Blood sample collection tube
Inventors
Weikart, Christopher • Clark, Becky L. • Stevenson, Adam • Felts, John T.
Assignees
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Publication Number
US-11116695-B2
Publication Date
2021-09-14
Expiration Date
Abstract
A blood sample collection tube and other vessels are described including an article surface and a coating set comprising a tie coating or layer of SiOxCy or SiNxCy applied to the article surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNxCy. The vessels optionally contain a fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the vessel.
Core Innovation
Thermoplastic blood sample collection vessels having a trilayer interior coating are provided, including a tie/adhesion layer, a SiOx barrier layer, and a pH protective layer formed from SiOxCy or SiNxCy. The tie layer comprises SiOxCy or SiNxCy, and the barrier layer comprises SiOx configured to reduce ingress of atmospheric gas through the wall compared to an uncoated wall. The coating set is arranged so that the barrier layer is positioned between the interior surface and the fluid and to resist transport into the lumen.
The pH protective layer comprises SiOxCy or SiNxCy, and is formed by chemical vapor deposition of a precursor selected from acyclic siloxane, monocyclic siloxane, polycyclic siloxane, polysilsesquioxane, monocyclic silazane, polycyclic silazane, polysilsesquiazane, silatrane, silquasilatrane, silproatrane, azasilatrane, azasilquasiatrane, azasilproatrane, or combinations thereof. When directly contacted by a fluid composition having a pH between 5 and 9, the pH protective coating or layer has a rate of erosion that is less than the rate of erosion of the barrier coating or layer.
The trilayer interior coating is described as mitigating dissolution or erosion of the SiOx barrier under pH 5 to 9 fluids while supporting long shelf life. The described performance rationale includes characterization and durability metrics, including O-parameter and N-parameter derived from ATR/FTIR, dissolution behavior, and calculated shelf life using total Si/Si dissolution rate to compare trilayer versus bilayer or monolayer behavior.
Claims Coverage
Two independent claim sets are covered by the provided independent claims, each describing a blood sample collection tube with a multilayer interior coating set. Across the independent claims, the inventive concept is expressed through three coordinated layers, a chemical vapor deposition precursor selection for the pH protective layer, and erosion or shelf-life performance relationships under fluid pH between 5 and 9, including quantified shelf-life duration.
Trilayer coated blood sample collection tube with tie, barrier, and pH protective layers
A blood sample collection tube comprising a wall surface and a coating set on the surface comprising a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer; the tie coating or layer comprising SiOxCy or SiNxCy with x from about 0.5 to about 2.4 and y from about 0.6 to about 3; the barrier coating or layer comprising SiOx with x from 1.5 to 2.9 and from 2 to 1000 nm thick, being effective to reduce ingress of atmospheric gas compared to an uncoated wall; and the pH protective coating or layer comprising SiOxCy or SiNxCy with x from about 0.5 to about 2.4 and y from about 0.6 to about 3, the pH protective coating or layer formed by chemical vapor deposition of a precursor selected from acyclic siloxane, monocyclic siloxane, polycyclic siloxane, polysilsesquioxane, monocyclic silazane, polycyclic silazane, polysilsesquiazane, silatrane, silquasilatrane, silproatrane, azasilatrane, azasilquasiatrane, azasilproatrane, or combinations thereof.
pH-protective layer erosion less than barrier layer erosion for pH 5 to 9
The blood sample collection tube in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH at some point between 5 and 9, is less than the rate of erosion of the barrier coating or layer, if directly contacted by the fluid composition.
Trilayer coated tube with increased calculated shelf life and at least six months at 4°C
A blood sample collection tube comprising a vessel with a wall interior surface and an interior coating set comprising a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer; the tie coating or layer comprising SiOxCy or SiNxCy with x from about 0.5 to about 2.4 and y from about 0.6 to about 3; the barrier coating or layer comprising SiOx with x from 1.5 to 2.9 and from 2 to 1000 nm thick, effective to reduce ingress of atmospheric gas into the lumen compared to a vessel without a barrier coating or layer; and the pH protective coating or layer comprising SiOxCy or SiNxCy with x from about 0.5 to about 2.4 and y from about 0.6 to about 3; wherein the combination of the tie coating or layer and the pH protective coating or layer is effective to increase the calculated shelf life of the package, and a fluid composition contained in the lumen has a pH between 5 and 9; wherein the calculated shelf life is more than six months at a storage temperature of 4°C.
PECVD-applied trilayer arrangement to keep barrier substantially undissolved for at least six months
A blood sample collection tube comprising a thermoplastic wall with an interior surface enclosing a lumen; a fluid contained in the lumen having a pH greater than 5; a tie coating or layer comprising SiOxCy or SiNxCy with x from about 0.5 to about 2.4 and y from about 0.6 to about 3; a barrier coating or layer of SiOx with x between 1.5 and 2.9 applied by PECVD and positioned between the interior surface of the tie coating or layer and the fluid; and a pH protective coating or layer of SiOxCy in which x is between 0.5 and 2.4 and y is between 0.6 and 3 applied by PECVD and positioned between the barrier coating or layer and the fluid, the pH protective coating or layer and tie coating or layer together being effective to keep the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months.
The independent claims define a thermoplastic blood sample collection tube with a coordinated trilayer interior coating: a tie layer, a SiOx barrier layer, and a PECVD-deposited pH protective SiOxCy or SiNxCy layer. The claims further require that under fluid pH between 5 and 9 the pH protective layer erodes less than the barrier layer, and that the resulting structure improves calculated shelf life, including thresholds tied to storage at 4°C or barrier-undissolved durability for at least six months.
Stated Advantages
Reduces ingress of atmospheric gas through the wall compared to an uncoated wall.
Provides a pH protective coating whose erosion rate is less than the erosion rate of the barrier coating when directly contacted by a fluid composition having a pH between 5 and 9.
Increases the calculated shelf life of the package, with calculated shelf life more than six months at 4°C.
Keeps the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months.
Documented Applications
Use as a blood sample collection tube configured to contain a fluid composition in the lumen with a pH between 5 and 9, or greater than 5, while maintaining barrier integrity and supporting shelf life.
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