Blood sample collection tube

Patent metadata

Field	Value
Publication number	US-11116695-B2
Application number	US-201916448689-A
Country	US
Kind code	B2
Filing date	Jun 21, 2019
Priority date	Nov 11, 2011
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

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.

First claim

The invention claimed is:

1. A blood sample collection tube comprising:
a wall having a 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 SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the wall surface and the tie coating or layer having an interior surface;
the barrier coating or layer comprising SiO x , wherein x is from 1.5 to 2.9, from 2 to 1000 nm thick, the barrier coating or layer of SiO x having an outer surface facing the interior surface of the tie coating or layer and the barrier coating or layer of SiO x having an interior surface, the barrier coating or layer being effective to reduce the ingress of atmospheric gas through the wall compared to an uncoated wall; and
the pH protective coating or layer comprising SiO x C y or SiN x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, on the barrier coating or layer, the pH protective coating or layer being formed by chemical vapor deposition of a precursor selected from an acyclic siloxane, a monocyclic siloxane, a polycyclic siloxane, a polysilsesquioxane, a monocyclic silazane, a polycyclic silazane, a polysilsesquiazane, a silatrane, a silquasilatrane, a silproatrane, an azasilatrane, an azasilquasiatrane, an azasilproatrane, or a combination of any two or more of these precursors; and
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.

2. The blood sample collection tube of claim 1 , in which the pH protective coating or layer as applied is between 100 and 700 nm thick.

3. The blood sample collection tube of claim 1 , in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is less than 20% of the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.

4. The blood sample collection tube of claim 1 , in which the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is from 5% to 20% of the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.

5. The blood sample collection tube of claim 1 , in which the silicon dissolution rate by a 50 mM potassium phosphate buffer diluted in water for injection, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant from the vessel is less than 170 ppb/day.

6. The blood sample collection tube of claim 1 , in which x is between 0.5 and 1.5 and y is between 0.9 and 2.

7. The blood sample collection tube of claim 1 , in which the tie coating or layer on average is between 10 and 100 nm thick.

8. The blood sample collection tube of claim 1 in which the barrier coating or layer on average is between 10 and 100 nm thick.

9. The blood sample collection tube of claim 1 in which the range of thickness of the pH protective coating or layer is between 50 and 400 nm thick.

10. The blood sample collection tube of claim 1 , in which an FTIR absorbance spectrum of the pH protective coating or layer has a ratio greater than 0.75 between:
the maximum amplitude of the Si—O—Si symmetrical stretch peak between about 1000 and 1040 cm−1, and
the maximum amplitude of the Si—O—Si asymmetric stretch peak between about 1060 and about 1100 cm −1 .

11. The blood sample collection tube of claim 10 , in which the ratio is at most 1.7.

12. The blood sample collection tube of claim 1 , wherein the pH protective coating or layer shows an O-Parameter measured with attenuated total reflection (ATR) of less than 0.4, measured as:

O
⁢

-

⁢
Parameter

=

Intensity
⁢

⁢
at
⁢

⁢
1253
⁢

⁢

cm

-
1

Maxium
⁢

⁢
intensity
⁢

⁢
in
⁢

⁢
the
⁢

⁢
range
⁢

⁢
1000
⁢

⁢
to
⁢

⁢
1100
⁢

⁢

cm

-
1

.

13. The blood sample collection tube of claim 12 , in which the O-parameter has a value of from 0.15 to 0.37.

14. The blood sample collection tube of claim 1 , wherein the pH protective coating or layer shows an N-Parameter measured with attenuated total reflection (ATR) of less than 0.7, measured as:

N
⁢

-

⁢
Parameter

=

Intensity
⁢

⁢
at
⁢

⁢
840
⁢

⁢

cm

-
1

Assignees

• Sio2 Medical Products Inc

Inventors

• Weikart Christopher
• Clark Becky L
• Stevenson Adam
• Felts John T

Classifications

• A61M2205/0238

  the material being a coating or protective layer · CPC title

• C23C16/30

  Deposition of compounds, mixtures or solid solutions, e.g. borides, carbides, nitrides · CPC title

• C23C16/045

  Coating cavities or hollow spaces, e.g. interior of tubes; Infiltration of porous substrates · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61M5/3129

  Syringe barrels (A61M5/3205 and A61M5/50 take precedence) · CPC title