This disclosure generally relates to fluid handling systems. In particular, the disclosure is directed to systems with ports for introducing fluids into the system and is particularly directed to reducing contaminants such as microorganisms being introduced to the system through the ports. A particular application is for fluid handling systems for radiopharmaceutical products, particularly nuclear medicine, and, more particularly, systems and methods of processing radioactive nuclides.
In general, fluid handling systems have ports for introducing fluids into the system. One of the concerns with such fluid intake ports is the prevention of microbes, such as bacteria and fungi, from contaminating the fluid intake ports. Contamination of the ports can then contaminate the fluids being introduced into and used in the system rendering the fluids unsafe and unsatisfactory for their intended purposes.
Such fluid contamination is a particular concern wherein the fluids are intended for introduction to the human body. If contaminants reach an unsafe level, it can cause serious health concerns in humans and possibly chronic diseases.
As a result, disinfection of ports for the purpose of aseptic connection is necessary to minimize the introduction of microbes, and other contaminates into a fluid system. A common method for disinfecting ports is the use of disinfecting wipes. The wipes can be provided in the form of alcohol wipes, hydrogen peroxide wipes, or the like. The wipes can be used to clean the port before connecting the ports to a fluid container and before the introduction of fluids. Once the connection between the port fluid container is removed, the port can be capped. The port can be disinfected after the connection is broken. Alternatively, or in addition to, the port can be disinfection at a later time when the connection is reestablished.
Such wipes, however, generate waste. Further, the wipes can be contaminated with microbes after wiping the port. The wipes can also be contaminated with radioactive material (RAM) and thus need to be disposed of as radioactive waste. These microbes and contaminants can then contaminate the user or operator of the fluid handling system and can also contaminate the environment. Further, if the wipes are not effective in cleaning the port, microbes or contaminants can get into the patient.
Moreover, in cases where radioactive fluids are being introduced or used in a fluid system, the resulting wipes may become radioactive after wiping the port. Such wipes are hazardous to the user and environment, and disposal of such wipes can be dangerous and expensive. Accordingly, safe and proper disposal of the wipes, especially the radioactive ones, is required.
Disposal of such wipes, however, can be complex and potentially expensive. Consequently, there is a need for safe and proper disinfection of such ports for a fluid handling system. Preferably such disinfection is also cost-efficient.
Waste production, as well as the complexities associated with radioactive waste disposal, can be eliminated or minimized with the use of an ultraviolet light port disinfection system. Ultraviolet (UV) light is an established approach to killing potentially harmful microbes, but the implementation of a UV port disinfection system for ports on an aseptic fill fluid handling system is not known to have been previously demonstrated.
The present invention contemplates a UV port disinfection system and assembly for the prevention of microbes, such as bacteria and fungi, and other microorganisms from contaminating fluid intake ports. In an exemplary embodiment, the UV port disinfection system and assembly is on an aseptic fluid handling system.
An exemplary embodiment is directed to a UV port disinfection system comprising a UV light source, a UV arm, and a UV arm pivoting axis, wherein the UV light source is connected to the UV arm, and wherein the UV arm is located on the UV arm pivoting axis and is rotatable on said axis to allow said UV arm to extend to one or more fluid input ports of a fluid handling system. Further, when said UV arm is over said port, said UV light source activates and emits UV light which disinfects said port.
In some embodiments, the UV light source is activated for a predetermined period of time
In a further exemplary embodiment, a UV port disinfection system includes a UV light, a UV arm, and a controller. UV light is housed in or on the UV arm, which can be positioned with a line of sight to the fluid contact surfaces of a fluid port. The controller can detect whether the UV arm is positioned appropriately to allow the UV light to be positioned with direct sight of the port's fluid contact surfaces. When the UV light is positioned in sight of the port, the controller can activate the light to kill microbes on the fluid port surfaces.
While activating the light, the current/voltage of the UV light can be measured, and the controller can infer the intensity of the light output based on these measurements and using data sheets so as to be consistent and effective microbial kill. The amount of intensity of UV light can depend on the parameters, and the controller can adjusts accordingly. Detection can occur via UV light sensor, current detection, voltage and wattage sensing, or some other means. In a further embodiment, the home position can include a UV detector which could be used to spot check the LED.
Accordingly, in some exemplary embodiments, the UV port disinfection system comprises at least one of a current detector designed to detect an amount of a current drawn by the UV light source and a temperature detector designed to detect a temperature rise on the UV light source. Further, in some embodiment, the controller is designed to determine the UV light source is activated when at least one of the current drawn by the UV light source and the temperature rise on the UV light source are greater than a predetermined threshold. In some embodiments, the controller is designed to prevent operation of the UV port disinfection system when the controller determines that the UV light source is not activated.
Another exemplary embodiment is directed to a port disinfection system comprising a movable arm comprising a pivoting axis; a plurality of light sources connected to the movable arm; and a plurality of fluid input ports, wherein the movable arm is designed to pivot about the pivoting axis so that in a first position, at least one light source of the plurality of light sources is positioned over at least one fluid input port of the plurality of fluid input ports, wherein when the at least one light source is positioned over the at least one fluid input port, the at least one light source activates and emits light which disinfects the least one fluid input port, and wherein when each light source of the plurality of light sources are not activated, the movable arm is positioned at a home position.
In a further exemplary embodiment, the movable arm is designed to pivot about the pivoting axis so that in a second position, a first light source of the plurality of light sources is positioned over a first fluid input port of the plurality of fluid input ports, and a second light source of the plurality of light sources is positioned over a second fluid input port of the plurality of fluid input ports.
In a further exemplary embodiment, each of the plurality of light sources are independent selected from the group consisting of a UV LED light source, a mercury UV light source, and a high intensity visible light flash source.
Another exemplary embodiment is directed to a method for disinfecting one or more fluid ports utilizing a UV port disinfection system with a UV arm and a UV light source located on the UV arm. The method comprises moving the UV arm over one input port, when the UV arm is over the input port, activating the UV light source, and emitting UV light from the UV light source and disinfecting the port.
The UV port disinfection system and method of the present invention is advantageous as it mitigates the risks previously associated with the use of automated ultraviolet light—including inconsistent or incomplete microbial kill—by detecting the position and electrical current, voltage, wattage, and LED temperature for the UV light applied to a surface.
In the drawings forming a part of this disclosure,
Although this invention is susceptible of embodiments in many different forms, that are shown in the drawings and will be described in detail herein in specific embodiments with the understanding that the present disclosure is an exemplification of the principles of the invention. It is not intended to limit the invention to the specific illustrated embodiments. The features of the invention disclosed herein in the description, drawings, and claims can be significant, both individually and in any desired combinations, for the operation of the invention in its various embodiments. Features from one embodiment can be used in other embodiments of the invention.
Referring to
In one embodiment, the UV arm 1 is capable of being rotated on pivot point/axis 6 to reach one or more input ports. The one or more input ports could be, for example, a NaOH input port 2, a saline input port 3, a sterile water input port 4, and an ozonated water output port 5. The ports shown herein are illustrative, as more or less, and/or different ports, for this and different purposes and objectives, are contemplated within the scope of this description. In a further embodiment, when not located over a port, the UV arm 1 can be located in a storage spot or a home position A.
The assembly 10, connection port area 20, and UV arm 1 are shown in a user-facing view in
As shown in the embodiment of
Once over the port, UV light is dispensed from UV light source 12 and disinfects the port. Once the port has been disinfected, the UV arm can be manually moved to each position by the user. In some embodiments, the UV can be designed to automatically move to another position once the port has been disinfected.
The controller can be a microprocessor. Alternately, the controller can include one or more discreet transistors, op-amps, comparators, 555-timers, field programmable gate arrays (FPGA), or any combination thereof. One example could be discreet circuitry that is powered through a microswitch and activates as soon as the arm is over a switch/detent.
In an exemplary embodiment, the UV port disinfection system assembly 10 is located on an aseptic fluid handling system. The UV arm 1 is positioned over an input port, such as, a NaOH input port 2, a saline input port 3, a sterile water input port 4 or an ozonated water output port 5 by rotating UV arm 1 on UV arm pivot point/axis 6. This allows the UV light to be positioned with direct sight of the port's fluid contact surfaces. When the UV light is positioned in sight of the port, the UV light source 12 is activated to disinfect the fluid port surfaces.
In a further embodiment, position detection is integrated into an ultraviolet disinfection system by the integration of functional detection, including current and temperature detection. This integration of functional detection into the ultraviolet disinfection system effectively mitigates the risks associated with the automation of such a system for microbial kill. Further, the controller can be configured to detect the amount of current drawn by the UV light and a temperature rise on the UV light PCBA. The combination of this current and temperature detection can ensure that the UV light is activated and mitigates the risk of a burnt-out UV light. Thus is can be effectively ensured that UV Light was delivered to the port.
In a further embodiment, the ultraviolet detection system described herein can also have the ability to prevent operation in the event of a failure of the disinfection system, and/or can request user intervention in the event of a failure, and/or can notify a third party of a failure or aging. This can be done by the controller in
In an alternative embodiment, the system as described above, can control and detect via voltage rather than current.
Each of the patents, patent applications, and articles cited herein is incorporated by reference. The use of the article “a” or “an” is intended to include one or more.
The foregoing description and the examples are intended as illustrative and are not to be taken as limiting. Still, other variations within the spirit and scope of this invention are possible and will readily present themselves to those skilled in the art.
Specific embodiments of an assembly of an ultraviolet (UV) port disinfection system according to the present invention have been described for the purpose of illustrating the manner in which the invention can be made and used. It should be understood that the implementation of other variations and modifications of this invention and its different aspects will be apparent to one skilled in the art and that this invention is not limited by the specific embodiments described. Features described in one embodiment can be implemented in other embodiments. The subject disclosure is understood to encompass the present invention and any and all modifications, variations, or equivalents that fall within the spirit and scope of the basic underlying principles disclosed and claimed herein.
This application claims the benefit of the filing date of U.S. provisional application Ser. No. 63/368,843, filed Jul. 19, 2022, entitled, “UV Disinfection of Ports On An Aseptic Fluid Handling System,” which is hereby incorporated by reference as if fully set forth herein.
Number | Date | Country | |
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63368843 | Jul 2022 | US |