Sterilization system and device
View Patent ↗A system, device and method for sterilizing or decontaminating an object that by exposing the object to a sterilant gas comprised of one or more oxides of nitrogen, such as NO, NO 2 , NO 3 , N 2 O 3 , N 2 O 4 , N 2 O 5 , N 2 O and mixtures thereof. The source of the sterilant gas can be generated from a sterilant gas-generating composition or provided by a source of the sterilant gas.
1. A method for sterilizing a packaged medical device in a gas-tight sterilizing chamber, the method comprising:
placing the packaged medical device sealed within a sterilization packaging into a gas-tight sterilizing chamber that contains air;
sealing the sterilizing chamber;
evacuating from the sealed sterilizing chamber at least a portion of the air contained in the sterilizing chamber to reach a selected pressure level within the sterilizing chamber;
after the sterilizing chamber reaches the selected pressure level, supplying the sterilizing chamber with a selected amount of a NO 2 -based sterilant gas consisting essentially of NO 2 ;
after supplying the sterilizing chamber with the selected amount of the NO 2 -based sterilant gas, providing a humidified gas into the sterilizing chamber to form a humidified NO 2 -based sterilant gas in the sterilizing chamber;
after providing the humidified gas into the sterilizing chamber, performing a dwelling operation at about room temperature for a selected period of time during which the humidified NO 2 -based sterilant gas sterilizes the medical device contained within the sterilization packaging;
removing at least a portion of the humidified NO 2 -based sterilant gas from the sterilizing chamber; and
removing the medical device sealed within the sterilization packaging from the sterilizing chamber.
2. The method of claim 1 , wherein the sterilant gas is generated from a sterilant gas-generating composition.
3. The method of claim 2 , wherein the gas generating chamber contains the sterilant gas-generating composition.
4. The method of claim 2 , wherein the sterilant gas-generating composition is comprised of at least one sterilant gas-generating compound.
5. The method of claim 1 , wherein the sterilizing chamber further comprises a port for introducing gases.
6. The method of claim 1 , wherein the time period is from about 30 seconds to about 20 minutes.
7. The method of claim 1 , wherein the time period is from about 30 seconds to about 12 hours.
8. The method of claim 1 , wherein the time period is from about 2 minutes to about 24 hours.
9. The method of claim 1 , wherein all gases entering the sterilizing chamber have been filtered.
10. The method of claim 1 , wherein the sterilizing chamber is purged after the object is exposed to the sterilant gas.
11. The method of claim 1 , wherein the selected pressure level is less than 2″ Hg.
12. The method of claim 1 , wherein the exposure to the sterilant gas includes humidity from about 40% to about 80%.
13. The method of claim 1 , wherein a concentration of oxygen in the sterilizing chamber is from about 0% to about 21%.
14. The method of claim 1 , wherein the method is conducted at a temperature from about 18° C. to about 30° C.
15. The method of claim 14 , wherein the time period is from about 2 minutes to about 24 hours.
16. The method of claim 1 , wherein the medical device is an implant.
17. The method of claim 16 , wherein the implant is selected from the group consisting of a cardiovascular stent, a peripheral drug-eluting stent, a polymer coated implant, and mixtures thereof.
18. The method of claim 1 , wherein the medical device is a stent.
19. The method of claim 1 , wherein the medical device is selected from the group consisting of a cardiac surgery product, an orthopedic surgery product, and a dental surgery product.
20. The method of claim 1 , wherein the medical device is an implant selected from the group consisting of a cardiac implant, an orthopedic implant, a dental implant, a gastrointestinal implant, and a vascular implant.
21. The method of claim 1 , wherein the medical device comprises at least one material selected from the group consisting of Poly(L-lactide), Poly(DL-Lactide), 50/50 Poly(DL-lactide-co-glycolide), Poly(e-caprolactone) and mixtures thereof.
22. The method of claim 1 , wherein the medical device comprises metal, non-metal, polymer or plastic, elastomer, or biologically derived material.
23. The method of claim 1 , wherein the medical device comprises a material selected from the group consisting of stainless steel, aluminum, nitinol, cobalt chrome, titanium and combinations thereof.
24. The method of claim 1 , wherein the medical device comprises a material selected from the group consisting of glass, silica, and ceramic.
25. The method of claim 1 wherein the medical device comprises a material selected from the group consisting of polyacetal, polyurethane, polyester, polytetrafluoroethylene, polyethylene, polymethylmethacrylate, polyhydroxyethyl methacrylate, polyvinyl alcohol, polypropylene, polymethylpentene, polyetherketone, polyphenylene oxide, polyvinyl chloride, polycarbonate, polysulfone, acrylonitrile-butadiene-styrene, polyetherimide, polyvinylidene fluoride, copolymers thereof and combinations thereof.
26. The method of claim 1 , wherein the medical device comprises a material selected from the group consisting of polysiloxane, fluorinated polysiloxane, ethylene-propylene rubber, fluoroelastomer and combinations thereof.
27. The method of claim 1 , wherein the medical device comprises a material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyparadioxanone, polytrimethylene carbonate and their copolymers, collagen, elastin, chitin, coral, hyaluronic acid, bone and combinations thereof.
28. The method of claim 1 , wherein the medical device further comprises a bioactive coating.
29. The method of claim 28 , wherein the bioactive coating is selected from the group consisting of a biocompatible coating, an infection resistance coating, an antimicrobial coating, a drug release coating, an antithrombogenic coating, a lubricious coating and combinations thereof.
30. The method of claim 28 , wherein the bioactive coating is selected from the group consisting of heparin, phosphoryl choline, urokinase, rapamycin and combinations thereof.
31. The method of claim 28 , wherein the bioactive coating comprises a hydrophilic or hydrophobic coating.
32. The method of claim 28 , wherein the bioactive coating comprises a polymer selected from the group consisting of polyvinyl pyrrolidone, polyethylene glycol, polypropylene glycol, polyethylene glycol-co-propylene glycol, polyethylene glycol acrylate, polyethylene glycol diacrylate, polyethylene glycol methacrylate, polyethylene glycol dimethacrylate, polyethylene oxide, polyvinyl alcohol, polyvinyl alcohol-co-vinylacetate, polyhydroxyethyl methacrylate, and polyhyaluronic acid, and hydrophilically substituted derivatives, monomers, unsaturated pre-polymers, uncrosslinked polymers, copolymers thereof and combinations thereof.
33. The method of claim 28 , wherein the bioactive coating comprises a polymer selected from the group consisting of polytetrafluoroethylene, polyethylene, polypropylene, poly(ethylene terephthalate), polyester, polyamides, polyarylates, polycarbonate, polystyrene, polysulfone, polyethers, polyacrylates, polymethacrylates, poly(2-hydroxyethyl methacrylate), polyurethanes, poly(siloxane)s, silicones, poly(vinyl chloride), fluorinated elastomers, synthetic rubbers, poly(phenylene oxide), polyetherketones, acrylonitrile-butadiene-styrene rubbers, polyetherimides, hydrophobically substituted derivatives thereof, their precursor monomers, copolymers thereof and combinations thereof.
34. The method of claim 1 , wherein the medical device is comprised of a material selected from the group consisting of a bioabsorbable polymer, a drug-bearing polymer and mixtures thereof.
35. The method of claim 1 , wherein the medical device is selected from the group consisting of an orthopedic bone graft and a bone scaffold.
36. The method of claim 1 , wherein the medical device is a biological product, wherein the biological product is selected from the group consisting of a tissue, an organ, a wound healing product, and a tissue engineering product.
37. The method of claim 1 , wherein the medical device is a protein.
38. The method of claim 1 , further comprising, after the exposing, scrubbing the sterilant gas.
39. The method of claim 38 , wherein the scrubbing comprises passing the sterilant gas through a scrubbing medium to reduce a concentration of NO 2 .
40. The method of claim 39 , wherein the concentration of NO 2 is reduced below 1 ppm.