Packaging for medical devices coated with perfluorinated liquids or dispersions thereof
Inventors
Bandyopadhyay, Saibal • Jones, Andrew K.
Assignees
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Publication Number
US-11998369-B2
Publication Date
2024-06-04
Expiration Date
Abstract
The present disclosure includes and provides for methods of packaging medical devices that are to be treated with a fluorinated liquid to alter their surface properties, packaging systems for such medical devices, and methods of utilizing the packaging systems to treat the medical devices. The packaging systems permit effective storage and distribution of medical devices that upon contact with mammalian blood have limited thrombogenicity or are non-thrombogenic and/or are resistant to adhesion of blood cells or clots.
Core Innovation
A medical device packaging system is provided for a medical device that includes a fluoropolymer and/or perfluoropolymer component or coating on all or part of its surface, and that further includes a fluorinated liquid comprising one or more perfluorinated liquids. The system includes a base having a channel substantially conforming to the shape of the medical device, so the packaging defines a conforming cavity for the device and associated components. A cover forms a substantially gas and liquid tight seal over the channel, and can be peeled away from the base exposing all or part of the channel.
The medical device disposed in the channel further comprises a connector to the medical device, and the connector is also disposed in the channel. The packaging system is configured so the fluoropolymer and/or perfluoropolymer component or coating of the medical device is maintained in the context of gas-and-liquid-tight packaging, together with the fluorinated liquid comprising one or more perfluorinated liquids.
In the packaging system, the fluorinated liquid comprises or is one or more perfluorinated liquids, including perfluorodecalin, perfluoroalkanes such as perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, and perfluorooctane, and additional perfluorinated liquids including perfluoroperhydrophenanthrene, perfluorooctylbromide, and perfluorotributyl amine, and further combinations. The system further includes features that relate to channel volume constraints and surface treatment to control wettability/omniphobicity, and the cover can be configured to be permeable to ethylene oxide for ethylene-oxide sterilization reaching the medical device.
Claims Coverage
The independent claims provide a core packaging system with a conforming base channel, a peelable gas-and-liquid-tight cover, a medical device with fluoropolymer/perfluoropolymer coatings disposed in the channel, a connector disposed in the channel, and a fluorinated liquid comprising one or more perfluorinated liquids. The claim set also includes dependent inventive features that further constrain channel volume, specify fluoropolymer materials, define the fluorinated liquid constituents, and add cover-permeability and separation of the fluorinated liquid into a reservoir.
Conforming base channel sealed by peelable gas-and-liquid-tight cover
A base having a channel substantially conforming to the shape of a medical device, and a cover forming a substantially gas and liquid tight seal over the channel, wherein the cover can be peeled away from the base exposing all or part of the channel.
Fluoropolymer/perfluoropolymer medical device disposed in the sealed channel
A medical device disposed in the channel, the medical device comprising a fluoropolymer and/or perfluoropolymer component or coating on all or part of its surface.
Connector disposed in the channel
The medical device comprises a connector to the medical device that is also disposed in the channel.
Fluorinated liquid comprising one or more perfluorinated liquids in the system
The medical device further comprises a fluorinated liquid which comprises or is one or more perfluorinated liquids.
Channel volume relative constraint
The channel has a volume such that the unoccupied channel volume is less than 300% of the medical device volume.
Fluoropolymer selection from a specified fluoropolymer set
The fluoropolymer and/or perfluoropolymer comprises fluoropolymers and/or perfluoropolymers selected from a specified group of fluoropolymer materials.
Fluorinated liquid defined by selected perfluorinated solvents
The fluorinated liquid contains one or more selected solvents from a listed set of perfluorinated or fluorinated compounds and combinations thereof.
Cover permeable to ethylene oxide
The cover is permeable to ethylene oxide so ethylene oxide can reach the medical device.
Separate reservoir for fluorinated liquid
The packaging system includes a reservoir that separately contains the fluorinated liquid from the channel.
Overall, the claims cover a medical device packaging system built around a conforming base channel and a peelable gas-and-liquid-tight cover, containing a fluoropolymer and/or perfluoropolymer-coated medical device with a connector disposed in the channel, together with a fluorinated liquid comprising one or more perfluorinated liquids. Dependent features further constrain channel volume, define selected fluoropolymer materials and selected perfluorinated solvent constituents, configure ethylene-oxide permeability of the cover, and provide a separate reservoir for the fluorinated liquid.
Stated Advantages
Reduces thrombogenicity.
Reduces clot/blood-cell adhesion.
Reduces biofilm formation.
Documented Applications
No documented applications found
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