Apparatus for a removable catheter visible light therapy system

Abstract

An apparatus is provided for a removable catheter visible light therapy system designed to deliver a non-antibiotic in vivo bactericidal treatment agent. A medical device assembly is provided for removably insertion into a catheter (36) having a lumen (30). The medical device assembly includes an electromagnetic radiation (EMR) source (26) for providing non-ultraviolet therapeutic EMR of sufficient intensity to inactivate one or more infectious agents and / or stimulate the growth of healthy cells to produce a healing effect, and a removable EMR conduction system (18) at least partially insertable into and removable from the lumen of the catheter. The EMR conduction system includes at least one optical element (14) that propagates the therapeutic EMR axially through an insertable elongate body (24). The elongate body can have an outer surface between the coupling end and the distal end (34) with at least one modification that allows the therapeutic EMR to radiate radially from the elongate body adjacent the modification. Such modification can be tapered along the outer surface.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Patent Application No. 16 / 747,315, filed January 20, 2020, entitled "Method and Apparatus for a Detachable Catheter Visible Light Therapy System," which is incorporated herein by reference.

[0002] The present invention relates to an apparatus for providing a therapeutic dose of non-ultraviolet light to inactivate infectious agents resident on, within, or generally around the exterior of a catheter when the catheter is placed within a body cavity and / or to stimulate the growth of healthy cells that produce a healing effect. In particular, the present disclosure relates to a medical device assembly that utilizes non-ultraviolet visible therapeutic electromagnetic radiation (EMR) of a sufficiently high intensity to stimulate the growth of healthy cells that produce a healing effect and / or to reduce or eliminate infectious agents in, within, or around a catheter when the catheter is placed within a body cavity.

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

[0004] Catheters are widely used as passageways for infusing medications into or withdrawing fluid samples from a patient's body. Each catheter typically comprises a tube made of plastic or other polymers, such as silicone, polyurethane, and the like, that is inserted into a site within the body and may contain one or more separate lumens through which fluids can be delivered or withdrawn. A "lumen" refers to the closed passage within the catheter that leads from outside the body to inside the body. Catheters are used in a variety of applications, including intravascular, urinary, gastrointestinal, ophthalmic, respiratory, intracranial, and the like. In all cases, catheters can be placed within spaces within the body where they remain, referred to herein as "body cavities." These devices often suffer from infections caused by the growth of infectious agents within, on, and around the catheter. Infectious agents can include bacteria, fungi, viruses, or the like that can enter the body and lead to patient illness. Depending on the location of catheter placement, these infections can occur in the form of urinary tract infections, bloodstream infections, soft tissue infections, and the like.

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

[0006] Catheters are available in a variety of sizes. Smaller diameter catheters, such as many PICC lines (peripherally inserted central catheters), have smaller diameter lumens. These smaller diameter catheters may be suitable for long-term insertion. Therefore, smaller diameter catheters may have inadequate catheter wall thickness for carrying a sterile delivery system. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need for devices designed to deliver non-antibiotic in vivo bactericidal therapeutics. Such devices, using novel technologies, can provide safe, effective, and reproducible removable delivery of disinfection. [Means for solving the problem]

[0008] A preferred embodiment of the present disclosure includes a device for inactivating infectious agents on, around, and in contact with the exterior of a catheter and / or stimulating the growth of healthy cells that result in a healing effect. In particular, the present disclosure utilizes a removably insertable device for causing this inactivation and / or healing while the catheter is indwelling within a patient's body cavity. Generally, the present disclosure relates to a medical device assembly for removably inserting into a lumen within a catheter. The medical device assembly includes an electromagnetic radiation (EMR) source, a detachable EMR conduction system, and at least one coupling for connecting the radiation source to the EMR conduction system. The EMR source has sufficient strength to inactivate one or more infectious agents and / or stimulate the growth of healthy cells that result in a healing effect. The detachable EMR conduction system is at least partially insertable into and removable from the lumen of the catheter.

[0009] The EMR source may be derived from a single EMR source or a group of sources including, but not limited to, light-emitting diodes, semiconductor lasers, diode lasers, incandescent (filtered or unfiltered), and fluorescent (filtered or unfiltered) light sources. The EMR source provides non-UV therapeutic EMR at one or more wavelengths ranging from greater than 380 nm to approximately 900 nm. To adequately inactivate infectious species and / or stimulate healthy cell growth, each EMR wavelength must be narrow spectral and centered around one wavelength in the group. The intensity must be sufficient to inactivate one or more infectious agents and / or stimulate healthy cell growth to produce a curative effect. This group includes several wavelengths: 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.

[0010] EMR sources may require drivers and electronic support for full functionality. Consideration must be given to addressing the supporting hardware and / or software, which may comprise a large portion of the functionality and efficiency of the EMR source. EMR sources generate heat, which may be harmful to the EMR source and may need to be limited.

[0011] One preferred embodiment of the EMR source and supporting components is simplified to include only the EMR source and necessary components. In another preferred embodiment of the EMR conduction system, a passive heat sink is required to dissipate the generated heat to the surrounding environment. In yet another preferred embodiment of the EMR source, the heat sink can be coupled to at least one fan to actively dissipate the heat generated by the EMR source.

[0012] Of particular importance to the present disclosure is the use of light with wavelengths of 380 nm to approximately 900 nm. In addition, the intensity and power of the emitted light is significantly effective in inactivating infectious agents, and therefore should be less than 0.1 J / cm. 2 ~1kJ / cm 2 irradiation dose in the range of 0.005mW to 1W, and output power in the range of 1mW / cm 2 ~1W / cm 2 Power densities in the range of 1000 to 15000 are critical to these preferred device assemblies and methods. These wavelengths, power densities, and irradiance ranges have been demonstrated to have antimicrobial or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased fibroblast proliferation, stimulation of collagen synthesis, induction of angiogenesis, and granulation tissue formation.

[0013] In each preferred embodiment described herein, the EMR conduction system and method for disinfection / healing is available with an adjustable or preset duty cycle. If treatment begins immediately after the sterilization procedure is initiated, device-associated infections can be prevented, including device-associated biofilm growth.

[0014] It should be understood that the use of "duty cycle" in this disclosure means or relates to the delivery of non-ultraviolet-visible therapeutic EMR via the EMR delivery system of the present disclosure by at least one of single, multiple, variable, continuous, infinite, increasing intensity lead-in, decreasing intensity phase-out, or any combination thereof, on-off cycles of EMR irradiation.

[0015] The treatment can include at least one wavelength of therapeutic EMR selected to sterilize one or more target organisms and acting as a dominant wavelength selected from the group of wavelengths centered around approximately 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm. Alternatively, the dominant wavelength selected to promote healing and healthy cell growth can be selected from the group of wavelengths centered around 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. Another treatment can include alternating between a first dominant wavelength and a second dominant wavelength (different from the first dominant wavelength) in a selected treatment pattern. Furthermore, sterilizing EMR and healthy cell growth-stimulating EMR can be delivered simultaneously, in series, or alternatively.

[0016] The removably insertable EMR delivery system can include at least one optical element having an elongate body that facilitates axial propagation of therapeutic EMR through the elongate body. The elongate body can have an outer surface between a coupling end and a distal tip. The outer surface can have at least one modification that allows the therapeutic EMR to radiate radially from the elongate body proximate the modification.

[0017] At least one coupling connecting a radiation source to an EMR conduction system can include at least one feature that allows the coupling to be easily removed from the removable EMR conduction system. This coupling can be achieved by utilizing a uniquely designed connection, a pre-fabricated coupling system, or any combination thereof that optimizes coupling efficiency and usability. Furthermore, the coupling connecting a removably insertable EMR conduction system to an EMR source can include multiple couplings. The intermediate section is further optimized for EMR propagation. In one preferred embodiment, the EMR source is coupled to a patch cable or EMR conduction extension section. This section is then coupled to a regular removably insertable EMR conduction system.

[0018] It should be understood that in this disclosure, "treatment" refers to or relates to the treatment of disease, including reducing or eliminating infectious agents, as well as aiding in or performed to maintain health, including enhancing the growth of healthy cells.

[0019] The optical element further comprises at least one optical feature selected from the group of optical features such as a reflective surface, an optically transparent material, a lens, an optical fiber filament, and any combination thereof. The optical element can also transmit multiple wavelengths or intensities of EMR. Multiple wavelengths can be transmitted simultaneously, sequentially, or in a sequence, or combinations thereof (e.g., one constantly on and the other pulsed). Multiple intensities can be transmitted through the same element simultaneously. Alternating patterns of light therapy can also be transmitted.

[0020] The EMR conduction system can be configured for at least partial insertion into one of any number of catheters, including (but not limited to) a central venous catheter, a peripherally inserted catheter, a peripherally inserted central venous catheter, a midline catheter, a jugular venous catheter, a subclavian catheter, a femoral catheter, a cardiac catheter, a cardiovascular catheter, a urethral Foley catheter, an intermittent urinary catheter, an endotracheal tube, a gastrointestinal catheter, a nasogastric tube, a wound drainage catheter, or any similar access medical catheter or tube inserted into a patient's body to deliver or retrieve fluids or specimens.

[0021] One preferred embodiment of an EMR delivery system has an optical element comprising a single insertable optical fiber. In the case of a single optical fiber, the single fiber can be made to transmit light radially or axially in various sections along its length. In the case of sections that transmit light radially, the outer surface of the optical element can be modified by chemical etching, physical etching, or electromagnetic ablation with plasma or laser to modify various sections along the length of the optical element. The modified sections allow light to be emitted radially.

[0022] In this disclosure, radially emitted light means that the light has a radial component, and thus the radially emitted light can be emitted orthogonally and / or obliquely to the central axis of the optical fiber at an axial emission point.

[0023] For embodiments with a modified section, the material comprising the optical fiber can be selected from the group of materials comprising optical fibers including plastic, silica, fluoride glass, phosphate glass, chalcogenide glass, plastic, and any suitable material that can propagate light axially and whose surface can be modified for radial emission. Additionally, the optical fiber can be single-mode, multimode, or plastic optical fiber optimized for modification using chemical, physical, or electromagnetic in-manufacturing modification processes. The optical fiber can be optimized for post-manufacturing modification.

[0024] Yet another preferred embodiment employs a physical abrasive modification method to modify an EMR transmission system comprising at least one optical fiber. The fiber is utilized based on its best optical response to a physical abrasive process. This process may include, but is not limited to, sanding, media blasting, grinding, buffing, or media blasting of at least one section of the optical fiber. The physical abrasive process will also necessarily be optimized with respect to the extent of the physical abrasion to optimize the appropriate radial EMR emission or absence thereof. This can be achieved by adjusting at least one of the speed, acceleration, pressure, modification time, or abrasive material utilized in modifying the optical fiber.

[0025] Yet another preferred embodiment employs microscopic porous structures in the optical fiber to transmit light radially. These microscopic structures can be located within the core and / or core-clad boundary of the optical fiber. The microscopic structures have a lower refractive index than areas without the microscopic structures. The microscopic structures can be materials such as metal, rubber, or plastic added to the core or core-clad boundary of the optical fiber. The microscopic structures can also be the absence of materials that create optical aberrations within the optical fiber or core-clad boundary. For example, the presence of microscopic bubbles in the optical fiber core creates optical aberrations or imperfections that alter the refractive index of the material, resulting in EMR radiating radially from the optical fiber.

[0026] Another preferred embodiment comprises at least one optical fiber having a cladding modified to optimize radial or axial propagation of EMR. For example, the cladding can be modified to at least partially eliminate or thin the cladding to partially transmit EMR radially. Another example can include an optical fiber in which only certain portions contain cladding, and EMR is transmitted axially in the cladded portion and at least partially axially and radially in the non-cladded portion.

[0027] In yet another preferred embodiment, radial transmission uniformity is achieved by having the radial emitting portion of the optical fiber have a substantially uniform intensity along the length of the emitting portion. This can be achieved by chemical etching, physical etching, plasma ablation, or laser ablation of a gradient pattern. Radial transmission uniformity can be achieved throughout each portion or length of the modified optical fiber by varying at least one of the velocity, acceleration, pressure gradient, flow rate, modification time, or modification material or process. During fabrication, gradient uniformity can also be achieved by adding microscopic structures within the core and / or core-clad boundary in a gradient pattern. Radial transmission uniformity achieved by gradient cladding or core features, whether substantially uniform throughout the portion length or varying as desired, is also contemplated for the desired radial emission.

[0028] In yet another preferred embodiment, at least a portion of the optical fiber emits EMR radially in a gradient distribution to obtain a gradient radial transmission. The gradient distribution can be obtained by uniform or gradient pattern chemical etching, physical etching, plasma, or laser ablation. By varying at least one of the velocity, acceleration, pressure gradient, flow rate, modification time, or modification material or process, a gradient radial transmission can be obtained across a portion of the modified optical fiber. This can also be obtained by adding microscopic structures within the core and / or core-cladding boundary.

[0029] Yet another preferred embodiment of a detachable EMR conduction system comprises at least one LED, its associated wiring components, and an optical element such as a scaffold. The LED can emit EMR based on the LED's inherent distribution or can utilize other optical elements such as lenses or mirrors to focus or diffuse the EMR in a targeted direction. Furthermore, multiple LEDs can be arranged in an array to appropriately emit EMR for maximum therapeutic effect. The LED, along with the associated wiring components, can be permanently or removably attached to a scaffold, thereby allowing the EMR conduction system to be removably inserted into a catheter. The scaffold can be rigid, semi-rigid, malleable, elastic, flexible, or a combination thereof.

[0030] Another preferred embodiment includes multiple optical elements, and the lumen is large enough to accommodate the multiple optical elements. The elongate body of each optical element has a length, and at least two of the elongate bodies can have different lengths such that the elongate bodies of different lengths terminate at different distances from the coupled end of the elongate body. Additionally, if the internal space of the lumen allows, multiple optical elements of various lengths can be arranged to achieve a gradient distribution pattern and / or multiple radiation portions.

[0031] For each preferred embodiment, assemblies and methods for disinfection are available with adjustable or preset duty cycle(s). If treatment begins shortly after the sterilization procedure is initiated, device-associated infections may be prevented. Also, if treatment begins after a device-associated infection is detected, treatment may inactivate one or more infectious agents. It should be understood that inactivation of infectious agents includes prevention of infectious agents, which includes device-associated biofilm growth.

[0032] In order to readily understand how the above-mentioned and other features and advantages of the present disclosure are obtained, reference will be made to preferred embodiments of the present disclosure as illustrated in the accompanying drawings, which will be described with reference to the accompanying drawings, with the understanding that these drawings merely depict exemplary preferred embodiments and should not be considered as limiting the scope of the present disclosure. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 is a schematic diagram of a triple lumen catheter, an insertable optical element, and EMR components. [Figure 2] FIG. 2 is a perspective view of a dual lumen catheter, with the insertable component external to the catheter. [Figure 3] FIG. 3 is a perspective view of a dual lumen catheter in which the insertable component is partially disposed within the catheter. [Figure 4] FIG. 4 is a partially exploded perspective view of a dual lumen catheter with the insertable component partially disposed within the catheter and showing the intermediate coupling. [Figure 5] FIG. 5 is a series of elevational views of several preferred embodiments of insertable optical elements that vary in location, length and degree of modification, with the optical element connectors shown as transparent. [Figure 6] FIG. 6 is a cross-sectional view of portions of an insertable optical element having various EMR radial gradient dispersion levels. [Figure 7] FIG. 7 is a cross-sectional view of the various gradient dispersion levels of FIG. 6, showing EMR ray diagrams of internal reflection and relative radial emission. [Figure 8] FIG. 8 is a cross-sectional view of various preferred dispersions of microscopic structures (such as flecks or bubbles) within the core, cladding, and core / cladding boundary of an optical fiber. [Figure 9] FIG. 9 is a schematic diagram of the treatment applied to the insertable optical element. [Figure 10]FIG. 10 is a transparent perspective view of the optical element connector showing the preferred collimating element. [Figure 11] FIG. 11 is a plan view of the optics assembly and EMR power supply, removed and installed, without the need for a collimator lens. DETAILED DESCRIPTION OF THE INVENTION

[0034] Preferred embodiments of the present disclosure can be best understood by reference to the drawings, in which like parts are designated with like reference numerals throughout. It should be understood that the components of the preferred embodiments, as described herein and illustrated in the drawings, could be arranged and designed in a wide variety of configurations. Thus, the following detailed description of preferred embodiments of the devices, systems and methods of the present disclosure, as shown in Figures 1-11, is not intended to limit the scope of the invention as claimed, but rather represents preferred embodiments only.

[0035] As used in this application, "connected to," "coupled to," and "in communication with" mean any type of interaction between two or more entities, including mechanical, capillary, electrical, magnetic, electromagnetic, pneumatic, hydraulic, fluid, and thermal interactions.

[0036] "Attached to," "fixed to," or "mounted to" means a type of mechanical connection that restricts relative translation or rotation between the attached, fixed, or mounted objects, respectively. "Slidably attached to" means a type of mechanical connection that allows relative translation while restricting other relative motion. "Directly attached to" means a type of fixation in which the fixed items are maintained in a fixed state through direct contact.

[0037] "Abut" means that the items may not be attached together, but are in direct physical contact with one another. "Grip" means that one item holds another firmly, in direct physical contact. "Integrally formed" means a body that is manufactured as a single piece without the need for assembling components. Multiple elements can be integrally formed with one another when directly attached to one another to form a single workpiece. Thus, elements that are "coupled" to one another can be formed together as a single piece.

[0038] 1 of the present disclosure is a schematic diagram of a preferred triple lumen catheter 10 shown positioned within a patient's body 12. An insertable optical element 14 is partially inserted into the catheter 10, and an EMR component 20 is connected to the insertable optical element 14.

[0039] The catheters 10 shown in Figures 1-4 are preferred multi-lumen catheters 10, each including a line tube 16, one or more (three in Figure 1, two in Figures 2-4) proximal catheter hub assemblies 32, an elongated catheter body 36, a distal tip 34, and a focusing chamber 40. The inner lumen 30 has an inner diameter (i.e., inside surface dimension) and extends along the length of the catheter 10 from the proximal catheter hub assembly 32, through the line tube 16, the focusing chamber 40, and the elongated catheter body 36, to the distal tip 34. The insertable optical element 14 is elongated and has an outer diameter (i.e., outside surface dimension) small enough to be insertable into at least one of the inner lumens 30, extending into the catheter 10 as far as the optical element terminal end 42, although insertion can be shorter than this length if desired.

[0040] Catheters 10 suitable for use with insertable optical element 14 can be of various makes, sizes, and capabilities. For example, a translucent catheter may be particularly suitable for providing a passageway for EMR to be emitted radially into tissue surrounding the catheter 10. A catheter 10 having an inner diameter (inner diameter) that is sufficiently larger than the outer diameter (outer diameter) of the insertable optical element 14 allows for fluids (liquid or gas) to be simultaneously infused or withdrawn through the catheter when the insertable optical element 14 is placed within the catheter 10.

[0041] Additionally, some catheters 10 have a radiopaque agent embedded in the wall of the catheter 10 to enable imaging of the area where the catheter 10 is positioned within the patient's body 12. However, some catheters do not have such a radiopaque agent. In either case, it is contemplated in the present disclosure that a radiopaque agent be included in or on the outer surface of the insertable optical element 14 to detect the location of the catheter 10 within the patient's body 12 when the catheter 10 does not have a radiopaque agent, and to detect the location of the insertable optical element 14 disposed within the catheter 10 regardless of whether the catheter 10 has a radiopaque agent (this may require different radiopaque agents in some instances so that the catheter 10 and the insertable optical element 14 can be distinguished).

[0042] In some preferred embodiments, at least one of the proximal catheter hub assemblies 32 can have a fiber optic element alignment shaft 98 that aligns the optical element connector 94 with the insertable optical element 14 .

[0043] 1 is a schematic diagram of a catheter 10 inserted into an insertion site A in the arm of a patient 12. The diagram illustrates how a non-ultraviolet therapeutic EMR can be delivered at insertion site A and to other sites within the patient's body 12. At insertion site A, the therapeutic EMR can be delivered to the percutaneous area 48 to inactivate infectious agents in the percutaneous area and enhance healing at insertion site A. Similarly, near the distal tip 34, in this case within a vena cava, the therapeutic EMR can be delivered to inactivate infectious agents and / or enhance healing in this vicinity.

[0044] The EMR component 20 includes an EMR power supply 26 (FIGS. 2-4), a light source (not shown, such as a laser or the like), electrical circuitry (not shown), and optics (depending on the light source, not shown), all housed within the elongated body 24. A coupling element 28 connects the EMR component 20 to an optical assembly 50. The optical assembly 50 includes an insertable optical element 14 and an optical element connector 94. The combination of the EMR component 20, the coupling element 28, and the optical assembly 50 including the insertable optical element connector 94 and the insertable optical element 14 is referred to herein as the detachable EMR conduction system 18.

[0045] Of particular importance to each of the embodiments is the use of light with wavelengths ranging from greater than 380 nm to about 900 nm. In addition, the intensity and power of the emitted light helps to inactivate infectious agents and / or promote healing. 0.1 J / cm 2 ~1kJ / cm 2 The irradiation dose ranges from 0.005mW to 1W and the output power ranges from 1mW / cm 2 ~1W / cm 2 Power densities in the range of are important to these preferred device assemblies and methods. These ranges of wavelengths, power densities, and irradiances have been demonstrated to have antimicrobial or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased fibroblast proliferation, stimulation of collagen synthesis, induction of angiogenesis, and granulation tissue formation.

[0046] In each preferred embodiment described herein, the EMR conduction system 18 and method for disinfection / healing can be utilized with adjustable or preset duty cycle(s). If treatment begins immediately after the sterilization procedure is initiated, device-associated infections can be inhibited. Also, if treatment begins after a device-associated infection is detected, treatment can inactivate one or more infectious agents. It should be understood that inactivation of an infectious agent includes inhibition of the infectious agent, which includes device-associated biofilm growth.

[0047] Preferred adjustable, preset duty cycle, output range 0.005mW to 1W, 1mW / cm 2 ~1W / cm 2 Power densities in the range of 0.1J / cm 2 ~1kJ / cm 2 and at least one of single, multiple, variable, continuous, infinite, increasing intensity lead-in, decreasing intensity phase-out, or any combination thereof, on-off periods. The EMR irradiation uses the EMR conduction system of the present disclosure, which operates on a duty cycle.

[0048] Infectious agents include, but are not limited to, bacteria, fungi, viruses, and protozoa that enter the body and cause or contribute to illness in patients. Depending on the application, infectious agents vary in type and sensitivity to EMR inactivation. Effective duty cycles and EMR exposures can be routinely optimized by those skilled in the art through empirical estimation. Such empirical estimation can identify an effective duty cycle that produces a therapeutic effect of at least one of inactivating one or more infectious agents or promoting healing.

[0049] One important preferred application relates to catheters utilized in environments subject to continuous contamination by infectious agents. In this preferred application, one effective duty cycle (on-off period) is continuously repeated for the useful life of the catheter. Treatment consisting of multiple effective duty cycles, each of sufficient intensity to inactivate one or more infectious agents, can inhibit or eradicate device-associated infections and / or device-associated biofilm growth.

[0050] Another preferred duty cycle may include an EMR conduction system utilizing a 120 minute "on" period followed by a 10 minute "off" period to deliver EMR of sufficient strength to inactivate one or more infectious agents and / or stimulate the growth of healthy cells resulting in a healing effect. This on-off pattern may be repeated continuously for 30 days to provide sterilizing and / or healing EMR for the useful life of the catheter.

[0051] The above is only a representative example, the duty cycle is adjustable and the output power ranges from 0.005mW to 1W, 1mW / cm 2 ~1W / cm 2 Power densities in the range of 0.1J / cm 2 ~1kJ / cm 2 It should be appreciated that the on-off period can be comprised of an infinite number of possible combinations of at least one of n doses ranging from 1 to 100 dW, and at least one of on-off periods that are single, multiple, variable, continuous, infinite, increasing intensity lead-in, decreasing intensity phase-out, or any combination thereof. The on-off period can be comprised of at least one of an infinite combination of nanoseconds, milliseconds, seconds, minutes, hours, or days.

[0052] The treatment can include at least one wavelength of therapeutic EMR selected to sterilize one or more target organisms and acting as a dominant wavelength selected from the group of wavelengths centered around 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 455 nm, 470 nm, 475 nm, 660 nm, and 808 nm. Another treatment can include alternating the dominant wavelength between a first dominant wavelength and a second dominant wavelength (different from the first dominant wavelength) in a selected treatment pattern. Furthermore, the sterilizing EMR and the EMR that stimulates healthy cell growth can be transmitted simultaneously or alternatively in series.

[0053] Another embodiment of the present disclosure is shown in Figure 2, a perspective view of a dual lumen catheter 10, in which the detachable EMR conduction system 18 is external to the catheter 10. The portion of the catheter 10 shown in the figure shows a flexible protective tube 44 that protects the connection between the line tubing 16 and the proximal catheter hub assembly 32 and protects the line tubing 16 from abrasion by the line clamp 46.

[0054] FIG. 3 shows the dual lumen catheter 10 of FIG. 2 with a removable, insertable EMR conduction system 18 partially inserted into one of the lumens 30 of the catheter 10.

[0055] 4 is an exploded perspective view of the preferred EMR conduction system 18 partially inserted into the proximal catheter hub assembly 32 and inner lumen 30. In this preferred embodiment, an intermediate coupling 52 is shown. This intermediate coupling 52 may include a patch cable 54 or EMR conductive extension section 56 used to extend the distance between the EMR power source 26 and the optical element connector 94 of the insertable optical element 14 without appreciable loss of light intensity. Each of the patch cables 54 or EMR conductive extension sections 56 may have a front connector 58 for fixedly engaging the coupling element 28 and a rear connector 60 for fixedly engaging the optical element connector 94. In this manner, by using the patch cables 54 or EMR conductive extension sections 56, the EMR power source 26 can be operated at a desired distance from the patient to reduce noise or heat concerns and / or to position the EMR power source 26 closer to a power source (not shown), such as an electrical outlet or battery pack.

[0056] 5 is a series of elevational views of several preferred embodiments of optical assembly 50, illustrating various positions with slope modifications to outer surface 62 of insertable optical element 14. Each view in the series shows optical assembly 50 with insertable optical element 14 connected to optical element connector 94. Optical element connector 94 (FIG. 10) includes connecting element 88, EMR hub connection 90, collimator lens 92, and alignment shaft 98.

[0057] The first (top) figure in the series shows the unmodified optical span 100 of the insertable optical element 14 with no radial dispersion (i.e., the insertable optical element 14 has not been modified to provide radial emission of light from the body of the insertable optical element 14). In this embodiment, therapeutic non-ultraviolet EMR is provided to the tip 64, and there is no radial emission from the unmodified optical span 100 other than at the tip 64.

[0058] The second figure in the series (next below) shows a preferred uniform radial transmission across the single modified portion 103 that emits radially dispersed light from the segmented modified optical span 102 (i.e., the modified portion 103 has a gradient modification such that the emitted light has substantially the same intensity and power across the length of the modified portion 103). The location of the single modified portion 103, in this example, corresponds to where the catheter 10 enters the insertion site A when the insertable optical element 14 is fully inserted into the catheter 10. In this embodiment, the radially emitted visible light can sterilize the insertion site A and the percutaneous area 48 or other predetermined site within the patient's body 12.

[0059] Figure 3 in the series of figures shows an example of a single elongated modified portion 105 that emits radially dispersed light from the optical element 14, extending along most of the complete modified optical span 104. The location of the single elongated modified portion 105 generally corresponds to the length of the insertable catheter component 22 of the catheter 10. In this embodiment, the therapeutic light can be emitted along substantially the entire length of the catheter 10 inserted into the patient's body 12.

[0060] Figure 4 in the series of figures shows an example of having uniform radial transmission at multiple locations. The uniform additive radial transmission of a single modified portion 103 and modified tip portion 107 are spaced along the multiple modified optical span 106. The locations of the modified portion 103 and modified tip portion 107 correspond to areas of the body where delivery of non-ultraviolet therapeutic EMR is desired for sterilization and / or healing, including, for example, insertion site A. It should be appreciated that multiple modified portions 103 can be positioned along the length of the multiple modified optical span 106 and / or each modified portion 103 can have various lengths.

[0061] Also, in each of these figures, the modified portions can have modifications other than modifications to the outer surface 62 of the insertable optical element 14, such as modifications including microscopic structures embedded within the insertable optical element 14 that allow light to be transmitted radially from the insertable optical element 14. Furthermore, such modified portions 103, 105, 107 can have a gradient pattern that allows light to be substantially uniformly distributed throughout the length of the modified portions 103, 105, 107.

[0062] FIG. 6 is a schematic diagram of an optical assembly 50, showing an insertable optical element 14 coupled to an optical element connector 94. The insertable optical element 14 has a fully modified optical span 104. Multiple locations along the insertable optical element 14 are shown in enlarged cross-sectional views. These locations are axially spaced along the insertable optical element 14 to illustrate preferred insertable optical element 14 properties at each location. As shown, there are four cross-sectional locations: a first cross-section 108, a second cross-section 110, a third cross-section 112, and a fourth cross-section 114. For simplicity, the outer surface of or modifications therein of the insertable optical element 14 at each of the four cross-sections are combined in the view of FIG. 6. Naturally, the modifications of the insertable optical element 14 may be single or multiple, may have any length or slope, and may be coincident, overlapping, or non-overlapping.

[0063] The first cross-section 108 represents the internally reflective region of the insertable optical element 14. As shown, at the first cross-section 108, the insertable optical element 14 has no ablation (or other modification) and no microscopic structure within the core 116. No therapeutic non-ultraviolet EMR radiates radially from the insertable optical element 14 at the first cross-section 108.

[0064] The second cross-section 110 represents the minimum emitting area of ​​the insertable optical element 14. As shown, at the second cross-section 110, there is minimal ablation (or other modification) on the outer surface 62 of the insertable optical element 14 and minimal dispersion of the microscopic structures 117 within the core 116 of the insertable optical element 14. From the second cross-section 110, minimal therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14. However, the amount of EMR emitted must have sufficient intensity and power to inactivate infectious agents and / or promote healing proximate the second cross-section 110.

[0065] The third cross-section 112 represents a moderate emission region of the insertable optical element 14. As shown, the third cross-section 112 exhibits moderate ablation (or other modification) of the outer surface 62 of the insertable optical element 14 and moderate dispersion of the microscopic structures 117 within the core 116 of the insertable optical element 14. From the third cross-section 112, a moderate amount of therapeutic non-ultraviolet EMR is emitted radially from the insertable optical element 14 adjacent the third cross-section 112. However, before reaching the third cross-section 112, the amount of light passing through the insertable optical element 14 is reduced by the radial emission of some of the light at the second cross-section 110, etc. Thus, the gradient of the modification is selected so that the amount of EMR emitted radially at the third cross-section 112 is substantially equivalent to the radial emission at the second cross-section 110. Thus, the intensity and power of the emitted EMR is substantially equivalent to the intensity and power emitted at the second cross-section 110 and has sufficient intensity and power to inactivate infectious agents and / or promote healing.

[0066] The fourth cross-section 114 represents the maximum emission area of ​​the insertable optical element 14. As shown, at the fourth cross-section 114, there is maximum ablation (or other modification) on the outer surface 62 of the insertable optical element 14 and maximum dispersion of the microscopic structures 117 within the core 116 of the insertable optical element 14. From the fourth cross-section 114, the maximum amount of therapeutic non-UV EMR is emitted radially from the insertable optical element 14 adjacent the fourth cross-section 114. Again, the amount of light continuing along the insertable optical element 14 before reaching the fourth cross-section 114 is reduced by the radial emission of some of the light at the second cross-section 110, the third cross-section 112, etc. Thus, the gradient of the modification is selected so that the amount of EMR emitted radially at the fourth cross-section 114 is substantially equal to that at the second cross-section 110 and the third cross-section 112. The intensity and power of the emitted EMR can be substantially equal to the intensity and power emitted at the second cross section 110 and the third cross section 112, and has sufficient intensity and power to inactivate infectious agents and / or promote healing.

[0067] The modifications can be made by chemical, physical, or other cladding modifications (e.g., ablation) to alter the critical angle sufficiently to allow radial emission of light. Additionally or alternatively, the modifications can be made by dispersing microscopic structures 117 of varying gradient concentrations within the core 116 of the insertable optical element 14. The gradient concentrations of the microscopic structures 117 within the core 116 shown in Figure 6 range from an area 109 without microscopic structures, to a minimum concentration 111 of the microscopic structures 117, to a medium concentration 113 of the microscopic structures 117, to a maximum concentration 115 of the microscopic structures 117.

[0068] The concentration of microscopic structures 117 within the core 116 affects the refractive index of the core 116 and the core-clad boundary 118. The microscopic structures 117 (e.g., voids such as bubbles) cause a change in the angle of incidence of light as it passes through the insertable optical element 14. At a particular angle of incidence, light leaves the cladding 119 of the optical element and is emitted radially from the cladding boundary 120.

[0069] FIG. 7 is a schematic diagram of the cross-section of FIG. 6, with arrows indicating light rays. The same cross-sections of the insertable optical element 14 are shown: first cross-section 108 (internal reflection), second cross-section 110 (minimum radial radiation), third cross-section 112 (moderate radial radiation), and fourth cross-section 114 (maximum radial radiation). These figures also show light rays traveling downstream through the core 116, where they collide with microscopic structures 117 at an angle of incidence, causing the light rays to pass through the optical element cladding 119. An increasing pixilation gradient at the cladding boundary 120 is shown, from the first cross-section 108 (no pixilation), to the second cross-section 110 (minimum pixilation), to the third cross-section 112 (moderate pixilation), to the fourth cross-section 114 (maximum pixilation), which represent chemical, physical, or other cladding modifications (e.g., ablation) at the cladding boundary 120. Such modification of the insertable optical element 14 alters the critical angle sufficiently to allow light to radiate radially. As shown schematically, the amount of light within the core 116 decreases as the light passes from proximal to distal, but the amount of light radiating away from the optical element cladding 119 is substantially equal at each location. Microscopic structures 117 of varying gradient concentrations are also shown within the core 116, ranging from a microscopic structure-free area 109 to a minimum concentration 111, a medium concentration 113, and a maximum concentration 115. Each of the microscopic structures 117 has a different refractive index than the core 116 and the optical element cladding 119. The microscopic structures 117 (e.g., voids such as bubbles) cause a change in the angle of incidence of light as it passes through the insertable optical element 14. At certain angles of incidence, light radiates radially away from the optical element cladding 119.

[0070] 8 is a cross-sectional view of various preferred distributions of microscopic structures 117 (such as flecks or bubbles) within the core 116, cladding 119, and core / cladding boundary 118 of an optical fiber. In each of the preferred embodiments shown, the microscopic structures 117 are distributed within the insertable optical element 14 (in this case, the optical fiber) to obtain radial transmission of light. These microscopic structures 117 may be located within the core 116 and / or at the core-cladding boundary 118 and / or within the cladding 119 of the optical fiber 14. The microscopic structures 117 have a lower refractive index than areas without the microscopic structures 117. The microscopic structures 117 may be a material added to the optical fiber core 116 or core-cladding boundary 118, such as metal, rubber, or plastic. The microscopic structures 117 may also be the absence of aberration-causing material within the optical fiber core 116 and / or the core-cladding boundary 118 and / or the cladding. For example, the presence of microscopic structures 117 (such as bubbles) in the optical fiber core 116 creates optical aberrations or imperfections that modify the refractive index of the material, causing EMR to be emitted radially from the optical fiber (insertable optical element 14).

[0071] 8 illustrates three preferred dispersions: first dispersion 121, second dispersion 123, and third dispersion 125. In first dispersion 121, the microscopic structures 117 (fluxes or bubbles) are dispersed only in an outer region 127 of the core 116. In second dispersion 123, the microscopic structures 117 are dispersed within an inner region 129 of the cladding 119 as well as within the outer region 127 of the core 116. In third dispersion 125, the microscopic structures 117 are dispersed close to the core / cladding boundary 118 and are shown as identifying a boundary region 131 that is thinner than the outer region 127 of the core 116 and the inner region 129 of the cladding 119. In each of the preferred dispersions, at least a portion of the light traveling the length of the insertable optical element 14 (optical fiber) does not encounter any microscopic structures 117, and the remaining light may encounter at least one microscopic structure 117 and be deflected and emitted radially from the insertable optical element 14.

[0072] Figure 9 is a schematic diagram of a preferred optical element modification method for creating a slope modification in the outer surface 62 of the insertable optical element 14. Such modifications to the core 116 or optical element cladding 118 alter the angle of incidence of a light ray so that it is different from the critical angle required for continued internal reflection. Figure 9 shows a control device 122 along with a wand 124 that delivers an acid spray 126 to etch the insertable optical element 14.

[0073] There are several ways to achieve such gradient modification. Chemically, the insertable optical element 14 can be etched using a strong acid, such as hydrofluoric acid or sulfuric acid, and hydrogen peroxide. Also, etching creams containing quartz powder, calcium fluoride, or typically fluorinated compounds can be used. Physically, physical modification, such as heating the insertable optical element 14 or ablation by sanding, media blasting, grinding, or laser ablation modification, are also methods for creating gradient modification. Additionally, plasma ablation by laser modification results in the ionization of molecules and alteration of the outer surface 62 of the insertable optical element 14. Other known methods for creating gradient ablation are also contemplated in this disclosure. Whether by modification or manufacturing process, currently known or not, the insertable optical element 14 can be modified to emit a substantially uniform radial beam of light along a desired length. This uniformity of the radially emitted beam of light allows for more precise therapeutic doses to inactivate infectious agents and / or promote healing.

[0074] 10 of the present disclosure is a transparent view of an optical element connector 94 that includes a connecting element 88, an EMR hub connection 90, a collimator lens 92, an alignment shaft 98, and an alignment hole 99. An insertable optical element 14 can be inserted into the alignment hole 99 of the optical element connector 94 to collimate light into the small diameter core 116 or one or more optical fibers.

[0075] Although the preferred disclosure shows the light diverting element as a single collimator lens 92, other types of light diverting elements, such as multiple lenses or different types of lenses, can be used to collimate the light beam. Depending on the diameter, numerical aperture, and refractive index of the optical element 14, specific lenses may be required as light diverting elements to minimize light loss.

[0076] 11 of the present disclosure shows a pair of EMR transmission systems 18, one exploded and one assembled. Each EMR transmission system has an EMR power supply 26 that can be attached to an optical assembly 50 with an optical element connector 94 without a collimator lens 92. In instances where the numerical aperture, diameter, and material can be matched to that of the optical element 14, the collimator lens 92 may not be necessary. In such instances, an EMR hub connector 90 can be connected directly to the EMR power supply 26 and optical element connector 94, as shown.

[0077] The present disclosure anticipates that the systems and methods of the present disclosure may be embodied in other obvious forms without departing from the structure, method, or other essential features of the disclosure as broadly described herein and as subsequently claimed. The embodiments described herein are to be considered in all respects as illustrative and not restrictive. The scope of the present disclosure is, therefore, indicated by the claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.

[0078] In the preferred methods or processes of the present invention, the order and / or sequence of steps described herein is exemplary and not limiting. Thus, although various process or method steps are illustrated and described in a sequential or chronological order, it should be understood that these process or method steps are not limited to being performed in any particular order or sequence unless otherwise indicated. In fact, such process or method steps can generally be performed in a variety of orders and sequences and still fall within the scope of the present invention.

[0079] Furthermore, references to advantages, benefits, unexpected results, or operability of the invention are not intended to assert that the invention has previously been put into practice or that any testing has been performed. Similarly, unless otherwise expressly stated, the use of a verb in the past tense (present perfect or past tense) is not intended to indicate or imply that the invention has previously been put into practice or that any testing has been performed.

[0080] Although preferred embodiments of the present invention are described above, no element, act, or instruction used herein should be construed as critical, necessary, essential, or essential to the present invention unless specifically and explicitly described as such. Although several preferred embodiments are described in detail herein, those skilled in the art will recognize that many modifications to these preferred embodiments are possible without materially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to be included within the scope of the present invention as defined in the claims.

[0081] In utility model claims, means-plus-function clauses are intended to encompass not only the structures described herein as performing the recited function and structural equivalents, but also equivalent structures. Thus, while nails and screws are not structurally equivalent in that nails employ cylindrical surfaces and screws employ helical surfaces to fasten wood parts together, in the context of fastening wood parts, nails and screws may be equivalent structures. Unless the precise phrase "means for" (means for performing a particular function or step) is recited in a claim, interpretation under Section 112, Paragraph 6, is not intended. Furthermore, the scope of protection afforded to this invention is not intended to be determined by reading into the claims any limitations found in this specification that are not expressly apparent in the claims themselves. The present disclosure also includes the following aspects. [Aspect 1] 1. A medical device assembly for delivering electromagnetic radiation (EMR) into, on or about a catheter having at least one lumen for placement within a patient, the medical device assembly comprising: an electromagnetic radiation (EMR) source for providing non-UV therapeutic EMR having an intensity comprising at least one of an irradiance of at least 0.5 J / cm to 1 kJ / cm, a power output of at least 0.005 mW to 1 W, and a power density of at least 0.1 mW / cm to 1 W / cm, wherein the intensity produces a therapeutic effect of at least one of inactivating one or more infectious agents and promoting healing; and An EMR delivery system comprising an optical element connector and an optical element having an elongated body and a distal tip, at least a portion of the optical element being insertable for deployment within and removable from the lumen of the catheter when the catheter is placed within the patient's body, the elongated body facilitating axial propagation of the non-ultraviolet therapeutic EMR therethrough, the elongated body having an outer surface between a proximal coupling end and the distal tip, the outer surface having at least one radially radiating portion between the proximal coupling end and the distal tip. and an EMR conduction system configured to emit non-ultraviolet therapeutic EMR from the elongate body into the lumen of the catheter and radially through the catheter, thereby delivering a predetermined duty cycle of the non-ultraviolet therapeutic EMR into, on an exterior surface of, and around the catheter when the optical element is deployed and the catheter is placed within the patient's body, the duty cycle including at least one of on-off periods: single, multiple, variable, continuous, infinite, increasing intensity lead-in, decreasing intensity phase-out, and any combination thereof; a coupling for connecting the EMR source to the optical connector of the EMR conduction system and for delivering the non-ultraviolet therapeutic EMR from the EMR source to the optical element for axial propagation of the non-ultraviolet therapeutic EMR through the elongated body; A medical device assembly comprising: [Aspect 2] 2. The medical device assembly of claim 1, wherein the optical element further comprises at least one optical feature selected from the group of optical features consisting of a reflective surface, an optically transparent material, a lens, an optical fiber filament, and any combination thereof. Aspect 3 2. The medical device assembly of claim 1, wherein the medical device assembly is configured to alternatively, alternately, or simultaneously deliver a sterilizing EMR and a healing EMR. Aspect 4 The medical device assembly of aspect 1, further comprising at least one light diversion element for redirecting the non-ultraviolet therapeutic EMR from at least one of the EMR source or the optical element into at least one fluid line, focusing chamber, and catheter connection hub. Aspect 5 2. The medical device assembly of claim 1, wherein the non-ultraviolet therapeutic EMR has a wavelength in the range of about greater than 380 nm to 900 nm. Aspect 6 2. The medical device assembly of claim 1, wherein the length of the duty cycle is adjustable. Aspect 7 2. The medical device assembly of claim 1, wherein the EMR source is selected from the group consisting of a solid state laser, a semiconductor laser, a diode laser, a light emitting diode, a fluorescent or an incandescent light source. Aspect 8 2. The medical device assembly of claim 1, wherein the delivery of the predetermined duty cycle of the non-ultraviolet therapeutic EMR around the catheter includes delivery of the non-ultraviolet therapeutic EMR to tissue adjacent to the catheter. Aspect 9 2. The medical device assembly of claim 1, wherein the on-off period of the duty cycle comprises at least one of nanoseconds, milliseconds, seconds, minutes, hours, and days. Aspect 10 2. The medical device assembly of claim 1, wherein at least a portion of the non-ultraviolet therapeutic EMR radiation is emitted to sterilize a portion of the medical device assembly outside a patient's body. Aspect 11 A medical device assembly as described in aspect 1, wherein the therapeutic effect is the inactivation of one or more infectious agents and the radial emission of the non-ultraviolet therapeutic EMR is onto the catheter and includes inhibiting device-associated biofilm growth. Aspect 12 1. A medical system for delivering electromagnetic radiation (EMR) into a patient's body, the medical system comprising: a catheter having at least one lumen; a medical device assembly for delivering EMR into, on, and around said catheter, comprising: an EMR source for providing non-ultraviolet therapeutic EMR having a wavelength in the range of greater than 380 nm to 904 nm and an intensity comprising at least one of an irradiance of at least 0.5 J / cm to 1 kJ / cm, a power output of at least 0.005 mW to 1 W, and a power density of at least 0.1 mW / cm to 1 W / cm, wherein the intensity produces a therapeutic effect of at least one of inactivating infectious agents and promoting healing; an EMR conduction system comprising at least one optical element having an elongate body that facilitates axial propagation of the non-ultraviolet therapeutic EMR along the elongate body, at least one of the optical elements being at least partially insertable into and removable from at least one of the lumens of the catheter when the catheter is placed within the patient's body, the non-ultraviolet therapeutic EMR radiating radially from the elongate body into the lumen and through the catheter, thereby delivering a predetermined duty cycle of the non-ultraviolet therapeutic EMR into, on an exterior surface of, and around the catheter when the catheter is placed within the patient's body, the duty cycle comprising at least one of on-off periods: single, multiple, variable, continuous, infinite, increasing intensity lead-in, decreasing intensity phase-out, and any combination thereof; at least one coupling for connecting the EMR source to the EMR conduction system and for delivering the non-ultraviolet therapeutic EMR from the EMR source to the optical element for axial propagation of the non-ultraviolet therapeutic EMR through the elongated body; a medical device assembly comprising: A medical system that includes: Aspect 13 13. The medical system of claim 12, wherein the wavelength of the non-ultraviolet therapeutic EMR is selected from the group of wavelengths centered around about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. Aspect 14 13. The medical system of claim 12, wherein the non-ultraviolet therapeutic EMR comprises one or more selected wavelengths emitted in at least one of alternating and parallel therapeutic patterns. Aspect 15 A medical system as described in aspect 12, wherein the optical element has an outer surface dimension smaller than the inner surface dimension of the lumen so that fluid can be injected into or withdrawn from the lumen between the inner surface dimension of the lumen and the outer surface dimension of the optical element when the optical element is placed within the catheter. Aspect 16 A medical system as described in aspect 12, wherein the therapeutic effect is the inactivation of one or more infectious agents, and the radial emission of the non-ultraviolet therapeutic EMR is onto the catheter, and includes the inhibition of device-associated biofilm growth. [Explanation of symbols]

[0082] 10 Catheter 12. Patient's body (inside) 14 Insertable Optical Elements 16 Line Tube 18 EMR Conduction System 20 Electromagnetic Radiation Components 22 Insertable Catheter Components 24 Elongated body 26 Electromagnetic Radiation Source 28 Bonding Elements 30 internal lumens 32 Proximal catheter hub assembly 34 Distal tip 36 Thin catheter body 38 Variable Length Catheter 40 Convergence Chamber 42 Optical element termination 44 Flexible protective tube 46 Line clamp 48 Transdermal Area 50 Optical assembly 52 Intermediate Coupling 54 patch cables 56 EMR Conduction Extension Section 58 Front Connector 60 Rear Connector 62 Exterior 64 Tip 88 Connecting Elements 90 EMR Hub Connector 92 Collimator Lens 94 Optical Element Connector 98 Alignment Shaft 99 Alignment holes 100 Uncensored Optical Span 102 Section Corrected Optical Span 103 Single Amendment 104 Fully Corrected Optical Span 105 Single elongated correction part 106 Multiple Correction Optical Span 107 Modified tip part 108 1st cross section 109 Areas without microscopic structures 110 Second section 111 Minimum concentration 112 Third section 113 Moderate concentration 114 4th section 115 Maximum concentration 116 cores 117 Microscopic structures 118 Optical element cladding 120 Cladding boundary 121 1st variance 122 Control equipment 123 2nd dispersion 124 ワンド 125 Third Dispersion 126 Acid Spray 127 Outer Domain 129 Inner Domain 131 Boundary Realm A. Insertion site

Claims

1. 1. A medical device assembly for delivering electromagnetic radiation (EMR) into, on or about a catheter having at least one lumen for placement within a patient, the medical device assembly comprising: At least 0.5 J / cm 2 ~1 kJ / cm 2 irradiance, with a power of at least 0.005 mW to 1 W and at least 0.1 mW / cm 2 ~1 W / cm 2 an electromagnetic radiation (EMR) source for providing non-ultraviolet therapeutic EMR having an intensity comprising at least one of a power density of 1000 Hz to 1000 Hz, wherein the intensity produces a therapeutic effect of at least one of inactivating one or more infectious agents and promoting healing; an EMR conduction system comprising an optical element connector and an optical element having an elongated body and a distal tip, at least a portion of the optical element being insertable for deployment within and removable from the lumen of the catheter when the catheter is placed within the patient's body, the elongated body facilitating axial propagation of the non-ultraviolet therapeutic EMR therethrough, the elongated body having an outer surface between a proximal coupling end and the distal tip, the outer surface having at least one radial radiating portion between the proximal coupling end and the distal tip, allowing the non-ultraviolet therapeutic EMR to radiate radially through the catheter from the elongated body into the lumen of the catheter; a coupling connecting the EMR source to the optical element connector of the EMR conduction system for adjustable delivery of the non-UV therapeutic EMR from the EMR source to the optical element for axial propagation of the non-UV therapeutic EMR through the elongate body, wherein the combination of the EMR source connected to the EMR conduction system is operable to deliver an adjustable duty cycle of the non-UV therapeutic EMR into, on an exterior surface of, and about the catheter when the optical element is deployed and at least a portion of the catheter is placed within the patient's body, the duty cycle being adjustable between single, multiple, variable, continuous, increasing intensity lead-in, decreasing intensity phase-out, and any combination thereof on-off periods; A medical device assembly comprising:

2. 10. The medical device assembly of claim 1, wherein the optical element further comprises at least one optical feature selected from the group of optical features consisting of a reflective surface, an optically transparent material, a lens, an optical fiber filament, and any combination thereof.

3. 10. The medical device assembly of claim 1, wherein the medical device assembly is configured to alternatively, alternately, or simultaneously deliver sterilizing EMR and healing MR.

4. 10. The medical device assembly of claim 1, further comprising at least one light diversion element for redirecting the non-ultraviolet therapeutic EMR from at least one of the EMR source or the optical element into at least one of a fluid line, a focusing chamber, and a catheter connection hub.

5. 10. The medical device assembly of claim 1, wherein the non-ultraviolet therapeutic EMR has a wavelength in the range of about greater than 380 nm to 900 nm.

6. The medical device assembly of claim 1 , wherein the length of the duty cycle is adjustable.

7. 10. The medical device assembly of claim 1, wherein the EMR source is selected from the group consisting of a solid state laser, a semiconductor laser, a diode laser, a light emitting diode, a fluorescent or an incandescent light source.

8. 10. The medical device assembly of claim 1, wherein the predetermined duty cycle delivery of the non-ultraviolet therapeutic EMR about the catheter includes delivery of non-ultraviolet therapeutic EMR to tissue adjacent the catheter.

9. 10. The medical device assembly of claim 1, wherein the on-off period of the duty cycle is based on at least one of nanoseconds, milliseconds, seconds, minutes, hours, and days.

10. 10. The medical device assembly of claim 1, wherein at least a portion of the non-ultraviolet therapeutic EMR radiation is emitted to sterilize a tubing portion of the medical device assembly between the EMR source and an insertion site outside the patient's body.

11. 10. The medical device assembly of claim 1, wherein the therapeutic effect is the inactivation of one or more infectious agents and the therapeutic effect includes inhibiting device-associated biofilm growth by radially emitting the non-ultraviolet therapeutic EMR onto the catheter.

12. 1. A medical system for delivering electromagnetic radiation (EMR) into a patient's body, the medical system comprising: a catheter having at least one lumen; 1. A medical device assembly for delivering EMR into, on, and around said catheter, comprising: A wavelength in the range of more than 380 nm to 904 nm and at least 0.5 J / cm 2 ~1 kJ / cm 2 irradiance, with a power of at least 0.005 mW to 1 W and at least 0.1 mW / cm 2 ~1 W / cm 2 an EMR source for providing non-ultraviolet therapeutic EMR having an intensity comprising at least one of a power density of 0.05 to 0.5 wt %, wherein the intensity produces a therapeutic effect of at least one of inactivating infectious agents and promoting healing; an EMR conduction system comprising at least one optical element having an elongate body that facilitates axial propagation of the non-UV therapeutic EMR along the elongate body, wherein at least one of the optical elements is at least partially insertable into and removable from at least one of the lumens of the catheter when the catheter is placed within the patient, and wherein the non-UV therapeutic EMR is emitted radially from the elongate body into the lumen and through the catheter; at least one coupling connecting the EMR source to the EMR conduction system for adjustable delivery of the non-UV therapeutic EMR from the EMR source to the optical element for axial propagation of the non-UV therapeutic EMR through the elongate body, wherein the combination of the EMR source connected to the EMR conduction system is operable to deliver an adjustable duty cycle of the non-UV therapeutic EMR into, on an exterior surface of, and about the catheter when the optical element is deployed and at least a portion of the catheter is indwelling within the patient's body, the duty cycle being adjustable between single, multiple, variable, continuous, increasing intensity lead-in, decreasing intensity phase-out, and any combination thereof on-off periods; a medical device assembly comprising: A medical system that includes:

13. 13. The medical system of claim 12, wherein the wavelength of the non-ultraviolet therapeutic EMR is selected from the group of wavelengths centered around 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.

14. 13. The medical system of claim 12, wherein the non-ultraviolet therapeutic EMR comprises one or more selected wavelengths emitted in at least one of alternating and parallel therapeutic patterns.

15. 13. The medical system of claim 12, wherein the optical element has an outer surface dimension that is smaller than an inner surface dimension of the lumen such that fluid can be injected into or withdrawn from the lumen between the inner surface of the lumen and the outer surface of the optical element when the optical element is placed within the catheter.

16. 13. The medical system of claim 12, wherein the therapeutic effect is the inactivation of one or more infectious agents, and the therapeutic effect includes inhibiting device-associated biofilm growth by radially emitting the non-ultraviolet therapeutic EMR onto the catheter.

Images