VESSEL INSPECTION APPARATUS AND METHODS

• US 20110252899A1
• Filed: 06/27/2011
• Published: 10/20/2011
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: SiO2 Medical products Inc.
• Original Assignee: SiO2 Medical products Inc.
• Inventors: Freedman, Jonathan R., Felts, John T., Ferguson, John, Pangborn, Robert J., Sagona, Peter J., Fisk, Thomas E., Abrams, Robert S.
• Granted Patent: US 8,512,796 B2
• Time in Patent Office: Days
• US Class Current: 73/865.8
• 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 2033/0096 : testing material properties on thin layers or coatings
• 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: 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 syringe barrel comprising:

a plunger;

a barrel made of thermoplastic base material defining a lumen and having an interior surface receiving the plunger for sliding;

a lubricity layer less than 1000 nm thick on the barrel interior surface, the plunger, or both, applied by plasma-enhanced chemical vapor deposition and comprising Si_wO_xC_yH_z or Si_wN_xC_yH_z in which w is 1, x is from about 0.5 to 1, y is from about 2 to about 3, and z is from 6 to about 9; and

a surface treatment covering the lubricity layer in an amount effective to reduce the leaching of the lubricity layer, the thermoplastic base material, or both into the lumen;

wherein the lubricity layer and surface treatment are composed, and present in relative amounts, effective to provide a plunger breakout force, plunger sliding force, or both less than the corresponding force required in the absence of the lubricity layer and surface treatment.

2. A method for inspecting a syringe barrel, comprising:

providing a syringe barrel made of base material, defining a lumen, and having an interior surface provided with a barrier layer;

drawing a partial vacuum on the lumen; and

measuring a vapor outgassed into the lumen.

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

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

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

10. The method of claim 2, further comprising, before measuring the outgassed gas, contacting the barrier layer with water vapor.

14. The method of claim 2, further comprising, before measuring the outgassed gas, contacting the barrier layer with oxygen.

20. The method of claim 2, in which the outgassed gas is measured at a pressure from 0.1 Torr to 100 Torr.

30. The method of claim 2, further comprising connecting the lumen via a duct to a vacuum source to at least partially evacuate the lumen and providing an outgassing measurement cell communicating between the lumen and the vacuum source.

32. The method of claim 2, in which measuring is carried out by determining the volume of outgassed material outgassed through the barrier layer per interval of time.

33. The method of claim 2, in which measuring is carried out using micro-flow technology.

34. The method of claim 2, in which measuring is carried out by measuring the mass flow rate of outgassed material.

35. The method of claim 2, in which measuring is carried out in a molecular flow mode of operation.

44. The method of claim 2, in which the base material is injection-molded thermoplastic.

48. The method of claim 2, in which the barrier layer comprises a coating having one of the following atomic ratios, measured by X-ray photoelectron spectroscopy (XPS), SiO_x, in which x is from about 1.5 to about 2.9.

61. The method of claim 2, in which measuring the outgassed gas is carried out under conditions effective to distinguish the presence or absence of the barrier layer.

62. The method of claim 61, in which conditions effective to distinguish the presence or absence of the barrier layer include a test duration of less than one minute.

75. The method of claim 61, in which the measurement of the presence or absence of the barrier layer is confirmed to at least a six-sigma level of certainty.

3. (canceled)

5-6. -6. (canceled)

9. (canceled)

11-13. -13. (canceled)

15-19. -19. (canceled)

21-29. -29. (canceled)

31. (canceled)

36-43. -43. (canceled)

45-47. -47. (canceled)

49-60. -60. (canceled)

63-74. -74. (canceled)

76-81. -81. (canceled)

82. A vessel processing system for coating and inspection of a vessel, the system comprising a processing station arrangement configured for:

performing a first inspection of the vessel for defects;

applying a first coating to the interior surface of the vessel;

performing a second inspection of the interior surface of the coated vessel for defects;

evaluating the data acquired during inspection;

wherein the second inspection and the data evaluation take less than 30 seconds.

83-95. -95. (canceled)

96. A method for inspecting the product of a coating process wherein a coating has been applied to the surface of a substrate to form a coated surface, the method comprising:

(a) providing the product as an inspection object;

(b) measuring the release of at least one volatile species from the inspection object into the gas space adjacent to the coated surface; and

(c) comparing the result of step (b) with the result of step (b) for at least one reference object measured under the same test conditions, thus determining the presence or absence of the coating or a physical or chemical property of the coating.

97-121. -121. (canceled)