Sterilization methods for medical devices

• US 9,682,162 B2
• Filed: 01/13/2014
• Issued: 06/20/2017
• Est. Priority Date: 08/15/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Freeman, Abigail, Huang, Bin
• Primary Examiner(s): Cleveland, Timothy
• Application Number:
  US14/153,477
• Publication Number:
  US 20140123602A1
• Time in Patent Office: 1,254 Days
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/082 X-rays
• CPC Class Codes: A61L 2/085 Infrared radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/22 Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices

Abstract

Methods of sterilizing medical devices, including implantable medical devices like stents, chemically and with radiation are disclosed. Methods of preparing a sterile, packaged medical device, including a sterile, packaged implantable medical device or stent are disclosed.

Claims

1. A method for preparing a sterilized packaged stent, the method comprising:

exposing a stent comprising a polymer to radiation to sterilize the stent while the stent is in an uncrimped state;

after exposing the stent to radiation to sterilize the stent, coating the stent aseptically; and

packaging the coated stent to form the sterilized packaged stent.

2. The method of claim 1, wherein the stent is exposed to radiation to sterilize the stent prior to mounting the stent on a delivery device.

3. The method of claim 1, further comprising mounting the coated stent onto a delivery device.

4. The method of claim 1, further comprising performing one or more additional stent processing operations, wherein all of the one or more stent processing operations subsequent to the exposure of the stent to radiation to sterilize the stent are performed aseptically.

5. The method of claim 1, wherein the sterilization is electron beam sterilization.

6. The method of claim 1, wherein the polymer is selected from the group consisting of poly(N-acetylglucosamine) (Chitin), Chitosan, poly(3-hydroxyvalerate), poly(lactide-co-glycolide), poly(-hydroxybutyrate), poly(-hydroxybutyrate), poly(3-hydroxybutyrate-co-3-hydroxyvalerate), polyorthoesters, polyanhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D,L-lactic acid), poly(D,L-lactide), poly(L-lactide-co-D,L-lactide), poly(caprolactone), poly(L-lactide-co-caprolactone), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), poly(trimethylene carbonate), polyester amides, poly(glycolic acid-co-trimethylene carbonate), co-poly(ether-esters) (e.g. PEO/PLA), polyphosphazenes, fibrin, fibrinogen, cellulose, starch, collagen, hyaluronic acid, polyurethanes, silicones, polyesters, polyolefins, polyisobutylene and ethylene-alphaolefin copolymers, acrylic polymers and copolymers, vinyl halide polymers and copolymers, polyvinyl chloride, polyvinyl ethers, polyvinyl methyl ether, polyvinylidene halides, polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polystyrene, polyvinyl esters, acrylonitrile-styrene copolymers, acrylonitrile butadiene styrene resins, polyamides, Nylon 66, polycaprolactam, polycarbonates, polyoxymethylenes, polyimides, polyethers, rayon, rayon-triacetate, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, ethylene vinyl alcohol copolymer, poly(butyl methacrylate), poly(vinylidene fluoride-co-hexafluoropropene), polyvinylidene fluoride, ethylene-vinyl acetate copolymers, poly(vinyl acetate), styrene-isobutylene-styrene triblock copolymers, polyethylene glycol, and combinations thereof.

7. The method of claim 1, wherein the stent further comprises a drug.

8. The method of claim 1, wherein the stent further comprises a bioactive agent.

9. The method of claim 1, wherein the stent further comprises a protein.

10. The method of claim 1, wherein the stent further comprises a macromolecule.