WO2005073091A2 - Package of sensitive articles - Google Patents
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- Publication number
- WO2005073091A2 WO2005073091A2 PCT/US2005/002241 US2005002241W WO2005073091A2 WO 2005073091 A2 WO2005073091 A2 WO 2005073091A2 US 2005002241 W US2005002241 W US 2005002241W WO 2005073091 A2 WO2005073091 A2 WO 2005073091A2
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- WO
- WIPO (PCT)
- Prior art keywords
- container
- gas
- interior
- permeable
- oxygen
- Prior art date
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
- B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
- B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0095—Packages or dispensers for prostheses or other implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
- B65B55/18—Sterilising contents prior to, or during, packaging by liquids or gases
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
- B65B55/19—Sterilising contents prior to, or during, packaging by adding materials intended to remove free oxygen or to develop inhibitor gases, e.g. vapour phase inhibitors
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/38—Articles or materials enclosed in two or more wrappers disposed one inside the other
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
- B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
- B65D81/2069—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere
- B65D81/2084—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere in a flexible container
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
- A61B2050/314—Flexible bags or pouches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/208—Hydrogen peroxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/18—Aseptic storing means
- A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Definitions
- the present invention relates generally to sterilized medical devices and packaging for sterilized medical devices.
- the present invention relates to the packaging of sterilized environmentally sensitive medical devices, such as drug-coated stents.
- the packaging which may be in the form of a pouch, bag, tube, box, or other sealed container, will maintain the sterility of the product until it is withdrawn from the packaging for use.
- a particularly successful system and method for sterile packaging of medical devices relies on use of high- density polyethylene (HDPE) pouches which are used to contain the medical device or other product. The device may be placed in the package prior to sterilization.
- HDPE high- density polyethylene
- Sterilization is then effected by placing the package in an environment including a sterilant gas, such as ethylene oxide (EtO), ethylene oxide with nitrogen, various blends of ethylene oxide and carbon dioxide, ethylene oxide with chlorofluorocarbon diluent(s), Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide, chlorine dioxide, or others.
- a sterilant gas such as ethylene oxide (EtO), ethylene oxide with nitrogen, various blends of ethylene oxide and carbon dioxide, ethylene oxide with chlorofluorocarbon diluent(s), Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide, chlorine dioxide, or others.
- the spun HDPE material such as Tyvek ® which is available from Medical Packaging Division of E. I. DuPont de Nemours and Company (DuPont), permits passage of the small molecule sterilant gas while remaining a barrier to bacteria, viruses, and other larger substances which might compromise sterility.
- the present invention is directed to packages of articles such as medical devices, methods of packaging such articles and is particularly directed to packaging articles which are labile when exposed to ambient oxygen concentrations or oxygen containing materials over prolonged periods of time.
- the present invention provides convenient, effective, and economical approaches for such packaging.
- the method of packaging, the packages and the packaging systems are particularly suitable for drug-device combinations, such as drug-eluting stents and other drug-coated medical articles.
- the packaging, the system and method may be utilized for sterilizing articles such as medical devices which are reactive to an ambient environment.
- the sterilized packaging embodying features of the invention generally includes a container which has a wall defining at least part of an interior configured to receive one or more articles or products for sterilization.
- the container has a portion, such as part of a wall forming the container, which is permeable to sterilizing gas, e.g. EtO, ethylene oxide with nitrogen, various blends of ethylene oxide and carbon dioxide, ethylene oxide with chlorofluorocarbon diluent(s), Oxyfume 2000 series of sterilant (from Honeywell Chemicals, Morristown, NJ), ozone, hydrogen peroxide, chlorine dioxide, or others.
- the permeable portion allows the article or articles to be placed in the interior, the container sealed, a vacuum applied to the container interior and an environment of sterilizing gas in contact with the permeable portion of the container under conditions which drives the sterilizing gas through the gas permeable portion into the inner chamber to sterilize the one or more products disposed within the chamber.
- the container interior is evacuated to about 15 psia to about 0.1 psia preferably 7 psia to about 0.5 psia for the purpose of aspirating the sterilizing gas through the permeable portion of the container.
- the container interior can be partially or totally evacuated of oxygen and replaced totally or partially with a non-reactive gas such as nitrogen.
- a steam injection slightly increasing the vacuum to about 0.1 psia to about 5 psia higher than the container interior, preferably to about 1 psia to about 3 psia higher than the container interior.
- Sterilizing gas maintained about the exterior of the permeable portion of the container is drawn into the container interior through the permeable portion thereof.
- the pressure of the sterilizing gas within the container interior for effective sterilization is about 20 psia to about 2 psia, preferably about 15 psia to about 5 psia.
- the dwell time of the sterilizing gas within the container interior at that pressure is about 1 to about 24 hours preferably about 6 to about 18 hours.
- the sterilizing gas is removed from the container interior, either by exposing the interior to a vacuum, by flushing or purging the container interior with air or a non reactive gas such as nitrogen, or some combination thereof or both.
- the sterilized package is left at room temperature for several days to ensure that the interior is essentially free of sterilizing gas, i.e. less than about 150 ppm, preferably about 10 to about 50 ppm, and typically about 25 ppm.
- the permeable portion of the container is sealed to prevent permeation of undesirable gas into the container interior while the one or more articles remain within the interior.
- the sealing of the container may comprise, for example, sealing the permeable portion of the container with a impermeable patch or partitioning the container to isolate or seal off the portion of the container interior which contains the article(s) from the portion of the container interior in fluid communication with the gas permeable portion of the container.
- the gas permeable portion of the container may be separated, e.g. severed, from the non-gas permeable portion.
- the gas permeable portion of the container will typically be composed of a material which is permeable to the sterilizing gas and impermeable to liquids.
- Suitable gas permeable materials include high-density polyethylene (HDPE), typically a spun HDPE or other spun olefin.
- HDPE high-density polyethylene
- Commercially available materials such as Tyvek ® (2FS, 1059B, 1073B or others) are specifically designed for packaging medical devices.
- the available materials are coated partially or totally with an adhesive for the purpose of sealing the material to itself or to adjacent materials.
- the permeability required for the sterilizing gas to permeate into the interior of the container and contact the one or more articles therein, can vary depending upon the pressure differential, the temperature and the time available for permeation of the sterilizing gas into the interior.
- the container has both a gas permeable portion, as described above, and a gas impermeable portion, typically formed from a metal or polymer film or a metal-polymer composite which is impermeable to gases.
- impermeable to gases it is meant that the permeation of oxygen is below about 30 cm 3 /100in 2 /day-atm, preferably below about 2 cm 3 /100in 2 /day- atm.
- suitable material for the gas impermeable portion include metal foils such as aluminum; polymer films such as polyethylene, polyester, polyester (PET)/modified low density polyethylene (LDPE) laminated film; or any combination thereof (e.g., metalized PET).
- the impermeable portions of the container may be incorporated with suitable oxygen scavenger materials or have adjacent thereto a partial or complete film of suitable oxygen absorbers or scavengers, such as ethylene-cyclohexenyl methyl acrylate copolymer (ECHA) and ethylene- methylacrylate-cyclohexeneylmethyl acrylate terpolymer (EMCM) described in Ching et al. (2001), referenced above.
- suitable oxygen absorbers or scavengers such as ethylene-cyclohexenyl methyl acrylate copolymer (ECHA) and ethylene- methylacrylate-cyclohexeneylmethyl acrylate terpolymer (EMCM) described in Ching et al. (2001), referenced above.
- oxygen scavengers include ethylenically unsaturated polymer, ferrous oxide (partially oxygenated iron), titanium oxide, activated carbon with sodium ascorbate, diethylhydroxylamine (DEHA), carbohydrazide, combination of above, or other chemicals which are readily reactive or combine with oxygen gas.
- suitable oxygen scavenger materials are incorporated or lie adjacent to the impermeable portion, oxygen within the interior of the container can be removed to very low levels. Suitable oxygen levels in the container interior in most instances will be below 5% oxygen, preferably below 1%, more preferably below 0.1%.
- the permeable portion or portions of the container may be incorporated with suitable oxygen scavenger materials or may be positioned adjacent to a partial or complete film of suitable oxygen scavengers. Not only oxygen is removed from the package, oxygen gas trying to permeate through the permeable portion will be limited from entering the package.
- Oxygen scavengers can be placed inside the package, such as inside a permeable packet that is placed within the interior of the container or within the interior of an enclosure surrounding the container. Oxygen scavengers can be embedded in a protective sheath over or adjacent to the article within the inner chamber.
- the sheath can be a polymer incorporated with suitable oxygen scavenger, or it can be formed of a polymer fully or partially coated with a suitable oxygen scavenger, or it can be made from suitable oxygen scavenger.
- Another approach for sealing the gas permeable enclosure is to place a patch, cover, or other gas impermeable barrier over that portion of the enclosure which is initially gas permeable.
- a window or other area of the enclosure typically a portion of a pouch, may be formed from gas permeable Tyvek or other material, while the remaining portion of the pouch or other enclosure is formed from a gas impermeable foil, polymer, or other material.
- a patch sized to cover the gas permeable window may be provided to be sealed over the window after the initial sterilization has been completed.
- Another approach for sealing the gas permeable enclosure is to place the enclosure inside of a separate gas impermeable enclosure after the initial sterilization has been performed.
- Preferred gas impermeable materials will also be non-transmissive for light, UV radiation, heat, and the like.
- the gas impermeable materials will also be impermeable to moisture.
- desiccant materials in or over a portion of the impermeable enclosure in order to sequester any moisture which may remain within the pouch after final sealing.
- the desiccant may be coated over or laminated within the polymer or metal film which comprises the gas impermeable enclosure.
- a small inserter canister of the desiccant material may be provided within the enclosure, similar to the desiccant placed in conventional pharmaceutical packaging.
- Figure 1 schematically illustrates a container embodying features of the present invention which includes both gas permeable and gas impermeable portions.
- Figure 2 schematically illustrates an alternate design of a container embodying features of the present invention which includes a gas impermeable portions, a gas permeable portion or window and a separate impermeable patch or cover for sealing the window.
- Figure 3 schematically illustrates an alternate design of a container having features of the present invention which includes gas permeable portions and a gas impermeable outer pouch or enclosure to seal the container.
- Figures 4A-4E schematically illustrate use of the container shown in Fig. 1 for packaging and sterilizing an article in a manner embodying features of the present invention.
- Figure 5 schematically illustrates one embodiment of the container constructed with an impermeable portion having a film adjacent thereto, the film comprising oxygen absorber or scavenger (in pure, composite, or matrix form).
- Figures 6A-6C schematically illustrate use of one embodiment of a container constructed with a permeable portion incorporated with or has a film adjacent to made from oxygen scavenger material.
- Figure 7 schematically illustrates use of one embodiment of a container with an oxygen scavenger packet or material.
- Figure 8 schematically illustrates use of one embodiment of a container with a sheath made from oxygen scavenger material.
- Figure 9 schematically illustrates use of one embodiment of a container within another enclosure that also contains oxygen scavenger material.
- a container 10 embodying features of the invention has a portion 12 which is not permeable to gas and a portion 14 which is permeable to gas, particularly to sterilizing gas such as EtO, ethylene oxide with nitrogen, various blends of ethylene oxide and carbon dioxide, ethylene oxide with chlorofluorocarbon diluent(s), Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide gas plasma, chlorine dioxide, or others.
- the container 10 typically has an open end 16 disposed at one end of the impermeable portion, while the permeable portion 14 is formed about another end of the portion 12.
- the container 10 is utilized by placing the article to be sterilized into the container interior 18 through the open end 16, sealing the open end 16, so that the article is fully contained within the gas permeable but otherwise impermeable structure of the container prior to sterilization.
- FIG. 2 An alternative container 20 is depicted in Figure 2 which has an impermeable portion 22 having a opening 24 covered by a gas permeable layer or wall 25.
- the article to be sterilized and packaged may be placed through open-end 26 of the container 20 into the container interior 27 prior to the sealing of the open end.
- the open end 26 sealed and then sterilization performed by evacuating the interior 27 while maintaining a sterilizing gas at the gas permeable layer 25.
- a impermeable sealing patch 28 is placed over the opening 24 as indicated by the dotted lines in order to seal the gas permeable layer 25 against subsequent gas permeation.
- FIG. 3 illustrates a third exemplary system 30 for sterilizing and packaging articles according to the present invention.
- the system 30 includes an inner container 32, at least a portion of which is formed from a gas permeable material, and an outer enclosure or pouch 34 which is at least substantially formed from a gas impermeable material.
- the one or more articles to be packaged and sterilized are placed within the interior of container 32 through the open end 33, the open end 33 sealed, and the sealed container sterilized using a sterilizing gas which passes through the permeable portion of the container. Residual sterilizing gas within the pouch may be removed as previously described.
- the container 32 may be placed into the open end 36 of the outer enclosure 34, and the open end 36 sealed in order to prevent subsequent gas permeation into the interior of the outer enclosure 34 and ultimately into the interior of the container 32.
- FIGs 4A-4E illustrate the use of the container 10 for packaging and sterilizing a catheter 40 which carries a drug eluting stent 42 (or any other environmentally sensitive medical or non-medical article).
- the catheter 40 is first placed through the open end 16 of the container 10 so that it is positioned within the interior 18 thereof.
- the container 10 is open at this point so that the gas impermeable portion 12 generally surrounds the catheter 40 and the gas permeable portion 14 is disposed to one side of the catheter, as shown in Figure 4A.
- Open end 16 is sealed, typically by heat sealing, adhesive sealing, lamination, or the like, along a sealing line 44, as shown in Figure 4B, and the EtO is introduced through the gas permeable portion 14, typically by placing the sealed container 10 within a conventional gas sterilizer.
- Other conditions of sterilization will be chosen to be compatible with the nature of the device and/or drug or other potentially labile component on the device.
- the EtO will be removed from the interior of container, typically by vacuum and/or by purging with air, nitrogen, or other inactive gas.
- a desiccant may be placed within the interior of the container and/or a portion of the container, typically the impermeable portion, may contain or be formed of a laminated or otherwise coupled oxygen absorbers or scavenger and/or moisture desiccants.
- the container may be flattened so that the catheter 40 remains in the impermeable portion 12, which is isolated from the permeable portion 14 along a partition line 46.
- the partition line 46 may then be flattened and sealed, as shown in Figure 4D, by conventional methods including heat sealing, adhesive bonding, ultrasonic welding, and the like.
- the permeable portion 14 is then severed from the impermeable portion 12, as shown in Figure 4E.
- the impermeable portion 12 is then ready for transportation and storage prior to use.
- the impermeable portion 12 itself may be placed in further packaging, such as boxes, trays, or the like.
- the impermeable portion 12 of the container 10 can be made from a material with oxygen absorbers or scavengers incorporated therein as well as being coated, including lamination or layer 48 partially or completely with suitable oxygen absorbers or scavengers.
- the presence of the oxygen absorbers or scavengers can remove oxygen gas as it permeates into the container interior 18 containing the sterilized articles (not shown) during processing and during storage.
- the permeable portion 14 of container 10 can be made from a material incorporated with oxygen absorbers or scavengers 50 as well as being coated partially or fully on the interior or exterior surface with a layer (or matrix of oxygen absorbers, scavenger, and/or permeable polymers) 50 or 52 of suitable oxygen absorbers or scavengers.
- the presence of the oxygen absorbers or scavengers can remove oxygen gas within the interior 18 as the gas permeates into the interior during sterilization and during storage. Even if the permeable portion of the enclosure is not eliminated from the path between outside and the drug device, oxygen can be limited from entering the interior 18.
- the container 10 contains oxygen absorbers or scavengers within the interior 18 that may be packaged in its own packet 54 made from oxygen permeable material such as silicone rubber, polystyrene or any polymer that has an oxygen permeability coefficient greater than about 30 cm 3 /100in 2 /day-atm, matrix into a oxygen permeable polymer, or in its original form with or without a oxygen permeable coating.
- oxygen absorbers or scavengers inside the packet 54 absorbs any oxygen gas that may enter the interior 18 during sterilization and storage.
- the container 10 contains a protective sheath 56 made from suitable oxygen absorbers or scavengers that is adjacent to the drug coated device 58.
- the sheath 56 can be made directly from suitable oxygen absorbers or scavengers such as ferrous oxide or ethylene-cyclohexenylmethyl acrylate copolymer, or an oxygen permeable polymer matrix with the oxygen absorber or scavenger.
- suitable oxygen absorbers or scavengers such as ferrous oxide or ethylene-cyclohexenylmethyl acrylate copolymer, or an oxygen permeable polymer matrix with the oxygen absorber or scavenger.
- the protective sheath oxygen absorbers or scavengers inside the enclosure and adjacent to the drug device will locally absorb any oxygen gas that may enter the inner chamber of the container 10 during sterilization and storage and minimize oxygen gas in the vicinity of the drug device.
- Figure 9 illustrates container 10 that is similar to the container shown in Fig. 5 and 6 or has oxygen absorbers or scavengers similar to that shown in Figure 7.
- the container 10 is disposed within the interior of an outer enclosure 34.
- Oxygen absorbers or scavengers are provided in the outer enclosure such as in a packet 60 as shown to reduce the oxygen level within the enclosure 34 to prevent penetration into the interior 18 of the container 10.
- such scavengers can reduce the oxygen level within the interior 18 through the permeable portion of the container since oxygen is freely transported through the permeable portion of the container and that the scavengers attract the oxygen gas.
- desiccants may be placed inside the interior of the outer and/or containers to reduce, maintain and/or control the moisture content of the container.
- the present invention relies upon gas sterilization where the articles to be sterilized are first placed and sealed within a container. At least a portion of the container is gas permeable so that one or more articles within the interior of the container may be sterilized by placing the container in an environment of the sterilizing gas, typically an environment of essentially all ethylene oxide. Once the one or more articles are placed in the interior of the container, the interior may be evacuated to remove ambient gases which may be present. Sterilizing gas is introduced into the container interior through the permeable portion of the container and maintained within the container interior at sufficient levels to sterilize the articles therein.
- an environment of the sterilizing gas typically an environment of essentially all ethylene oxide.
- the interior is preferably evacuated to remove the sterilizing gas, and the container is modified, partitioned, replaced into a secondary enclosure, or otherwise placed in a condition so that further gas exchange between the exterior and interior of the container is inhibited or prevented.
- the method and system of the present invention provide for convenient and effective sterilization of articles using a conventional gas sterilant, and prevent the degradation of the sterilized articles or portions thereof by subsequent exposure to oxygen, water, or other ambient gases.
- EtO sterilization and packaging usually employs five major steps, including: pre-sterilization conditioning, sterilization, evacuation, air wash, and aeration.
- the conditioning step includes placing the one or more articles to be sterilized into the interior of the container, sealing the container and evacuating the gas from the container interior.
- the sterilization step includes introducing the sterilant into the interior of the container by passing a sterilizing gas through the permeable portion of the container, establishing the appropriate operating parameters, such as temperature, pressure, and relative humidity, within the inner chamber and keeping these conditions in the chamber for a pre-determined period of time for effective sterilization of the articles.
- the container may be placed in a sterilization vessel with the atmosphere surrounding the container within the vessel being adjusted to control the procedure.
- the evacuation step after sterilization includes the removal of EtO from the container interior by one or more vacuum washes and/or one or more purges with air or nitrogen, or combinations thereof.
- the container package then undergoes aeration which can be performed in either the sterilization vessel or in a separate aeration chamber.
- the EtO sterilization process embodying features of the present invention is performed at process parameters which are particularly useful and effective in the sterilization of an article which is at least in part formed of a reactive or labile material, such as a therapeutic agent coated on the device, while minimizing adverse effects on the integrity of the reactive or labile material during and post sterilization process.
- a reactive or labile material such as a therapeutic agent coated on the device
- the packaged device sterilized according to the present invention enables enhanced product shelf-life and greater confidence in the integrity and suitability of the sterilized aged device.
- the sterilization step is preferably carried out at a temperature below 30°C. with a dwell time of about 6 to 18 hours or greater. While ethylene oxide is reactive in both liquid and gaseous phase, it is preferred to employ EtO in gaseous phase to increase penetration of the gas into the device/package and its reactivity. Either or both, higher temperature and lower pressure as well as relative humidity can increase gas penetration and/or reactivity.
- the boiling point for ethylene oxide at atmospheric pressure is about
- the temperature of the container interior can be any temperature at which to perform the sterilization step at atmospheric pressure.
- the temperature of the container interior can be any temperature at which to perform the sterilization step at atmospheric pressure.
- the sterilization step can effectively be performed at a temperature of 0°C by reducing the pressure within the container interior to about 4 psi (pounds per square inch).
- Example 1 A drug eluting stent mounted onto the balloon of a stent delivery catheter (a drug eluting stent system) is packaged in a foil pouch that has a permeable portion or patch formed of Tyvek®.
- the pouch is subjected to a vacuum within the inner chamber with a surrounding atmosphere of EtO gas at temperatures of 60°C to sterilize the drug eluting stent and delivery catheter. After sterilization, the pouch is resealed with the stent and delivery system within the post seal area and the Tyvek patch outside the post-seal area.
- Example 2 A drug eluting stent mounted onto the balloon of a stent delivery catheter is packaged in a Tyvek pouch along with ferrous oxide as an oxygen absorber and desiccant. The pouch is closed, subjected to ethylene oxide gas which permeates the pouch. After sterilization, the Tyvek pouch is evacuated and purged with nitrogen and air to remove essentially all EtO and then placed inside a gas impermeable foil pouch. The foil pouch is evacuated by vacuum to remove the remaining air and nitrogen gas, and then finally sealed.
- Example 3 A drug eluting stent crimped onto a PTCA catheter or a drug eluting stent system is packaged on Tyvek pouch along with ferrous oxide oxygen absorbers and desiccant.
- the pouch is sterilized by ethylene oxide gas with sterilization temperatures of about 55°C.
- the sterilized Tyvek pouch with the stent system sealed inside is inserted inside a foil pouch.
- the foil pouch is sealed using a vacuum sealer that first purge the bag with nitrogen gas which replaces the air inside the foil pouch and that finally seal the foil pouch.
- Example 4 A drug eluting stent mounted onto the balloon of a stent delivery catheter is packaged in an essentially gas impermeable foil container that has a Tyvek patch which allows for gas permeability through the gas permeable patch. The pouch is exposed to ethylene oxide gas using the following cycle:
- Example 5 A drug eluting stent mounted onto the balloon of a stent delivery catheter is packaged on foil pouch that has a Tyvek patch (i.e., breathable). The pouch is exposed to ethylene oxide gas using the following cycle:
- Example 6 A drug eluting stent is crimped onto the balloon of a stent delivery catheter.
- a protective sheath made from ethylene-cyclohexenylmethyl acrylate copolymer (an oxygen absorber) is inserted over the drug eluting device.
- the drug eluting stent and delivery catheter is packaged in a Tyvek pouch, the pouch is sealed and then sterilized by ethylene oxide gas at normal sterilization parameters.
- the protective sheath formed of oxygen absorbing polymer material minimizes the oxidative degradation of the drug eluting stent by limiting exposure to oxygen gas.
- the invention has been described herein primarily in terms of packaging medical devices, and in particular to drug eluting stents, it is also suitable for sterilization and packaging of other articles, including foods, pharmaceuticals, diagnostic and assay systems, sensitive electrical components, chemical system components, and the like, where the ability to sterilize articles after initial packaging has been completed is desirable.
- the methods and systems of the present invention are simple to perform, require minimum changes from existing packaging practices, and provide a package to the end user which is as convenient and easy to use as prior packaging systems.
Abstract
Description
Claims
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US11/038,377 US20050268573A1 (en) | 2004-01-20 | 2005-01-19 | Package of sensitive articles |
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