Optical coupling cap sterilization system

Abstract

A light coupling cap can sterilize a target including a connector and other devices such as a catheter with a luer fitting that complies with ISO 594 or ISO 80369 standards. The cap can be disposable. The light coupling cap can reversibly attach to a connector of the target, forming a physical seal and barrier between the interior of the connector and the external environment while allowing light to be transmitted into the connector. When the cap is connected to the target, a sterilizer can be connected to the cap. The sterilizer can include a UV light emitter that emits UV light into the target through the cap. The light coupling cap sterilization system can implement self-repair by measuring internal performance indicators and adjusting its operation according to these indicators. The light coupling cap sterilization system can provide an indication to the user of the amount of light dose applied to the target.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to sterilization, and more particularly to sterilization using ultraviolet radiation. BACKGROUND

[0002] Central venous catheters (CVCs) are medical devices used to provide access to a patient's bloodstream. CVCs are widely used in many healthcare settings, such as critical care or intensive care units (ICUs) within Acute Care Hospitals (ACHs), outpatient specialty care clinics and hospitals, and home healthcare. CVCs have many applications, including parenteral nutrition, chemotherapy, and hemodialysis (HD).

[0003] Despite being widely used in many applications and being critical to providing healthcare, CVCs are susceptible to infection by pathogenic microorganisms that colonize the external (extraluminal) and internal (intraluminal) portions of the catheter and migrate to the blood flow-contacting portion of the catheter. Catheter-Related Bloodstream Infection (CRBSI) can occur once a sufficient number of pathogens can enter the patient's bloodstream. CRBSI is a serious, life-threatening event that can cause great harm to the patient and cost the global healthcare system billions of dollars. Improvements in practices such as hand hygiene and aseptic technique have not eliminated the problem. A more effective CVC sterilization system is needed. SUMMARY

[0004] The present invention helps to reduce or eliminate the CRBSI problem by enabling the safe application of ultraviolet (UV) light to the intraluminal portion of CVCs and other medical devices to kill microorganisms before they can colonize the medical device. UV light can kill microorganisms by breaking their DNA through a photochemical reaction. In addition, UV light disinfection has advantages over chemical or antibiotic disinfection methods because it does not carry the patient health risks associated with chemical exposure nor does it carry the risk of contributing to the development of antibiotic resistance in microorganisms.

[0005] In illustrative embodiments, a sterilizer cap can include an outer shroud (which can be internally threaded), an inner connector interface (which can be frustoconical), and optics within the inner connector interface. The inner connector interface can define a hollow interior cavity. Illustratively, the sterilizer cap is adapted for interconnection with a medical device. The medical device can include a luer fitting, and the outer shroud is adapted to engage and relatively lock the luer fitting. One or more photosensitive indicators can receive light from a sterilization system incident on the medical device, and these indicators can include photochromic and irreversible photoreactive substances, photodiodes, phototransistors, and / or optical power sensors. The photochromic or irreversible photoreactive chemical substances can be incorporated or embedded into the material of the sterilizer cap. Illustratively, the optics can be operatively connected to a beamsplitter that splits light passing through the optics. One or more sensors can be adapted to receive redirected light from the optics and transmit information about the redirected light to one or more processors. The transmitted information can include at least one of intensity, or irradiance, or radiant power, or irradiance, or wavelength and spectral power. A photointerrupter system can detect when the interface is interconnected with the medical device based on light transmission between the interface and the medical device. BRIEF DESCRIPTION OF DRAWINGS

[0006] The following invention description refers to the accompanying drawings, wherein:

[0007] Figure 1A is a perspective view of a sterilization cap according to an illustrative embodiment;

[0008] Figure 1B is a cross-sectional view of the sterilization cap taken along section line 1B-1B of Figure 1A is a cross-sectional view of the sterilization cap taken along section line 1B-1B of

[0009] Figure 2A is a partial cross-sectional view of an inner connector interface according to an illustrative embodiment, showing the interior of the inner connector interface;

[0010] Figure 2B is a partial cross-sectional view of a cap according to an illustrative embodiment, showing an inserted light source;

[0011] Figure 3A is a partial cross-sectional view of an inner connector interface of a cap according to an illustrative embodiment, showing an inserted light transmitter;

[0012] Figure 3B is a partial cross-sectional view of an inner connector interface of a cap according to an illustrative embodiment, showing internal workings of light transmission through the light transmitter;

[0013] Figure 4 is a partial cross-sectional view of an optical element with a retainer according to an illustrative embodiment;

[0014] Figure 5 is a side view of a sterilization cap having a fixation point to fix the sterilization cap to a medical device, according to an illustrative embodiment;

[0015] Figure 6A is a top view of an optical device, according to an illustrative embodiment;

[0016] Figure 6B is a side view of an optical device, according to an illustrative embodiment;

[0017] Figure 6C is a partial cross-sectional view of a cap and a separate optical element joined together, showing an interior region, according to an illustrative embodiment;

[0018] Figure 6D is an end view from the back of an end cap, showing an optical device joined to an interior surface of an interior connector interface, according to an illustrative embodiment; and

[0019] Figure 6E is a cross-sectional view of an optical device within an interior connector interface of Figure 6D , taken along section line 6E-6E of Figure 6D ;

[0020] Figure 7A is a schematic view of an external light source having a photo interrupter sensing system, according to an illustrative embodiment;

[0021] Figure 7B is a schematic view of a photo interrupter sensing system having a light blocker, according to an illustrative embodiment;

[0022] Figure 7C is a schematic view of a photo interrupter sensing system having a light transmitter, according to an illustrative embodiment;

[0023] Figure 7D is a schematic view of a photo interrupter sensing system having a light transmitter and a light blocker, according to an illustrative embodiment;

[0024] Figure 7E is a schematic view of a photo detector system, according to an illustrative embodiment, in which a light source is located at the back of a cap and a photo sensor is located at the side of the cap;

[0025] Figure 7F is a schematic view of a photo detector system of Figure 7E , in which the cap is removed and light shines on the photo detector;

[0026] Figure 8Ais a partial cross-sectional view of a sterilization system according to an exemplary embodiment, showing internal workings with an end cap attached to an external light source and a medical device;

[0027] Figure 8B is a partial cross-sectional view of a sterilization system according to an illustrative embodiment, showing internal workings with multiple disinfecting light sources emitting light from different positions and at different angles;

[0028] Figure 8C is a partial cross-sectional view of a sterilization system according to an illustrative embodiment, showing internal workings with a light emitter functioning as a primary disinfecting light emitter and an auxiliary light emitter;

[0029] Figure 9A is a partial cross-sectional view of a connector system showing internal workings according to an illustrative embodiment;

[0030] Figure 9B is a partial cross-sectional view of a connector system showing internal workings with a mechanical linkage according to an illustrative embodiment;

[0031] Figure 9C is a partial cross-sectional view of a connector system showing internal workings with a mechanical linkage having a connecting configuration according to an illustrative embodiment;

[0032] Figure 10 is a partial cross-sectional view of a sterilization system with a remote monitoring system for data collection, communication, and control according to an illustrative embodiment, showing a schematic of internal workings;

[0033] Figure 11A is a schematic of an end cap with a beam splitter according to an illustrative embodiment;

[0034] Figure 11B is a schematic of a sterilizer system with an end cap having a beam splitter and an external light source according to an illustrative embodiment;

[0035] Figure 12A - I is a chemical diagram of a photochromic pigment for an energy transfer status indicator according to an illustrative embodiment; and

[0036] Figure 13 is a schematic of a sterilization system including an end cap with one or more light sensitive indicators according to an illustrative embodiment. DETAILED DESCRIPTION

[0037] The light coupling end cap can be used in a medical device with a connector port accessing an interior space or lumen. As a non-limiting example, the connector for the connector port can be a luer fitting as described in the ISO 594 standard. This example luer fitting can be a female fitting with external threads (commonly referred to as a "luer lock" connector). This connector can be used as a port for delivering or outputting a fluid such as water, blood, plasma, nutrients, saline, etc. into or from the space or lumen within the medical device. As a non-limiting example, the medical device can be a tube or catheter with a space or lumen that is a lumen of the tube or catheter.

[0038] The end cap can have mating features suitable for securely connecting to a connector port of a device. The end cap can form a physical barrier or seal between the device port and the external environment. At the same time, the end cap can have optically transparent or partially transparent features and surfaces so that light of a desired wavelength band (as a non-limiting example, UV-C) can be transmitted through the end cap into the lumen of the port and the interior space or lumen of the device, e.g., the lumen of the tube or catheter if the medical device is a tube or catheter. The end cap can be referred to as a plug or optical plug because it can be inserted into a receiving port and form a physical barrier or seal against materials such as fluids or solids passing through the port, but at the same time can allow light of a predetermined wavelength (e.g., UV-C, or UV-A or UV-B) to pass through the port.

[0039] The end cap can be referred to as a cap because it can have retention features such as threads (e.g., screw threads) or one or more latches, or other mechanisms or features to provide retention force to secure the cap to a mating port. Since the end cap can couple light from an external light source into an interior space of a separate device or object, it can be described as a light coupling, and can be referred to as a light coupling cap, or a light coupling plug, or a light coupling end cap, etc.

[0040] The cap can have one or more internally threaded portions to attach to one or more threaded portions of a corresponding mating connector. As a non-limiting example, the mating connector that can correspond to the cap can be a female luer lock with external threads.

[0041] Figure 1A is a perspective view of a disinfecting end cap according to an illustrative embodiment. The disinfecting end cap 100 can also be referred to as a cap, end cap, light coupling cap, plug, or optical plug. Figure 1B is a perspective view of a cap according to an illustrative embodiment taken along Figure 1A is a cross-sectional view of the cap taken along section line 1B-1B of Figure 1A and 1BThe end cap 100 can have an outer cover 110 and an inner connector interface 120. The inner connector interface can be a male taper. The outer cover 110 and the inner connector interface 120 can individually or in combination form a connector for mating with a complementary connector on a separate body or device or object. The connector formed individually or in combination by the outer cover 110 and / or the inner connector interface 120 can be a luer type connector as defined by ISO 594 or other standards, or other type of connector. The inner connector interface can be the size and shape of the tapered male portion of a luer fitting. The outer cover 110 can protect the inner connector interface 120. The outer cover 110 can be a structure suitable for allowing a user to operate and manipulate the end cap 100. The outer cover 110 can have an outer surface 112 and an inner surface 114. The outer surface 112 can be suitable for being operated by a user to manipulate the end cap 110. The outer surface 112 can be textured and / or have various features such as knurling, treads, cavities, or ridges, etc. to facilitate user operation. The inner surface 114 can have attachment features 116 such as screw threads for securely attaching to a mating connector on a separate body, device, or object. The inner connector interface 120 can have an outer surface 122. The outer surface 122 can be shaped to conform to a standard such as ISO 594 (luer fitting standard) or other standards. The inner connector interface 120 can have a front portion 124. The end cap can have an optical 130 that can be located at the front portion 124 of the inner connector interface 120. The optical 130 can be made of a solid material such as glass, plastic, fused silica, sapphire, or other materials. The optical 130 can be a lens, a lens array, a window, or other type of optical. In various embodiments, the inner connector interface can include an open space at the front portion 124. The inner connector interface 120 can have an inner cavity 126 which can be frustoconical, cylindrical, square, or other shape, and can extend to the back side of the end cap 100 to terminate in a hole 128. The inner cavity 126 can be filled with an optical material such as plastic, fused silica, sapphire, glass, or other type of optical material. The material filling the inner cavity 126 can act as an optical such as a light guide, light pipe, or light homogenizing rod. The inner cavity 126 can be hollow. The inner cavity 126 can have an optical 130 such as a lens, or a window, or a lens array, or other optical embedded or mounted therein.

[0042] In various embodiments, the end cap can be a light coupling end cap in that it can act as a cap as described above, while also acting as a window allowing light to pass through the cap and into the connector on the medical device. Thus, it can allow light to be coupled from an external light source into the interior space or cavity through the connector port.

[0043] In various embodiments, the end cap can conform to an ISO 594 Luer lock male connector shape. The end cap can be manufactured using an injection molding process. The cap can be made of a plastic resin such as a cyclic olefin copolymer (COC). An exemplary COC resin, TOPAS 8007X10, can transmit a significant percentage (40-70%) of UV-C / UV-B light (260-280 nanometers) through the end cap. Additionally, a fused silica or fused quartz optic 130 can be inserted into the distal end of the internal connector interface 120 to further increase the intensity of the transmitted light, as fused silica / quartz can transmit nearly 90% of incident light in the range of 260 to 280 nanometers. The optic 130 can be a disc or other shape that fits into the Luer portion, which can be made of plastic. The optic 130 can be 0.5 mm thick, or 1 mm thick, or other suitable thickness to ensure mechanical strength and provide a physical barrier or seal between the lumen (e.g., catheter lumen) and the external environment. The interior of the internal connector interface 120 can be solid, or a hollow cavity filled with air or a fluid such as water. If a fluid, the fluid can act as a liquid light pipe and can be sealed at the other end with a second fused silica window or other material. The hollow cavity can contain a solid light pipe made of a material such as fused silica. The interior walls of the hollow cavity can be coated with a reflective material, such as aluminum or another material that has reflective properties in the desired wavelength range for the appropriate application. The reflective coating can transmit light from an external light source through the cap and into the interior space or cavity of the mating port to which the cap can be attached.

[0044] The hollow cavity can receive a light source from a compatible device or from a standalone light source. The received light source can be positioned very close to or abutting the tip of the internal connector interface, which can increase the intensity of the light emitted through the optic to the space or cavity or surface on the other side of the optic. As a non-limiting example, the cap can be connected to a connector port of a central venous catheter, and light from a light source within the internal cavity of the cap can pass through the tip of the end cap, which can include the optic 130. The light can pass through the lumen of the catheter connector port and through the catheter lumen, and the light can “strike” the interior surface of the catheter connector port and the interior surface of the catheter lumen. The received light source can be positioned within a range of about 0.5 mm to about 10.0 mm from the tip of the luer fitting. The received light source can be positioned between about 0.5 mm and about 1.0 cm, about 1.0 mm and about 1.5 mm, about 1.5 mm and about 2.0 mm, about 2.0 mm and about 2.5 mm, about 2.5 mm and about 3.0 mm, about 3.0 mm and about 3.5 mm, about 3.5 mm and about 4.0 mm, about 4.0 mm and about 4.5 mm, about 4.5 mm and about 5.0 mm, about 5.0 mm and about 5.5 mm, about 5.5 mm and about 6.0 mm, about 6.0 mm and about 6.5 mm, about 6.5 mm and about 7.0 mm, about 7.0 mm and about 7.5 mm, about 7.5 mm and about 8.0 mm, about 8.0 mm and about 8.5 mm, about 8.5 mm and about 9.0 mm, about 9.0 mm and 9.5 mm, and about 9.5 mm and 10.0 mm from the tip of the luer fitting.

[0045] The optic 130 can be embedded as an insert in the end cap at the time of injection molding, or it can be inserted after the end cap is injection molded. If inserted after the end cap is formed, the optic 130 can be held in place by friction, or it can be held in place by an adhesive or other type of chemical or physical bonding, or it can be held in place by a combination of these and / or other methods.

[0046] The optic can be scored, nicked, or otherwise featured on its circumference to allow it to be held more securely within the plastic portion of the assembly. One or more circumferential edges of the optic 130 can be roughened or modified to aid in sealing and holding the optic 130 within another body such as an end cap. The edge modification can involve a chemical modification to change material properties (e.g., as non-limiting examples, hydrophobicity or hydrophilicity), or it can involve the addition of mechanical features, e.g., as non-limiting examples, protruding or recessed features.

[0047] Figure 2Ais a partial cross-sectional view of an internal connector interface according to an illustrative embodiment, showing the interior of the internal connector interface. The internal connector interface can be a male luer taper. The internal connector interface 120 can have a body 220, which can be frustoconical in shape. The body 220 can conform to a standard connector specification, such as ISO 594 (luer taper), or other shapes that conform to another standard connector specification, or any shape that conforms to a proprietary or custom specification. The internal connector interface body 220 can have a frustoconical shape, such as a luer connector that conforms to the ISO 594 / ISO 80369 standard, although other shapes that are suitable for connection with other types of connectors are possible. The internal connector interface body 220 can have an outer surface 122 and an inner surface 224. The internal connector interface body 220 can be made of an injection moldable plastic material or other material. As non-limiting examples, the body can be made of a cyclic olefin polymer (COP) or copolymer (COC), or can be made of a fluoropolymer such as fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), or polyvinylidene fluoride (PVDF), as these materials have transmission properties for ultraviolet light. As further non-limiting examples, the body 220 can be made of polymethyl methacrylate (PMMA) or acrylic. The internal connector interface 120 can have an optical 130. The optical 130 can have an outer surface 212 and an inner surface 214. The optical element 130 can be made of a suitable optical material for transmitting or shaping or both transmitting and shaping light of a predetermined wavelength. As non-limiting examples, the light can be ultraviolet light, visible light, or infrared light. As further non-limiting examples, the light can be ultraviolet light in the wavelength range of 250-290 nm. As non-limiting examples, the optical 130 can be made of an optical material such as glass, fused silica, sapphire, or other optical material. The optical element 130 can be a window, a lens, a lens array, a light pipe, or other optical component. The internal connector interface 120 can have a hollow cavity 126. The optical element 130 can be a separate piece that is mounted within the body 220, or it can be made of the same material as the body 220 and integrated into the body 220. In various embodiments that utilize a separate optical 130, the optical can be insert molded or overmolded into the body 220, or installed using another manufacturing process that forms the body 220 around the optical element 130. In various embodiments, the optical element 130 can be installed in the body 220 after the body 220 has been made.The optical element 130 can be attached, secured, or mounted within the body 220 using an adhesive, or chemical bonding, or welding, or friction, or retention features integrated into the end cap body, or by other retention methods.

[0048] In various embodiments, the optical device 130 can be made of the same material as the body and integrated into the body 220, and the optical element 130 can be formed as a feature of the body 220 during manufacture of the body. As non-limiting examples, the optical device 130 and the body 220 can be formed as a single continuous piece from a mold in a plastic injection molding process or other molding process, or a subtractive process such as milling or cutting, or other manufacturing process. In Figure 2AIn the illustrated embodiment, optical element 130 is depicted as being located at one end of body 220, however, in various embodiments, optical components can be located in any arbitrary position. The outer surface 122, or the inner surface 224, or the outer surface 212, or the inner surface 214, or any combination of the outer and inner surfaces 122, 224, 212, and 214 of the internal connector interface body can have a surface finish suitable for optical transmission of ultraviolet light or other wavelengths of light. The surface finish of 122, 224, 212, and / or 214 can be designed for a particular optical quality, such as low reflectance, low diffusion, low refraction, high transmission, or any other optical characteristic. In various embodiments, the surface can have a scratch-mash of about 80-20. In various embodiments, the surface can have a scratch-mash of about 40-20. In various embodiments, the surface can have a scratch-mash of about 20-10. In various embodiments, the surface can have a scratch-mash of about 10-5. In various embodiments, the surface finish can be less than 100 Angstroms RMS. In various embodiments, the surface finish can be less than 50 Angstroms RMS. In various embodiments, the surface finish can be less than 20 Angstroms RMS. In various embodiments, the surface finish can be less than 5 Angstroms RMS. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 1.4-4.0, similar to common optical glasses. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 1.4. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 1.52, such as NBK7 optical glass at 586 nm. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 1.8. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 1.83, such as sapphire at 265 nm. In various embodiments, some or all of the internal connector interface and / or optics can have an index of refraction that can be about 4.0. In various embodiments, some or all of the internal connector interface and / or optics can have an Abbe number of about 25-60. In various embodiments, some or all of the internal connector interface and / or optics can have an Abbe number greater than 55. In various embodiments, some or all of the internal connector interface and / or optics can have an Abbe number of about 64.17, such as NBK7 optical glass. In various embodiments, some or all of the internal connector interface and / or optics can have an Abbe number of about 72.24, such as sapphire.

[0049] Figure 2Bis a partial cross-sectional view of a cap according to another illustrative embodiment, showing an inserted light source. In one embodiment, an external light source 240 can be inserted into an interior hollow cavity 126 of a cap 100. The cap 100 can have a cap body 200, which can include an outer housing 110 and an interior connector interface 120. The cap body 200 can be made of a rigid or semi-rigid material, and the material can have optical properties suitable for light transmission. The cap body 200 can have an outer surface 112 and an attachment feature 116, which can be an internal thread. The attachment feature 116 can attach to a complementary external thread or tab feature on a mating connector. As a non-limiting example, the attachment feature 116 can be an internal thread that can comply with a connector standard such as ISO 594 or ISO 80369 or other standards. An optical device 130 can be integral with the cap body 200. In this embodiment, a light source 240 can be inserted into the interior hollow cavity 126 of the cap body 200. The light source 240 can have a body 244 and an optical component 242, which can be a lens, an array of lenses, or a window. As a non-limiting example, the light source 240 can be a light-emitting diode (LED). The light source 240 can be mounted on a platform 250. The light source platform 250 can provide a physical platform to mount and support the light source 240, and it can also provide electrical connections to deliver power (current) and other control and communication signals to and from the light source 240. As a non-limiting example, the light source platform 250 can be a printed circuit board (PCB). The platform 250 can be attached to a stem 260. The stem 260 can be a circular or rectangular stem, or it can be other shapes. The stem 260 can have one or more interior spaces that can contain electrical components, electronics, or mechanical elements that can form various mechanisms, sensors, or other components. As a further non-limiting example, the stem 260 can have electrical wires in its interior spaces that can carry current to the light source platform 250 or the light source 240 or both.

[0050] In various embodiments, the stem 260 can be operably connected to a linear actuator 270 that can move the light source back and forth within the hollow interior cavity 126 in the direction of arrow 272. The linear actuator can be positioned outside the stem, or it can be partially or entirely within the stem 260. The linear actuator can include gears, belts, electromagnets, or other mechanisms within the interior spaces of the stem 260 or outside the stem 260 to produce linear motion.

[0051] Figure 3Ais a partial cross-sectional view of a portion of an internal connector interface of a cap according to an illustrative embodiment, showing an inserted light pipe. The internal connector interface 120 can have a body 220, which can be frustoconical in shape. The body 220 can conform to a standard connector specification, such as ISO 594 (Luer), or be another shape that conforms to another standard connector specification, or be any shape that conforms to a proprietary or custom specification. The internal connector interface body 220 can have a frustoconical shape, but other shapes can also be suitable for connection with various types of connectors. The internal connector interface body 220 can have an outer surface 122 and an inner surface 224. The internal connector interface body 220 can be made of an injection moldable plastic material or other material. As non-limiting examples, the body can be made of a cyclic olefin polymer (COP) or co-polymer (COC), or can be made of a fluoropolymer such as fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), or polyvinylidene fluoride (PVDF), as these materials have transmission properties for ultraviolet light. As further non-limiting examples, the body 220 can be made of PMMA or acrylic. The internal connector interface 120 can have an optical 130. The optical 130 can have an outer surface 212 and an inner surface 214. The optical element 130 can be made of a suitable optical material for transmitting or shaping or both transmitting and shaping light of a predetermined wavelength, such as ultraviolet, visible, or infrared light. As further non-limiting examples, the optical 130 can be made of an optical material such as glass, fused silica, sapphire, or other optical material. The optical element 130 can be a window, a lens, a lens array, a light pipe, or other optical component. The internal connector interface 120 can have a hollow cavity 126. The optical 130 can be a separate piece that is mounted within the body 220, or it can be made of the same material as the body 220 and integrated into the body 220. In various embodiments that utilize a separate optical 130, the optical can be insert molded or overmolded into the body 220, or installed using another manufacturing process that forms the body 220 around the optical 130. In various embodiments, the optical 130 can be installed in the body 220 after the body has been made. The optical 130 can be attached, secured, or mounted within the body 220 using an adhesive, or chemical bonding, or welding, or friction, or retention features integrated into the end cap body, or by other retention methods.

[0052] In Figure 3AIn various embodiments, optical element 130 is depicted as being located at one end of body 220, however, in various embodiments, optical components can be located in any arbitrary position. Internal connector interface body outer surface 122, or inner surface 224, or optical element outer surface 212, or inner surface 214, or any combination of outer and inner surfaces 122, 224, 212, and 214 can have a surface finish suitable for optical transmission of ultraviolet light or other wavelengths of light. The surface finish of 122, 224, 212, and 214 can be designed for a particular optical quality, such as low reflectance, low diffusion, low refraction, high transmission, or any other optical characteristic. In various embodiments, the surface can have a scratch-mottle of approximately 80-20. In various embodiments, the surface can have a scratch-mottle of approximately 40-20. In various embodiments, the surface can have a scratch-mottle of approximately 20-10. In various embodiments, the surface can have a scratch-mottle of approximately 10-5. In various embodiments, the surface finish can be less than 100 Angstroms RMS. In various embodiments, the surface finish can be less than 50 Angstroms RMS. In various embodiments, the surface finish can be less than 20 Angstroms RMS. In various embodiments, the surface finish can be less than 5 Angstroms RMS. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 1.4-4.0, similar to common optical glasses. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 1.4. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 1.52, for example, NBK7 optical glass at 586 nm. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 1.8. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 1.83, for example, sapphire at 265 nm. In various embodiments, some or all of the internal connector interface and / or optical devices can have an index of refraction that can be approximately 4.0. In various embodiments, some or all of the internal connector interface and / or optical devices can have an Abbe number of approximately 25-60. In various embodiments, some or all of the internal connector interface and / or optical devices can have an Abbe number greater than 55. In various embodiments, some or all of the internal connector interface and / or optical devices can have an Abbe number of approximately 64.17, for example, NBK7 optical glass. In various embodiments, some or all of the internal connector interface and / or optical devices can have an Abbe number of approximately 72.24, for example, sapphire.

[0053] The end cap can have a light transmitter 340 with an end surface 342 and a side surface 344. The light transmitter 340 can be a lens, a light pipe, a window, a light source, or other type of optical component. The light transmitter can transmit light from an external light source into the hollow cavity 126 within the internal connector interface 120. The linear actuator can move the light pipe 340 between various positions, including a fully inserted position 350 and partial insertion positions 352, 354, and 356. In various embodiments, the light transmitter 340 can be statically positioned within the hollow cavity 126, or it can be dynamically adjusted while the system is in operation to change the way light is emitted into the medical device through the main body 220, or through the optics 130, or through both the main body and the optics. The position of the distal end of the light transmitter can be selected to affect how much of the mating female connector is exposed to the light exiting the light pipe. As a non-limiting example, if the light transmitter is a light pipe, light can be emitted only through the end surface 342, so the end surface position within the hollow cavity will determine the origin from which light radiates out of the hollow cavity 126. The cone of light exiting the light pipe will intersect with a larger portion of the luer connector the farther the light pipe is from the distal tip of the male luer connector. The light transmitter 340 can be made of a material suitable for transmitting light of a predetermined wavelength, such as ultraviolet, visible, or infrared light. As a non-limiting example, the light transmitter 340 can be made of fused silica, sapphire, glass, or other materials.

[0054] Figure 3B is a partial cutaway view of the internal connector interface of a cap according to an illustrative embodiment, showing internal workings of light transmission through a light transmitter. The cap can have a light transmitter 340 that can be fixed to the end cap in a fixed position, or can have an adjustable position within the end cap. In various embodiments, the light transmitter 340 can be removable or can be fixedly attached to the end cap. The internal cavity 126 of the internal connector interface can have an internal shoulder 332 against which the light transmitter 340 can rest when the light transmitter 340 is in the fully inserted position. The position of the internal shoulder 332 within the internal cavity 126 can determine the fully inserted position.

[0055] The light transmitter 340 can transmit light rays 350 through the light transmitter and emit the light rays 350 out of the light transmitter. The light rays can be emitted from the light transmitter and through the internal connector interface 120. The light rays 350 can pass through the optics 130, and the light rays can pass through the internal connector interface main body 220 and exit the external surface 122. The emitted light rays can pass through the internal connector interface 120, including the optics 130, such that the light rays impinge on various surfaces on the medical device, which can include a catheter and / or a connector.

[0056] The light rays can be any predetermined wavelength suitable for the application. As a non-limiting example, the light rays can be ultraviolet light. As a further non-limiting example, the light rays can be ultraviolet light in the UV-C or UV-B range. As a further non-limiting example, the light rays can have a wavelength in the 255-300 nm range. The light rays 350 can be transmitted through the light pipe 340 with or without internal reflection of the side surface 344 and exit from the end surface 342. The light rays can exit from the end surface 342 at different angles and can be transmitted through the internal connector interface body 120 and / or the optic 130. In various embodiments, the light pipe 340 can be a light pipe that can transmit light rays at large angles through the physical mechanism of total internal reflection. The light rays can then exit from the end surface 342 and pass through the body 120.

[0057] Figure 4 is a partial cross-sectional view of an optic with retention features according to an illustrative embodiment. The optic 130 can be a lens, window, light pipe, or other optical element. The optic 130 can have an outer surface 212, an inner surface 214, and a circumferential surface 404. Light can pass through the optical element 130, enter the optic through the inner surface 214, and exit through the outer surface 212. The inner surface 214 and the outer surface 212 can be optical interfaces that can refract, reflect, diffract, diffuse, or otherwise modify or control the path of light passing through the optical element 130.

[0058] The optical element 130 can have one or more retainers 402. As a non-limiting example, the retainers 402 can be one or more ridges, holes, grooves, blind holes, or protrusions, or other types of features that can fit into complementary features on another object, such as an internal connector interface body. In various embodiments, the retainers 402 can be grooves around all or a portion of the optic 130, and the internal connector interface body can have corresponding ridges that can fit within the grooves. The corresponding ridges of the internal connector interface body can fill the grooves and secure the optic.

[0059] The optical element 130 can be made of a material such as plastic, glass, fused silica, sapphire, cyclic olefin polymer or copolymer, FEP, ETFE, PMMA, acrylic, or other material suitable for a particular application. As a non-limiting example, the optic 130 can be made of a material suitable for transmitting light of a predetermined wavelength, such as ultraviolet light, visible light, or infrared light. As a further non-limiting example, the optical element 130 can be made of UV-grade fused silica and used to transmit light in the UV-C and UV-B range, such as approximately 255 nm to 300 nm.

[0060] Figure 5is a side view of a sterilization cap having a fixation point to secure the sterilization cap to a medical device, according to an illustrative embodiment. The sterilization cap 100 can have an outer cover 110, an internal connector interface (partially shown in dashed lines), and one or more fixation points 502. The fixation points 502 can be used to securely connect the cap 100 to a separate object, such as a medical device, using complementary receiving features on the separate object. The fixation points 502 can allow the sterilization cap 100 to be selectively connected to and disconnected from the separate object, which can be a medical device. As non-limiting examples, the fixation points 502 can be tabs or hooks or other features. The fixation points can correspond to various standards for connecting to medical devices, including luer standards. In various embodiments, the fixation points 502 can be protruding features, and the complementary receiving features on the medical device can be indented, dented, or other recessed features. In various embodiments, the fixation points 502 can be indented, dented, or other recessed features, and the complementary receiving features on the medical device can be protruding features. In various embodiments, the fixation points 502 can safely disconnect from the complementary receiving features under certain conditions, for example, if the connection is subjected to excessive tension, or compression or other forces, as non-limiting examples.

[0061] Figure 6A is a top view of an optical device, according to an illustrative embodiment, and Figure 6B is a side view of an optical device, according to an illustrative embodiment. The optical device 130 can be a flat disc window. The optical device 130 can be made of various materials, including TOPAS COC 8007X10. A 2 millimeter thick optical device made of TOPAS COC 8007X10 can have about 35% transmittance at 260 nm, a 1 millimeter thick optical device can have about 59% transmittance, a 2 / 3 millimeter thick optical device can have about 70.47% transmittance, and a 3 / 4 mm thick optical device can have about 67.46% transmittance at 260 nm.

[0062] Thinner optical devices can be desirable for increased transmissivity, while a disinfecting cap including an outer cover and an internal connector interface can benefit from having increased wall thickness, which can result in increased structural strength. However, having a variable wall thickness can increase the difficulty of injection molding, so it can be desirable to mold the thinner optical device and the thicker structural portion of the cap separately. The structural portion of the cap can include the internal connector interface and the outer cover. After the structural portion and the optical device are molded separately, they can be assembled together using a physical or chemical adhesive, a laser welding operation, an ultrasonic welding operation, or some other operation to attach the optical device to the body of the disinfecting cap. The cap can have various bond seams that can be exposed for thermal bonding. The bond seams can be heated directly so that other portions of the cap do not deform. The bond seams can be designed to be out of the optical path so that they do not interfere with the transmission of light through the optical path (i.e., the optical properties of the bond seams or joints do not change the path of light passing through the end cap optical path by refraction, reflection, diffraction, etc.).

[0063] Figure 6C is a partial cutaway view of a cap and a separate optical device bonded together according to an illustrative embodiment, showing an interior region. The disinfecting cap 600 can have two or more non-integral, separate components, which can include an optical device 130, and a structural portion of the disinfecting cap, which includes an outer cover 110 and an internal connector interface 120. The optical device 30 can be outside of the cap 600, and can have a common exposed edge with the end cap 600. The common exposed edge of the optical device and the rest of the end cap can then be heated in a targeted (i.e., localized) manner so that the optical device and the portion of the end cap melt and become fused and fuse together. The fused edge can be cooled passively or through active heat sinking so that it solidifies and the two separate pieces are fused together at the seam 602.

[0064] The end cap body, including the internal connector interface 120 and the outer cover 110, and the optical device 130 can be joined at the seam 602 using various chemical or physical adhesives, ultrasonic welding, thermal bonding, or various other bonding. The optical device 130 and the end cap body can be separate but made of the same type of substrate. As a non-limiting example, the substrate can be a plastic, such as a cyclic olefin polymer (COP) or a cyclic olefin copolymer (COC). If the optical device 130 and the end cap body are made of the same type of substrate, they can be fused together using a thermal bonding technique. The seam 602 at which the optical device 130 is joined with the end cap body can be heated in a targeted manner so that certain portions of the optical device 130 and the end cap body melt and become fused, and fuse together, while other portions are not affected by the heat. The seam 602 can then be cooled passively or through active heat sinking so that it solidifies. If the optical device 130 is made of the same type of substrate as the end cap body, as described above, the optical device 130 and the end cap body can be fused together using a thermal bonding technique. The seam 602 at which the optical device 130 is joined with the end cap body can be heated in a targeted manner so that certain portions of the optical device 130 and the end cap body melt and become fused, and fuse together, while other portions are not affected by the heat. The seam 602 can then be cooled passively or through active heat sinking so that it solidifies. Figure 6D and 6ELocated inside the end cap, this hot melt technique or method can also be used.

[0065] Figure 6D is an end view from the rear of the end cap showing the optical device bonded to the interior surface of the interior connector interface according to an illustrative embodiment, and Figure 6E is a cross-sectional view of Figure 6D taken along section line 6E-6E of Figure 6D is a cross-sectional view of the optical device within the interior connector interface of The optical device 130 can be bonded within the interior connector interface 120 of the end cap body at the seam 604 between the interior sidewall 612 of the interior connector interface 120 and the optical device 130.

[0066] It is specifically contemplated that the one or more junctions between the separate optical device and the end cap body can be located anywhere within the end cap or outside the end cap, so long as the junctions are configured to meet any combination of mechanical bonding strength requirements, or fluidic or air tightness requirements, or optical requirements, or the specific application requirements described above for the end cap and optical device.

[0067] Figure 7A is a schematic diagram of an external light source with a photo interrupter sensing system according to an illustrative embodiment. In various embodiments, the external light source 700 can be used in conjunction with an end cap. The end cap and the external light source can include features that can work together to detect whether the end cap is securely connected to the connector port of the medical device and whether the end cap is securely connected to the external light source. As a non-limiting example, the external light source 700 can include a primary UV germicidal light emitter 710 and a photo interrupter system 720. The primary light emitter 710 can emit light that can propagate outside the external light source, through a disinfecting end cap 712, and into a medical device 714 to sterilize the medical device.

[0068] The photo interrupter system 720 of the auxiliary light source can include an auxiliary light emitter 722 and a photo sensor 724. The auxiliary light emitter 722 can emit a different wavelength than the primary UV germicidal light emitter 710, or it can emit the same wavelength. As non-limiting examples, the auxiliary light emitter 722 can be an infrared light emitter in the 700-1,000,000 nm wavelength range, or it can be a visible light emitter in the 400-700 nm range, or it can be a ultraviolet light emitter in the 100-400 nm range. As non-limiting examples, the auxiliary emitter 722 can be an LED and the photo sensor 724 can be a photodiode. Light from the auxiliary light emitter 722 can follow a light path 726 between the auxiliary light emitter 722 and the photo sensor 724, and the light path can only be interrupted when the end cap is securely connected to both the external light source and the target medical device. The external light source 700 can include a system controller 728, which can be operatively connected to the photo interrupter system 720 and to the primary light emitter 710. The system controller 728 can detect the interruption, and the system controller 728 can use this information as a signal to prevent or allow the primary germicidal light emitter 710 to turn on. This can be a safety feature if, as a non-limiting example, the primary germicidal light emitter 710 can emit wavelengths that can have potentially harmful effects on human tissue.

[0069] Figure 7B is a schematic diagram of a photo interrupter sensor system with a light blocker according to an illustrative embodiment. The end cap or end cap assembly can have a light blocker 730 that can change the light transmission properties of the internal or external light path 726. As a non-limiting example, the light blocker 730 can block light, however, in various embodiments, the light blocker 730 can also decrease the transmissivity of the light path 726, or increase the absorption of the light path 726, or increase the attenuation of the light path 726, or increase the reflectivity of the light path 726. The light blocker can be enabled or disabled, or can be gradually changed or adjusted in a continuous range. The light blocker 730 can be controlled depending on whether the end cap is connected to a medical device or a disinfection UV light emitter or both.

[0070] The end cap may have a mechanical linkage that allows for alteration of its profile. As a non-limiting example, the mechanical linkage may include a light blocker, such as a pin, shaft, post, or other such feature that can be raised and protrude from the outer surface of the end cap. When the end cap is connected to an auxiliary light source or a medical device, or both, the mechanical linkage may cause the light blocker to rise from the surface of the end cap. The light blocker may be enabled or disabled, or may be gradually changed or adjusted within a continuous range. The enabling, disabling, or gradual adjustment of the light blocker may be controlled by the connection state of the end cap relative to the external light source or medical device. As a non-limiting example, the light blocker may be enabled if the end cap is connected to an external light source. As a further non-limiting example, the light blocker may be enabled if the end cap is connected to both an external light source and a medical device. As a further non-limiting example, the light blocker may be disabled if the end cap is connected to an external light source, and enabled if the end cap is not connected to an external light source.

[0071] Go to Figure 7A and 7B The end cap's light blocker 730, which can alter the light transmission properties of the internal or external light path 726, can work with an external light source 700 to detect the connection status of the end cap relative to the external light source / or medical device. As a non-limiting example, the external light source 700 may have an auxiliary light emitter 722 and a photoelectric sensor 724, with an light path 726 between the auxiliary light emitter 722 and the photoelectric sensor 724. The end cap's light blocker 730 can interfere with the light path 726. In a first unblocked state, such as... Figure 7A As shown, the end cap is not fully in the sterilization position, and the light blocker does not block the light path. In the second blocking state, as... Figure 7B As shown, the end cap is connected to the medical device, causing the light blocker 730 to block the light path 726. The photoelectric interruptor system 720 can detect whether the end cap is connected to the medical device based on the strength of the signal received by the photoelectric sensor 724. In this way, the light blocker of the end cap can change the optical transmission properties of the optical path of the photoelectric interruptor system to trigger the photoelectric interruptor system and indicate that the end cap is connected to the medical device. In various embodiments, the end cap may consist of an end cap body, a light transmitter, and a spring-loaded mechanical linkage, as explained more fully below.

[0072] Figure 7C This is a schematic diagram of an optoelectronic interruptor sensing system with optical transmitters according to an illustrative embodiment. The optoelectronic interruptor system may include an optical emitter 722, a photodetector 724, and one or more optical transmitters 740 and 742. The optical transmitters 740 and 742 may be part of an end cap. Figure 7Dis a schematic diagram of a photoelectric interrupter sensor system with a light transmitter and a light blocker according to an illustrative embodiment. The light blocker 730 can block the light path 726, indicating that the end cap is in place. The photoelectric interrupter system 720 can detect whether the light blocker 730 is present between the emitter 722 and the photoelectric sensor 724, and the photoelectric interrupter system 720 can output a signal allowing the primary light emitter to be illuminated when the light blocker 730 blocks the light path 726. The signal can be detected by a system controller 728, which can be a microcontroller or other electronic system as non-limiting examples. The system controller 728 can control the primary light emitter 710, and can use the signal from the photoelectric interrupter system 720 to determine whether the primary light emitter 710 can be turned on. In various embodiments, the light transmitters 740 and 742 can be designed such that they are not detected by the photoelectric interrupter system 720, and the photoelectric interrupter only detects the presence of a light blocker. In various embodiments, the light transmitters can be detected by the photoelectric interrupter system, indicating that the end cap is securely connected to the external light source 700.

[0073] Figure 7E is a schematic diagram of a photoelectric detector system with a light source located at the back of the cap and a photoelectric sensor located at the side of the cap according to an illustrative embodiment. As explained more fully below in connection with Figure 8C The light emitter 722 can be positioned at the back of the cap, and one or more photoelectric detectors 724 can be positioned at the side of the cap. In various embodiments, the cap can act as the light blocker 730, or the cap can include a separate light blocking component, which can be the light blocker 730.

[0074] Figure 7F is a schematic diagram of a photoelectric detector system with a light source located at the back of the cap and a photoelectric sensor located at the side of the cap according to an illustrative embodiment. As explained more fully below in connection with Figure 7E is a schematic diagram of a photoelectric detector system with a light source located at the back of the cap and a photoelectric sensor located at the side of the cap according to an illustrative embodiment. As explained more fully below in connection with Figure 7F When there is no cap in the system, light from the light emitter 722 can shine onto the photoelectric sensor 724, as shown. When light from the light emitter 722 shines onto the photoelectric sensor 724, the system can be prevented from using high intensity sterilization light, as explained more fully below in connection with Figure 8C .

[0075] The light emitted from the auxiliary emitter 722 can be continuous, pulsed, or otherwise varied over time to allow more sophisticated sensing algorithms to reject ambient light and“lock onto” only the light emitted by the auxiliary light emitter 722. In this way, the photoelectric interrupter system 720 and the system controller 728 can be made insensitive to interference from ambient or environmental light.

[0076] Figure 8Ais a partial cutaway view of a sterilization system according to an example embodiment, showing internal workings with an end cap attached to an external light source and a medical device. The sterilization system 802 can have an end cap 810 and an external light source 830. The end cap 810 of the sterilization system 802 can connect to a connector 820 of a separate object, such as a medical device, which can be disinfected or sterilized by the system 802. As a non-limiting example, the connector 820 can be a catheter hub having a female luer fitting that complies with standards such as ISO 594 or other standards or proprietary designs. The external light source 830 can have a housing 832, one or more primary disinfection light emitters 710, one or more auxiliary light emitters 722, one or more light transmitters 740, 742, one or more photodetectors 724, and one or more disinfection light channels 838.

[0077] The end cap 810 can have a connector interface to complement the connector 820 of a separate object, such as a medical device, to be disinfected. The end cap 810 can have internal threads 814 to securely attach to complementary threads on the connector 820. As a non-limiting example, the end cap connector interface and threads 814 can comply with standards such as ISO 594, other standards, or proprietary designs.

[0078] The end cap 810 can have an optical device 812. The optical device can be a window, or a lens, or a lens array, or a light pipe, or a light homogenizer, other types of optical devices. The end cap 810 and the optical device 812 can be made of optical materials suitable for transmitting or blocking certain wavelengths or ranges of wavelengths as needed. As a non-limiting example, the end cap 810 and the optical device 812 can be made of plastic, such as cyclic olefin polymer (COP) or co-polymer (COC), FEP, ETFE, PMMA, or other plastics. As a further non-limiting example, the end cap 810 and the optical device 812 can be made of glass, or fused silica, or sapphire, or other materials. The end cap 810 and the optical device 812 can be made of the same material or different materials. The optical device 812 can be an integrated component of the end cap 810, or can be a separate component that is manufactured separately from the end cap 810 and then attached to the end cap. The end cap 810 and the optical device 812 can be manufactured using manufacturing techniques such as injection molding, thermoforming, cutting, milling, grinding, 3D printing, or other manufacturing techniques or combinations of techniques. The end cap 810 and the optical device 812 can be manufactured using the same manufacturing techniques or combinations thereof, or different techniques or combinations thereof.

[0079] In Figure 8AIn the illustrated embodiment, the connector 820 can act as a light blocker by blocking a light path between the auxiliary light emitter 722 and the photosensor 724. When the connector 820 is not connected into the system, there can be a clear light path from the one or more auxiliary light emitters 722 to the one or more photosensors 724; when the connector 820 is connected, the light path is blocked or interrupted. The one or more photosensors 724 can output a digital or analog signal based on the state of the light path, and the system controller unit can receive the signal and use the signal to change the function of the system based on the state of the signal. As a non-limiting example, the system controller can be a microcontroller, microprocessor, or other type of digital electronic system. As a further non-limiting example, the system controller can change the function of the system to prevent the user from turning on the disinfecting light source when the light path is not blocked.

[0080] The one or more primary disinfecting light emitters 710 can emit light at one or more wavelengths or wavelength ranges. The one or more primary disinfecting light emitters 710 can emit disinfecting light through the optic 812 into the end cap 810 through one or more disinfecting light channels 838. As a non-limiting example, the one or more primary disinfecting light emitters 710 can be LEDs, xenon arc lamps, mercury lamps, lasers, laser diodes, or other types of light sources. As a non-limiting example, the one or more disinfecting light channels 838 can be windows, lenses, lens arrays, light pipes, light homogenizers, or other types of optical components or combinations of different optical components. The disinfecting light can pass through the end cap 810 and into the connector 820 and other portions of the individual object or device to be sterilized.

[0081] The one or more auxiliary light emitters 722 can emit light at one or more wavelengths or wavelength ranges. Light from the one or more auxiliary light emitters 722 can pass through the one or more emitter light transmitters 740 and can travel through a light path that terminates at the one or more photosensors 724, which can include one or more detector light transmitters 742. The one or more photosensors can receive and be sensitive to one or more wavelengths or wavelength ranges. As a non-limiting example, the one or more auxiliary light emitters 722 can be LEDs, incandescent bulbs, arc lamps, lasers, or other types of emitters. As a non-limiting example, the one or more photosensors 724 can be photodiodes, phototransistors, or other types of photodetectors.

[0082] Figure 8Bis a partial cutaway view of a sterilization system according to an illustrative embodiment showing internal workings with multiple disinfecting light sources emitting light from different positions and at different angles. The sterilization system 840 can have three primary disinfecting light emitters 710 and three disinfecting light channels 838; the primary disinfecting light emitters 710 and disinfecting light channels 838 can surround the end cap 810 and the connector 820. The primary disinfecting light emitters 710 can emit disinfecting light onto the end cap 810 and the connector 820 from multiple angles and directions. The disinfecting light can be transmissible through the end cap 810 to disinfect the outer surface of the connector 820.

[0083] Figure 8C is a partial cutaway view of a sterilization system according to an illustrative embodiment showing internal workings with light emitters functioning as both primary disinfecting light emitters and auxiliary light emitters. Figure 8C is an embodiment of a disinfecting or sterilization system 860 having a combined light emitter 862 that can be both a primary disinfecting light emitter and an auxiliary emitter. The sterilization system 860 can have one or more phototransistors 724 that can detect light from the combined light emitter. In various embodiments, the combined light emitter 862 can emit a first light at a first light intensity that can be a reduced intensity, and if the phototransistor 724 does not detect the first light, the combined light emitter can increase the light intensity to a second light at a second light intensity. In various embodiments, the combined light emitter 862 can start with light at full intensity, and if the phototransistor 724 detects light from the light emitter above a predetermined light intensity threshold, the system can shut off power to the light emitter 862 and can provide an error message. In various embodiments, the system can lock for a predetermined period of time after the phototransistor 724 detects light from the light emitter above the predetermined threshold.

[0084] Figure 9A is a partial cutaway view of a connector system according to an illustrative embodiment showing internal workings. The connector system 900 can include an end cap 910 and a connector 920 of a connection device (e.g., a medical device). As a non-limiting example, the end cap 910 can include a male luer lock, or other component that conforms to at least a portion of the standards for a male luer lock having internal threading. At least a portion of the connector 920 can enter an engagement region 930 of the end cap 910. At least a portion of the connector 920 can enter the engagement region 930 when the connector 920 is connected to the end cap 910, and at least a portion of the connector 920 can exit the engagement region 930 when the connector 920 is disconnected from the end cap 910.

[0085] Figure 9Bis a partial cutaway view of a connector system according to an illustrative embodiment, showing internal workings of a mechanical linkage with a connection configuration. Turning to

[0086] Figure 9C is a partial cutaway view of a connector system according to an illustrative embodiment, showing internal workings of a mechanical linkage with a connection configuration. Turning to Figure 9A and 9C When the connector 920 enters the engagement region 930, the connector 920 can actuate the actuator 942, and the toggle 946 can change position via the spring 920 in response to the actuation. In various embodiments, the toggle 946 can change the light transmission properties of the light path. In various embodiments, the toggle 946 can change the internal or external mechanical profile of the end cap. Although the connector 920 has been omitted from Figure 9C for clarity, it should be clear that the connector can cause the position of the toggle 946 to change from a first position shown in Figure 9B to a second position shown in Figure 9C .

[0087] Figure 10 is a partial cutaway view of a sterilization system with a remote monitoring system for data collection, communication, and control according to an illustrative embodiment, showing a schematic of internal workings. The sterilization system 1000 can include an end cap 1010, a sterilizer 1020, a medical device 1050 that can be sterilized, and a remote monitoring system 1060 for data collection, communication, and control.

[0088] As described above, the sterilizer 1020 can be an external light source. The sterilizer 1020 can have a housing 1022 that houses internal components. The sterilizer 1020 can have a primary disinfecting light emitter 1024, a disinfecting light channel 1026, one or more temperature monitors (thermometers) 1028, one or more current monitors (ammeters) 1030, one or more voltage monitors (voltmeters) 1032, a light source controller 1034, one or more radiant power monitors 1036, attachment features 1038 for securing the end cap, or any combination thereof. The sterilizer can have a power source 1040, which can be an internal power source such as a battery, or can provide power from an external source such as an external battery or other electrical connection.

[0089] The medical device 1050 can be a catheter system. The medical device 1050 can have a female coupling 1052 (e.g., a female luer) and a catheter 1054 having a catheter lumen 1056. The disinfecting light can be emitted by the sterilizer 1020 and can pass through the end cap 1010 to the female coupling 1052 and the catheter 1054. The disinfecting light can illuminate the interior surfaces of the female coupling 1052 and the catheter lumen 1056.

[0090] The remote monitoring system 1060 can have a communication network 1062, a processor 1064, and a database (db) 1066. A data connection 1070 can share data 1068 from the sterilizer 1020 with the remote monitoring system 1060. The data 1068 can be shared unidirectionally or bidirectionally between the light source controller 1024 and the remote monitoring system 1040. The data 1068 can include system condition information collected from the sterilizer regarding the condition and performance of the sterilizer. The remote monitoring system 1040 can maintain the condition of the sterilizer and can maintain a record of the system condition information. The system condition information can be measured by sensors (as non-limiting examples, the temperature monitor 1028, the current monitor 1030, the voltage monitor 1032, the radiant power monitor 1036, etc.) and can be received by the light source controller 1034. The light source controller 1034 can share the data with the remote monitoring system. The light source controller 1034 can also monitor the incoming data and can identify potential problems, such as degradation or suboptimal operating conditions, including a decrease in light source intensity due to wear and tear and aging, ambient temperature, or depletion of power reserves. The light source controller 1034 can then implement a self-repairing solution by adjusting the light source intensity, the exposure duration, or both, based on the sensor measurements to compensate for the degradation or suboptimal operating conditions.

[0091] The remote monitoring system can monitor the health and well-being of the device. The monitoring can include how many hours the light source has been used, how many times the light source has been used, how many times the battery has been charged, how many times the battery has been fully discharged, how many times the battery has been fully charged, etc. The remote monitoring system can monitor the usage of the device and can inform the user how many times the device has been used per day, per week, total, etc. The remote monitoring system can monitor the usage of the device and can inform the user when the device needs maintenance. The remote monitoring system can inform the user when a particular unit is reporting any performance issues. The remote monitoring system can report compliance issues. The compliance issues can include whether the device is being used correctly and / or whether the device is being used for the entire time period. The remote monitoring system can monitor the input voltage and / or current that the device is using and / or can monitor the light intensity, as lower voltage or current will limit the total light energy that the device delivers. The remote monitoring system can inform the user whether the device has sufficient voltage or current and / or whether the device is delivering sufficient energy.

[0092] Figure 11A is a schematic diagram of an end cap with beam splitters according to an illustrative embodiment. End cap 1100 can have an end cap body 1112 and one or more beam splitters 1114. As non-limiting examples, the beam splitters can work by optical refraction or reflection or other means, and can be beam splitters, beam samplers, lenses, lens arrays, or other optical devices. One or more light sources 1120 can emit light 1122 that can be incident on and pass through end cap 1110. One or more beam splitters 1114 can be embedded within end cap 1110 and can redirect all or a portion of the incident light 1122. Light from light source 1120 can be incident on beam splitter 1114 and can be split into a redirected portion 1124 and a non-redirected or transmitted portion 1126. The incident light can be part of a primary disinfecting light beam, and the redirected portion of the light beam can be used to measure total light energy delivered to a target or for other purposes. The non-redirected or transmitted portion 1126 of the incident light 1122 can be transmitted through the end cap to a target 1140 to sterilize the target. Target 1140 can be a medical device such as a catheter. The redirected portion 1124 of the incident light 1122 can be transmitted through the end cap to one or more sensors 1130. One or more sensors 1130 can receive the redirected light 1124 and can transmit information about the light properties to other devices or components through electrical signals. As non-limiting examples, one or more sensors 1130 can be photodiodes, phototransistors, spectrometers, optical power meters, or other types of light sensors. Sensors 1130 can output information about the received light in output signals. The information can include light intensity, radiant power, radiant flux, wavelength, spectral flux, spectral power, polarization state, or other properties of the received light. The output signals can be received by a controller or processor, and the controller or processor can be programmed to adjust various functions according to the information contained in the received signals. Adjusting various functions can include increasing or decreasing voltage or current to the LEDs. Adjusting various functions can include increasing or decreasing the time of LED enablement.

[0093] Light 1122 emitted by one or more light sources can be a single wavelength, or multiple wavelengths, or one continuous wavelength spectrum, or multiple continuous wavelength spectra, or any combination thereof. As a non-limiting example, the light can be in the range of 250-400 nm. As a further non-limiting example, light 1122 can be in the wavelength range of 250-280 nm. As a further non-limiting example, the light can be 265 nm. As a further non-limiting example, the light can be 280 nm. The light can be polarized or non-polarized.

[0094] Figure 11Bis a schematic illustration of a sterilizer system with an end cap having a beam splitter and an external light source according to an illustrative embodiment. The sterilizer system 1100 can include one or more light sources 1120 that can emit light 1122. The emitted light can be incident on the end cap 1110 and can travel through the body 1112 of the end cap. The cap can include one or more beam splitters 1114 that can redirect all or a portion of the incident light 1122. The non-redirected or transmitted portion 1126 of the incident light 1122 can be transmitted through the end cap 1110 to a target 1150. As a non-limiting example, the target 1150 can be a medical device, such as a catheter. The target 1150 can have a connector 1152 and a body 1158. As a non-limiting example, the connector 1152 can be a luer lock connector and can conform to a connector standard such as ISO 594 or other standard, or to a proprietary design. As a further non-limiting example, the connector 1152 can be a female luer lock connector. The connector 1152 can have a securement feature 1156 that can attach to a corresponding securement feature 1116 of the end cap 1110. As a non-limiting example, the securement features 1156 and 1116 can be threads, and as a further non-limiting example, can be threads that conform to the ISO 594 standard. The target device can have an inner connector wall 1154 and an inner body wall 1151. The transmitted light 1126 can illuminate all or a portion of the target device 1150, including the inner walls 1151 and 1154. The walls of the target device 1151 can be opaque to the light 1126 such that no light or only a small portion of the light is transmitted through the walls of the device.

[0095] The redirected light 1124 can be transmitted through the end cap 1110 to one or more sensors 1130. The sensors 1130 can receive the redirected light 1124 and can transmit information about the redirected light 1124 through a signal 1132 to one or more processors 1160. As a non-limiting example, the information can include intensity, or irradiance, or radiant power, or irradiance, or wavelength, or spectral power, or other characteristic. As a non-limiting example, the one or more sensors 1130 can be a light power sensor, a photodiode, a phototransistor, a spectrometer, or other type of sensor, or any combination thereof. The one or more light sources 1120, the one or more sensors 1130, and the one or more processing units 1160 can be part of a sterilizer 1170 that can be contained within a housing 1172.

[0096] The end cap can have one or more features that can indicate to a user the light energy at a particular wavelength, or wavelengths, or range of wavelengths, or ranges of wavelengths, that have been transmitted through the end cap as a whole, or a particular location, or a particular surface, or a plurality of particular locations or surfaces.

[0097] The end cap or end cap assembly can have an indicator 1118 that can change state based on light energy transmitted at a particular wavelength, multiple wavelengths, a range of wavelengths, or multiple ranges of wavelengths at a whole of the cap, or a particular location, or a particular surface, or multiple locations or surfaces. The light energy transmission state indicator 1118 can be based on a material, substance, component, or device that can change state as a function of the instantaneous or cumulative amount of light energy received. As a non-limiting example, a material that can change color in response to absorbed light energy (such as a caged dye or a photochromic pigment or other material or substance) can be embedded in the end cap or end cap assembly in a whole or at a particular location or multiple locations, which can change color as a function of the ultraviolet light energy absorbed by the dye. In this non-limiting example, the color of the caged dye can indicate to the user whether the UV light dose applied to the target location via the end cap or end cap assembly was sufficient to kill microorganisms. As a further non-limiting example, the color change can be reversible or irreversible. As a further non-limiting example, the photochromic pigment can be a spiropyran or other photochromic pigment.

[0098] Figure 12A - I is a chemical diagram of photochromic pigments for energy transmission state indicators according to illustrative embodiments. These photochromic pigments change color when exposed to sterilizing light. The pigments can be designed to require a certain amount of light energy to change color and will not change color until they receive a predetermined amount of light energy. In this way, the user can know that a sufficient dose of light has been applied to sterilize the medical device when the pigments change color. The pigments can be designed so that they are tuned to respond to a particular wavelength or multiple wavelengths, or a range of wavelengths, or multiple ranges of wavelengths. The pigments can be used to indicate that a sufficient dose of light has been applied to cause the pigments to change and can be calibrated to the dose required to cause the pigments to change to indicate that a sufficient dose of light has been applied to sterilize the medical device. The user can see that the color has changed and thus can know that a sufficient light has been applied to sterilize. Figure 12A A reversible conversion of a spiropyran to a merocyanine is depicted. The spiropyran on the right can convert to the merocyanine on the left when exposed to sufficient light energy and back to the spiropyran when the light energy is reduced. Figure 12B - D depicts an example spiropyran. Figure 12B An example spiropyran 8-methoxy-1 ',3',3'-trimethyl-6-nitrospiro[benzopyran-2,2'- indole] (PubChem CID 99765) is described. Figure 12C An example spiropyran 1 ',3',3'-trimethyl-1 ',3'-dihydrospiro[benzo[ / ]benzopyran-3,2'- indole] (PubChem CID 2728827) is depicted. Figure 12DExemplary spiropyran 1,3,3-trimethyl-6'-(piperidin-l-yl)spiro[dihydroindole-2,3'- naphtho[2,l-b][l,4]oxazine] (PubChem CID 5125966) is depicted. Figure 12E - I depicts an exemplary diarylethene, which can indicate exposure to light of a particular preselected wavelength or wavelengths or wavelength range. Figure 12E Exemplary diarylethene 2,3-bis(2,4,5-trimethyl-3-thienyl)maleic anhydride (PubChem CID 11382417) is depicted. Figure 12F Exemplary diarylethene 2,3-bis(2,4,5-trimethyl-3-thienyl)maleic anhydride (PubChem CID 11382417) is depicted. Figure 12G Exemplary diarylethene cis-l,2-dicyano-l,2-bis(2,4,5-trimethyl-3-thienyl)ethene (PubChem CID 44630141) is depicted. Figure 12H Exemplary diarylethene 1,2-bis(2,4-dimethyl-5-phenyl-3-thienyl)-3,3,4,4,5,5- hexafluoro-l-cyclopentene (PubChem CID 10721339) is depicted. Figure 12I Exemplary diarylethene 1,2-bis[2-methylbenzo[b]thiophen-3-yl]-3,3,4,4,5,5- hexafluoro-l-cyclopentene (PubChem CID 11408746) is depicted.

[0099] Figure 13is a schematic of a sterilization system including an end cap with one or more light sensitive indicators according to an illustrative embodiment. The sterilization system can include one or more light emitters 1320. A sterilizing portion of light 1322 can pass through the end cap 1310 and be incident on a medical device 1330, and a detection portion of light 1324 can be incident on one or more light sensitive indicators 1118 of the end cap 1310. As non-limiting examples, the light sensitive indicators 1118 can be a photochromic substance, such as a spiropyran, or a diarylethene, or other types of photochromic substances. In various embodiments, the light sensitive indicators 1118 can include irreversible photo-reactive substances. In various embodiments, the light sensitive indicators 1118 can be photodiodes, or phototransistors, or optical power sensors, or other types of electronic sensors. If the light sensitive indicators 1118 are photochromic or irreversible photo-reactive chemicals, they can be incorporated or embedded into the material of the end cap body 1316. In various embodiments, the end cap body material can be injection molded plastic, and the spiropyran photochromic substance can be mixed with or embedded in the material. If the light sensitive indicators 1118 are electronic sensors, they can be embedded within the end cap body 1316 and can transmit signals containing information about the received light.

[0100] A sterilizing portion of light 1322 can be transmitted through the end cap 1310 to a target 1330. The target 1330 can be a medical device. The target 1330 can have one or more attachment features 1332. The attachment features 1332 can be securely attached to corresponding attachment features 1314 of the end cap 1310. The sterilizing portion of light 1322 can irradiate all or a portion of the target 1330. The target 1330 can have an interior space 1334 and interior sidewalls 1336, which can be sterilized by the sterilizing portion of light 1322.

[0101] Illustrative embodiments of the application have been previously described in detail. Various modifications and additions can be made without departing from the spirit and scope of the application. Features of each of the individual embodiments described above can be combined with features of the other described embodiments as is equitably within the scope of the associated new embodiments. Moreover, although the application has been described in detail with respect to the specific embodiments illustrated above, it will be apparent that numerous modifications and additions can be made thereto without departing from the spirit and scope of the application. For example, the sterilizer unit can have a housing designed to engage with an end cap that mates with a luer fitting, or the sterilizer unit can have a housing designed to engage with or otherwise sterilize various other devices, which can include a toothbrush, contact lenses, or other items that can benefit from sterilization. Various features described herein can be combined and / or rearranged. For example, the light coupling end cap can have a light sensitive portion and mechanical features that can change the light transmission properties of the internal or external light path. The light coupling end cap can have optics in the front and can have one or more securing features that enable the end cap to be securely connected to a separate object. The light coupling end cap can have a body that is thermally coupled to the optics and can function in a photo interrupter sensing system. Furthermore, as used herein, the terms "process" and / or "processor" are to be interpreted broadly to include various electronic hardware and / or software-based functions and components (and can alternatively be referred to as functional "modules" or "elements"). Moreover, the depicted processes or processors can be combined or divided into various sub-processes or sub-processors. Such sub-processes and / or sub-processors can be variously combined according to the embodiments herein. Likewise, it is expressly contemplated that any of the functions, processes, and / or processors herein can be implemented using electronic hardware, software composed of program instructions of a non-transitory computer-readable medium, or a combination of both hardware and software. Furthermore, various directional and arrangement terms, such as "vertical," "horizontal," "up," "down," "bottom," "top," "side," "front," "back," "left," "right," and the like, as used herein are only used as relative conveniences and not as absolute directions / arrangements with respect to a fixed coordinate space (e.g., the direction of action of gravity). Moreover, where the term "substantially" or "approximately" is used in reference to a given measurement, value or characteristic, it is meant to encompass amounts that are not only identical to reference amounts but also amounts to be within acceptable manufacturing tolerances and / or expected variations. Thus, the description is not intended to be limited to the particular form set forth herein, but to encompass all modifications and additions that come within the scope and spirit of the application.

Claims

1. A sterilizer lid, comprising: Outer cover, the outer cover having an internal threaded area; A truncated conical internal connector interface, the internal connector interface being at least partially disposed within the outer casing and defining a hollow inner cavity, the inner cavity being separated from the internal thread region and having an open outer end and an open inner end, the inner end being configured to engage with a medical device; as well as A light guide element, located within and fixed to the internal connector interface within the cavity defined by the internal connector interface, thereby sealingly separating the open outer end of the cavity from the inner end, the light guide element being used to control the path of light appearing at the open outer end for sterilizing the medical device; A photoelectric interruptor system is configured to detect engagement of a connector associated with the medical device relative to the internal connector interface, thereby facilitating sterilization using the sterilizer lid.

2. The sterilizer lid according to claim 1, wherein, The outer casing and the internal connector interface are adapted to interconnect with the medical device.

3. The sterilizer lid according to claim 2, wherein, The medical device includes a Luer connector, and the outer casing is adapted to engage and lock the Luer connector relative to each other.

4. The sterilizer lid according to claim 2, further comprising one or more photosensitive indicators that receive light incident on the medical device from the sterilization system.

5. The sterilizer lid according to claim 4, wherein, The one or more photosensitive indicators include photochromic substances, irreversible photoreactive substances, photodiodes, phototransistors, or optical power sensors.

6. The sterilizer lid according to claim 5, wherein, Photochromic or irreversible photoreactive chemicals are incorporated into or embedded in the material of the sterilizer lid.

7. The sterilizer lid according to claim 1, wherein, The light guide element is operatively connected to a beam splitter that separates light passing through the light guide element.

8. The sterilizer lid according to claim 1, further comprising: One or more sensors, said one or more sensors being adapted to receive redirected light from said light guide element and communicate digital information about said redirected light to one or more processors.

9. The sterilizer lid according to claim 8, wherein, The information includes at least one of intensity, radiant flux, radiant power, irradiance, wavelength, or spectral power.

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