PECVD coating methods for capped syringes, cartridges and other articles

• US 9,458,536 B2
• Filed: 10/12/2012
• Issued: 10/04/2016
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: SiO2 Medical products Inc.
• Original Assignee: SiO2 Medical products Inc.
• Inventors: Felts, John T., Fisk, Thomas E., Kinney, Shawn, Weikart, Christopher, Hunt, Benjamin, Raiche, Adrian, Fitzpatrick, Brian, Sagona, Peter J., Stevenson, Adam
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US13/651,299
• Publication Number:
  US 20130041241A1
• Time in Patent Office: 1,453 Days
• Field of Search: 427/2.28, 427/2.1, 427/230, 427/237, 427/569
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150595 by snap-lock (i.e. based on axial displacement)
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: B05D 7/22 to internal surfaces, e.g. of tubes
• 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 16/505 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: G01M 3/329 : for verifying the internal pressure of closed containers
• CPC Class Codes: G01N 33/0096 : Testing material properties on thin layers or coatings

Abstract

A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, optionally a dispensing portion, and a cap. The cap is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the cap. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication from the barrel lumen to the exterior via the front opening, optionally further via the dispensing portion lumen if present, at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.

Claims

1. A method comprising:

providing a capped pre-assembly comprising;

a barrel comprising an internal wall defining a barrel lumen and a front opening through the internal wall;

a dispensing portion comprising a hypodermic needle secured to the barrel, the hypodermic needle comprising a distal opening located outside the barrel and a dispensing portion lumen communicating between the front opening of the barrel and the distal opening of the dispensing portion; and

a cap secured to the barrel and at least substantially isolating the front opening from pressure conditions outside the cap, the cap being sufficiently permeable to a sterilizing gas to sterilize the portions of the assembly isolated by the cap; and

applying a plasma enhanced chemical vapor deposition (PECVD) coating or layer directly or indirectly to at least a portion of the internal wall of the barrel, while the pre-assembly is capped and the dispensing portion lumen of the hypodermic needle is communicating between the front opening and the distal opening of the dispensing portion, under conditions effective to maintain communication between the barrel lumen and the exterior via the front opening at the end of the applying step, in which essentially no PECVD coating is formed in the dispensing portion lumen of the hypodermic needle.

2. The method of claim 1, further comprising, before the providing step, assembling the capped pre-assembly.

3. The method of claim 2, further comprising, before the assembling step, forming the barrel.

4. The method of claim 3, in which the barrel is formed by placing the dispensing portion in an injection mold and injection molding thermoplastic material about the dispensing portion, thus forming the barrel and securing the dispensing portion to the barrel.

5. The method of claim 1, in which the cap is made of a thermoplastic elastomer.

6. The method of claim 1, in which the cap of the pre-assembly isolates the distal opening at least partially due to:

contact between the cap and the distal opening, contact between the cap and the barrel, or both.

7. The method of claim 1, in which the barrel further comprises an opening spaced from the dispensing portion and communicating through the internal wall.

8. The method of claim 7, in which the vapor-deposited coating or layer is applied through the opening.

9. The method of claim 8, in which the PECVD coating or layer is applied by flowing a reactant vapor material through the opening and employing plasma enhanced chemical vapor deposition to deposit a reaction product of the reactant vapor material on the internal wall of the barrel.

10. The method of claim 1, further comprising, while drawing at least a partial vacuum through the barrel opening, measuring the pressure decay of gas drawn from the barrel opening and any leakage paths.

11. The method of claim 10, further comprising comparing the pressure decay of gas to a predetermined standard to determine the container closure integrity of the capped pre-assembly.

12. The method of claim 11, in which the pressure decay is measured with sufficient precision to detect a pressure decay due to an intact container versus a container having a single perforation in the cap having a diameter of 5 microns, to 0.5 microns.

13. The method of claim 12, in which the pressure decay is measured within a time between 1 second and 60 seconds.

14. The method of claim 10, in which the pressure decay of gas drawn from the barrel opening and any leakage paths is measured after applying a vapor-deposited coating or layer.

15. The method of claim 1, in which the vapor-deposited coating or layer is a barrier coating or layer.