Patent Description:
The present invention is an apparatus to provide therapeutic doses of non-ultraviolet light to inactivate infectious agents residing on, within, or generally around a catheter while the catheter is residing within a body cavity and/or to stimulate healthy cell growth causing a healing effect. In particular, the disclosure is a medical device assembly that utilizes non-ultraviolet visual therapeutic electromagnetic radiation (EMR) at a high enough intensity to stimulate healthy cell growth causing a healing effect and/or to reduce or eliminate infectious agents in, on, and around a catheter while it resides inside a body cavity.

Various exemplary embodiments of the present invention are described below. Use of the term "exemplary" means illustrative or by way of example only, and any reference herein to "the invention" is not intended to restrict or limit the invention to exact features or steps of any one or more of the exemplary embodiments disclosed in the present specification. References to "exemplary embodiment," "one embodiment," "an embodiment," "some embodiments," "various embodiments," and the like, may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase "in one embodiment," or "in an exemplary embodiment," do not necessarily refer to the same embodiment, although they may.

Catheters are commonly used as channels to inject medications or retrieve fluid samples in a patient. Each catheter comprises a tube, usually derived from plastic or other polymers, such as silicone, polyurethane, and the like, that is inserted into an area of the body and may contain one or more separate lines in which these fluids may be delivered or retrieved. A "lumen" designates a pathway in the catheter that goes from outside the body to inside the body. Catheters are used in various applications, including intravascularly, abdominally, urologically, gastrointestinally, ophthalmically, within the respiratory tract, within cranial space, within the spinal column, and the like. In all cases, the catheter is placed inside of a space in the body where the catheter resides, herein referred to as a "body cavity". These devices frequently give rise to infections caused by growth of infectious agents in, on, and around the catheter. Infectious agents can include bacteria, fungi, viruses, or the like that enter the body and lead to illness of a patient. Depending on the location of the catheter placement, these infections can arise in the form of urinary tract infections, blood stream infections, soft tissue infection, and the like.

Catheter related infections (CRIs) are a large problem in medicine, leading to high morbidity and mortality rates. Current methods of reducing or eliminating the number of infectious agents in and on a catheter are of low efficacy. Typically, catheters will be removed if they are suspected to be harboring infectious agents, increasing both the cost associated with treatment and patient discomfort. Various methods to deter or eliminate growth of infectious agents in catheters have been attempted, such as using sterile handling techniques, antibiotics, and replacing the catheter when an infection is suspected. Despite these techniques, infections resulting from catheters remain a major problem. According to the Centers for Disease Control and Prevention, over <NUM>,<NUM> people died specifically from catheter-related bloodstream infections in <NUM>. These infections, along with urinary tract infections, gastrointestinal infections, and other infections from catheters, increase both medical costs and patient discomfort.

Catheters come in various sizes. Those that are smaller in diameter, such as many PICC lines (peripherally inserted central catheters), have small diameter lumens. Such smaller diameter catheters may be suitable for prolonged insertion. Consequently, with smaller diameter catheters, there may be inadequate thickness to the catheter wall to carry a sterilization and/or healthy growth enhancing delivery system.

The use of ultraviolet (UV) light, disinfecting chemicals, catheters impregnated with drugs, to name a few, have been attempted to reduce the prevalence of infection. Many patents have attempted to utilize UV light to disinfect catheters. Unfortunately, UV light is well known to cause damage to living cells. Methods to disinfect connectors, stopcocks, and valves using sterilizing electromagnetic radiation (EMR) have also been attempted using <NUM> light to sterilize these points, but these methods neglect disinfection of the catheter body as well as the tip of the catheter.

The emergence of infectious agents that are resistant to current treatments, such as methicillin-resistance staphylococcus aureus (MRSA), further substantiate the need for another treatment of CRIs. To reduce the costs associated with having to remove and replace the catheters from the patient, there is a need for a catheter that can be sterilized while residing in the patient. Additionally, it would be advantageous to be able to stimulate healthy cell growth by providing therapeutic EMR via the indwelling catheter.

Immediate disinfection after placement could help prevent the growth of biofilm on the catheter. Biofilm consists of extracellular polymeric material created by microorganisms after they adhere to a surface. This biofilm facilitates the growth of infectious agents and is very difficult to break down once it has begun to grow.

The growth of infectious agents can result from agents outside the patient (at the point of access as the catheter crosses the skin or from the catheter hub) or from inside the patient, wherein infectious agents already in the body attach to the surface of the catheter and proliferate. Scientific literature suggests that approximately <NUM>% of CRI's come from infectious agents residing on the skin of the patient (<NPL>). These agents travel down the outside of the catheter and colonize the catheter tip. For short term catheterization, this is believed to be the most likely mechanism of infection (<NPL>). Thirty percent (<NUM>%) of CRIs are believed to come from a contaminated hub, in which infectious agents travel down the interior of the catheter (Öncü). This is believed to be the most likely mechanism of infection for long-term catheterization (Crump).

EMR in the range of <NUM>-<NUM> has been shown to be effective in killing infectious agents. Research done by a group at the University of Strathclyde shows that light in this range is effective in killing surface bacteria in burn wards without harming the patients (<NPL>). Published patent application <CIT>, written by the members who conducted the study, utilizes ambient lighting to disinfect a large surrounding area. The mechanism proposed by the team suggests that light in this range leads to photosensitization of endogenous porphyrins within the bacteria, which causes the creation of singlet oxygen, leading to the death of the bacteria.

<CIT> provides a device for insertion into a mammalian patient comprises a shaft and a light delivery element. The shaft comprises a proximal end, a distal end, and a lumen therebetween. The light delivery element is constructed and arranged to deliver light to prevent infection, reduce infection and/or cause a therapeutic benefit or physiologic effect. <CIT> provides a therapeutic endotracheal tube assembly is provided for insertion into a patient's trachea to ventilate, to maintain patency of the patient's airway, and to deliver therapeutic electromagnetic radiation (EMR) to the patient. The EMR delivery system has an EMR source for emitting non-ultraviolet, therapeutic EMR having intensity sufficient to activate desired therapeutic properties within the patient and an EMR conduction line conducive to the propagation of EMR from the EMR source along the endotracheal tube.

Heretofore, however, there has never been apparatus or methods for making or using such apparatus to safely and effectively disinfect a catheter while it is still implanted in a patient. Accordingly, there exists a need for a methods and apparatus designed to deliver non-antibiotic, bactericidal therapeutics in-vivo. Such a methods and apparatus, using novel technology, may provide removable delivery of safe, effective, and reproducible disinfection and/or enhance healthy cell growth.

The exemplary embodiments of this disclosure relate to a medical device assembly for insertion into a cavity of a patient's body and for delivery and retrieval of fluids. The assembly comprises an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having intensity sufficient to inactivate one or more infectious agents and/or to enhance healthy cell growth. This catheter has an elongate catheter body with at least one internal lumen, a coupling end, and a distal end. This distal end is insertable into the cavity of the patient's body whether the cavity is venous, arterial, gastrointestinal, abdominal, urological, respiratory, cranial, spinal, or the like, wherein the indwelling catheter body directs both the fluid and the propagation of the therapeutic EMR axially relative to the catheter body for radial delivery into the patient's body and/or at the distal end. An optical element disposed within a lumen of the catheter body and/or within the catheter body acts conducive to the axial propagation of the therapeutic EMR relative to the catheter body. The optical element or another optical element also may be disposed to act conducive to propagation of therapeutic EMR through at least one coupling element to connect the EMR component to the insertable catheter component.

For the purposes of this disclosure the use of the term "therapeutic" should be understood to mean of or relating to the treatment of disease, including reducing or eliminating infectious agents, as well as serving or performed to maintain health, including enhancing healthy cell growth.

The exemplary medical device assembly comprises an EMR source, an EMR conduction system, and at least one coupling to connect the EMR source to the EMR conduction system. The EMR source provides non-ultraviolet, therapeutic EMR having intensity sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect. In at least one exemplary embodiment, the EMR conduction system may be at least partially insertable into and removable from the lumen of an indwelling catheter.

In some exemplary embodiments, methods and apparatuses are provided for effectively sterilizing a catheter and the surrounding area while in a body cavity. Such medical device assemblies use sterilizing EMR to reduce or eliminate the count of infectious agents in, on, or around the catheter while in a body cavity.

The EMR source can be from a single or group of EMR sources including, but not limited to, a light emitting diode, a semiconductor laser, a diode laser, an incandescent (filtered or unfiltered) and a fluorescent (filtered or unfiltered) light source. This EMR source provides non-ultraviolet, therapeutic EMR providing one or more wavelengths in the range of above <NUM> to about <NUM>. In order to provide sufficient inactivation of infectious species and/or stimulation of healthy cell growth, each EMR wavelength should be of a narrow spectrum and centered around one wavelength from the group. The intensity should be sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect. This group includes several wavelengths centered about: <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

The EMR source may require drivers and electronic support for full functionality. Consideration should be given to accommodating the support hardware and/or software, which may encompass a significant portion of the EMR source's functionality and efficacy. It is possible that the EMR source may generate heat, which could be detrimental to the EMR source and may need to be limited.

This disclosure describes a catheter having an elongate catheter body with at least one internal lumen, a coupling end and a distal end, the distal end being insertable into the cavity of the patient's body. The catheter body is meant to direct both the fluid and the therapeutic EMR axially relative to the catheter body for delivery into the patient's body at the distal end. This disclosure includes an optical element disposed within the catheter body and conducive to the axial propagation of the therapeutic EMR through the catheter body. Finally, this disclosure describes at least one coupling element to connect the radiation source to the catheter body.

The sterilizing EMR is transmitted down a specialized path within the catheter via an optical element conducive to the axial propagation of the light. Various methods could be used to facilitate axial propagation of the light relative to the catheter, including a reflective coating within a line of the catheter, a fiber optic cable, a lens, a waveguide, or the like. The light source can be a light-emitting diode (LED), laser, fiber optic filament, or the like.

One exemplary embodiment of the EMR source and support components is simplified to contain only the EMR source and necessary components. In another exemplary embodiment of the EMR conduction system, a passive heat sink is required to diffuse the heat generated into the surrounding environment. In yet another exemplary embodiment of the EMR source, a heat sink may be couple to at least one fan to actively dissipate heat generated by the EMR source.

Of particular interest to this disclosure is the use of light between <NUM> and about <NUM> wavelengths. Additionally, the intensity and power of the light emitted bear significantly on the inactivation of infectious agents, thus a range of radiant exposures covering <NUM> J/cm<NUM> to <NUM> kJ/cm<NUM> and a range of powers from <NUM> mW to <NUM> W, and power density range covering <NUM> mW/cm<NUM> and <NUM> W/cm<NUM> are of interest for these exemplary device assemblies and methods. These ranges of wavelengths, power densities, and radiant exposures have been shown to have either antimicrobial effects or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased proliferation of fibroblasts, stimulation of collagen synthesis, angiogenesis inducement and granulation tissue formation.

For each exemplary embodiment described herein, the EMR conduction system and method for disinfection/healing could be utilized in an adjustable or predetermined duty cycle. If treatments begin immediately after sterile procedure was initiated, device related infections may be inhibited. This includes device related biofilm growth.

A treatment may include at least one wavelength of therapeutic EMR that acts as a predominant wavelength selected to sterilize one or more target organisms and selected from the group of wavelengths centered about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>. Or, a predominant wavelength selected to promote healing and healthy cell growth may be selected from the group of wavelengths centered about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>. Another treatment may include alternating the predominant wavelength between a first predominant wavelength and a second predominant wavelength (differing from the first predominant wavelength) in a selected treatment pattern. Further, sterilizing EMR and EMR that stimulates healthy cell growth may be transmitted simultaneously in tandem or alternatively.

A method for constructing an exemplary medical device assembly for insertion into a cavity of a patient's body and for delivery of a fluid to or retrieval from the patient's body may comprise the steps of: providing a catheter having an elongate catheter body with at least one internal lumen, a coupling end and an distal end, the distal end being insertable into the cavity of the patient's body; applying an optical element within the at least one lumen of the catheter body and/or within a wall of the catheter body, the optical element being conducive to the axial propagation of therapeutic EMR relative to the catheter body; and coupling an EMR source to the catheter body, the EMR source for providing non-ultraviolet, therapeutic EMR having an intensity sufficient to inactivate one or more infectious agent and/or to enhance healthy cell growth.

In one exemplary embodiment, the device uses a catheter that is inserted into a cavity of a patient's body, wherein said catheter allows both fluid and therapeutic EMR to travel axially relative to the catheter body. The catheter also contains at least one coupling lumen to connect an EMR source that will transmit the therapeutic EMR through the coupling lumen and axially relative to the catheter line. A coupling element in this context will usually refer to a typical hub on the therapeutic EMR source.

At least one coupling connects the radiation source to the EMR conduction system and, in some exemplary embodiments, may comprise at least one feature that allows for the coupling to be readily removable from the EMR conduction system. The exemplary coupling may be achieved by utilizing a uniquely designed connection, a pre-manufactured coupling system, or any combination thereof that optimizes the coupling efficiency and utility. Further, such couplings couple the removably insertable EMR conduction system to the EMR source and may comprise more than one coupling with an intermediate section optimized to further the propagation of the EMR. In one exemplary embodiment, the EMR source may be coupled to a patch cable or EMR conduction extending segment, which is then coupled to the formal removably insertable EMR conduction system.

The optical element further may comprise at least one optical feature selected from a group of optical features such as a reflective surface, an optically transmissible material, a lens, a fiber optic filament, and any combination thereof. The optical element also may be capable of transmitting more than one wavelength or intensity EMR. Multiple wavelengths may be transmitted simultaneously, one after another or in tandem, or a combination thereof (for example, one constantly on and the other wavelength pulsed). Multiple intensities may be transmitted through the same element simultaneously. Alternating patterns of light treatments may also be transmitted.

The EMR conduction system may be configured to insert, at least partially, into one of any number of catheters, such as by way of example only and not to be limiting: a central venous catheter, a peripheral insertion catheter, a peripheral insertion central catheter, a midline catheter, a jugular catheter, a subclavian catheter, a femoral catheter, a cardiac catheter, a cardiovascular catheter, a urinary Foley catheter (see <FIG> and <FIG>), an intermittent urinary catheter, an endotracheal tube, a dialysis catheter (whether hemodialysis or peritoneal dialysis), a gastrointestinal catheter, a nasogastric tube, a wound drainage catheter, or any similar accessing medical catheter or tube that has been inserted into a patient for the purpose of delivering or retrieving fluids or samples.

One exemplary embodiment of the EMR conduction system has an optical element comprising a single, insertable optical fiber. With a single optical fiber, the single fiber may allow light to transmit radially or axially at various sections along its length. For sections where light will transmit radially, the exterior surface of the optical element may be altered to facilitate the radial emission of the EMR. The alteration of the exterior surface may be achieved by chemical etching, physical etching, or electromagnetic ablation through plasma or lasers to create various radial emission portions along the length of the optical fiber. The radial emission portions permit light to emit radially from the optical fiber.

For purposes of this disclosure, light emitted radially means that the light has a radial component. Hence, the light emitted radially may emit perpendicularly and/or obliquely to the central axis of the optical fiber at the axial point of emission.

For embodiments having radial emission sections, the material comprising the optical fiber may be selected from a group of materials comprising optical fibers including plastic, silica, fluoride glass, phosphate glass, chalcogenide glass, and any other suitable material that is capable of axial light propagation and surface alteration to achieve radial emission. In addition, the optical fibers may be single mode, multi-mode, or plastic optical fibers that may have been optimized for alteration using a chemical, physical, or electromagnetic manufacturing alteration process. The optical fibers may also be optimized for alteration post-production.

Yet another exemplary embodiment employs a physical abrasion method of alteration to modify the EMR conduction system comprised of at least one optical fiber. This fiber would be utilized based on its optimal optical response to the physical abrasion process. This process may include, but is not limited to, sanding, media blasting, grinding, buffing, or media blasting at least one section of the optical fiber. The physical abrasion process would also necessarily be optimized in terms of the extent of physical abrasion to optimize the appropriate radial EMR emission or lack thereof. This may be accomplished by adjusting at least one of the velocity, acceleration, pressure, modification time, or abrasion material utilized in modifying the optical fiber.

Yet another exemplary embodiment employs microscopic porous structures suspended within the optical fiber to achieve radial transmission of light. These microscopic structures may be positioned within the core and/or core-cladding boundary of the optical fiber. The microscopic structures having a refractive index lower than the region free of microscopic structures. The microscopic structures may be a material added to the optical fiber core or the core-cladding boundary, such as a metal, rubber, glass, or plastic. The microscopic structures may also be the lack of material creating an aberration within the optical fiber core or the core-cladding boundary. For example, the presence of microscopic bubbles in the optical fiber core would create an aberration or imperfection that would alter the materials refractive index, resulting in EMR being emitted radially from the optical fiber.

Another exemplary embodiment may comprise at least one optical fiber with cladding altered to optimize the radial or axial propagation of EMR. For example, the cladding may be altered to at least partially remove or thin the cladding in order to achieve partial radial transmission of EMR. Another example could include an optical fiber with only certain portions containing cladding, the EMR transmitting axially in the clad portions and at least partially axially and radially in the non-clad portions.

Yet another exemplary embodiment achieves uniform radial transmission wherein the radial emission portion of the optical fiber has substantially equivalent intensity over the length of the radial emission portion along the optical fiber. This may be done through chemical etching, physical etching, plasma ablation, or laser ablation in a gradient pattern. By altering at least one of the velocity, acceleration, pressure gradients, flow, modification time, or modification material or process, it is possible to achieve radial transmission equivalency throughout each portion or the entire length of the modified optical fiber. During manufacturing, a gradient-provided uniformity also may be achieved through addition of microscopic structures positioned within the core and/or core-cladding boundary in a gradient pattern. Also, radial transmission uniformity achieved through gradient cladding or core features are contemplated for achieving desired radial emission, whether substantially uniform over a portion length or varying as desired.

Still another exemplary embodiment achieves a gradient radial transmission wherein at least one portion of the optical fiber emits EMR radially in a gradient distribution. The gradient distribution may also be accomplished through chemical etching, physical etching, plasma or laser ablation in a uniform or gradient pattern. By altering at least one of the velocity, acceleration, pressure gradients, flow, modification time, or modification material or process, it is possible to achieve a gradient radial transmission throughout a portion of the optical fiber. This may also be achieved through addition of microscopic structures positioned within the core and/or core-cladding boundary.

A further exemplary embodiment of a removably insertable EMR conduction system comprises an optical element such as at least one LED, its associated wiring components, and a scaffold. The LED(s) may emit EMR based on the LED's inherent distribution, or may utilize another optical element, such as a lens or mirror, to focus or diffuse the EMR in the direction of interest. In addition, more than one LED could be arranged in an array to appropriately emit EMR for maximal therapeutic benefit. The LED(s), together with associated wiring components may be permanently or removably attached to the scaffold, which allows for removable insertion of the EMR conduction system into a catheter. The scaffold may be rigid, semi-rigid, malleable, elastic, or flexible, or any combination thereof.

In another exemplary embodiment, a catheter with multiple lumens for fluid injection or retrieval contains a separate lumen for transmission of the therapeutic EMR. Each lumen may have a separate proximal catheter hub assembly. These internal lumens converge at a convergence chamber, where individual internal lumens consolidate into a single elongated catheter body while retaining their individual internal paths. Such exemplary device may include use of an optical method for diverting the radiation between the convergence chamber and axially through the designated catheter internal lumen.

Samples retrieved through the distal end are often used to characterize the type of infection. One exemplary embodiment of the disclosure focuses on maintaining axial propagation of the light relative to the catheter and delivering therapeutic light of sufficient intensity to the distal end of the catheter to reduce or eliminate the count of infectious agents residing thereon.

In yet another exemplary embodiment, the medical device assembly aforementioned would be used in a urological setting. The catheter (such as a Foley catheter) would be placed into the urethra and bladder of the urinary tract.

In yet another exemplary embodiment, the medical device assembly aforementioned would be used in a gastrointestinal setting.

In yet another exemplary embodiment, the medical device assembly aforementioned would be used in an intravascular setting.

In yet another exemplary embodiment, the medical device assembly aforementioned would be used within the cranial cavity of a patient.

In yet another exemplary embodiment, the medical device assembly aforementioned would be used within the spinal cavity of a patient.

In still another exemplary embodiment, the medical device assembly aforementioned would be used within an ophthalmic cavity of a patient.

In still another exemplary embodiment, the medical device assembly would be used within a dialysis catheter (whether hemodialysis or peritoneal dialysis).

Exemplary embodiments of the invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the invention's scope, the exemplary embodiments of the present disclosure will be described with additional specificity and detail through use of the accompanying drawings in which:.

Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the exemplary embodiments, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the exemplary embodiments of the apparatus, system, and method of the present disclosure, as represented in <FIG>, is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments.

The phrases "attached to", "secured to", and "mounted to" refer to a form of mechanical coupling that restricts relative translation or rotation between the attached, secured, or mounted objects, respectively. The phrase "slidably attached to" refer to a form of mechanical coupling that permits relative translation, respectively, while restricting other relative motions. The phrase "attached directly to" refers to a form of securement in which the secured items are in direct contact and retained in that state of securement.

The term "abutting" refers to items that are in direct physical contact with each other, although the items may not be attached together. The term "grip" refers to items that are in direct physical contact with one of the items firmly holding the other. The term "integrally formed" refers to a body that is manufactured as a single piece, without requiring the assembly of constituent elements. Multiple elements may be formed integral with each other, when attached directly to each other to form a single work piece. Thus, elements that are "coupled to" each other may be formed together as a single piece.

Referring now to <FIG>, a catheter <NUM> is insertable into a patient's body <NUM>. An assembly of the present disclosure comprises a non-ultraviolet, electromagnetic radiation (EMR) component <NUM>, and an insertable catheter component <NUM>. The non-ultraviolet, EMR component <NUM> broadly comprises an elongate body <NUM> used to enclose the EMR power source <NUM> and a coupling element <NUM> to couple the two components of the assembly. The EMR used manifests as visible light emitted in a range from <NUM> to <NUM> having a high intensity sufficient to create a therapeutic effect such as inactivating one or more infectious agents and/or enhancing healthy cell growth. In some embodiments, the EMR source <NUM> has an adjustable duty cycle length so that the EMR can be provided with appropriate desired intensity at the most effective times and for beneficial time periods.

The catheters <NUM> depicted in <FIG> are exemplary multiple lumen catheters <NUM> each of which also comprises line tubing <NUM>, one or more (in <FIG>, <FIG>, and <FIG> two are shown, in <FIG> and <FIG>, three are shown) proximal catheter hub assemblies <NUM>, an elongate catheter body <NUM>, a distal end <NUM> with one or more apertures <NUM> that open into internal lumens <NUM>, and a convergence chamber <NUM>. Each internal lumen <NUM> has an inner diameter (i.e., an interior surface dimension, for example see outer diameter <NUM> of <FIG>) and runs the length of the catheter <NUM>, from the proximal catheter hub assembly <NUM>, through the line tubing <NUM>, the convergence chamber <NUM>, and the elongate catheter body <NUM>, to the distal end <NUM>. Fluids may be injected into the lumen <NUM> and exit through the aperture <NUM> into the patient's body <NUM>, or fluids may be drawn from the patient's body <NUM> through the aperture <NUM> into the lumen <NUM>. Additionally, some catheters <NUM> may have inflatable balloon cuffs <NUM> (see <FIG> and <FIG>) that may seal the catheter <NUM> against the wall of the patient's body <NUM> cavity into which the catheter <NUM> is inserted. The optical element <NUM> is elongate may be a reflective coating or it may be a fiber optic with an outer diameter (i.e., an exterior surface dimension, for example see outer diameter <NUM> of <FIG>) sufficiently small to be insertable within at least one of the internal lumens <NUM> and may extend at least as far into the catheter <NUM> as a termination of the optical element <NUM>, although the insertion may be less than that length if desired.

Catheters <NUM> suitable for use with an insertable optical element <NUM> may be of several different makes, sizes, and functions. For example, a urinary catheter <NUM> (see <FIG> and <FIG>) inserted through a patient's urethra <NUM> into a patient's bladder <NUM> may have an input port <NUM>, an output port <NUM>, and an inflatable balloon cuff <NUM> to facilitate draining urine from the patient's bladder <NUM> while permitting fluids (or in the case of the present disclosure therapeutic EMR) to be injected into the patient's body <NUM>. As another example, catheters <NUM> that are translucent may be particularly suited to permit the passage of radially emitted EMR through the catheter wall <NUM> (see an exemplary catheter wall <NUM> in <FIG>) to the tissue surrounding the catheter <NUM>. Catheters <NUM> that have an interior surface dimension (inside diameter <NUM>) sufficiently larger than the exterior surface dimension (outer diameter <NUM>) of the insertable optical element <NUM> create a void <NUM> or passageway (see <FIG>) that may permit the injection or withdrawal of fluid (liquid or gas) simultaneously through the catheter <NUM> while that insertable optical element <NUM> resides within the catheter <NUM>.

Also, some catheters <NUM> have radiopacifiers embedded within the walls of the catheter <NUM> so that an image of where the catheter <NUM> is located within the patient's body <NUM> may be determined. However, some catheters <NUM> have no such radiopacifiers. In either case, it is contemplated by this disclosure that radiopacifiers may be contained in or on the insertable optical element <NUM> to provide detection of the location of the catheter <NUM> within the patient's body <NUM> when the catheter <NUM> does not have radiopacifiers, and to provide detection of the location of the insertable optical element <NUM> disposed within the catheter <NUM> whether or not the catheter <NUM> has radiopacifiers (this may require differing radiopacifiers in some instances so that the catheter <NUM> and the insertable optical element <NUM> may be distinguished).

With some exemplary embodiments, at least one of the proximal catheter hub assemblies <NUM> may have an optical fiber element alignment shaft <NUM> that aligns an optical element connector <NUM> and the insertable optical element <NUM>.

<FIG> and <FIG> show the catheter <NUM>, in a schematic view, inserted at an insertion site A in the chest of the patient's body <NUM> (<FIG>) and in an arm of the patient's body <NUM> (<FIG>), respectively. The depiction shows how non-ultraviolet, therapeutic EMR may be delivered at the insertion site A and to other sites within the patient's body <NUM>. At the insertion site A, the therapeutic EMR may be delivered to a transdermal area <NUM> to inactivate infectious agents in that area and to enhance healing of the insert site A. Similarly, proximate the distal end <NUM>, in this case within the vena cava, therapeutic EMR may be delivered to inactivate infectious agents and/or to enhance healing in that proximate vicinity.

Referring specifically to <FIG> of the present disclosure, a schematic view of another embodiment of the medical device assembly comprises a non-ultraviolet, EMR component <NUM>, and an insertable catheter component <NUM>. The embodiment shown is specifically a tunneled triple lumen central line variation of the disclosure; however it should be understood that the catheter may encompass any type of accessing catheter <NUM> (e.g., vascular, gastrointestinal, etc.) without departing from the scope of the invention. The non-ultraviolet EMR component <NUM> is coupled to the proximal catheter hub assembly <NUM> of the insertable catheter component <NUM>. The other coupling hubs <NUM> are available for axial propagation of fluid (whether by injection or retrieval). Each designated internal lumen <NUM> propagates the EMR or fluid between its proximal catheter hub assembly <NUM> and distal end <NUM>.

Although the triple lumen catheters <NUM> of <FIG> and <FIG> depict specific uses of the triple lumen catheter <NUM>, it should be understood that a triple lumen embodiment may be a desirable option in areas where multiple fluid delivery or extraction is necessary simultaneously. For example, in hemodialysis, venous and arterial blood is exchanged simultaneously. Similarly, in peritoneal dialysis, fluids and dissolved substances (electrolytes, urea, glucose, albumin, and other small molecules) are exchanged from the blood by catheter access through peritoneum in the abdomen of a patient. This exemplary triple lumen embodiment allows for the delivery of therapeutic EMR simultaneously with such dialysis function.

The incision site A and the proximate transcutaneous region of the insertable catheter body <NUM> is often a high source of infections. To reduce infections at this site and in this region, a dedicated area <NUM> is a region that facilitates radial emission of the therapeutic EMR from the optical element <NUM> within the elongate catheter body <NUM>. This allows the sterilizing EMR to irradiate outward and inactivate the infectious agents at the insertion site A and transcutaneous in that region.

Proximate the distal end <NUM> of the elongate catheter body <NUM>, the optical element <NUM> discontinues at termination point <NUM> so that the therapeutic EMR can irradiate throughout the distal end <NUM> of the catheter <NUM> and the surrounding cavity area.

The EMR component <NUM> comprises the EMR power source <NUM> (<FIG>), a light source (not shown, such as a laser or the like), electrical circuitry (not shown), and optics (not shown, but dependent upon the light source) all housed within an elongate body <NUM>. A coupling element <NUM> connects the EMR component <NUM> to an optical assembly <NUM>. The optical assembly <NUM> comprises the insertable optical element <NUM> and the optical element connector <NUM>. The combination of the EMR component <NUM>, the coupling element <NUM>, and the optical assembly <NUM>, comprising the insertable optical element connector <NUM> and the insertable optical element <NUM>, will be referred to herein as an EMR conduction system <NUM>. In some embodiments, the EMR conduction system <NUM> is removable from its inserted disposition within the catheter <NUM>. When the EMR conduction system <NUM> is insertably removable, therapeutic EMR may be directed into an existing indwelling catheter <NUM> in a retrofit context.

Of particular interest to each of the embodiments is the use of light having wavelengths ranging from above <NUM> and about <NUM>. Additionally, the intensity and power of the light emitted server to inactivate of infectious agents and/or to promote healing. A range of radiant exposures covering <NUM> J/cm<NUM> to <NUM> kJ/cm<NUM> and a range of powers from <NUM> mW to <NUM> W, and power density range covering <NUM> mW/cm<NUM> and <NUM> W/cm<NUM> are of interest for these exemplary device assemblies and methods. These ranges of wavelengths, power densities, and radiant exposures have been shown to have either antimicrobial effects or positive biological effects on healing tissue. These positive biological effects include reduction of inflammatory cells, increased proliferation of fibroblasts, stimulation of collagen synthesis, angiogenesis inducement and granulation tissue formation.

For each exemplary embodiment described herein, the EMR conduction system <NUM> and method for disinfecting/healing could be utilized in an adjustable or predetermined duty cycle. If treatments began immediately after sterile procedure has been initiated, device-related infections may be inhibited. This includes device-related biofilm growth.

Additionally, although a wavelength in a range from <NUM> to <NUM> with a sufficient intensity will inactivate one or more infectious agents and/or enhance healthy cell growth, more precise wavelengths may have more particular efficacy against certain infectious agents or for a desired healing purpose. It has been determined that sterilizing EMR of wavelengths including wavelengths centered about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> have particular efficacy. A wavelength selected to promote healing and healthy cell growth may be selected from the group of wavelengths centered about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

The insertable catheter component <NUM>, being capable of at least partially being inserted into a cavity of the patient's body <NUM> to deliver the non-ultraviolet, therapeutic EMR, comprises of at least one internal lumen <NUM>, a proximal catheter hub assembly <NUM>, and a distal end <NUM>. An internal lumen <NUM> being simply defined as the internal path by which fluid or EMR may travel. In cases of a single or multi-lumen catheter <NUM>, similar features in the drawings will be labeled with the same number. It should be noted that examples of multi-lumen catheters are described and depicted in the parent application (<CIT>) which has been incorporated into this application by a specific reference above. In multi-lumen embodiments, a dedicated single lumen may also be designated for the axial propagation of EMR and each additional lumen dedicated for the injection or retrieval of fluid axially. In this way both fluid and EMR can be axially propagated simultaneously through their individual lines and the EMR-delivering optical element <NUM> and fluids need not occupy the same lumen.

The distal end <NUM> being insertable into the cavity of the patient's body <NUM> at a determined incision site A, enables the elongate catheter body <NUM> to direct the delivery and/or retrieval of fluid and the therapeutic EMR axially relative to the elongate catheter body <NUM> for delivery into the patient's body <NUM>. The elongate catheter body <NUM> is described as being an elongated catheter <NUM> having at least one internal lumen <NUM>. Another embodiment of the present disclosure is depicted in <FIG>, showing a perspective view of a dual lumen catheter <NUM> with the removable EMR conduction system <NUM> outside the catheter <NUM>. The catheter <NUM> portion of the depiction shows flexible protection tubing <NUM> that protects the coupling of the proximal catheter hub assembly <NUM> with the line tubing <NUM> and also protects line tubing <NUM> from wear imposed by line clamps <NUM>.

Therapeutic EMR will travel axially relative to the catheter <NUM> which may be of varying lengths <NUM> depending on its specific need. The fluids passing through the internal lumen <NUM> may be injected and contain pharmacological compounds (e.g., a drug) or may be retrieved biological fluids (e.g., blood, urine, or cerebral spinal fluid).

This figure depicts a multi-lumen embodiment of the disclosure. Each multi-lumen embodiment may contain a convergence chamber <NUM>, at the point where individual internal lumens <NUM> converge into a single elongated catheter body <NUM> while retaining their individual internal paths. At the distal end <NUM> of the elongate catheter body <NUM>, the optical element <NUM> discontinues at the termination point <NUM> so that the therapeutic EMR can irradiate throughout the distal end <NUM> of the catheter <NUM> and surrounding cavity area.

This embodiment also is fitted with flexible protection tubing <NUM> to protect the lumen at the proximal catheter hub assembly <NUM> and between the proximal catheter hub assembly <NUM> and convergence chamber <NUM>. If manual line occlusion is necessary it may be performed with the line clamp <NUM>.

<FIG> shows the dual lumen catheter <NUM> of <FIG> with the removably insertable EMR conduction system <NUM> partially inserted into one of the lumens <NUM> of the catheter <NUM>.

<FIG> shows an exploded perspective view of an exemplary EMR conduction system <NUM> as partially inserted into the proximal catheter hub assembly <NUM> and an internal lumen <NUM>. With this exemplary embodiment, an intermediate coupling <NUM> is shown. Such intermediate coupling <NUM> may comprise a patch cable <NUM> or an EMR conduction extending segment <NUM> used to extend the distance between the EMR power source <NUM> and the optical element connector <NUM> of the insertable optical element <NUM>, without appreciable loss of light intensity. Each of the patch cable <NUM> or EMR conduction extending segment <NUM> may have a forward connector <NUM> to securely engage coupling element <NUM>, and a rearward connector <NUM> to securely engage the optical element connector <NUM>. Hence, by using a patch cable <NUM> or an EMR conduction extending segment <NUM>, the EMR power source <NUM> may be operated some desired distance from the patient to reduce noise or heat concerns and/or to position the EMR power source <NUM> closer to a power source (not shown) such as an electrical outlet or battery pack.

<FIG>is a series of illustrative cross sectional views of alternative optical elements <NUM> as disposed within an exemplary single-lumen catheter <NUM>. Of course, multi-lumen catheters <NUM> are also contemplated by this disclosure and the context of <FIG>can easily be understood by those skilled in the art to apply equally to multi-lumen catheters <NUM> wherein one or more optical elements <NUM> may reside within one or more of the multiple lumens <NUM>. The depiction of single lumen catheter <NUM> cross sections is provided in the interest of brevity. However, examples of multi-lumen catheters are described and depicted in the parent application (<CIT>) which has been incorporated into this application by a specific reference above.

<FIG> is a cross sectional view along line B-B of <FIG> showing an exemplary embodiment of a cladding-encased fiber optic <NUM> as centered within a lumen <NUM> of the catheter line tubing <NUM>. However, <FIG> may also depict a cross section of a single lumen catheter <NUM>. The single lumen line tubing <NUM>/catheter <NUM>, depicted in cross section, has an inner diameter <NUM> and a catheter wall <NUM>. The cladding-encased fiber optic <NUM> is an optical element <NUM> and has an outer diameter <NUM>, a core-cladding boundary <NUM> and a cladding outer boundary <NUM>. When the cladding-encased fiber optic <NUM> is centered, as depicted in <FIG>, an annular void <NUM> is created between the cladding outer boundary <NUM> and the catheter wall <NUM> when the inner diameter <NUM> of the catheter wall <NUM> is larger than the outer diameter <NUM> of the cladding-encased fiber optic <NUM>. Fluids may travel through this void <NUM>, whether by injection or retrieval, when the cladding-encased fiber optic <NUM> resides within the lumen <NUM> of a single lumen catheter <NUM> (or a EMR designated lumen <NUM> within a multi-lumen catheter <NUM>.

<FIG> is a cross sectional view along line B-B of <FIG> showing an exemplary embodiment of the cladding-encased fiber optic <NUM> non-centered within a lumen <NUM> of the catheter line tubing <NUM>. Similarly, <FIG> may also depict a cross section of a single lumen catheter <NUM>. However, the void <NUM> formed within the lumen <NUM> is not annular, and without structure to hold the cladding-encased fiber optic <NUM> in a centered disposition, the non-centered disposition may occur when the optical element <NUM> is removably inserted into the lumen <NUM> of the catheter <NUM>. Consequently, the therapeutic EMR emitted radially from the optical element <NUM> must pass through the void <NUM> before reaching and passing through the catheter wall <NUM>. Especially when there is fluid present within the void <NUM>, the intensity of the therapeutic EMR may need to be increased so that the therapeutic EMR emerging from the catheter wall <NUM> is sufficient to inactivate infectious agents and/or to enhance healthy cell growth in the tissue surrounding the indwelling catheter <NUM>.

<FIG> is a cross sectional view along line B-B of <FIG> showing another exemplary embodiment of a bare fiber optic <NUM> as centered within a lumen <NUM> of the catheter line tubing <NUM>. With this embodiment, the void <NUM> is created between the catheter wall <NUM> and the exterior surface <NUM> of the bare fiber optic <NUM>.

<FIG>is a series of elevation views of several exemplary embodiments of an optical assembly <NUM> showing various locations with gradient degrees of alteration on the exterior surface <NUM> of the insertable optical element <NUM>. Each view of the series of views shows an optical assembly <NUM> with an insertable optical element <NUM> connected to the optical element connector <NUM>. The optical element connector <NUM> (see also <FIG> and <FIG>) has a connecting element <NUM>, an EMR hub connection <NUM>, a collimating lens <NUM>, and an alignment shaft <NUM>.

The first view (uppermost, <FIG>) of the series of views shows an unaltered optical span <NUM> of the insertable optical element <NUM> that is without any radial dispersion (i.e., the insertable optical element <NUM> has not been treated or altered to provide radial emission of light from the body of the insertable optical element <NUM>). With this embodiment, therapeutic, non-ultra-violet EMR may be provided to a distal end <NUM> of the optical element <NUM> with no radial emission from the optical span <NUM> other than at the distal end <NUM>.

The second view (next view down, <FIG>) of the series of views shows an exemplary radial transmission equivalency over a radial emission portion <NUM> (i.e., radial emission portion <NUM>, as depicted, has a gradient modification such that the emitted EMR has substantially uniform intensity and power over the length of the radial emission portion <NUM>) that provides radially dispersed light from a segment-modified optical span <NUM>. The location of the single radial emission portion <NUM>, in this instance, corresponds to where the catheter <NUM> enters the insertion site A when the insertable optical element <NUM> is inserted fully into the catheter <NUM>. With this embodiment, radially emitted visual light may sterilize and/or enhance healthy cell growth at the insertion site A and the transdermal area <NUM> or any other predetermined site within the patient's body <NUM>.

Each of the views in <FIG>depicts a gradient modification to facilitate emitting EMR in a pattern wherein there is substantially uniform intensity and power over the length of the radial emission portion(s). It should be understood, however, that although each of the views depict EMR of uniform intensity and power, any desired pattern of EMR emission may be achieved by varying the degree of modification within the radial emission portion because less ablation will permit less radial emission of EMR and more ablation will permit more radial emission of EMR. For example, a radial emission portion with less oblation proximate each end and more ablation in the middle will emit EMR of lesser intensity and power on each end with more intensity and power emitting in the middle. Hence, the desired pattern of EMR emission is created by adjusting the pattern of ablation within the radial emission portion.

The third view of the series of views (<FIG>) shows an example of a single radial emission portion <NUM> that provides radially dispersed EMR from optical element <NUM> extending along most of a fully-modified optical span <NUM>. The location of the single radial emission portion <NUM> corresponds generally to the entire length of the insertable catheter component <NUM> of the catheter <NUM>. With this embodiment, therapeutic EMR may be provided for substantially the entire length that the catheter <NUM> that would be inserted within the patient's body <NUM>.

The fourth view of the series of views (<FIG>) shows an example of radial transmission uniformity at multiple locations. A single radial emission portion <NUM> and an additional distal end region radial emission portion <NUM> are spaced along a multi-modified optical span <NUM>. The locations of the radial emission portion <NUM> and the distal end region radial emission portion <NUM> correspond to areas of the body, including for example the insertion site A, where the delivery of non-ultraviolet, therapeutic EMR may be desired for sterilization and/or healing. It should be understood that there may be more than one radial emission portion <NUM> disposed along the length of the multi-modified optical span <NUM> and/or each radial emission portion <NUM> may be distinct from each other radial emission portion <NUM> and each may have differing lengths.

Also, it should be understood that in each of these views the radial emission portions depicted may be of modifications other than modification of the exterior surface <NUM> of the insertable optical element <NUM>, such as for example, modifications including microscopic structures embedded within the insertable optical element <NUM> that allow radial transmission of light from the insertable optical element <NUM>. Further, such radial emission portions <NUM>, <NUM>, <NUM> may have gradient patterns that allow for an overall substantially-uniform distribution of light over the length of each radial emission portion <NUM>, <NUM>, <NUM>.

<FIG> is a schematic view of an optical assembly <NUM> with an insertable optical element <NUM> coupled to an optical element connector <NUM>. The insertable optical element <NUM> has a fully-modified optical span <NUM>. Multiple locations along the insertable optical element <NUM> are shown in enlarged cross-sectional views. These locations are axially spaced along the insertable optical element <NUM> to assist in describing the nature of an exemplary insertable optical element <NUM> at each location. As depicted, there are four section locations, a first section <NUM>, a second section <NUM>, a third section <NUM>, and a fourth section <NUM>. For brevity, the modifications on and in the insertable optical element <NUM> at each of the four sections are combined in the depictions of <FIG>. Of course, the radial emission portions of the insertable optical element <NUM> may be singular or multiple, may be any length or gradient, and may be coincident, overlapping or not.

The first section <NUM> represents an internally reflected region of the insertable optical element <NUM>. As shown at the first section <NUM>, there is no ablation (or other modification) and no microscopic structure within the core <NUM> of the insertable optical element <NUM>. No therapeutic non-ultraviolet EMR will emit radially from the insertable optical element <NUM> at the first section <NUM>.

The second section <NUM> represents a minimally emissive region of the insertable optical element <NUM>. As shown at the second section <NUM>, there is minimal ablation (or other modification) to the exterior surface <NUM> of the insertable optical element <NUM> and a minimal dispersal of microscopic structures <NUM> within the core <NUM> of the insertable optical element <NUM>. From the second section <NUM>, minimal therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element <NUM>. However, the amount of EMR emitted should have sufficient intensity and power to inactivate infectious agents and/or promote healing proximate the second section <NUM>.

The third section <NUM> represents a moderately emissive region of the insertable optical element <NUM>. As shown at the third section <NUM>, there is moderate ablation (or other modification) to the exterior surface <NUM> of the insertable optical element <NUM> and moderate dispersal of microscopic structures <NUM> within the core <NUM> of the insertable optical element <NUM>. From the third section <NUM>, a moderate amount of therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element <NUM> proximate the third section <NUM>. However, prior to reaching the third section <NUM>, the amount of light traveling axially along the insertable optical element <NUM> diminishes due to the radial emission of some of the light such as at second section <NUM>. Consequently, the degree of the gradient of modification is selected so that the amount of EMR emitted radially at third section <NUM> should be substantially uniform with the radial emission at the second section <NUM>. Hence, the intensity and power of the EMR emitted may be substantially uniform with the intensity and power emitted at second section <NUM> and is of sufficient intensity and power to inactivate infectious agents and/or promote healing.

The fourth section <NUM> represents a maximally emissive region of the insertable optical element <NUM>. As shown at the fourth section <NUM>, there is maximal ablation (or other modification) to the exterior surface <NUM> of the insertable optical element <NUM> and maximal dispersal of microscopic structures <NUM> within the core <NUM> of the insertable optical element <NUM>. From the fourth section <NUM>, a maximum amount of therapeutic, non-ultraviolet EMR will emit radially from the insertable optical element <NUM> proximate the fourth section <NUM>. Again, prior to reaching the fourth section <NUM>, the amount of light continuing to travel axially along the insertable optical element <NUM> diminishes due to the radial emission of some of the light such as at second section <NUM> and at third section <NUM>. Consequently, the degree of the gradient of modification is selected so that the amount of EMR emitted radially at fourth section <NUM> should be substantially uniform with the emissions at second section <NUM> and third section <NUM>. The intensity and power of the EMR emitted may be substantially uniform with the intensity and power emitted at second section <NUM> and third section <NUM> and is of sufficient intensity and power to inactivate infectious agents and/or promote healing.

The radial emission portions may be modified by chemical, physical or other cladding modification (e.g., ablation) to alter the critical angle enough to allow light to emit radially. Additionally or alternatively, the radial emission portions may be modified by dispersing microscopic structures <NUM> of varying gradient concentration inside the core <NUM> of the insertable element <NUM>. The gradient concentration of microscopic structures <NUM> within the core <NUM> shown in <FIG> range from a microscopic structures free area <NUM>, to a minimal concentration <NUM> of microscopic structures <NUM>, to a moderate concentration <NUM> of microscopic structures <NUM>, to a maximal concentration <NUM> of microscopic structures <NUM>.

The concentration of microscopic structures <NUM> within the core <NUM> affects the refractive index of the core <NUM> and the core-cladding boundary <NUM>. The microscopic structures <NUM> (which may be, for example, reflective flakes or voids, such as bubbles) create changes in the incident angle of the light as it passes through the insertable optical element <NUM>. At certain incident angles, light leaves the optical element cladding <NUM> and emits radially from the cladding outer boundary <NUM>.

<FIG> is a schematic view of the cross-sectional views of <FIG> depicting light rays as arrows. The same cross-sectional views of the insertable optical element <NUM> are shown: namely, the first section <NUM> (internally reflected), the second section <NUM> (minimally radially emissive), the third section <NUM> (moderately radially emissive), and the fourth section <NUM> (maximally radially emissive). These views also show light rays traveling axially along the core <NUM>, that collide with microscopic structures <NUM> at an incident angle causing the light ray to pass through the optical element cladding <NUM>. An increasing pixilated gradient is depicted on the cladding boundary <NUM> from the first section <NUM> (no pixilation), to the second section <NUM> (minimal pixilation), to the third section <NUM> (moderate pixilation), to the fourth section <NUM> (maximal pixilation) represents the chemical, physical or other cladding modification (e.g., ablation) at the cladding boundary <NUM>. Such modification of the insertable optical element <NUM> alters critical angles enough to allow light to emit radially. As schematically depicted, the amount of rays leaving the optical element cladding <NUM> are substantially equivalent at each site although the amount of rays the core <NUM> diminishes as the light travels from proximal to distal. The microscopic structures <NUM> of varying gradient concentration are also shown inside the core <NUM>, from the microscopic structure free area <NUM>, to a minimal concentration <NUM>, to a moderate concentration <NUM>, to a maximal concentration <NUM>. Each of the microscopic structures <NUM> has a refractive index that differs from that of the core <NUM> and the optical element cladding <NUM>. The microscopic structures <NUM> (which may be, for example, reflective flecks or voids, such as bubbles) create changes in the incident angle of the light as it passes through the insertable optical element <NUM>. At certain incident angles, light leaves the optical element cladding <NUM> and emits radially.

<FIG> shows cross-sectional views of various exemplary dispersals of microscopic structures <NUM> (such as flecks or bubbles) within a fiber optic's core <NUM>, cladding <NUM>, and the core/cladding boundary <NUM>. With each of the exemplary embodiments depicted microscopic structures <NUM> are dispersed within the insertable optical element <NUM> (in this case an optical fiber) to achieve radial transmission of light. These microscopic structures <NUM> may be positioned within the core <NUM> and/or at the core-cladding boundary <NUM> and/or within the cladding <NUM> of the optical fiber <NUM>. The microscopic structures <NUM> having a refractive index lower than the region free of microscopic structures <NUM>. The microscopic structures <NUM> may be a material added to the optical fiber core <NUM> or the core-cladding boundary <NUM>, such as a metal, rubber, glass beads, or plastic. The microscopic structures <NUM> may also be the lack of material creating an aberration within the optical fiber core <NUM> and/or the core-cladding boundary <NUM> and/or within the cladding <NUM>. For example, the presence of microscopic structures <NUM> (such as bubbles) in the optical fiber core <NUM> creates an aberration or imperfection that would alter the materials refractive index, resulting in EMR being emitted radially from the optical fiber (insertable optical element <NUM>).

In <FIG>, three exemplary dispersals, a first dispersal <NUM>, a second dispersal <NUM>, and a third dispersal <NUM>, are depicted. The first dispersal <NUM> has microscopic structures <NUM> (such as flecks or bubbles) dispersed within and outer region <NUM> of the core <NUM> only. The second dispersal <NUM> has microscopic structures <NUM> dispersed within an inner region <NUM> of the cladding <NUM> as well as within the outer region <NUM> of the core <NUM>. The third dispersal <NUM> has microscopic structures <NUM> dispersed proximate to the core/cladding boundary <NUM> and are depicted as identifying a boundary region <NUM> that is thinner than the outer region <NUM> of the core <NUM> and the inner region <NUM> of the cladding <NUM>. With each of these exemplary dispersals, at least some of the light traveling the length of the insertable optical element <NUM> (fiber optic) will not encounter any microscopic structures <NUM> while the remainder of the light may encounter at least one microscopic structure <NUM> and be deflected to emit radially from the insertable optical element <NUM>.

<FIG> is a schematic view of an exemplary optical element modification method for creating gradient modification on the exterior surface <NUM> of the insertable optical element <NUM>. Such modification of the core <NUM> or optical element cladding <NUM> alters the incident angle of light rays so that they differ from the critical angle needed to remain internally reflected. Depicted in <FIG> is a control device <NUM> with a wand <NUM> delivering an acid spray <NUM> for etching the insertable optical element <NUM>.

There are several methods for achieving this gradient modification. Chemically, the insertable optical element <NUM> may be etched using a strong acid such as hydrofluoric acid or sulfuric acid and hydrogen-peroxide. Also, quartz powder, calcium fluoride, or an etching cream, usually carrying a fluorinated compound, may be used. Physically, heating the insertable optical element <NUM> or physical modification such as ablation by sanding, media blasting, grinding, or laser ablation modifications are also methods for creating gradient modification. Additionally, plasma ablation by laser modification causes the ionization of molecules and alteration of the exterior surface <NUM> of the insertable optical element <NUM>. Other known methods for creating gradient ablation are contemplated by this disclosure. Regardless of the modification or manufacturing process, whether presently known or not, the insertable optical element <NUM> may be modified to have substantially equivalent radially emitted light along desired lengths. This uniformity in radially emitted light allows for a more accurate treatment dose for inactivating infectious agents and/or promoting healing.

In <FIG>, <FIG>, and <FIG> of the present disclosure, a transparent view of the optical element connector <NUM> is depicted, comprising a connecting element <NUM>, an EMR hub connection <NUM>, a collimating lens <NUM>, and an alignment shaft <NUM>. The insertable optical element <NUM> may be inserted into an aligning bore of the optical element connector <NUM> to collimate the light into a small diameter core <NUM> or one or more optical fibers.

The exemplary disclosure depicts an optical diversion element as a single collimating lens <NUM>, but other types of optical diversion elements such as multiple lenses or different types of lenses may be used to collimate the light. Depending on the optical element <NUM> diameter, numerical aperture, and refractive index, specific lenses will be needed as an optical diversion element to reduce light loss.

Turning now to <FIG>, a urinary catheter assembly is depicted. The urinary catheter assembly comprises and electromagnetic radiation component <NUM> and an insertable catheter component <NUM>. The insertable catheter component comprises a proximal catheter hub assembly <NUM>, an elongate catheter body <NUM> and a distal end <NUM> region. The proximal catheter hub assembly <NUM> serves as an input port <NUM> (the arrow showing the direction of fluid flow and/or therapeutic EMR propagation <NUM>). The elongate catheter body <NUM> also comprises an output port <NUM> for draining urine from the patient (the arrow showing the direction of urine flow <NUM>), an inflatable balloon cuff <NUM> (shown inflated), and an aperture <NUM>, the balloon cuff <NUM> and aperture <NUM> are disposed within the distal end <NUM> region. The insertable catheter component <NUM> may be made in varying lengths <NUM> as female urinary catheters are typically shorter than male urinary catheters which are made to different lengths.

The electromagnetic radiation component <NUM> comprises an EMR power source <NUM>, a coupling element <NUM>, and an optical element <NUM>. As depicted, the coupling element <NUM> is spaced from the catheter hub assembly <NUM> to reveal the optical element <NUM> that is partially inserted into the lumen of the elongate catheter body <NUM>. When the coupling element <NUM> is connected to the catheter hub assembly <NUM>, the optical element will be fully inserted and the distal end of the optical element <NUM> will extend to the termination <NUM> so not to interfere with the inflatable balloon cuff <NUM> or the aperture <NUM>. In this fully inserted disposition, the optical element <NUM> may emit radially therapeutic EMR at the incision site A and into the transdermal area <NUM>.

<FIG> depicts another exemplary urinary catheter <NUM> as positioned within a male patient. As shown, the urinary catheter <NUM> has been inserted into the patient's bladder <NUM> through the urethra <NUM> and the balloon cuff <NUM> has been inflated to seal the bladder <NUM> from leaking around the urinary catheter <NUM>. This exemplary urinary catheter <NUM> comprises an elongate catheter body <NUM>, an adapter <NUM>, a securing sleeve <NUM>, and a drain tube <NUM>. The adapter <NUM> has an input port <NUM> and an output port <NUM>. An EMR component <NUM> may be utilized in conjunction with the exemplary urinary catheter <NUM> to provide therapeutic EMR along the urethra <NUM> and into the bladder <NUM> to inactivate infectious agents and/or to promote healthy cell growth. The EMR component <NUM> comprises a control device <NUM> that houses an EMR power source <NUM>, operational control features <NUM> and a display <NUM>, an optical element <NUM>, and an optical jack <NUM>.

When positioned as shown in in <FIG>, the optical element <NUM> has been threaded into the adapter <NUM> and secured by the securing sleeve <NUM> and urine freely drains through the elongate body <NUM> into the drain tube <NUM> to be deposited in a urine drain bag (not shown). Frequently, urinary catheters <NUM> are indwelling for long periods of time and consequently are a concern for the build-up and proliferation of infectious agents in or around the urinary catheter <NUM>. To provide therapeutic EMR to prevent, reduce, or eliminate the proliferation of infectious agents and/or to enhance healthy cell growth, the optical jack <NUM> is plugged into the control device <NUM> connecting the optic al element <NUM> to the EMR power source <NUM> and the operational control features <NUM> are activated to set the frequency or frequencies, intensity, power, duty cycle, and other operational parameters, and turn on the EMR delivery into the optical element <NUM>. The setting of the operational features and the monitoring of the parameters may be viewed on the display <NUM>.

For exemplary methods or processes disclosed herein, the sequence and/or arrangement of steps described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal arrangement, the steps of any such processes or methods are not limited to being carried out in any particular sequence or arrangement, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and arrangements while still falling within the scope of the present invention.

Additionally, any references to advantages, benefits, unexpected results, or operability of the present invention are not intended as an affirmation that the invention has been previously reduced to practice or that any testing has been performed. Likewise, unless stated otherwise, use of verbs in the past tense (present perfect or preterit) is not intended to indicate or imply that the invention has been previously reduced to practice or that any testing has been performed.

Claim 1:
A medical device assembly for insertion into a cavity of a patient's body [<NUM>] and for delivery of a fluid to and/or retrieval of fluid from the patient's body [<NUM>], comprising:
an electromagnetic radiation, EMR, source [<NUM>] for providing non-ultraviolet, therapeutic EMR having an intensity comprising a radiant exposure of at least <NUM> J/cm<NUM> and up to <NUM> kJ/cm<NUM> and power of at least <NUM> mW and up to <NUM> Watt, for inactivating one or more infectious agents and enhancing healthy cell growth;
a catheter [<NUM>] having an elongate catheter body [<NUM>] with at least one internal lumen [<NUM>], a coupling end and a distal end [<NUM>], the distal end [<NUM>] being insertable into the cavity of the patient's body [<NUM>], wherein the catheter body [<NUM>] is configured to direct both the fluid and the therapeutic EMR axially relative to the catheter body [<NUM>], to facilitate at least one of delivery of fluid into the patient's body [<NUM>] and retrieval of fluid from the patient's body [<NUM>];
an optical element [<NUM>] conducive to the axial propagation of the therapeutic EMR relative to the catheter body [<NUM>], the optical element [<NUM>] having a position with respect to the catheter body [<NUM>] of being at least one of in, on, or within a wall of the catheter body [<NUM>] and within at least one internal lumen [<NUM>] of the catheter body [<NUM>], the optical element [<NUM>] having an elongate body [<NUM>] conducive to the axial propagation of the therapeutic EMR through the elongate body [<NUM>], the elongate body [<NUM>] having an exterior surface [<NUM>] between a coupling end and a distal end [<NUM>], the exterior surface [<NUM>] having at least one radial emission portion [<NUM>], wherein the radial emission portion [<NUM>] facilitates the radial emission of therapeutic EMR from the elongate body [<NUM>] proximate each radial emission portion [<NUM>]; and at least one coupling [<NUM>] to
connect the EMR source [<NUM>] to the catheter body [<NUM>];
characterized in that the
at least one radial emission portion [<NUM>] comprises an ablated surface having a gradient ablation pattern.