Calibration and detection of silicone oil in syringe barrels

• US 10,247,679 B2
• Filed: 10/14/2016
• Issued: 04/02/2019
• Est. Priority Date: 10/16/2015
• Status: Active Grant

• Current Assignee: Zebrasci, Inc. (Becton, Dickinson & Co)
• Original Assignee: Zebrasci, Inc. (Becton, Dickinson & Co)
• Inventors: Gertz, Frederick Talley, Schultheis, Robert James, Noolandi, Jaan
• Primary Examiner(s): Seth, Manav
• Application Number:
  US15/293,573
• Publication Number:
  US 20170108451A1
• Time in Patent Office: 900 Days
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 2420/00 Materials or methods for coatings medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• 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: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: G01N 2021/8427 Coatings
• CPC Class Codes: G01N 21/643 non-biological material
• CPC Class Codes: G01N 21/8422 Investigating thin films, e.g. matrix isolation method
• CPC Class Codes: G01N 21/8851 Scan or image signal processing specially adapted therefor, e.g. for scan signal adjustment, for detecting different kinds of defects, for compensating for structures, markings, edges G01N21/8806 and G01N21/93 - G01N21/95692 take precedence; optical measurement of dimensions G01B11/00; optical scanning G02B26/10; image transformation G06T3/00; computerised image enhancement G06T5/00; image processing per se for flaw detection G06T7/0002
• CPC Class Codes: G01N 21/9018 Dirt detection in containers
• CPC Class Codes: G01N 21/93 Detection standards; Calibrating baseline adjustment, drift correction
• CPC Class Codes: G01N 21/954 Inspecting the inner surface of hollow bodies, e.g. bores
• CPC Class Codes: G06T 7/0012 Biomedical image inspection

Abstract

Medical syringe barrels having the inner surface coated with cured silicone oil are used for calibration and detection of silicone oil in medical syringe barrels. Calibration standards as provided in this invention allow for quick determination how well a lubrication system for lubricating medical syringe barrels with silicone oil is working.

Claims

1. A method of calibration and detection of silicone oil in syringe barrels, comprising:

(a) providing a syringe barrel which has the inner surface coated with a silicone oil;

(b) obtaining an image with an imaging system of the inner surface of the syringe barrel coated with the silicone oil, wherein the imaging system is capable of detecting silicone oil;

(c) determining with a computer image analysis program executed by a computer a distribution pattern of the silicone oil at the inner surface from the obtained image;

(d) determining by the computer image analysis program executed by the computer a comparison between (i) the distribution pattern of the silicone oil at the inner surface of the syringe barrel, with (ii) a calibration distribution pattern of an inner surface of a calibration syringe barrel coated with a cured silicone oil, wherein the silicone oil in the cured silicone oil is the same silicone oil as in the syringe barrel, wherein the calibration distribution pattern of the cured silicone oil is obtained from a calibration image obtained with the imaging system of the inner surface of calibration syringe barrel; and

(e) outputting the comparison by the computer image analysis program executed by the computer.

2. The method as set forth in claim 1, wherein the cured silicone oil is chemically doped with a fluorescent material or a fluorescent tag that can be dissolved in silicone oil.

3. The method as set forth in claim 1, wherein the cured silicone oil is chemically or physically doped with a hydrophobic quantum dot.

4. The method as set forth in claim 1, wherein the cured silicone oil is a curable Polydimethylsiloxane (PDMS).

5. The method as set forth in claim 1, wherein the outputting the comparison comprises heatmaps.

6. A system for calibration and detection of silicone oil in syringe barrels, comprising:

(a) a syringe barrel which has the inner surface coated with a silicone oil;

(b) an imaging system capable of obtaining an image and detecting silicone oil of the inner surface of the syringe barrel;

(c) a computer image analysis program executed by a computer to analyze a distribution pattern of the silicone oil at the inner surface from the obtained image;

(d) the computer image analysis program executed by a computer capable of determining a comparison between (i) the distribution pattern of the silicone oil at the inner surface of the syringe barrel, with (ii) a calibration distribution pattern of an inner surface of a calibration syringe barrel coated with a cured silicone oil, wherein the silicone oil in the cured silicone oil is the same silicone oil as in the syringe barrel, wherein the calibration distribution pattern of the cured silicone oil is obtained from a calibration image obtained with the imaging system of the inner surface of calibration syringe barrel; and

(e) the computer image analysis program executed by a computer capable of outputting the comparison.

7. The system as set forth in claim 6, wherein the cured silicone oil is chemically doped with a fluorescent material or a fluorescent tag that can be dissolved in silicone oil.

8. The system as set forth in claim 6, wherein the cured silicone oil is chemically or physically doped with a hydrophobic quantum dot.

9. The system as set forth in claim 6, wherein the cured silicone oil is a curable Polydimethylsiloxane (PDMS).

10. The system as set forth in claim 6, wherein the outputting the comparison comprises heatmaps.

11. A calibration syringe barrel, comprising:

a syringe barrel wherein the inner surface of the syringe barrel is coated with a cured silicone oil, wherein the cured silicone oil defines a reference silicone oil distribution pattern, wherein the reference silicone oil distribution pattern is useful as a reference pattern for a silicone oil distribution pattern of other syringe barrels which have the inner surface coated with silicone oil, and wherein the silicone oil in the cured silicone oil is the same silicone oil as in the other syringe barrels.