Patent Description:
The golden age of antibiotic discovery occurred from <NUM> to <NUM>, whereafter the consensus outside the microbiology community was that the war on pathogenic microbes was over. Over forty years later it is apparent the war against infectious microorganisms continues and the growing rate of resistance among pathogens in both the hospital and community environment represents a serious medical crisis.

Every year over <NUM> million deaths worldwide are attributed to the emergence of new infectious disease or to the reemergence of diseases previously controlled and which can be attributed to drug resistance. Infections linked to healthcare practices are particularly concerning. Using the most recent data available, the CDC in <NUM> reported, based upon a survey of <NUM> hospitals throughout <NUM>, that, on any given day while receiving acute care, <NUM> in <NUM> patients will contract a hospital acquired infection (HAI). This corresponded to <NUM>,<NUM> HAIs in <NUM> and carried a mortality rate of greater than <NUM>%. These infections cost the U. healthcare system billions of dollars each year and lead to the loss of tens of thousands of lives.

One of the most challenging microbes to treat is Methicillin Resistant Staphylococcus aureus (MRSA), where infections account for up to <NUM>% of both nosocomial and community-associated staphylococcal infections. The MRSA incidence in US intensive care has skyrocketed from <NUM>% in <NUM> to <NUM>% by <NUM>. A plethora of disease states are caused by MRSA; it is found to be among the most frequently identified pathogens causing pneumonia, and is associated with increased morbidity and mortality rates, where it accounts for <NUM>%-<NUM>% of all hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). It causes skin and soft tissue infections (SSTIs), such as diabetic MRSA wound infections, leads to increased costs, prolongs healing time and contributes to an unfavorable prognosis. MRSA infections may also be associated with persistent or recurrent bacteremia especially in long-term hemodialysis patients with renal disease. Persistent MRSA bacteremia is associated with infective endocarditis eventually leading to heart failure and even death. Bone infections constitute another difficult-to-treat clinical entity, with diabetes and peripheral vascular disease predisposing patients to MRSA osteomyelitis.

Catheters represent a ubiquitous component in the healthcare environment and are used to administer therapeutics (chemotherapy agents, antibiotics, pharmaceuticals, blood, and the like) during routine treatment of patients including those diagnosed with a chronic disease state requiring long term care. Central line-associated bloodstream infections (CLABSIs) are one of the deadliest types of HAIs, with a mortality rate of <NUM>%-<NUM>%. Encouragingly, due to directed efforts against this problem, the incidence of CLABSI appears to be on the decline with an overall <NUM>% decrease between <NUM> and <NUM>. This corresponds to approximately <NUM>,<NUM> lives saved and $<NUM> million in potential excess healthcare costs in <NUM> and approximately $<NUM> billion in cumulative excess healthcare costs since <NUM>. Despite this downward trend in mortality, MRSA still remains a globally significant public health threat. Globally, key factors contributing to this problem are healthcare practices, human factors, an immunocompromised or immunodeficient population, and highly virulent, antibiotic-resistant pathogens. The rise of antibiotic "superbugs" is a direct result of antibiotic overuse.

This rise in life-threatening drug resistant pathogens, not limited solely to MRSA, has increased the need for new classes of antibiotics against both hospital-acquired and community-acquired pathogens, with urgent need to treat Enterococcus faecalis, Staphylococcus aureus, Acinetobacter baumannii, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterobacter species.

These pathogens are dubbed ESKAPE pathogens to emphasize that they currently cause the majority of US hospital infections and effectively "escape" the effects of antibacterial drugs. For example, more people die in US Hospitals of methicillin-resistant S. aureus (MRSA) than HIV/AIDS and tuberculosis combined. The problem has become so dire that clinicians are forced to use older, previously discarded drugs such as colistin, associated with significant toxicity, and this current climate does not bode well for the aging baby-boomer generation, immunocompromised patients, patients undergoing surgery, transplantation, and chemotherapy, nor the increasing number of neonatal patients in intensive care, all of whom are at increased risk to infections by drug resistant pathogens.

Streptococcus pneumoniae results in <NUM>,<NUM> deaths in the US each year and by <NUM><NUM>% of all US isolates were penicillin resistant with small children and the elderly at an increased risk.

Pseudomonas is an opportunistic pathogen, causes fatal wound infections, bum infections, and chronic infections of the lungs in cystic fibrosis patients. Few antibiotics inhibit this pathogen although the organism rarely infects non-compromised patients. Pseudomonas is capable of colonizing practically any tissue of patients compromised in some manner. It also causes urinary tract infections, respiratory system infections, dermatitis, soft tissue infection, bacteremia, bone and joint infections, gastrointestinal infections and a variety of other disease states.

In addition to MRSA, VRSA (vancomycin resistant S. aureus) and VISA (vancomycin intermediate S. aureus) strains also pose an important threat to second-line treatments for MRSA. The first report of VRSA in Europe was published last year from Portugal. Resistance to linezolid and daptomycin has also been documented.

In some locations, candidaemia is the most common cause of all bloodstream infections related to vascular catheters. Inappropriate antifungal therapy is associated with increased mortality, increased attributable costs, and increased burden of fluconazole non-susceptible Candida species. Candida is associated with a mortality rate of ~<NUM>% and higher treatment costs and length of hospitalization. Patients with resistant infections may experience delay in receiving appropriate therapy, which can increase costs, length of stay, and morbidity and mortality. In <NUM>, CDC estimated that each case of Candida infection results in <NUM>-<NUM> days of additional hospitalization, and incurs a total of US$ <NUM>,<NUM> to US$ <NUM>,<NUM> in direct health-care costs. Based on current data and projections, these infections add a total of US$ <NUM> billion to US health-care expenditures every year.

According to the World Health Organization, it is suspected that resistant infections greatly increase these costs. However, few data exist on the economic impact of resistant Candida infections. Candida infections are a persistent and increasingly important public health problem, particularly for vulnerable populations such as cancer patients, dialysis patients, transplant recipients, and in neonates and other patients in intensive care units. In some locations, half of all infections are resistant to first-line therapy. Resistance to azoles is probably increasing, and resistance to the echinocandins is emerging. It is likely that the global burden will increase with increasing populations of immunocompromised patients as economies develop and health care improves. Given these changes, it is critically important to have active surveillance activities for resistance trends in Candida infections, to determine the burden of infections due to antifungal-resistant Candida, its economic impact, and possible areas where prevention and control strategies can be focused.

This trend in resistance has spurred a new crisis, the "antibiotic crisis" and has gained the attention of the United States Congress, which has partnered with the Infectious Diseases Society of America (IDSA), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Center for Disease Control (CDC), and other stakeholder groups to highlight this problem. Alarmingly, despite mobilization of funds and resources, only two new classes of antibiotic have been introduced into the market over the past <NUM> years. Overall, the consumption rate of antibiotics has been on a steady decline, with trends strongest in France and Japan where antibiotic usage between <NUM> and <NUM> decreased by <NUM>% and <NUM>%, respectively, as clinicians fear usage will further promote the rise in antibiotic resistant "superbugs.

The CDC has stated there is a consensus to eliminate HAIs. Alternative strategies, designed to reduce the incidence of infection, represent an expanding area for the development of new treatment modalities, a necessity as existing antibiotics continue to fail against formerly susceptible pathogens. In this context, UV light is well known to have a sterilizing effect and has been used to sterilize medical devices, in particular medical connectors. Examples for sterilizers configured to sterilize medical connectors using UV light can be found in <CIT>, <CIT>, and <CIT>.

This invention relates to a sterilizer for sterilizing a female Luer fitting using UV light. In general, this disclosure provides a method and apparatus for a chemical-free, non-drug approach to killing germs with UV light, and in particular germs associated with indwelling catheters and catheter attachment systems, including Luer systems, and other attachment systems.

An optical plug for sterilizing a female Luer fitting can include an insertion end having an insertion sidewall and a front window at a proximal end of the insertion end, and a base end having a base window at a distal end of the base end, whereby light can enter the base window and exit through the insertion sidewall and the front window. Furthermore, the base end sidewall(s) can be designed so that light rays within the base end are transmitted through the length of the base end via multiple internal reflections, allowing the base end to be of arbitrary length.

The insertion end of the optical plug can be axisymmetric. The insertion end can also include a bezel or fillet between the insertion sidewall and the front window. This insertion end bezel can have an angle of approximately <NUM>°, or an angle of approximately <NUM>° from the central axis of the optical plug. The insertion end can have a diameter in the range of approximately <NUM> to <NUM> where the insertion sidewall meets the bezel. The insertion sidewall can be frustoconical with an approximately <NUM>% slope. The optical plug can be comprised of a fused silica quartz. The insertion sidewall and the front window can be ground to an approximately <NUM> grit surface finish.

The base end of the optical plug can be axisymmetric. The base end can also include a bezel or fillet between the base sidewall and the base window. This base end bezel can have an angle of approximately <NUM>°, or an angle of approximately <NUM>° from the central axis of the optical plug. The base end cross section can be circular or in the shape of a regular polygon such as a hexagon. The base sidewall can be polished to a smooth optical surface finish to enable total internal reflection of internal light rays incident on its sidewall surfaces.

According to the invention, a sterilizer for sterilizing a female Luer fitting includes an optical plug, the optical plug including a base end, an insertion end, and a front window at a proximal end of the insertion end, wherein the insertion end is adapted to be inserted into the female Luer fitting. The sterilizer also includes a sterilizer body, the body including a catheter hamess and a female Luer fitting harness. The sterilizer also includes at least one UV light source, wherein UV light can be radiated through the optical plug, thereby sterilizing the female Luer and at least a portion of a catheter. The sterilizer can also include a means of supplying power to the at least one UV light source, wherein the means of supplying power can be an internal power source, such as a battery, combined with electronics for conditioning/converting and distributing electrical power to electrical/optoelectronic components within the sterilizer, or the means of supplying power can be a connection to an external electrical power source combined with electronics for conditioning/converting and distributing electrical power to components within the sterilizer. The sterilizer can also include a means of controlling/adjusting the light output of the at least one UV light source. The sterilizer can also include a means of self-calibrating the light output of the at least one UV light source, wherein the light output of the at least one UV light source is measured and then adjusted accordingly to maintain a desired light output level.

The catheter harness prevents ambient light from entering into the catheter and its female Luer fitting. The at least one UV light source includes a UV-C light source. The UV-C light source can provide light in a range of approximately <NUM> to <NUM>. The at least one light source comprises a UV-C light source and a UV-A light source. The UV-C light source can provide light in a range of approximately <NUM> to <NUM>, and the UV-A light source can provide light in a range of approximately <NUM> to <NUM>.

A method of sterilizing a female Luer fitting and a catheter attached to the female Luer fitting can include inserting an insertion end of an optical plug into the female Luer fitting, placing the catheter into a catheter harness of a sterilizer, placing the female Luer fitting into a female Luer fitting harness of the sterilizer, closing the sterilizer, and turning on at least one UV light source, so that UV light enters the optical plug and irradiates the female Luer fitting and the catheter.

The at least one UV light source includes a UV-C light source. The UV-C light source can emit light in a range of approximately <NUM> to <NUM>. The at least one UV light source comprises emrbe a UV-C light source and a UV-A light source. The UV-C light source can emit light in a range of approximately <NUM> to <NUM>, and the UV-A light source can emit light in a range of approximately <NUM> to <NUM>.

The invention description below refers to the accompanying drawings, of which:.

The combination of UV-A and UV-C light together can have a synergistic sterilizing effect. The effect of the two light wavelengths together can be greater than the sum of each light wavelength individually. UV-A light, for example in a range of approximately between <NUM> and <NUM>, and by way of further example in a range of approximately between <NUM> and <NUM>, can induce cells to increase production of pigments such as antioxidants and porphyrins and other proteins that protect against damage to the cell from terrestrial UV light such as UV-A and UV-B. By way of non-limiting examples, these pigments can include porphyrin, carotenoids, melanins, xanthomonadin, ferritin, luteine, cytochromes, spirilloxanthin, chlorobactene, and lycopene.

<FIG> is a structural diagram of porphyrin, an exemplary pigment endogenous to bacteria. These endogenous pigments arise within a bacterium, however it should be noted that this is only one of many pigments that are produced within the bacterial kingdom. Each species of bacteria can make many different kinds of pigments, and pigments between species differ.

By way of non-limiting examples, <FIG> show a variety of different pigments that occur naturally in bacteria. <FIG> is a structural diagram of xanthomonadin, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of luteine, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of ferritin, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of cytochromes, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of melanin, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of lycopene, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of spirilloxanthin, an exemplary pigment endogenous to bacteria. <FIG> is a structural diagram of chlorobactene, an exemplary pigment endogenous to bacteria.

All of these pigments shown in <FIG> contain a chromophore. When a chromophore within the pigment absorbs a sufficient dose of UV light, a Reactive Oxygen Species (ROS) is liberated. UV light, including UV-A and UV-C light, can convert the pigments produced in response to a UV-A light, such as pigment <NUM>, into photoreactive byproducts, such as free radicals and other damaging byproducts. Because of the shorter wavelength, UV-C can convert the pigments into the photoreactive byproducts more efficiently, or with less energy. The UV-C light can cause the atoms in the pigments (chromophores) to get excited to the point that they can become phototoxic by-products (also called reactive oxygen species, ROS). The UV light, including UV-A and UV-C light, can thereby poison the cell through its own innate defense mechanism to UV-A light, so that the cell is killed by its own defense system. The net effect can be that the cell is tricked into preparing against one type of damage from the UV-A light, and then the cell's own defenses can be used against it with exposure to UV-C light. This effect combined with the DNA damage caused by UV-C light can synergistically render the cell unable to maintain viability. The DNA damage can include, by way of non-limiting examples, lesions in DNA induced by UV light, including the cyclobutane pyrimidine dimers (CPD) and the pyrimidine-pyrimidone photoproduct [<NUM>-<NUM>]. UV radiation induces DNA lesions (CPDs) and <NUM>-<NUM> photoproducts (<NUM>-4PPs) and their Dewar valence isomers. In addition to DNA damage and conversion of chromophores to ROS, other types of UV induced photodamage contributing to synergistic lethality include any toxic photoproduct resulting from photo oxidation against intracellular aldehydes, ketones, and carboxylic acids. Photodamage from UV light can also include damage to cellular membranes and cell walls. Any survivors of the treatment should be inherently less virulent since one of the functions of pigmentation is virulence; specifically, under normal conditions, the pigments serve as antioxidants to ROS, however in this treatment scheme, the pigment is instead coopted to become a ROS itself. The combination of UVA and UVC irradiation treatment has a synergetic effect on the killing of bacteria and yeast, especialy on the surface of a biofilm. This system of combined UV-C and UV-A radiation can be effective against fungi, bacteria, parasites, and viruses. The body uses peroxides to kill the remaining bacteria, and the sick and bleached bacteria become susceptible to the peroxides, resulting in additional synergistic lethality.

The effectiveness of the use of UV light to kill microorganisms may be influenced by many factors, including the wavelength used, the energy (calculated as Power (W) x time (s) = Energy (J)), the irradiance (calculated as Power (W) / Area (m<NUM>) = Irradiance), and the radiant exposure (calculated as Energy (J) / m<NUM> = radiant exposure). Other factors can increase effectiveness, such as an engineered light structure. This engineered light structure can include a duty cycle and pulse frequency. Microorganisms can have a photoreactivation mechanism whereby they can better recover from UV photodamage when they are exposed to visible light following UV photodamage, so effectiveness of the treatment can be also increased by minimizing exposure of the treated surfaces to ambient light following the UV treatment. By way of non-limiting example, ambient light can stimulate photolyase to repair DNA lesions caused by the UV light treatment (repair of the CPD). Repairing the damaged DNA lesions is required for cellular transcription, which is a necessary part of cellular replication. Blocking ambient light is one way to prevent photoreactivation in microorganisms upon exposure to DNA damage, and thereby prevent cellular replication.

When a sufficient dose of UV light irradiates all surfaces to be disinfected, UV light can be effective at killing microorganisms. UV light may be used for sterilization in many applications, including sterilizing indwelling catheters in patients. However, for UV light to be effective, it is necessary for the UV light to irradiate the interior surfaces of the indwelling catheter with a sufficient dose of UV light. Surfaces that do not receive a sufficient dosage of UV light may not be fully sterilized.

<FIG> is a cross-section of a standard ISO <NUM> Luer system. A standard Luer system <NUM> can have a female Luer fitting <NUM> and a male Luer fitting <NUM>. The female Luer fitting <NUM> is adapted to mate with the male Luer fitting <NUM>. Male Luer fitting <NUM> has an insertion end <NUM> adapted for insertion into an intemal cavity <NUM> of the female Luer fitting <NUM>. Both the male insertion end <NUM> and the female intemal cavity <NUM> have an approximately <NUM>% slope. The male insertion end is wider at the base and narrower at the end, with an approximately <NUM>% slope, and the female intemal cavity has a corresponding shape and <NUM>% slope, so that the two parts can mate together snugly. Male Luer fitting <NUM> has a male lumen <NUM> through the male fitting <NUM>, and female Luer fitting <NUM> has a female lumen <NUM> through the female fitting <NUM>, so that when the two parts are mated together fluid can flow through one lumen to the other without leakage. The male Luer fitting <NUM> has threads <NUM> adapted to be engaged by tabs <NUM> on the female Luer fitting <NUM>. Indwelling catheters can have a female Luer fitting <NUM> at the end of the catheter. A medical professional can prepare, for example, a IV drip with a male Luer fitting <NUM> at the end of an IV tube, and can quickly attach the male Luer fitting <NUM> to the female Luer fitting <NUM> at the end of an indwelling catheter, and can begin an IV drip into the patent without having to introduce a new tube into the patent. Over time, a biofilm can build up on the inside surfaces of the Luer fitting and the attached catheter. To avoid introduction of pathogens into the patent, including from biofilms within the internal cavity <NUM>, it is necessary to sterilize the internal cavity <NUM> of the female Luer fitting <NUM> and at least a portion of the attached catheter before fluids can be passed through them and into the patient.

<FIG> is perspective view of an optical plug, according to an embodiment. Optical plug <NUM> is ISO <NUM> compatible, and can be inserted into an ISO <NUM> female Luer fitting, allowing UV light to be introduced into a female Luer fitting and catheter, thereby sterilizing the female Luer fitting and catheter. The optical plug can transmit light through the optical plug, and can be referred to as a light pipe. The optical plug can also mix various wavelengths of light within the plug, and can be referred to as a light combiner, or light mixer, or light mixing rod. Light from one or multiple light sources can be made more spatially uniform in intensity as it propagates through the optical plug via multiple internal reflections, so that the optical plug can act as a light homogenizer, or light homogenizing rod. Optical plug <NUM> can have an insertion end <NUM> and a base end <NUM>. Optical plug <NUM> can have an intermediate bevel <NUM> between the insertion end <NUM> and the base end <NUM>. The insertion end <NUM> can have a front window <NUM>, an insertion fillet or insertion bevel <NUM>, and an insertion sidewall <NUM>. Insertion sidewall <NUM> can be frustoconical. The insertion end <NUM> is designed to be inserted into the internal cavity <NUM>, and can have a corresponding approximately <NUM>% slope. Base end <NUM> can have a base sidewall <NUM>, base bevel <NUM>, and base window (not shown). Optical plug <NUM> can be made of fused silica, sapphire (which can be Al<NUM>O<NUM>), Teflon, or other material appropriate for the introduction of UV light into the female Luer fitting and indwelling catheter. Appropriate materials can be moldable, formable, or machinable, and with low losses and low absorption in the UV spectrum The front window <NUM> and insertion sidewall <NUM> can be ground to <NUM> grit surface finish or other surface finish so as to achieve a desired diffusion effect or other effect. The base window (not shown) and base sidewall <NUM> can be polished to have a surface quality of <NUM>-<NUM> scratch-dig. The base end of the optical plug can be axisymmetric. The base window (not shown) and base sidewall <NUM> can be circular or polygonal, so that the cross-section of the base end <NUM> is in the shape of a circle, or an irregular or regular polygon such as a hexagon. This base end can be a circular prism or other geometric prism. The base sidewall can be polished to a smooth optical surface finish to enable total or near total intemal reflection of intemal light rays incident on its sidewall surfaces. The polished base sidewall <NUM> surface can act as a light pipe so that light rays entering the plug through the base window (not shown) are transmitted through the plug to the insertion end <NUM> via multiple internal reflections off of the base sidewall <NUM>. Multiple light sources can introduce light of different wavelengths into the optical plug, so that the optical plug can act as a light combiner, or light mixer, or light mixing rod. The different wavelengths can be reflected internally within the optical plug and can be combined together. Light from one or multiple light sources can be made more spatially uniform in intensity as it propagates through the optical plug via multiple internal reflections, so that the optical plug can act as a light homogenizer or light homogenizing rod. The cross-section shape of the base sidewall <NUM> can be designed to achieve desired light-mixing properties. The front window <NUM> and base window (not shown) can be coated with an anti-reflection (AR) coating to reduce back-reflection of incident light rays. The base sidewall can be designed so that light rays within the base end are transmitted through the length of the base end via multiple internal reflections, thereby allowing the base end to be of arbitrary length.

<FIG> is an end view of the base end of optical plug of <FIG>, according to the embodiment. The base window <NUM> can have a window diameter WD of approximately <NUM>, and the base end <NUM> can have a base diameter BD of approximately <NUM>. <FIG> is a side view of the optical plug of <FIG>, according to the embodiment. Optical plug <NUM> can have a plug length PL of approximately <NUM>. Base bevel <NUM> can have a base bevel length BBL of approximately <NUM>, and a base bevel angle BBA of approximately <NUM>°. The base bevel <NUM> and base sidewall <NUM> together can have a combined base length BL of approximately <NUM>. Intermediate bevel <NUM> can have an intermediate bevel angle INBA of approximately <NUM>°. Insertion sidewall <NUM> can have an insertion sidewall length ISL of approximately <NUM>, and an insertion sidewall angle ISA of approximately <NUM>°. The insertion bevel <NUM> can have an insertion bevel length IBL of approximately <NUM>, and an insertion bevel angle IBA of approximately <NUM>°. The insertion end <NUM> can have a length IEL of approximately <NUM>.

<FIG> is an end view of the insertion end of the optical plug of <FIG>, according to the embodiment. This end of the optical plug can be inserted into the internal cavity <NUM> of the Luer fitting, and it is shown here from the perspective from inside the cavity <NUM>. The front window <NUM> can have a front window diameter FWD of approximately <NUM>. The insertion end <NUM> can have a front diameter FD of approximately <NUM> where the sidewall <NUM> meets the insertion bevel <NUM>. The insertion end <NUM> can have an intermediate diameter ID of approximately <NUM> where the sidewall <NUM> meets the intermediate bevel <NUM>. The base <NUM> can have a base diameter BD of approximately <NUM>. The optical plug <NUM> is designed to prevent any shadows or areas of decreased light intensity within the female Luer and indwelling catheter when UV light is introduced through the optical plug <NUM> and into the female Luer fitting and indwelling catheter. The UV light sterilization treatment of the female Luer fitting and indwelling catheter can be free of shadows.

<FIG> is side view of an optical plug for use in sterilizing a female Luer fitting and indwelling catheter, according to an alternate embodiment. Optical plug <NUM> is ISO <NUM> compatible, and can be inserted into an ISO <NUM> female Luer fitting, allowing UV light to be introduced into a female Luer fitting and catheter, thereby sterilizing the female Luer fitting and catheter. Optical plug <NUM> can have a length L of <NUM>. Optical plug <NUM> can have an insertion end <NUM> and a base end <NUM>. Optical plug <NUM> can have an intermediate bevel <NUM> between the insertion end <NUM> and the base end <NUM>. The insertion end <NUM> can have a front window <NUM>, an insertion bevel <NUM>, and a sidewall <NUM>. Insertion sidewall <NUM> can be frustoconical. The insertion end <NUM> is designed to be inserted into the intemal cavity <NUM>, and can have a corresponding approximately <NUM>% slope. The insertion end <NUM> can have a front diameter FD of approximately <NUM> where the sidewall <NUM> meets the insertion bevel <NUM>. The insertion end <NUM> can have an intermediate diameter ID of approximately <NUM> where the sidewall <NUM> meets the intermediate bevel <NUM>. The sidewall <NUM> can have a sidewall length SL of approximately <NUM>. The insertion portion of the sidewall that is designed to be inserted into the female Luer can have an insertion portion length IPL of approximately <NUM>. The external portion of the sidewall that is designed to remain outside of the female Luer can have an external portion length EPL of approximately <NUM>. Base end <NUM> can also have a base sidewall <NUM>, a base bevel <NUM> and a base window <NUM>. The base bevel <NUM>, base sidewall <NUM>, and intermediate bevel <NUM> can have a combined base length BAL of approximately <NUM>. The base can have a base diameter BD of approximately <NUM>. The base window <NUM> and base sidewall <NUM> can be circular or polygonal, so that the cross-section of the base end <NUM> is in the shape of a circle, or an irregular or regular polygon such as a hexagon. This base end can be a circular prism or other geometric prism. The base sidewall can be polished to a smooth optical surface finish to enable total or near total intemal reflection of internal light rays incident on its sidewall surfaces. The polished base sidewall <NUM> surface can act as a light pipe so that light rays entering the plug through the base window (not shown) are transmitted through the plug to the insertion end <NUM> via multiple intemal reflections off of the base sidewall <NUM>. Multiple light sources can introduce light of different wavelengths into the optical plug, so that the optical plug can act as a light combiner, or light mixer, or light mixing rod. The different wavelengths can then be reflected intemally within the optical plug and can be combined together. Light from one or multiple light sources can be made more spatially uniform in intensity as it propagates through the optical plug via multiple internal reflections, so that the optical plug can act as a light homogenizer or light homogenizing rod. The cross-section shape of the base sidewall <NUM> can be designed to achieve desired light-mixing properties. The front window <NUM> and base window (not shown) can be coated with an anti-reflection (AR) coating to reduce back-reflection of incident light rays. The base sidewall can be designed so that light rays within the base end are transmitted through the length of the base end via multiple internal reflections, thereby allowing the base end to be of arbitrary length.

Optical plug <NUM> can be made of a fused silica quartz, sapphire, which can be Al<NUM>O<NUM>, or other appropriate materials for allowing UV light to pass into the base window <NUM>, through the optical plug <NUM>, and into the female Luer and indwelling catheter. The insertion end <NUM>, insertion bevel <NUM>, and the front window <NUM> can be ground to a <NUM> grit. The base end <NUM>, base sidewall <NUM>, and base window <NUM> can be polished to have a surface quality of <NUM>-<NUM> scratch-dig. The optical plug <NUM> is designed to prevent any shadows or areas of decreased light intensity within the female Luer and indwelling catheter when UV light is introduced through the optical plug <NUM> and into the female Luer fitting and indwelling catheter. The UV light sterilization treatment of the female Luer and indwelling catheter can be free of shadows.

<FIG> is a side view of an optical plug according to an alternate embodiment. Optical plug <NUM> is ISO <NUM> compatible, and can be inserted into an ISO <NUM> female Luer fitting, allowing UV light to be introduced into a female Luer fitting and catheter, thereby sterilizing the female Luer fitting and catheter. Optical plug <NUM> can have an insertion end <NUM> and a base end <NUM>. Optical plug <NUM> can have an intermediate bevel <NUM> between the insertion end <NUM> and the base end <NUM>. The insertion end <NUM> can have a front window <NUM>, an insertion bevel <NUM>, and an insertion sidewall <NUM>. Insertion sidewall <NUM> can be frustoconical. The insertion end <NUM> can have an insertion portion <NUM> that is designed to be inserted into the internal cavity <NUM>. The insertion portion <NUM> can have an approximately <NUM>% slope corresponding to the female Luer fitting. Base end <NUM> can also have a base sidewall <NUM>, base bevel <NUM>, and base window <NUM>. The base window <NUM> and base sidewall <NUM> can be circular or polygonal, so that the cross-section of the base end <NUM> is in the shape of a circle, or an irregular or regular polygon such as a hexagon. This base end can be a circular prism or other geometric prism. The base sidewall can be polished to a smooth optical surface finish to enable total or near total internal reflection of intemal light rays incident on its sidewall surfaces. The polished base sidewall <NUM> surface can act as a light pipe so that light rays entering the plug through the base window (not shown) are transmitted through the plug to the insertion end <NUM> via multiple internal reflections off of the base sidewall <NUM>. Multiple light sources can introduce light of different wavelengths into the optical plug, so that the optical plug can act as a light combiner, or light mixer, or light mixing rod. The different wavelengths can then be reflected internally within the optical plug and can be combined together. Light from one or multiple light sources can be made more spatially uniform in intensity as it propagates through the optical plug via multiple internal reflections, so that the optical plug can act as a light homogenizer or light homogenizing rod. The cross-section shape of the base sidewall <NUM> can be designed to achieve desired light-mixing properties. The front window <NUM> and base window (not shown) can be coated with an anti-reflection (AR) coating to reduce back-reflection of incident light rays. The base sidewall can be designed so that light rays within the base end are transmitted through the length of the base end via multiple intemal reflections, thereby allowing the base end to be of arbitrary length.

Optical plug <NUM> can be made of a fused silica, sapphire (which can be Al<NUM>O<NUM>), or other material appropriate for the introduction of UV light into the female Luer fitting and indwelling catheter. By way of non-limiting example, the optical plug can be made of a GE type <NUM> fused silica rod or the equivalent. The front window <NUM> and insertion portion <NUM> can be ground to approximately <NUM> grit. The base window can be polished to have a surface quality of <NUM>-<NUM> scratch-dig.

Optical plug <NUM> can have a plug length PL of approximately <NUM>. Insertion end <NUM> can have a front diameter FD where the sidewall <NUM> meets the insertion bevel <NUM> of approximately between <NUM> and <NUM>. The insertion end can have a total insertion sidewall length TSL of approximately <NUM>. The insertion end can have a first insertion sidewall length FSL of approximately <NUM>, and can have a first insertion diameter FID at the first insertion sidewall length FSL of approximately between <NUM> and <NUM>. The insertion end can have a second insertion sidewall length SSL of approximately <NUM>, and a second insertion diameter SID at the second insertion sidewall length SSL of approximately between <NUM> and <NUM>. The portion of the insertion end <NUM> between the first insertion diameter and the front diameter can have an approximately <NUM>% slope. These dimensions are designed to approximately correspond with the dimensions of the female Luer fitting <NUM>, so that the insertion portion <NUM> of the optical plug <NUM> can be inserted into the female Luer fitting <NUM>.

<FIG> is a side view of an optical plug according to an alternate embodiment. Optical plug <NUM> is ISO <NUM> compatible, and can be inserted into an ISO <NUM> female Luer fitting, allowing UV light to be introduced into a female Luer fitting and catheter, thereby sterilizing the female Luer fitting and catheter. Optical plug <NUM> can have an insertion end <NUM> and a base end <NUM>. Optical plug <NUM> can have an intermediate bevel <NUM> between the insertion end <NUM> and the base end <NUM>. The insertion end <NUM> can have a front window <NUM>, an insertion bevel <NUM>, and an insertion sidewall <NUM>. Insertion sidewall <NUM> can be frustoconical. The insertion end <NUM> can have an insertion portion <NUM> that is designed to be inserted into the internal cavity <NUM>. The insertion portion <NUM> can have an approximately <NUM>% slope corresponding to the female Luer fitting. Base end <NUM> can also have a base sidewall <NUM>, base bevel <NUM>, and base window <NUM>. The base window <NUM> and base sidewall <NUM> can be circular or polygonal, so that the cross-section of the base end <NUM> is in the shape of a circle, or an irregular or regular polygon such as a hexagon. This base end can be a circular prism or other geometric prism. The base sidewall can be polished to a smooth optical surface finish to enable total or near total internal reflection of intemal light rays incident on its sidewall surfaces. The polished base sidewall <NUM> surface can act as a light pipe so that light rays entering the plug through the base window <NUM> are transmitted through the plug to the insertion end <NUM> via multiple internal reflections off of the base sidewall <NUM>. Multiple light sources can introduce light of different wavelengths into the optical plug, so that the optical plug can act as a light combiner, or light mixer, or light mixing rod. The different wavelengths can then be reflected internally within the optical plug and can be combined together. Light from one or multiple light sources can be made more spatially uniform in intensity as it propagates through the optical plug via multiple internal reflections, so that the optical plug can act as a light homogenizer or light homogenizing rod. The cross-section shape of the base sidewall <NUM> can be designed to achieve desired light-mixing properties. The front window <NUM> and base window <NUM> can be coated with an anti-reflection (AR) coating to reduce back-reflection of incident light rays. The base sidewall can be designed so that light rays within the base end are transmitted through the length of the base end via multiple internal reflections, thereby allowing the base end to be of arbitrary length.

Optical plug <NUM> can be made of a fused silica, sapphire (which can be Al<NUM>O<NUM>), or other material appropriate for the introduction of UV light into the female Luer fitting and indwelling catheter. The front window <NUM> and insertion portion <NUM> can be ground to approximately <NUM> grit. The base window can be polished to have a surface quality of <NUM>-<NUM> scratch-dig.

Insertion end <NUM> can have a front diameter FD where the sidewall <NUM> meets the insertion bevel <NUM> of approximately between <NUM> and <NUM>. The sidewall can have a maximum insertion diameter SMID of approximately between <NUM> and <NUM>. The sidewall can have a sidewall insertion length SIL of approximately <NUM>. The portion of the insertion end <NUM> between the maximum insertion diameter and the front diameter can have an approximately <NUM>% slope. The portion of the insertion end <NUM> from the maximum insertion diameter SMID to the front window <NUM> is the insertion portion <NUM>. These dimensions are designed to approximately correspond with the dimensions of the female Luer fitting <NUM>, so that the insertion portion <NUM> of the optical plug <NUM> can be inserted into the female Luer fitting <NUM> up to the maximum insertion diameter SMID.

Insertion bevel <NUM> can have an insertion bevel length IBL of approximately <NUM> +/- <NUM>. Insertion end can have an insertion portion length IPL of <NUM>. Insertion end <NUM> can have an insertion end length IL of approximately <NUM>. Optical plug <NUM> can have a plug length PL of approximately <NUM>. Base bevel <NUM> can have a base bevel length BBL of approximately <NUM> or less. Intermediate bevel <NUM> can have an intermediate bevel length INBL of approximately <NUM> or less.

The dimensions provided herein are intended as non-limiting examples of optical plugs that are appropriate for insertion within and sterilization of an ISO <NUM> female Luer lock. Variations in dimensions may be necessary, for example, when a protective cover, made of plastic or other UV optically transmissive materials, is used over the optical plug. By way of non-limiting example, the insertion end may have a diameter that is <NUM> to <NUM> smaller, depending on the thickness of a UV-transmissive cover. If a protective plastic cover is used over the optical plug, the optical plug dimensions will need to be reduced by an amount approximately corresponding to the thickness of the protective cover. Furthermore, variations on these exemplary dimensions are possible for alternate connector types.

The optical plug <NUM> is designed to prevent any shadows or areas of decreased light intensity within the female Luer and indwelling catheter when UV light is introduced through the optical plug <NUM> and into the female Luer fitting and indwelling catheter. The UV light sterilization treatment of the female Luer fitting and indwelling catheter can be free of shadows.

<FIG> is a perspective view of an exemplary cover for an optical plug, according to an embodiment. The cover is UV-transmissive, and can be disposable. The cover <NUM> can have an insertion end <NUM> and a base end <NUM>. The cover <NUM> can have an intermediate bevel <NUM> between the insertion end <NUM> and the base end <NUM>. The insertion end can have a front window <NUM>, an insertion bevel <NUM>, and an insertion sidewall <NUM>. Insertion sidewall <NUM> can be frustoconical. The insertion end <NUM> can have an insertion portion <NUM> that is designed to be inserted into the internal cavity <NUM>. The insertion portion <NUM> can have an approximately <NUM>% slope corresponding to the female Luer fitting. Base end <NUM> can have a base sidewall <NUM>, and a rear opening <NUM>. An optical plug can be inserted into the protective cover <NUM> through the rear opening <NUM>.

The cover <NUM> can be made of a UV-transmissive material such as a disposable plastic. By way of non-limiting example, the cover can be made of a fluoropolymer, such as fluorinated ethylene propylene (FEP), ethylene-tetrafluoroethylene (ETFE), or polyvinylidene fluoride (PVDF) because of the transmissive properties of these materials for UV light. The cover <NUM> can have an exemplary thickness in a range of <NUM> to <NUM> inch (<NUM> to <NUM>), and preferably in a range of <NUM> to <NUM> inch. The cover <NUM> is sized and shaped to be placed over an optical plug, and be inserted into a female Luer fitting with the optical plug inside. The exterior dimensions of the cover <NUM> can be approximately the same as the exterior dimensions of any of the above exemplary optical plugs. The cover <NUM> can have appropriate exterior dimensions to meet the ISO <NUM> specification and can be inserted into the female Luer lock. An optical plug that is designed for use with a cover can have dimensions that are reduced by approximately the thickness of the cover.

Light can enter the optical plug through the base window of the optical plug. The cover <NUM> may not cover the base window of the optical plug. Light can then travel through the optical plug, and different wavelengths can be combined through internal reflection in the optical plug. The light can then exit the insertion sidewall, insertion bevel, and front window of the optical plug. The light can then pass through the insertion sidewall <NUM>, insertion bevel <NUM>, and front window <NUM> of the cover. Light can pass through the cover into the female Luer fitting and the attached catheter.

Various embodiments of the cover can sheathe all of the optical plug, most of the optical plug, or various amounts of the optical plug. The cover can sheathe the front window plus various amounts of the optical plug. In some embodiments, the cover can sheathe the front window plus at least a portion of the insertion end of the optical plug. In some embodiments of the cover, the base end of the optical plug may not be sheathed by the cover. In some embodiments, a portion of the insertion end of the optical plug may not be sheathed by the cover.

<FIG> is a perspective view of an exemplary cover for an optical plug, according to a different embodiment. The cover is UV-transmissive, and can be disposable. The cover <NUM> can sheathe all or a portion of the insertion end of an optical plug. The cover <NUM> can have a front window <NUM>, a bevel <NUM>, and a sidewall <NUM>. Sidewall <NUM> can be frustoconical. The cover <NUM> can be designed to sheathe at least a portion of the insertion end of an optical plug, and to be inserted into the internal cavity <NUM> of a female Luer lock. The sidewall <NUM> can have an approximately <NUM>% slope corresponding to the female Luer fitting. The cover <NUM> can have a rear opening <NUM>. An optical plug can be inserted into the cover <NUM> through the rear opening <NUM>.

The cover <NUM> can be made of a UV-transmissive material such as a disposable plastic. The cover <NUM> can have an exemplary thickness in a range of <NUM> to <NUM> inch (<NUM> to <NUM>), and preferably in a range of <NUM> to <NUM> inch. The cover <NUM> is sized and shaped to be placed over an optical plug, and be inserted into a female Luer fitting with the optical plug inside. The exterior dimensions of the cover <NUM> can be approximately the same as the exterior dimensions of the insertion end of any of the above exemplary optical plugs. The cover <NUM> can have appropriate exterior dimensions to meet the ISO <NUM> specification and can be inserted into the female Luer lock. An optical plug that is designed for use with a cover can have dimensions that are reduced by approximately the thickness of the cover.

Light can enter the optical plug through the base window of the optical plug. The cover <NUM> may not cover the base window of the optical plug. Light can then travel through the optical plug, and different wavelengths can be combined through internal reflection in the optical plug. The light can then exit the insertion sidewall, insertion bevel, and front window of the optical plug. The light can then pass through the sidewall <NUM>, bevel <NUM>, and front window <NUM> of the cover. Light can pass through the cover into the female Luer fitting and the attached catheter. In some embodiments, the cover may be free of an insertion bevel. In some embodiments, the cover can have a curved exterior, or curved edges between the front window and the sidewall.

<FIG> is a cross section view of an exemplary cover for an optical plug along cross section line 6C-6C of <FIG>, according to an embodiment. Cover <NUM> is shown covering an optical plug <NUM>. Cover <NUM> can be free of a front bevel, and can have a front window <NUM> and a sidewall <NUM>. Sidewall <NUM> can be frustoconical. The cover <NUM> can be designed to sheathe at least a portion of the insertion end of an optical plug, and to be inserted into the internal cavity <NUM> of a female Luer lock. The sidewall <NUM> can have an approximately <NUM>% slope corresponding to the female Luer fitting. The cover <NUM> can have a rear opening (not shown). An optical plug can be inserted into the cover <NUM> through the rear opening.

The cover <NUM> can be made of a UV-transmissive material such as plastic. The cover <NUM> can have an exemplary thickness in a range of <NUM> to <NUM> inch (<NUM> to <NUM>), and preferably in a range of <NUM> to <NUM> inch. The cover <NUM> is sized and shaped to be placed over an optical plug, and be inserted into a female Luer fitting with the optical plug inside. The exterior dimensions of the cover <NUM> can be approximately the same as the exterior dimensions of the insertion end of any of the above exemplary optical plugs. The cover <NUM> can have appropriate exterior dimensions to meet the ISO <NUM> specification and can be inserted into the female Luer lock. An optical plug that is designed for use with a cover can have dimensions that are reduced by approximately the thickness of the cover.

Light can enter the optical plug through the base window of the optical plug. The cover <NUM> may not cover the base window of the optical plug. Light can then travel through the optical plug, and different wavelengths can be combined through internal reflection in the optical plug. The light can then exit the sidewall and front window of the optical plug. The light can then pass through the sidewall <NUM> and front window <NUM> of the cover. Light can pass through the cover into the female Luer fitting and the attached catheter. The cover can have a curved exterior, or curved edges between the front window and the sidewall.

<FIG> is a cross section view of an exemplary UV sterilizer for sterilizing a female Luer fitting and catheter. Sterilizer <NUM> can have a UV light unit <NUM> and a cord <NUM>. UV light unit <NUM> can include at least one UV LED, or other source of UV light. Cord <NUM> can connect to a power source, external control system, or both. Sterilizer <NUM> can have a body <NUM>. UV light unit <NUM> can also receive power from an internal battery (not shown). Various electronic components (not shown) can condition and/or convert and distribute electrical power to the electrical and/or optoelectrical components such as UV light unit <NUM>. These electronic components can be within the sterilizer body or can be located within a base unit connected to the sterilizer by cord <NUM>. The sterilizer can include a means of controlling and/or adjusting the light output of the at least one UV light source, wherein the light output of the at least one UV light source is measured and then adjusted accordingly to maintain a desired light output level. The sterilizer body <NUM> can be used to hold the female Luer fitting <NUM> and the catheter <NUM>. The sterilizer body <NUM> can have a female Luer fitting harness <NUM> to hold the female Luer fitting <NUM> in a straight line extending outward from the UV light unit <NUM>. Body <NUM> can have a catheter harness <NUM> designed to hold the catheter <NUM> in a straight line extending outward from the UV light unit <NUM>. Catheter harness <NUM> can be at least <NUM> long. Catheter harness <NUM> prevents shadows by keeping the catheter straight, thereby allowing the UV light to irradiate the catheter without any shadows. Catheter harness <NUM> can align the catheter and female Luer fitting with the optical axis of the sterilizer. This can be accomplished by holding the soft, flexible catheter in a straightened orientation so that there are no bends in the catheter, while also securing the catheter in a coaxial position with respect to the principal center axis of the optical plug. Catheter harness <NUM> additionally prevents ambient light from reaching the lumen of the catheter <NUM> so that photoreactivation of microorganisms within the catheter lumen is prevented. Female Luer fitting harness <NUM> additionally prevents ambient light from reaching the lumen of the female Luer fitting <NUM> so that photoreactivation of microorganisms within the lumen of the female Luer fitting <NUM> is prevented. Ambient light is prevented from illuminating the catheter and the female Luer fitting because ambient light enables microorganisms to repair DNA damage.

A user can insert the insertion end of an optical plug <NUM> into a female Luer fitting <NUM> with an attached catheter <NUM>. A user can optionally include a UV-transparent cover <NUM> over the optical plug <NUM> before inserting the optical plug <NUM> into the female Luer fitting <NUM>. The UV-transparent cover <NUM> can be disposable. This cover can have a thickness in a range of <NUM> to <NUM> inch (<NUM> to <NUM>), and preferably in a range of <NUM> to <NUM> inch. It should be clear that the dimensions of the insertion end of the optical plug will need to be decreased to account for the thickness of the transparent cover, so that the optical plug and cover together meet the ISO <NUM> spec and can be inserted into the female Luer lock. The optical plug and optional UV-transparent cover are designed to work together to meet ISO <NUM> requirements. An optical plug that is designed for use with a UV-transparent cover may not be used without the UV-transparent cover, because the optical plug with decreased dimensions that is designed to be used with a cover will not meet the ISO <NUM> requirements without the associated UV-transparent cover. The UV-transparent cover can be a semi-rigid plastic polymer shape that can slip over the insertion end of the optical plug. In various embodiments the cover can be made of polymers in the fluoropolymer family, including FEP, PTFE, etc. The cover can be manufactured using a compression molding process. The interior surface of the cover can be coated with an impedance matching film or other anti-reflection film that can reduce back-reflection. This film, which can be an oil or other material, can reduce power loss by reducing back-reflection at the material interface between the plug and the cover.

The user can then place the catheter <NUM>, optional protective cover, and the female Luer fitting <NUM> with the inserted optical plug <NUM> into the body <NUM> of the sterilizer <NUM>. The catheter <NUM> can be placed within the catheter harness <NUM>. The female Luer fitting can be placed within the female Luer fitting harness <NUM>. The sterilizer <NUM> can then be closed around the catheter <NUM>, female Luer fitting <NUM> and optical plug <NUM>. The sterilizer body <NUM> can prevent non-UV light from entering into the sterilizer <NUM>. The UV light unit <NUM> can be switched on, so that UV light radiates outward from the UV light unit <NUM> and into the base window <NUM> of the optical plug <NUM>. The UV light can then radiate through the optical plug <NUM>. UV light can radiate out of the sidewall <NUM> and front window <NUM> of the optical plug, thereby irradiating the inner surfaces of the female Luer fitting <NUM> and the inside of the catheter <NUM>. The catheter harness <NUM> holds the catheter in a straight line extending outward from the UV light unit <NUM> so that UV light radiates the inner surfaces of the female Luer fitting <NUM> and the inside of the catheter <NUM> without shadows or areas of decreased light intensity. Sterilizer <NUM> can kill pathogenic microbes dwelling intraluminally inside the catheter surface.

The UV light unit <NUM> can provide light in a range of wavelengths, including wavelengths outside of the UV spectrum. Light can be provided in desired wavelengths ranging from approximately <NUM> to <NUM>. The UV light unit <NUM> can provide UV-C light in a range of approximately <NUM> to <NUM>, and preferably in a range of approximately <NUM> to <NUM>. The UV light unit <NUM> can also provide UV-A light in a range of approximately <NUM> to <NUM>. The combination of UV-A and UV-C light together can have a synergistic sterilizing effect, so that the sterilizing effect of the two light wavelengths together can be greater than the sum of each light wavelength individually.

<FIG> is a cross section view of an exemplary UV sterilizer for a female Luer fitting and catheter, according to an alternate embodiment. Sterilizer <NUM> can have a sterilizer body <NUM>, a catheter harness <NUM>, and an optical plug <NUM>. The sterilizer body <NUM> can have a harness-engaging region <NUM>. The harness engaging region <NUM> can engage with the catheter harness <NUM>. The harness engaging region <NUM> and the catheter harness <NUM> can be engaged through threadings, or the sterilizer body can be constructed as a two-piece clamshell that can be closed around the catheter harness <NUM>, or other possible arrangements. The sterilizer body <NUM> can have an optical plug region <NUM> that optionally can be in contact with the optical plug <NUM> to ensure proper alignment of the optical plug <NUM> with the central axis of the sterilizer <NUM>. The optical plug region can optionally have a reflective coating so that any light that escapes from the base end of the optical plug due to scratches or other damage to the base end can be redirected back into the optical plug so that it can irradiate the inside of the female Luer fitting <NUM> and attached catheter <NUM>.

The sterilizer body <NUM> can have a UV light unit <NUM> and a cord <NUM>. UV light unit <NUM> can include at least one UV LED, or other source of UV light. Cord <NUM> can connect to an external power source, external control system, electrical control unit, and/or external user interface. Sterilizer <NUM> can have can have a user interface <NUM>. User interface <NUM> can include a means for controlling and/or adjusting the light output of the at least one UV light source. Sterilizer <NUM> can have an electrical control unit <NUM>. Electrical control unit <NUM> can condition, convert, and/or distribute electrical power to UV light <NUM>. Power and/or external controls can be carried through cord <NUM> to user interface <NUM> and to electrical control unit <NUM>, and from electrical control unit <NUM> to UV light unit <NUM>. In various embodiments, components such as the user interface <NUM> and electrical control unit <NUM> can be within the sterilizer body or in an external base unit, and connections between them can be configured appropriately.

Catheter harness <NUM> can have a sterilizer body engagement feature <NUM>, such as threads, tabs, or other possible arrangements configured to engage with the sterilizer body <NUM>. Catheter harness <NUM> can be configured to secure and align the catheter <NUM> and female Luer fitting <NUM> with the optical axis of the sterilizer. Catheter harness <NUM> can have a Luer-holding region <NUM> and a catheter-holding region <NUM>. In an embodiment, Luer-holding region <NUM> can engage with the threads of the female Luer fitting <NUM>, or can be a two-piece clamshell arrangement that holds the female Luer lock in place, or other configurations. Catheter-holding region <NUM> can hold and align the catheter <NUM> in a straightened orientation so that there are no bends in the catheter, while also securing the catheter in a coaxial position with respect to the principal center axis of the optical plug. The catheter-holding region <NUM> can be at least <NUM> long, and can prevent shadows in the first <NUM> of the catheter <NUM> so that UV light can irradiate at least the first <NUM> of the catheter <NUM> without (free of) any shadows. Catheter harness <NUM> additionally prevents ambient light from reaching the lumen of the catheter <NUM> so that photoreactivation of microorganisms within the catheter lumen is prevented. Catheter harness <NUM> additionally prevents ambient light from reaching the lumen of the female Luer fitting <NUM> so that photoreactivation of microorganisms within the lumen of the female Luer fitting <NUM> is prevented.

A user can insert an optical plug <NUM> into a female Luer fitting <NUM> with an attached catheter <NUM>. If the optical plug is designed for use with a UV-transparent cover, a user can include a UV-transparent cover <NUM> over the optical plug <NUM> before inserting the optical plug <NUM> into the female Luer fitting <NUM>. The user can then secure the female Luer fitting <NUM> and attached catheter <NUM> within the catheter harness <NUM>. The catheter harness <NUM> can then be secured within the sterilizer body <NUM>. The user can use user interface <NUM> to send power to the UV light unit <NUM>, thereby causing UV light to shine into the rear window of the optical plug <NUM>, through the body of the optical plug, and out of the insertion end where it can irradiate the inside of the female Luer lock and the attached catheter. This irradiation can kill many bacteria and other microbes present within the female Luer lock and attached catheter without (free of) the use of chemicals or drugs such as antibiotics or antimocrobials. Because prolonged high doses of UV-C exposure can damage DNA in human cells and can be a carcinogen, the sterilizer <NUM> can be designed to prevent or minimize leakage of light from the sterilizer.

<FIG> is a schematic block diagram of exemplary components of a sterilizer, according to an embodiment. Sterilizer <NUM> can have a user interface <NUM>, a power conditioning and distribution module <NUM>, a UV light source control module <NUM>, a UV light source <NUM>, and an optical plug <NUM> with insertion end <NUM> (not shown to scale). A user can use the user interface <NUM> to control the sterilizer <NUM>. The sterilizer can also include a user interface for an operator to adjust sterilizer settings and be informed of sterilizer operational and functional status. The user interface can consist of buttons, knobs, switches, touch-sensitive surfaces, display screens, and/or touchscreens, etc. UV light source <NUM> can then emit light into the optical plug <NUM>, and the light can be emitted out of the insertion end <NUM>. Sterilizer <NUM> can engineer the light structure, including the duty cycle and pulse frequency.

A user can use the user interface to control the time duration of UV irradiation. Longer irradiation times can result in greater germicidal efficacy. A user can use additional irradiation durations if, for example, a treatment has been skipped, or if the user suspects greater contamination than normal, or the user otherwise wants to increase germicidal efficacy. A user can use the user interface to control the radiant power of UV irradiation. Higher radiant power can result in greater germicidal efficacy. A user can use the user interface to control the proportion of time duration and/or radiant power at different wavelengths, e.g. <NUM>% UV-A and <NUM>% UV-C. Different organisms can be more or less susceptible to different wavelengths, so the radiant power and/or time duration of different wavelengths can be engineered for killing a specific organism. A user can use the user interface to control the duty cycle and/or pulse frequency. A user can control the duty cycle and/or pulse frequency to target a specific organism. A user can use the user interface to perform a manual calibration, status check, and or manual self-test of the sterilizer.

<FIG> is a diagram of an exemplary UV light source unit, according to an embodiment. UV light source unit <NUM> can have a multitude of LEDs arranged in an LED array. As shown, UV light source unit <NUM> can have LEDs <NUM>, <NUM>, <NUM>, and <NUM>. LEDs <NUM>, <NUM>, <NUM>, and <NUM> can be all the same wavelength, all different wavelengths, or a combination of possible wavelengths. A diagonal distance from one outer corner of the LED array to the opposite outer corner the LED array, defined as the square root of (W<NUM> + H<NUM>), can be equal to or less than the diameter of the base end of the optical plug. The diagonal distance can be equal to or less than the diameter of the base window. Light from the UV light source <NUM> can be directed from the LEDs into the base end of the optical plug.

<FIG> shows a light beam redirector, according to an embodiment. The light beam redirector <NUM> can be a component in the UV light unit <NUM>. A UV-C light source <NUM>, such as an LED, can be focused on the light beam redirector <NUM> so that the light is directed out of the UV light unit <NUM> along the direction of light vector L and towards the optical plug <NUM>. A UV-A light source <NUM>, such as an LED, can be focused on the light beam redirector <NUM> so that the light is directed out of the UV light unit <NUM> along the direction of light vector L and towards the optical plug <NUM>. UV-C and UV-A radiation can be emitted from the UV light unit <NUM> simultaneously, individually, or in various engineered forms of pulses.

<FIG> is an exemplary diagram of UV light from the UV light source being directed into and through the optical plug (not to scale), according to an embodiment. UV light source <NUM> is shown with LEDs <NUM> and <NUM>, and window <NUM>. Optical plug <NUM> is shown with optional antireflective coatings <NUM> and <NUM> (not shown to scale). Antireflective coating <NUM> is over base window <NUM>, and antireflective coating <NUM> is over insertion window <NUM>. By way of non-limiting example, antireflective coatings <NUM> and <NUM> can be made from thin layers of materials such as Magnesium fluoride (MgF<NUM>), fluoropolymers, and various other materials. Antireflective coatings <NUM> and <NUM> can be made of the same or different materials. Antireflective coating <NUM> can help to ensure that a greater percentage of light from the LEDs enters through the base window <NUM>, and antireflective coating <NUM> can help to ensure a greater percentage of light emerges out of the optical plug through the insertion window <NUM>. LED <NUM> is shown emitting light rays <NUM> through window <NUM>, and into the base window <NUM> of the optical plug <NUM>. Optical plug <NUM> can be designed to act as a light pipe, or light mixing rod, or light combiner. Optical plug <NUM> can further be designed to act as a light homogenizer, or light homogenizing rod. Light <NUM> can enter the optical plug <NUM> through the base window <NUM>, and can then propagate through the optical plug via multiple internal reflections off the sidewalls of the optical plug. Additional light (not shown) from other LEDs such as <NUM> can also enter the optical plug, and can propagate through the optical plug via multiple internal reflections off the sidewalls of the optical plug. In an embodiment, base end <NUM> can cause light to reflect internally within the base end <NUM>, and insertion end <NUM> can allow light to escape into the female Luer fitting and attached catheter. This internal reflection in the base end <NUM> and escape from the insertion end <NUM> can be controlled by the shape of the optical plug, the properties of the material used to make the optical plug, the grit and polish of the base end and the insertion end, or a combination of these factors. The reflection within the optical plug can mix the light from the different LEDs together so that polychromatic light, that can consist of different wavelengths of light, and can have each constituent wavelength have more uniform spatial distribution of intensity, can emerge from the optical plug through the insertion end <NUM>, the insertion window <NUM>, and through the antireflective coating <NUM>. The light from multiple sources can be reflected internally and mixed within the optical plug, and can emerge from the optical plug as a blended polychromatic light.

<FIG> shows light entering a female Luer fitting without an optical plug. As depicted, light <NUM> from light source <NUM> enters the female Luer fitting <NUM> at a narrow angle, and illuminates illumination area <NUM>, including the inner surface <NUM> of the female Luer fitting <NUM> and the inner surface <NUM> of the attached catheter. <FIG> shows light entering a female Luer fitting through the insertion end of an optical plug. Light is reflected internally and combined within the optical plug, and exits the insertion end of the optical plug at a broad range of angles. Light enters the female Luer fitting <NUM> from the optical plug <NUM> at a broad range of angles, including light <NUM> exiting from the front window of the optical plug and light <NUM> exiting from the insertion sidewall of the optical plug. The light <NUM> exiting from the front window of the optical plug has been reflected internally and redirected, and illuminates illumination area <NUM> with a broad range of illumination angles, including the inner surface <NUM> of the female Luer fitting <NUM> and the inner surface <NUM> of the attached catheter. Because the light of <FIG> strikes illumination area <NUM> at a narrow angle, the inner surface <NUM> of the Luer fitting <NUM> is illuminated with a decreased intensity as compared with <FIG>. In <FIG>, light that is reflected internally within the optical plug <NUM> exits from the insertion end <NUM> at a much broader range of angles. This broader range of angles allows a greater light intensity to strike the inner surface <NUM> of the Luer fitting <NUM> as compared to <FIG>.

<FIG> shows a system of lenses for focusing UV light radiation, according to an embodiment. The system of lenses for UV light radiation can be a component in the UV light unit <NUM>. Light sources <NUM>, such as LEDs, can provide light in a range from approximately <NUM> to <NUM>, which can include light outside of the UV range. In some embodiments, light sources <NUM> can include either UV-C sources, UV-A sources, or a combination of both. Spherical ball lenses <NUM> can direct the light from a UV light source towards a focusing lens <NUM>. The focusing lens <NUM> can direct the light out of the UV light unit and focus the light at the optical plug <NUM>.

<FIG> shows a system for beam splitting and combining, according to an embodiment. A UV-C light source <NUM>, such as an LED, can project UV-C light onto a <NUM>:<NUM> UV fused silica quartz beamsplitter <NUM>. A UV-A light source <NUM>, such as an LED, can project UV-A light onto the <NUM>:<NUM> UV fused silica quartz beamsplitter <NUM>. The beamsplitter <NUM> can produce two mixed wavelength beams <NUM> and <NUM> of approximately equal power. Beam <NUM> can then be reflected off a mirror <NUM>. Each of these beams can then be passed through a dual lens beam shaping system. The first lens <NUM> is a positive lens that can focus the beams <NUM> and <NUM>. The second lens <NUM> can then reshape the beams for projection through an optical plug <NUM> and into a catheter. This dual-lens combination of first a converging lens and then a diverging lens can reduce the beam diameter so that it matches the inlet diameter of the female Luer fitting. This system results in two separate beams of combined UV-C and UV-A light. This system can be used, for example, to irradiate a dual-port type hemodialysis catheter, as both ports can be treated simultaneously. Other optics designs are specifically contemplated, such as a knife-edge right-angle prism that could be used to combine the UV-A and UV-C light beams instead of a planar beam splitter.

Claim 1:
A sterilizer (<NUM>, <NUM>) for sterilizing a female Luer fitting (<NUM>) comprising:
an optical plug (<NUM>, <NUM>) comprising a base end, an insertion end having a frustoconical insertion sidewall (<NUM>), and a front window (<NUM>) at a proximal end of the insertion end, wherein the insertion end is adapted to be inserted into a corresponding internal cavity of the female Luer fitting (<NUM>);
a sterilizer body (<NUM>, <NUM>), the body (<NUM>, <NUM>) comprising a catheter harness (<NUM>, <NUM>) configured to prevent ambient light entering a catheter (<NUM>) associated with the female Luer fitting (<NUM>) and a female Luer fitting harness (<NUM>) configured to prevent ambient light entering the female Luer fitting (<NUM>);
at least one UV light source (<NUM>) providing light in a range of approximately <NUM> to <NUM>, wherein the at least one UV light source (<NUM>) is a UV-A light source and a UV-C light source, and wherein the UV light can be radiated through the optical plug (<NUM>, <NUM>) and out of the insertion sidewall (<NUM>) and front window (<NUM>), thereby irradiating the inner surfaces of the female Luer fitting (<NUM>) and the inside of the catheter (<NUM>); and
a means of controlling or adjusting the light output or duty cycle of the at least one UV light source (<NUM>) such that the UV-A light source is turned on alone for a predetermined period of time and then turned off, and then the UV-C light source is turned on for a predetermined period of time and then turned off, such that the UV-A and UV-C light sources are turned on sequentially with the UV-A light source preceding the UV-C light source.