Syringe with PECVD lubrication
Inventors
Felts, John T. • Fisk, Thomas E. • Abrams, Robert S. • Ferguson, John • Freedman, Jonathan R. • Pangborn, Robert J. • Sagona, Peter J.
Assignees
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Publication Number
US-11624115-B2
Publication Date
2023-04-11
Expiration Date
Abstract
A syringe or other vessel having a substrate surface coated by PECVD is provided. The PECVD coating is made by generating plasma from a gaseous reactant comprising an organosilicon precursor and optionally O2. The lubricity, hydrophobicity and/or barrier properties of the coating are set by setting the ratio of the O2 to the organosilicon precursor in the gaseous reactant, and/or by setting the electric power used for generating the plasma. In particular, a lubricity coating made by said method is provided. Vessels coated by said method and the use of such vessels protecting a compound or composition contained or received in said coated vessel against mechanical and/or chemical effects of the surface of the uncoated vessel material are also provided.
Core Innovation
The invention relates to a syringe comprising a barrel and a plunger, where the barrel has an interior surface coated at least in part with a lubricity coating made by plasma enhanced chemical vapor deposition (PECVD). The coating is formed by providing a gas comprising a monocyclic siloxane, O2, and a noble gas in the vicinity of the interior surface and generating a plasma in the gas using charged electrodes. The PECVD conditions are effective to form a lubricity coating comprising a crosslinked monocyclic siloxane chemical structure on the interior surface.
The lubricity coating is characterized by a plunger initiation force Fi of 4.8 to 11 N, and in one disclosure 5.1 to 11 N. The conditions effective include a ratio of the O2 to the monocyclic siloxane, a power used for generating the plasma, a ratio of the noble gas to the monocyclic siloxane, or any combination thereof. The document further describes coating performance metrics, coating thickness, composition, roughness, and barrier coating properties based on SiOx barrier coatings.
The disclosed embodiments further specify particular monomers and noble gases, including octamethylcyclotetrasiloxane (OMCTS), O2, and Ar, and describe related RF-PECVD coating system approaches that deposit inside tubes and syringe barrels. The document also characterizes the coating by atomic ratios such as SiwOxCy or SiwNxCy, coating thickness, and differences in atomic ratios and reduced silicon atomic concentration compared with the feed gas, as determined using XPS.
Claims Coverage
The independent claim coverage centers on one inventive concept: forming a syringe barrel interior lubricity coating by PECVD from a monocyclic siloxane/O2/noble gas plasma generated using charged electrodes, producing a crosslinked monocyclic siloxane coating with a defined plunger initiation force Fi range. Dependent claims refine the gas species, gas ratios and plasma power, Fi range, atomic ratio form, and coating thickness.
Monocyclic siloxane/O2/noble-gas PECVD lubricity coating on syringe interior
A syringe comprising a barrel and a plunger, the barrel having an interior surface coated at least in part with a lubricity coating made by providing a gas comprising a monocyclic siloxane, O2, and a noble gas in the vicinity of the interior surface and generating a plasma in the gas using charged electrodes, thus forming a coating on the interior surface by plasma enhanced chemical vapor deposition (PECVD).
Crosslinked monocyclic siloxane chemical structure lubricity coating and Fi window
The PECVD conditions are effective to form a lubricity coating on the interior surface comprising a crosslinked monocyclic siloxane chemical structure and having a plunger initiation force Fi of 4.8 to 11 N.
Defined PECVD condition parameters via gas ratios and plasma power
The conditions effective include a ratio of the O2 to the monocyclic siloxane, a power used for generating the plasma, a ratio of the noble gas to the monocyclic siloxane, or any combination thereof.
OMCTS, O2, and argon plasma gas for lubricity coating
The monocyclic siloxane is octamethylcyclotetrasiloxane (OMCTS), and the gas comprises OMCTS, O2, and Ar to generate plasma.
Plunger initiation force Fi in a narrower range
The plunger initiation force Fi is 5.1 to 11 N.
Lubricity coating atomic ratio constraints (SiwOxCy or SiwNxCy)
The lubricity coating has an atomic ratio of either SiwOxCy or SiwNxCy with w=1, x=about 0.5 to about 2.4, and y=about 0.6 to about 3.
Lubricity coating thickness range
The lubricity coating has an average thickness in the range of 10 to 1000 nm.
Overall, the claim coverage centers on forming a crosslinked monocyclic siloxane lubricity coating on the syringe barrel interior using PECVD from a monocyclic siloxane/O2/noble gas plasma generated by charged electrodes, with the resulting coating characterized by a specified Fi range and by PECVD conditions defined through relevant gas ratios and plasma power.
Stated Advantages
Reduced friction, including breakout/initiation and plunger sliding or maintenance forces.
Uniform covalently attached lubricity coatings.
Reduced extractables/leachables versus silicon oil.
Improved vacuum retention and blood/insulin stability.
Lower substrate heating and delamination risk with RF compared to microwave.
Reduced silicone migration and leachables.
Improved scalability via pucks/movable vacuum-sealed interface.
Reduction of insulin precipitation in coated vessels (optional).
Reduction of blood clotting in coated vessels (optional).
Notable improvements in comparative coating performance versus uncoated, SiOx-only, and a silicon-oil standard (as reflected in described comparative results).
Documented Applications
Protecting sensitive compounds/biologics, including insulin and blood, from mechanical/chemical effects in coated vessels such as syringe barrels and related collection tubes.
Use with blood collection products such as sodium citrate blood collection tubes.
Coating syringe barrels and syringe openings/interior surfaces to provide lubricity and barrier properties for pharmaceutical/biological contents, including improving blood/insulin stability.
Applying RF-PECVD coatings inside tubes using a movable vacuum-sealed puck interface.
Coated syringe/barrel vessels, including syringe lumen and barrel (COC syringe barrel), as examples for PECVD lubricity coating.
Coated vessels evaluated for insulin precipitation and blood clotting.
Characterization of lubricity performance using plunger initiation/maintenance forces (Fi/Fm) in syringe/barrel testing.
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