Vessel inspection apparatus and methods

• US 8,512,796 B2
• Filed: 06/27/2011
• Issued: 08/20/2013
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: SiO2 Medical products Inc.
• Original Assignee: SiO2 Medical products Inc.
• Inventors: Felts, John T., Fisk, Thomas E., Abrams, Robert S., Ferguson, John, Freedman, Jonathan R., Pangborn, Robert J., Sagona, Peter J.
• Primary Examiner(s): Meeks, Timothy
• Assistant Examiner(s): SELLMAN, CACHET I
• Application Number:
  US13/169,811
• Publication Number:
  US 20110252899A1
• Time in Patent Office: 785 Days
• Field of Search: None
• US Class Current: 427/2.3
• CPC Class Codes: A61B 5/150206 Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: B05C 13/00 Means for manipulating or holding work, e.g. for separate articles B05C1/0821 takes precedence
• CPC Class Codes: B05C 13/025 relatively small cylindrical objects, e.g. cans, bottles
• CPC Class Codes: B23Q 7/04 by means of grippers B23Q7/1494 takes precedence
• CPC Class Codes: B23Q 7/1494 using grippers
• CPC Class Codes: C23C 16/045 Coating cavities or hollow spaces, e.g. interior of tubes; Infiltration of porous substrates
• CPC Class Codes: C23C 16/401 containing silicon
• CPC Class Codes: C23C 16/458 characterised by the method used for supporting substrates in the reaction chamber
• CPC Class Codes: C23C 16/50 using electric discharges generation and control of plasma in discharge tubes for surface treatment H01J37/32, H01J37/34
• CPC Class Codes: C23C 16/505 using radio frequency discharges
• CPC Class Codes: C23C 16/52 Controlling or regulating the coating process C23C16/45557, C23C16/279 take precedence
• CPC Class Codes: C23C 16/54 Apparatus specially adapted for continuous coating
• CPC Class Codes: G01N 15/082 Investigating permeability by forcing a fluid through a sample
• CPC Class Codes: G01N 23/2273 : Measuring photoelectron spectrum, e.g. electron spectroscopy for chemical analysis [ESCA] or X-ray photoelectron spectroscopy [XPS]
• CPC Class Codes: G01N 30/7206 : interfaced to gas chromatograph interfaces in general for introducing or extracting samples to be analysed with specially adapted mass spectrometer, see H01J49/04
• CPC Class Codes: G01N 33/00 : Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
• CPC Class Codes: G01N 33/0096 : Testing material properties on thin layers or coatings
• CPC Class Codes: Y10T 428/13 : Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1383 : Vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit is sandwiched between layers [continuous layer]

Abstract

Methods for processing a vessel, for example to provide a gas barrier or lubricity, are disclosed. First and second PECVD or other vessel processing stations or devices and a vessel holder comprising a vessel port are provided. An opening of the vessel can be seated on the vessel port. The interior surface of the seated vessel can be processed via the vessel port by the first and second processing stations or devices. Vessel barrier, lubricity and hydrophobic coatings and coated vessels, for example syringes and medical sample collection tubes are disclosed. A vessel processing system and vessel inspection apparatus and methods are also disclosed, for example using material outgassed from a surface to inspect the properties of a surface coating.

Claims

1. A method for inspecting the product of a coating process wherein a coating has been applied to at least a portion of the surface of a vessel to form a coated surface, the method comprising:

(a) providing a product of the coating process having a coated surface defined by a coating prepared by PECVD from an organosilicon precursor;

(b) providing a space adjacent to the coated surface that is a lumen of the vessel;

(c) for a test duration of less than 30 seconds, measuring a release characteristic of at least one volatile species into the space adjacent to the coated surface;

(d) identifying the release characteristic of the at least one volatile species from an acceptably coated surface of the inspection object; and

(e) determining whether the release characteristic measured in step (c) satisfies the release characteristic identified in step (d).

2. The method of claim 1, in which the vessel comprises thermoplastic base material.

3. The method of claim 2, in which the vessel is an injection-molded thermoplastic part.

4. The method of claim 2, in which the vessel is a blow molded thermoplastic part.

5. The method of claim 2, in which the thermoplastic base material comprises a polyester.

6. The method of claim 2, in which the thermoplastic base material comprises polypropylene.

7. The method of claim 2, in which the thermoplastic base material comprises a cyclic olefin copolymer.

8. The method of claim 1, wherein the vessel is a syringe barrel.

9. The method of claim 1, wherein the vessel is a vial.

10. The method of claim 1, further comprising drawing at least a partial vacuum on the lumen before measuring the release characteristic.

11. The method of claim 10, further comprising connecting the lumen via a duct to a vacuum source to at least partially evacuate the lumen.

12. The method of claim 11, further comprising providing an outgassing measurement cell communicating between the lumen and the vacuum source.

13. The method of claim 11, in which the lumen is evacuated to a pressure from 0.1 Torr to 100 Torr.

14. The method of claim 1, further comprising, before measuring the release characteristic, contacting the coating with a gas.

15. The method of claim 14, in which the gas comprises water vapor.

16. The method of claim 14, in which the gas comprises oxygen.

17. The method of claim 14, in which the gas comprises carbon dioxide.

18. The method of claim 1, in which the release characteristic is measured by determining the volume of material outgassed into the space adjacent to the coated surface per interval of time.

19. The method of claim 1, in which the release characteristic is measured using micro-flow technology.

20. The method of claim 1, in which the release characteristic is measured by measuring the mass flow rate into the space adjacent to the coated surface.

21. The method of claim 1, in which the release characteristic is measured in a molecular flow mode of operation.

22. The method of claim 1, in which the coating is a barrier layer having a thickness of less than 500 nm.

23. The method of claim 22, in which the barrier layer comprises SiO_x, in which x, the atomic ratio of oxygen to silicon atoms, is from about 1.5 to about 2.9 as measured by X-ray photoelectron spectroscopy (XPS).

24. The method of claim 22, in which the release characteristic is measured under conditions effective to distinguish the presence or absence of the barrier

25. The method of claim 24, in which the measurement of the presence or absence of the barrier layer is confirmed to at least a six-sigma level of certainty.