.

[0102] The peritoneum means the inner membrane that surrounds the organs within the patient's abdomen. This inner membrane is called the peritoneal membrane. It forms a space called the peritoneal cavity that can hold fluid. In peritoneal dialysis, a long-term indwelling catheter or a permanent catheter is inserted through the inner membrane into the space around the patient's organs. A dialysis solution (also known as dialysate) is delivered through the catheter into this space. The peritoneal inner membrane contains many blood vessels. The dialysate draws out excess fluid, chemicals, and waste products from these blood vessels and out through the inner membrane. The inner membrane acts as a filter. The dialysate remains in a given position for several hours while dialysis is being performed. Then, the old solution containing waste (also known as spent dialysate) is drained out through the catheter for disposal. Fresh and clean solution (dialysate) is immediately delivered to fill the space again. This process of exchanging spent dialysate for fresh dialysate is called an exchange.

[0103] The two-cuff PD catheter 166 shown in FIGS. 14A - C includes a connector hub 168, a peritoneal cuff 170, a subcutaneous cuff 172, and a coiled Tenckhoff 174. This exemplary PD catheter 166 has three regions, namely an external region 176, a tunnel region 178 (extending from the exit site location 180 to just inside the peritoneum), and an intraperitoneal region 182. When the two-cuff PD catheter 166 is placed within the patient's body, the external region 176 projects out from the patient's body at the exit site location 180 and is visible, the tunnel region 178 tunnels through subcutaneous tissue, rectus muscle, and the peritoneum, while the intraperitoneal region 182 is disposed inside the peritoneal cavity. It should be understood that the exit site is the region where the external region 176 projects out from the patient's body and is depicted as the exit site location 180 (in FIGS. 14A - C) on the PD catheter 166 when the PD catheter 166 is positioned for dialysis. An optical fiber 98 is shown as being disposed within the lumen of the PD dialysis catheter 166 that extends slightly beyond the peritoneal cuff 170.

[0104] FIG. 14A depicts an exemplary two-cuff PD catheter 166, showing an exemplary radial emission of EMR (including radial EMR emission within the external region 176 and the tunnel region 178) extending from the connector hub 168, including the connector hub 168, to a point proximal to and downstream of the peritoneal cuff 170 inside the peritoneum.

[0105] FIG. 14B depicts an exemplary two-cuff PD catheter 166 showing radial EMR emission (radial EMR emission within the tunnel region 178) between the location 180 of the exit site upstream of the subcutaneous cuff 172 and a point downstream of the peritoneal cuff 170 within the peritoneum.

[0106] FIG. 14C depicts an exemplary two-cuff PD catheter 166 showing radial EMR emission (including radial EMR emission within the external region 176, the tunnel region 178, and the intraperitoneal region 182) between the connector hub 168 and a point downstream of the peritoneal cuff 170 and extending into the peritoneal dialysis solution region 184 during dialysis.

[0107] FIG. 15A depicts an exemplary extended PD catheter assembly 186 including a Y-port adapter 188, extension line tubing 190, and a connecting luer 192. Radial EMR emission is shown only within the Y-site / taper region 194. In this configuration, the Y-port adapter 188 differs from the fiber optic introducer 148 in that the fiber optic 98 can be introduced into the branch line 156, through the branch line 156 into the extension line tubing 190, through this tubing, and into the PD catheter 166. The extent to which the fiber optic 98 extends into the extended PD catheter assembly 186 is determined by the length of the fiber optic 98. For example, for the configuration and radial emission shown in FIG. 15A, the fiber optic 98 need only have an overall length that extends slightly beyond the Y-port adapter 188 when fully inserted.

[0108] Figure 15B depicts an exemplary extended PD catheter assembly 186 of FIG. 15A showing radial EMR emission only outside the patient's body, within the Y-site / transition region 194, within the extended subset region 196, within the connection hub region 198, and within the external region 176. Further, for the configuration and radial emission shown in FIG. 15B, the optical fiber 98 need only have an overall length that extends to just before the position 180 of the withdrawal site when fully inserted.

[0109] Figure 15C depicts an exemplary extended PD catheter assembly 186 of FIG. 15A showing radial EMR emission along the entire length of distinct regions, namely, within the Y-site / transition region 194, the connection hub region 198, the tunnel region 178, and the intraperitoneal region 182. This exemplary embodiment provides radial EMR emission within the external regions that are susceptible to infection due to contamination, namely within the Y-site / transition region 194 and the connection hub region 198, simultaneously with the radial EMR emission within the patient's body. For the configuration and radial emission shown in FIG. 15B, the optical fiber 98 has an overall length that extends in a coiled Tenckhoff 174 through the extended PD catheter assembly 186.

[0110] Radial EMR emission in distinct regions can be achieved by emitting EMR along the optical fiber 98 from a plurality of distinct radial emission portions, as disclosed and described in this patent application.

[0111] Similarly, FIG. 15D depicts an exemplary extended PD catheter assembly 186 of FIG. 15A, but this configuration shows radial EMR emission along the entire length of the extended PD catheter assembly 186 to a point within the coiled Tenckhoff 174. This exemplary embodiment demonstrates that radial EMR emission may be delivered over the entire extent of the extended PD catheter assembly 186, including an external region susceptible to infection due to contamination and a region within the patient's body. In combination with other figures, FIG. 15D demonstrates that any combination of regions along the length of the extended PD catheter assembly 186 can turn the radially emitted EMR on or off as desired to utilize a controlled relative intensity of a therapeutic dose and / or a treatment region-specific application.

[0112] Similarly, by extending the optical fiber 98 into the coiled Tenckhoff 174 as shown in FIG. 15D, the optical fiber 98 can prevent occlusion of the aperture 200 and / or adhesion of tissue to the coiled Tenckhoff 174. To avoid uncoiling of the coiled Tenckhoff 174, an optical fiber 98 of a smaller diameter may be required (at least within the region of the optical fiber 98 that extends into the coiled Tenckhoff 174).

[0113] FIG. 16A is a schematic diagram of another exemplary embodiment of a PD catheter 166 inserted within a peritoneal dialysis solution 202 inside the body 204 of a female patient. This exemplary embodiment demonstrates a single cuff PD catheter 166 connected to the light engine box 12 via an umbilical optical transmission cable 44 and a Y-port adapter 188. Since the light engine box 12 is switched off, no radial EMR emission lines are shown.

[0114] Figure 16B depicts an exemplary single-cuff PD catheter 166 in a state of being inserted inside the body 204 of a female patient. This exemplary embodiment shows that the optical engine box 12 has been switched on to provide radial EMR emission downstream of the optical engine box 12 and the attached umbilical optical transmission cable 44. For purposes of illustration only (this configuration is never intentionally used during actual operation), the umbilical optical transmission cable 44 is slightly detached and pulled out from its attachment to the Y-port adapter 188, introduced into the branch line 156, and an optical fiber 98 extending downstream within the peritoneal dialysis solution region 184 within the lumen of the PD catheter 166 is shown. As depicted, radial EMR emission is provided through the Y-site / transition region 194 and the external region 176 upstream of the subcutaneous cuff 172, into the tunnel region 178, and into the peritoneal dialysis solution 202 within the peritoneal dialysis region 184. This configuration demonstrates that, for the needs of a particular treatment, it may be possible to supply radial EMR emission at clearly different positions inside the patient's body while also supplying radial EMR emission outside the patient's body 204.

[0115] FIG. 17 is a schematic diagram of an exemplary embodiment of a peritoneal dialysis system 206 showing a dialysis fluid supply and return bag. The schematic depiction is a basic representation of the peritoneal dialysis system 206. The use of this basic representation is not intended to limit the scope of the present invention. Rather, the present disclosure contemplates the use of the disclosed invention within the scope of the present invention within different or more advanced peritoneal dialysis systems that are known and yet to be further developed. For example, there are two types of peritoneal dialysis: continuous ambulatory peritoneal dialysis (known as CAPD), which is the type depicted in FIG. 17, and automated peritoneal dialysis (known as APD). CAPD is “continuous,” machine-free, and is performed while the patient goes about their normal activities. The exchange of dialysis fluid (dialysate and spent dialysate) is performed manually by the user / patient, and the fluid flow is typically driven by gravity. APD differs from CAPD in that a machine (cycler) automatically delivers and then drains the cleansing fluid for the patient. The treatment is typically performed while the patient is asleep at night. One of ordinary skill in the art given this disclosure will understand where, when, and how the delivery of the EMR disclosed herein can be used in different (e.g., APD systems) or more advanced peritoneal dialysis systems that are known and yet to be further developed.

[0116] The basic peritoneal dialysis system 206 (depicted in FIG. 17) includes dialysis access via a PD catheter 166, a fluid extension line 208, a dialysate exchange switch 210, a dialysate supply bag 212, and a waste dialysate collection bag 214. As depicted with reference to FIGS. 14A - C, 15A - D, and 16A - B, the catheter (also referred to as PD catheter 166) has an external region 176, a tunnel region 178, an intraperitoneal region 182, a proximal end and a distal end. The proximal end of the PD catheter 166 is connected to the fluid extension line 208 via an extension portion connector 216. The fluid extension line 208 is connected to the dialysate exchange switch 210. The dialysate exchange switch 210 has an extension line portal 218, a dialysate inlet 220, a waste dialysate outlet 222, and an exchange selector 224 for selecting the fluid flow path. The dialysate supply bag 212 stores dialysate 202 (also referred to as peritoneal dialysis solution 202) and is connected to the dialysate exchange switch 210 via a supply line 226 and the dialysate inlet 220 to establish a dialysate supply flow path from the dialysate supply bag 212 into the supply line 226, through the dialysate exchange switch 210 into the fluid extension line 208, and through this line to the PD catheter 166 for delivery into the patient's body 204 (when the exchange selector 224 is moved to select the dialysate flow).

[0117] In peritoneal dialysis, a long-term, indwelling, or permanent PD catheter 166 may be present or already inserted through the peritoneal membrane into the abdominal space 184 (sometimes referred to as the peritoneal dialysis solution region 184) around the patient's organs. Dialysate 202 (also called dialysis fluid 202) is delivered in the direction of arrow A through the PD catheter 166 from the optical fiber supply bag 212 into this abdominal space 184. The peritoneal membrane contains many blood vessels. The dialysate 202 draws excess fluid, chemicals, and waste out of these blood vessels through the peritoneal membrane. Thus, the peritoneal membrane acts as a filter. The dialysate 202 remains in a predetermined position for several hours while dialysis is being performed. Thereafter, the old dialysis solution 228 (sometimes called the waste dialysis fluid 228) containing waste is drained through the PD catheter 166 for disposal. Fresh and clean solution (dialysate) 202 is immediately delivered into the abdominal space 184 to refill it. This process of exchanging the old (waste dialysis fluid) solution 228 for the new dialysate 202 is called an exchange.

[0118] The peritoneal dialysis system 206 is enhanced by adding an optical engine system 10 that includes an optical engine box 12 and an optical fiber 98. This enhancement of the peritoneal dialysis system 206 may be part of a kit that includes the peritoneal dialysis system 206 and the optical engine system 10 (regardless of whether the optical engine system 10 is permanently connected to the peritoneal dialysis system 206 or is insertable in a removable form within the peritoneal dialysis system 206). Alternatively, the optical engine system 10 may be retrofitted to an existing peritoneal dialysis system 206. As depicted, the optical fiber 98 of the optical engine system 10 is introduced into the outer region 176 of the PD catheter 166 through an introduction adapter 230 that facilitates the passage of the optical fiber 98 into the lumen of the PD catheter 166 without impeding the free flow of fluid through the PD catheter 166.

[0119] For purposes of illustration only (and not for any intended use of this configuration during actual operation), the umbilical optical transmission cable 44 is shown slightly disengaged and pulled out from its attachment to the introducer adapter 230, exposing the optical fiber 98 introduced into the lumen of the PD catheter 166. When the umbilical optical transmission cable 44 is coupled to the light engine box 12 and the optical fiber 98 is disposed within the lumen of the PD catheter 166 (the connection between the umbilical optical transmission cable 44 and the optical fiber 98 is omitted so as not to obscure the other features depicted), therapeutic non-ultraviolet EMR may be delivered if desired. The depiction in FIG. 17 shows the radial delivery of EMR within the outer region 176 and the tunnel region 178 of the PD catheter 166.

[0120] It should be understood that the inventive aspects of the present disclosure described herein are capable of providing radial emission of EMR light at the locations, intensities, and controlled relative intensities and / or treatment region-specific applications of the therapeutic dose of EMR light discussed above.

[0121] As depicted in FIG. 17, the dialysate exchange switch 210 is set up for the following waste cycle, i.e., the waste dialysate 228 travels from the abdominal space 184 in the direction of arrow B, through the dialysis access such as the PD catheter 166 and the extension connector 216, into the fluid extension line 208, through the extension line portal 218 into the dialysate exchange switch 210, and out through the waste dialysate outlet 222, into the drain line 232 and the waste dialysate collection bag 214, where it is withdrawn and discarded.

[0122] FIG. 18 is a schematic depiction of another exemplary embodiment of a portion of a peritoneal dialysis system 206 (dialysate supply bag 212 and waste dialysate collection bag 214 are omitted) showing the emission of EMR light into a dialysate exchange switch 210 near an extension line portal 218 at a treatment location within a fluid extension line 208 (sometimes referred to as a PD extension catheter). This exemplary embodiment utilizes a light engine system 10 with a light engine box 12, an umbilical light transmission cable 44, a disposable optical fiber article 96, and an optical fiber introducer 148 to deliver EMR to the fluid extension line 208 and the dialysate exchange switch 210, where a PD catheter 166 with a coiled Tenckhoff 174 is also connected to the optical fiber introducer 148 via a branch line 156. This depiction illustrates the versatility of this light engine system 10 in that the light engine system 10 can be used to sterilize the fluid extension line 208 and the dialysate exchange switch 210, independent of delivering EMR to the PD catheter 166, by inserting an optical fiber 98 into the fluid extension line 208. In this configuration, therapeutic EMR may be delivered before dialysis begins, during dialysis, during collection of waste dialysate 228, and / or after the dialysis treatment is complete.

[0123] FIG. 19 is a schematic depiction of another exemplary embodiment of a portion of peritoneal dialysis system 206 (dialysate supply bag 206 and waste dialysate collection bag 214 are omitted) showing dual EMR delivery from light engine box 12. In this embodiment, two optical fibers 98 extend to distal connector 60 of umbilical light transmission cable 44, and two laser assemblies 34 inside light engine box 12 supply two distinct EMR sources, and can be coupled to dual receiver adapter 234 that receives and directs the EMR into one optical fiber 98 inserted into fluid extension line 208 and the other optical element 18 inserted into PD catheter 166. The delivered EMR light may be the same for each optical fiber 98. In other cases, receiver adapter 234 may be used, which splits a single EMR source into two separate optical fibers 98 inside it. Similarly, when two or more EMR sources deliver EMR to respective optical fibers 98, the delivered EMR may be different for each optical fiber 98. For example, alternatively, alternately or simultaneously, and at different frequencies, intensities and dosages, EMR may be delivered to provide controlled relative intensities of therapeutic doses of EMR and / or treatment area-specific applications, as desired and when desired inside peritoneal dialysis system 206.

[0124] FIG. 19 shows an exemplary configuration leading to simultaneous EMR delivery into fluid extension line 208 and PD catheter 166. Also depicted is line clamp 236, used to occlude fluid extension line 208 so that when peritoneal dialysis solution region 184 is once filled, during the dialysis process and prior to the waste cycle, fluid (waste dialysate 228 as depicted) does not flow out through fluid extension line 208 into waste dialysate collection bag 214. As depicted, the portion of fluid extension line 208 between line clamp 236 and dialysate exchange switch 210 is being sterilized by EMR emitted radially from optical fiber 98.

[0125] Yet another exemplary embodiment of peritoneal dialysis system 206 is schematically depicted in FIG. 20 showing dual EMR delivery using two optical engine systems 10. In this embodiment, two optical fibers 98 extend from separate optical engine boxes 12 and into a dual introduction multi-directional adapter 238, with one optical fiber 98 inserted within fluid extension line 208 and the other optical fiber 98 inserted within PD catheter 166. The EMR delivered may be the same for each optical fiber 98. However, separate optical line boxes 12 enable each optical fiber 98 to operate completely independently of the other optical fiber 98. Thus, the EMR delivered may alternatively, alternately, or simultaneously, and at different frequencies, intensities, and dosages, provide a controlled relative intensity of the therapeutic dose of EMR and / or treatment area-specific application, as desired and when desired within peritoneal dialysis system 206. Specifically, FIG. 20 shows simultaneous EMR delivery into fluid extension line 208 and PD catheter 166. However, each may emit EMR at different frequencies, intensities, and dosages.

[0126] Yet another exemplary embodiment of peritoneal dialysis system 206 is depicted in FIG. 21 and shows dual EMR delivery (such as the configuration in FIG. 20) using a single light engine box 12. In this embodiment, two umbilical light transmission cables 44 extend from the light engine box 12 (each connected to a different laser assembly 34 not shown), and each of the umbilical light transmission cables is connected to a dual introduction multi-directional adapter 238. One optical fiber 98 is inserted within the fluid extension line 208 and the other optical fiber 98 is inserted within the PD catheter 166. Again, the EMR delivered may be the same for each optical fiber 98. However, in this case, the single light engine box 12 may deliver different EMRs to each optical fiber 98, allowing each optical fiber 98 to operate independently of one another. Again, the EMR delivered may alternatively, alternately or simultaneously, and at different frequencies, intensities and dosages, provide a controlled relative intensity of the therapeutic dose of EMR and / or treatment area-specific application, as desired within the peritoneal dialysis system 206 and at the desired time. Specifically, FIG. 21 similarly shows simultaneous EMR delivery into the fluid extension line 208 and the PD catheter 166. However, each may emit EMR at different frequencies, intensities and dosages.

[0127] Hemodialysis is a treatment that removes waste products and excess fluid from a patient's blood when the patient's own kidneys are malfunctioning. Before a patient can undergo hemodialysis, a connection to the patient's blood inside the blood vessels must be made. One of several different types of dialysis access 240, such as a vascular access, reaches the patient's blood for hemodialysis. The dialysis access 240 allows the patient's blood to travel through flexible tubing (such as extension tubing, catheters, etc.) to a dialysis machine, where the blood is purified as it passes through a special filter that acts as an artificial kidney, called a dialysis device. Generally, there are three main different types of dialysis access 240 used for hemodialysis. They are called fistulas, grafts, and catheters (or hemodialysis catheters). Each has its advantages and disadvantages. Typically, a specialized surgeon with experience in hemodialysis access will determine, recommend, and / or select which type of dialysis access 240 is appropriate for each patient.

[0128] To put blood into the dialysis device, a dialysis access 240 or entrance into the patient's blood vessels must be created. Typically, this is done by a minor surgical procedure at the arm or leg or other location depending on where it is most appropriate to provide the dialysis access 240 for the patient 204.

[0129] For hemodialysis, generally, a catheter is used as a temporary dialysis access 240 when dialysis is urgently needed or while waiting for a dialysis access surgery to create either a fistula or a graft and while waiting for the fistula or graft to mature, although sometimes a catheter may provide a permanent dialysis access 240. A hemodialysis catheter is a soft tube placed inside a large vein, such as in the neck or sometimes in other locations such as in the leg.

[0130] A arteriovenous fistula, which is a dialysis access 240 created by joining an artery and a vein in a patient's arm (or leg), is generally considered advantageous because it lasts relatively long and has relatively few problems such as infection and thrombosis. The arteriovenous fistula should be placed several months before dialysis needs to be initiated. This allows the fistula to be adequately prepared and initiated in sufficient time when treatment is required. A fistula typically takes 1 to 4 months to "mature," i.e., to expand to the point where it can be used. However, there are patients who cannot receive a fistula because their blood vessels are not strong enough.

[0131] An arteriovenous graft is a dialysis access 240 created by joining an artery to a vein that is very close by. A minor surgery is performed using an access tube between the vein and the nearby artery. The arteriovenous graft is typically placed inside or above the bend of the patient's arm. Sometimes, it may be placed in the patient's leg or chest wall. The arteriovenous graft generally needs to be in place at a predetermined position for at least 2 weeks after the surgery until it can be used. These dialysis access 240 options are each susceptible to infectious agents.

[0132] FIG. 22 is a schematic diagram of an exemplary representative embodiment of a hemodialysis system 300, depicting a hemodialysis unit 302 shown in dashed lines, components of the hemodialysis system 300 according to the present invention of the present disclosure, and an insertion area that is enlarged as in FIG. 22A.

[0133] The components of the hemodialysis system 300 related to the invention of the present disclosure include, without limitation, a dialysis access 240, a dialysis device 304, a blood pump 306, a dialysate tank 308, a waste dialysate tank 310, a physiological saline bag 312, a heparin pump 314, an air trap / air detector 316, an arterial pressure monitor 318, a venous pressure monitor 320, an inflow pressure monitor 321, an inbound blood flow tubing 322, and an outbound blood flow tubing 324. Some or most of these components can be enclosed within the hemodialysis unit 302. However, as depicted in FIG. 22, the dialysate tank 308, the waste dialysate tank 310, and the physiological saline bag 312 are typically external to the hemodialysis unit, and since the dialysis access 240 is an access into the patient's body 204, it is always external to the hemodialysis unit 302.

[0134] FIG. 22A is an enlarged view of the insertion region identified in FIG. 22, showing an exemplary dialysis access 240, which is a representative fistula access into the patient's arm 204, and showing an outbound venous line 326 and an inbound arterial line 328.

[0135] Blood from the patient 204 is drawn into the outbound venous line 326 and the outbound blood flow tubing 324 in the direction of the flow arrow C, pumped into the dialysis device 304, where the blood is cleaned. The dialysate solution is drawn into the dialysis device 304 from the dialysate tank 308 in the direction of the inflow arrow D via the supply line 332, interacts with the blood drawn in via the vein to remove waste products and excess fluid from the blood, thereby serving as an artificial kidney. The cleaned fresh blood exits the dialysis device 304 and (also in the direction of the flow arrow C) flows into the inbound blood flow tubing 322 and then into the inbound arterial line 328 to circulate within the patient 204's body. The dialysate solution exiting the dialysis device 304 is the waste dialysate 228, and the waste dialysate 228 carries out waste products, other impurities, and excess fluid when it is drained into the waste dialysate tank 310 through the drain line 334 in the direction of the drain arrow E for disposal.

[0136] As the filtered fresh blood circulates through the patient's body 204, it collects waste products, other impurities, and excess fluid, and then is drawn back into the outbound venous line 326 and the outbound blood flow tubing 324 in the direction of arrow C from the patient 204, and is pumped into the dialysis device 304 for purification. The circulation cycle through the patient's body 204 and the hemodialysis unit 302 continues to repeat until dialysis is completed.

[0137] During dialysis, the blood pump 306 regulates the flow rate of the blood through the hemodialysis unit. The heparin pump 314 injects heparin into the blood to prevent blood clot formation. The physiological saline solution flowing from the physiological saline bag 312 through the physiological saline line 330 into the outbound blood flow tubing 324 (or in some cases directly into the dialysis device 304) is essential for the dialysis process. The physiological saline solution in the dialysis device 304 serves as an agent used to clean the blood drawn in via the vein inside the dialysis device 304. The venous pressure monitor 320 monitors the pressure inside the outbound blood flow tubing 324 so that the pressure can be maintained within an operable range. Further, the inflow pressure monitor 321 monitors the pressure at a position downstream of the blood pump 306 and upstream of the dialysis device so that the blood entering the dialysis device is within the proper operating range of the dialysis device 304. Similarly, the arterial pressure monitor 318 monitors the pressure inside the inbound blood flow tubing 322 so that the pressure can be maintained within an operable range. The air trap / air detector 316 detects and collects unwanted air bubbles inside the inbound blood flow tubing 322 before they enter the patient's body 204 and cause serious consequences to the patient 204.

[0138] During the preparation for dialysis and the actual hemodialysis process, the patient 204 or a person assisting the patient 204 may have the opportunity to access or handle various connections, materials, or components involved in dialysis. Such access or handling may introduce or increase the possibility that the hemodialysis equipment or process becomes contaminated by infectious agents. Certain components can be identified as particularly susceptible to such contamination. As a result, by sterilizing such components and / or reducing or eliminating such infectious agents, the most significant concerns regarding receiving dialysis can be reduced or eliminated.

[0139] FIG. 22 depicts several representative positions that may be useful in preventing, reducing, or eliminating infections known to be fatal to the performance of dialysis during the delivery of therapeutic EMR. In FIG. 22, four separate light engine systems 10 are depicted as representative positions for delivering therapeutic EMR. Each of the depicted positions is shown external to the hemodialysis unit 302 and thus can be retrofitted to an existing hemodialysis system 300, although it should be understood that one or more of the light engine systems 10 may be permanently disposed within the hemodialysis unit 302. Similarly, although FIG. 22 depicts four separate light engine systems 10 having four separate light engine boxes 12, it should be understood that one, two or more, or all of the EMR delivery positions may be operated by a single light engine box 12.

[0140] As depicted, one light engine system 10 is installed to deliver EMR so as to sterilize the aqueous saline solution and / or saline line 330, or to inactivate infectious agents in or on the aqueous saline solution and / or saline line 330. This light engine system 10 includes a light engine box 12 that provides EMR at a desired intensity, an umbilical optical transmission cable 44 that receives EMR from the light engine box 12 and conveys the EMR into the saline line 330 through an introduction adapter 230.

[0141] Another light engine system 10 is installed to deliver EMR to sterilize the dialysate solution and / or the supply line 332, or to inactivate infectious agents in and / or on or within the dialysate solution or the supply line 332. This light engine system 10 includes a light engine box 12 that provides EMR at a desired intensity, and an umbilical optical transmission cable 44 that receives EMR from the light engine box 12 and carries the EMR into the supply line 332 through an introduction adapter 230.

[0142] Two other light engine systems 10 used to deliver EMR to the representative dialysis access 240 are best shown in FIG. 22A. The depicted representative dialysis access 240 is a fistula that includes an arterial access 328 and a venous access 326. The arterial access 328 and the venous access 326 each include an access needle (not shown) and inbound blood flow tubing 322 and outbound blood flow tubing 324, respectively. One of the light engine systems 10 is installed to deliver EMR to sterilize the blood and / or the outbound blood flow tubing 324, or to inactivate infectious agents in and / or on or within the blood or the outbound blood flow tubing 324. The other light engine system 10 is installed to deliver EMR to sterilize the blood and / or the inbound blood flow tubing 322, or to inactivate infectious agents in and / or on or within the blood or the inbound blood flow tubing 322. Each light engine system 10 includes a light engine box 12 that provides EMR at a desired intensity, and an umbilical optical transmission cable 44 that receives and carries the EMR from the light engine box 12 through an introduction adapter 230 and into the outbound blood flow tubing 324 and the inbound blood flow tubing 322.

[0143] Regarding the exemplary methods or processes of the present invention, the order and / or arrangement of the steps described herein are exemplary and not limiting. Thus, although various processes or methods or steps of a process may be shown and described as being in one order or temporal arrangement, it should be understood that the steps of any such process or method are not limited to being carried out in any one order or arrangement unless otherwise indicated. In fact, the steps of such a process or method can generally be carried out in various orders and arrangements and still fall within the scope of the present invention.

[0144] Furthermore, any reference to the advantages, benefits, unexpected results or practicability of the present invention is not intended to affirm that the present invention has been previously practiced or that any tests have been conducted. Similarly, unless otherwise described, the use of verbs in the past tense (present perfect or past form) is not intended to suggest or imply that the present invention has been previously practiced or that any tests have been conducted.

[0145] Exemplary embodiments of the present invention have been described above. Any element, act or instruction used in this description should not be considered important, necessary, critical or essential to the present invention unless explicitly described as such. Although several exemplary embodiments have been described herein, those skilled in the art will readily recognize that many modifications are possible in these exemplary embodiments without substantially 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 appended claims.

[0146] In the claims, any means - plus - function clauses are intended to cover not only the structures and structural equivalents described in this specification as performing the recited functions, but also equivalent structures. Thus, nails and screws may not be structural equivalents in that a nail utilizes a cylindrical surface to hold wooden parts together while a screw utilizes a helical surface, but in an environment of fastening wooden parts, nails and screws may be equivalent structures. A construction based on 35 U.S.C. § 112, paragraph 6 is not intended unless the exact term "means for" (performing a particular function or step) is recited in the claim. Further, it is not intended to define the scope of patent protection given to the invention by reading into any claim limitations that are found in the specification but not explicitly recited in the claim itself.

[0147] Although specific embodiments and fields of use of the invention have been illustrated and described, it should be understood that the invention is not limited to the exact construction and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art are possible in the arrangement, operation, and details of the method and system of the invention disclosed herein without departing from the spirit and scope of the invention.

Description of Reference Numerals

[0148] 10 (Smart) Optical Engine System 12 Optical Engine Box 14 Front Panel Overlay 16 Laser Aperture 18 Battery Output Indicator 20 RFID Feature 22 Optical Test Aperture 24 Treatment On / Off Actuator 26 Alarm Feature 28 Rear Panel 30 On / Off Switch 32 Output Port 34 Laser assembly 35 Central processing unit 36 Battery assembly 38 Side port test module 40 Front panel 42 Dust cover 44 Umbilical optical transmission cable 46 Venting feature 48 User interface 50 Warning icon 52 Alarm alert 54 Alarm on / off actuator 56 Side port test adapter 58 Cable adapter or SMA adapter 60 Distal connector 62 Proximal connector 64 Cable 66 Optical fiber 68 Wire 70 Cable sleeve 72 First optical interlock 74 Optical interlock 76 Proximal SMA 78 Mounting magnet 80 Proximal connector shell 81 Front extending edge 82 SMA adapter 84 Second optical interlock 86 Press-fit ball joint 88 Distal SMA 90 Distal connector shell 92 Front cover 94 Pin 96 Disposable optical fiber supplies 98 Optical fiber 100 Foldable / storable sleeve 102 Proximal end 104 Distal end 106 Packaging 108 PFID adhesive tag 110 Face seal blister packaging 112 Sheath-through bladder surface 114 Opaque packaging 116 Barrel 118 Female Luer adapter 120 Male Luer plug 122 Check valve 124 Capture ring 126 Check valve body 128 Check valve disk 130 Check valve cap 132 Central bore 134 Barrel plug 136 Barrel plug cap 138 Ferrule 140 Magnetic washer 142 Ferrule cap 144 Bore for optical fiber accommodation 146 Reinforced end 148 Optical fiber introducer 150 Main line 152 Entry port 154 Exit port 156 Branch line 158 Side port 160 Clamp 162 Sealing cap 164 Extension part set 166 PD catheter 168 Connector hub 170 Peritoneal cuff 172 Subcutaneous cuff 174 Coiled Tenckhoff 176 External region 178 Tunnel region 180 Position of exit site 182 Intraperitoneal region 184 Peritoneal dialysis solution region 186 Extended PD catheter assembly 188 Y-port adapter 190 Extension line tubing 192 Connecting Luer 194 Y-site / transition region 196 Extension Set Region 198 Connection Hub Region 200 Hole 202 Peritoneal Dialysis Solution 204 Patient's Body 206 Peritoneal Dialysis System 208 Fluid Extension Line 210 Dialysate Exchange Switch 212 Dialysate Supply Bag 214 Discarded Dialysate Recovery Bag 216 Extension Portion Connector 218 Extension Line Portal 220 Dialysate Inlet 222 Discarded Dialysate Outlet 224 Exchange Selector 226 Make-up Line 228 Discarded Dialysate 230 Introduction Adapter 232 Drainage Line 234 Receiver Adapter 236 Line Clamp 238 Dual Introduction Multi-directional Adapter 240 Dialysis Access 300 Hemodialysis System 302 Hemodialysis Unit 304 Dialysis Device 306 Blood Pump 308 Dialysate Tank 310 Discarded Dialysate Tank 312 Normal Saline Bag 314 Heparin Pump 316 Air Trap / Air Detector 318 Arterial Pressure Monitor 320 Venous Pressure Monitor 321 Inflow Pressure Monitor 322 Inbound Blood Flow Tubing 324 Outbound Blood Flow Tubing 326 Outbound Venous Line (Venous Access) 328 Inbound Arterial Line (Arterial Access) 330 Normal Saline Line 332 Supply line 334 Drain line Arrow A Arrow B Flow arrow C Inflow arrow D Drain arrow E

Claims

1. An electromagnetic radiation (EMR) delivery system for delivering EMR at a wavelength, intensity, exposure amount, and duration capable of preventing, reducing, and / or eliminating infectious agents in, on, and around a catheter and / or catheter extension portion having a lumen, to internal and / or external positions of the patient's body inside, on, and around the catheter and / or catheter extension portion, the EMR delivery system being connected to a power source and, at least one light engine box for connection to the power source and for generating therapeutic EMR, each light engine box, receives an output from the power source and generates non-ultraviolet therapeutic EMR having an intensity including a radiation exposure amount range of 0.1 J / cm ２ to 5 kJ / cm ２ and an output range of 0.005 mW to 5 W and an output density range of 1 mW / cm ２ and 2 W / cm ２ at least one laser assembly disposed inside the light engine box, such intensity being sufficient to produce at least one of the therapeutic effects of inactivating one or more infectious agents and enhancing the growth of healthy cells, the laser assembly, and at least one cable adapter, each connected to one laser assembly, including a light engine box, An optical transmission cable having a proximal end and a distal end, the proximal end being connected to the cable adapter, the cable adapter receiving therapeutic EMR from the laser assembly and for the purpose of facilitating the propagation of the therapeutic EMR from the laser assembly to the optical transmission cable and through the optical transmission cable to the distal end of the laser assembly for delivery to at least one of the catheter and the catheter extension portion, an optical transmission cable, An optical element connected to the optical transmission cable, the optical element including an optical fiber for placement inside the lumen of at least one of the catheter and the catheter extension portion, the optical fiber guiding the axial propagation of the therapeutic EMR with respect to at least one of the catheter and the catheter extension portion, the optical fiber further including at least one radially emitting portion disposed between a coupling end of the optical fiber and a distal end of the optical fiber, and the optical element. An EMR delivery system including.

2. The EMR delivery system according to claim 1, wherein the optical engine box is a smart optical engine box and further includes a central processing unit (CPU) for controlling features provided by the smart optical engine box, and the CPU is connected to the power supply and is at least one of pre-programmed and programmable.

3. The smart optical engine box further includes a test module and a small form factor version A (SMA) optical fiber connector, the SMA optical fiber connector facilitating connection of the test module to the distal end of the optical transmission cable such that therapeutic EMR is delivered from the distal end of the optical transmission cable to the test module and the delivered therapeutic EMR is tested by the test module, the test module sending test results to the CPU for analysis in light of predetermined EMR parameters, and the CPU determining the integrity of the laser assembly and any degradation in the therapeutic EMR delivered to the test module. The EMR delivery system according to claim 2.

4. The smart optical engine box further includes an alarm alert, and the alarm alert is activated when the CPU suggests that the therapeutic EMR does not meet the predetermined therapeutic EMR parameters for the alarm alert, and one of the soundness of the laser assembly is impaired, or the optical transmission cable is deteriorated or in need of replacement. The EMR delivery system according to claim 3.

5. The smart optical engine box further includes a treatment actuator for initiating a pre-programmed dose treatment of a therapeutic EMR that meets predetermined therapeutic EMR parameters, and the treatment actuator is manually activated. The EMR delivery system according to claim 2.

6. The smart optical engine box further includes an alarm alert, and the alarm alert is activated when the CPU suggests that the smart optical engine box is in a failure mode for the alarm alert, and the treatment actuator is manually deactivated when the failure mode is suggested. The EMR delivery system according to claim 5.

7. The optical transmission cable is an umbilical optical transmission cable including at least one transmission line to facilitate the transmission of at least one of data and electricity. The EMR delivery system according to claim 2.

8. The smart optical engine box further includes an alarm alert, and the alarm alert is activated when the CPU suggests that any transmission in any transmission line has been interrupted for the alarm alert. The EMR delivery system according to claim 1.

9. The optical element includes a disposable optical fiber article, the disposable optical fiber article having an elongated structure, a storage mode, and a folded mode, and including the optical fiber, a proximal end for connection to the distal end of the optical transmission cable, a distal end for connection to at least one of the catheter and the catheter extension portion, and a foldable / storable sleeve sealed between the proximal end and the distal end of the disposable optical fiber article, the foldable / storable sleeve enclosing the optical fiber within a sterile environment within the foldable / storable sleeve when the disposable optical fiber article is in the storage mode, and the optical fiber being advanced into the lumen of at least one of the catheter and the catheter extension portion when the disposable optical fiber article is in the folded mode, the EMR delivery system according to claim 2.

10. The proximal end of the disposable optical fiber article includes a barrel, a coupling adapter for connection to at least one of the catheter and the catheter extension portion, and a check valve that allows one-way movement of the sterile environment through the coupling adapter, the barrel having an internal volume defined by an inner wall, and the check valve being nested within the internal volume, the foldable / storable sleeve being nested within the internal volume when the disposable optical fiber article is in the folded mode, the EMR delivery system according to claim 9.

11. The proximal end of the disposable optical fiber article includes a barrel plug and a bore for receiving the optical fiber, the bore for receiving the optical fiber facilitating the aligned connection of the optical fiber to the distal end of the optical transmission cable, the barrel plug being snugly seated within the internal volume when the disposable optical fiber article is in the folded mode, the EMR delivery system according to claim 10.

12. The disposable optical fiber article is identified by a radio frequency identification (RFID) tag, and the smart optical engine box further includes an RFID reader proximate to an RFID feature indicator, and when the RFID tag is read by the RFID reader, the RFID reader transmits information to the CPU, and the CPU begins to monitor the use of the disposable optical fiber article, the EMR delivery system according to claim 9.

13. The CPU shuts off the activation of the laser assembly when monitoring the use of the disposable optical fiber article cannot complete another treatment before the expiration of a predetermined useful life of the disposable optical fiber article, the EMR delivery system according to claim 12.

14. An EMR delivery system for delivering EMR at wavelengths, intensities, exposure amounts, and durations that can prevent, reduce, and / or eliminate infectious agents within, on, and around a catheter and / or catheter extension each having a lumen to internal and / or external positions of a patient's body within, on, or around the catheter and / or catheter extension, the EMR delivery system being connected to a power source and A CPU that controls features provided by a smart optical engine box, the CPU being at least one of those connected to the power source and pre-programmed and programmable, the CPU; At least one smart optical engine box for connection to the power source and for generating therapeutic EMR, each smart optical engine box Receives an output from the power source, 0.1 J / cm ２ ~5 kJ / cm ２ Of the radiation exposure range and the output range of 0.005 mW to 5 W and 1 mW / cm ２ And 2 W / cm ２At least one laser assembly disposed inside the light engine box that generates EMR for non-ultraviolet therapy having an intensity that includes the output density range, such intensity being sufficient to produce at least one of the therapeutic effects of inactivating one or more infectious agents and enhancing the growth of healthy cells, and A smart light engine box including at least one cable adapter each connected to one laser assembly via an SMA optical fiber connector, An umbilical optical transmission cable having a proximal end and a distal end, the proximal end being connected to the cable adapter, the cable adapter receiving therapeutic EMR from the laser assembly and for delivery to at least one of the catheter and the catheter extension portion, for the purpose of facilitating the propagation of the therapeutic EMR from the laser assembly to the umbilical optical transmission cable and through the umbilical optical transmission cable to the distal end of the umbilical optical transmission cable, the umbilical optical transmission cable including at least one transmission line for facilitating the transmission of at least one of data and electricity, an umbilical optical transmission cable, A disposable optical fiber article, the disposable optical fiber article having an elongated structure, a storage mode and a folded mode, and including an optical fiber, a proximal end for connection to the distal end of the umbilical optical transmission cable, a distal end for connection to at least one of the catheter and the catheter extension portion, and a foldable / storable sleeve sealed between the proximal end and the distal end of the disposable optical fiber article, the foldable / storable sleeve enclosing the optical fiber within a sterile environment within the foldable / storable sleeve when the disposable optical fiber article is in the storage mode, the optical fiber being advanced into the lumen of at least one of the catheter and the catheter extension portion when the disposable optical fiber article is in the folded mode, the optical fiber guiding the axial propagation of the therapeutic EMR with respect to at least one of the catheter and the catheter extension portion when in the folded mode, and the optical fiber further including at least one radially emitting portion disposed between the coupling end of the optical fiber and the distal end of the optical fiber, a disposable optical fiber article, An EMR delivery system including.

15. The EMR delivery system according to claim 14, wherein the smart optical engine box further includes a treatment actuator for initiating a pre-programmed dose delivery treatment of the therapeutic EMR that meets pre-determined therapeutic EMR parameters, and the treatment actuator is manually activated.

16. The EMR delivery system according to claim 15, wherein the smart optical engine box further includes an alarm alert, the alarm alert being activated by the CPU when the CPU suggests that the smart optical engine box is in a failure mode with respect to the alarm alert, and the treatment actuator being manually deactivated when the failure mode is suggested.

17. An EMR delivery system for delivering EMR at a wavelength, intensity, exposure dose, and duration that can prevent, reduce, and / or eliminate infectious agents in, on, and around a dialysis catheter and / or a dialysis extension set having lumens through which dialysate and / or waste dialysate flow, to internal and / or external positions of the body of a dialysis patient within, on, or around the dialysis catheter and / or the dialysis extension set, the EMR delivery system being connected to a power source and a CPU that controls features provided by a smart light engine box, the CPU being connected to the power source and being at least one of pre-programmed and programmable, and at least one smart light engine box for connection to the power source and for generating therapeutic EMR, each smart light engine box receiving an output from the power source and generating non-ultraviolet therapeutic EMR having an intensity that includes a radiation exposure dose range of 0.1 J / cm ２ to 5 kJ / cm ２ and an output range of 0.005 mW to 5 W and an output density range of 1 mW / cm ２ and 2 W / cm ２ such that the intensity is sufficient to produce at least one of the therapeutic effects of inactivating one or more infectious agents and enhancing the growth of healthy cells, a laser assembly, and at least one cable adapter, each connected to one laser assembly via an SMA optical fiber connector, the smart light engine box including An umbilical optical transmission cable having a proximal end and a distal end, wherein the proximal end is connected to the cable adapter, and the cable adapter receives therapeutic EMR from the laser assembly and, for delivery to at least one of the dialysis catheter and the dialysis extension subset, promotes propagation of the therapeutic EMR from the laser assembly to the umbilical optical transmission cable and through the umbilical optical transmission cable to the distal end of the umbilical optical transmission cable, and the umbilical optical transmission cable includes at least one transmission line for promoting transmission of at least one of data and electricity, the umbilical optical transmission cable and, A disposable optical fiber article, the disposable optical fiber article having an elongated structure, a storage mode and a folded mode, an optical fiber, a proximal end for connection to the distal end of the umbilical optical transmission cable, a distal end for connection to at least one of the dialysis catheter and the dialysis extension subset, and a foldable / storable sleeve sealed between the proximal end and the distal end of the disposable optical fiber article, the foldable / storable sleeve enclosing the optical fiber within a sterile environment within the foldable / storable sleeve when the disposable optical fiber article is in the storage mode, and when the disposable optical fiber article is in the folded mode, the optical fiber is advanced into the lumen of at least one of the dialysis catheter and the dialysis extension subset, the optical fiber guiding axial propagation of the therapeutic EMR with respect to at least one of the dialysis catheter and the dialysis extension subset when the optical fiber is in the folded mode, the optical fiber further including at least one radially emitting portion disposed between the coupling end of the optical fiber and the distal end of the optical fiber, the disposable optical fiber article and, An EMR delivery system including. Claim 18 The EMR delivery system further includes an optical fiber introducer for placement intermediate the disposable optical fiber article and the dialysis extension subset, the optical fiber introducer including a main line, an inlet port, an outlet port, a branch line, and a side port, the EMR delivery system of claim 17.

19. The main line has the inlet port and the outlet port, and the branch line has the side port that communicates with the main line and forms a Y-connector, the inlet port being connected to the distal end of the disposable optical fiber article, the outlet port being connected to a dialysis line, the side port being connected to the dialysis catheter, the optical fiber entering the main line through the inlet port and entering the dialysis extension subset through the outlet port when the disposable optical fiber article is in the folded mode, and the dialysate and / or spent dialysate flowing into and out of the dialysis catheter through the outlet port, the main line, the branch line, and the side port, the EMR delivery system of claim 18.

20. The EMR delivery system of claim 19, wherein the optical fiber has at least one radially emitting portion disposed within the main line.

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