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Publication Number
US-10610609-B2
Publication Date
2020-04-07
Expiration Date
Abstract
Described herein generally are sterilization devices that can allow sterilization of luminal connection ports. Methods of using these devices are also described.
Core Innovation
The invention relates to a handheld sterilization device for luminal connection ports, comprising a body with a battery, a light source, and at least one indicator light, together with an adapter cap. The adapter cap includes luer threading, a lens, and a substrate that irreversibly changes color to indicate that sterilization has taken place. The adapter cap is inserted into a luminal connection port so that sterilizing light is applied to a surface of the luminal connection port.
The device architecture connects the power source and the light source to optical delivery through the adapter cap lens, and provides visual signaling through the indicator light and the irreversible color change substrate. Completion of sterilization is indicated by the irreversible color change of the substrate associated with the sterilization pathway through the adapter cap. Indicator light functionality is included as part of the device, with specific completion-linked color indication described for an intravenous connection port.
The document further addresses safety-related aspects using an inter-locking safety circuit, including an RF communication feature and/or optical communication to prevent premature UV emission. The specification describes that sterilization is achieved by ultraviolet light, with UVC and a wavelength constraint described, and reports microbial reduction performance. Example efficacy results are presented for MRSA using the device to sterilize connection port surfaces, and the status signaling is described through indicator light colors that progress with sterilization completion.
Claims Coverage
The claims provide coverage for two independent areas: a sterilization device configured to deliver sterilizing light to luminal connection port surfaces with completion indication, and a sterilization method performed by using that device configuration. Across the dependent claims, the inventive aspects are refined to include luer-structured adapter cap components, irreversible substrate color-change completion signaling, and specified sterilizing light characteristics including ultraviolet/UVC and wavelength/time constraints, together with indicator light completion colors for an intravenous connection port.
Sterilization device with luer adapter cap and irreversible color-change completion
A sterilization device comprising a body comprising at least one indicator light, a battery, and a light source; an adapter cap consisting of a luer threading, a lens, and a substrate that irreversibly changes color to indicate that sterilization has taken place; wherein the adapter cap is inserted into a luminal connection port.
Method of sterilization using luminal port sterilization with irreversible color-change substrate
A method of sterilization comprising inserting a luminal connection port into a sterilization device comprising at least one indicator light, a battery, a light source, and an adapter cap to apply sterilizing light to the luminal connection port; wherein the adapter cap consists of a luer threading, a lens, and a substrate; wherein the device sterilizes a surface of the luminal connection port; and wherein completion of sterilization is indicated by an irreversible color change of the substrate.
Overall claim coverage centers on delivering sterilizing light to luminal connection port surfaces via a luer-threaded adapter cap that includes a lens and an irreversible color-change substrate to indicate completion, with device-level indicator light signaling and method coverage that mirrors the same device configuration and completion indication.
Stated Advantages
Reduced sterilization time, including time reduction versus CDC/Joint Commission isopropyl pad scrubbing.
Cost savings.
Suitability for routine IV changes.
Inter-locking safety circuit to prevent premature UV emission.
High microbial kill performance reported against MRSA, including 99.99% kill and higher reductions at longer times.
Documented Applications
Sterilizing luminal medical connection ports, including intravenous (IV) connector surfaces, using a handheld sterilization system with an adapter cap.
Sterilizing one or multiple ports sequentially or with caps during IV bag changes, as described in example workflows.
Efficacy testing/application context against MRSA using the sterilization device for connection port surfaces.
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