WO2005073091A2 - Emballage pour articles sensibles - Google Patents

Emballage pour articles sensibles Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
container
gas
interior
permeable
oxygen
Prior art date
Application number
PCT/US2005/002241
Other languages
English (en)
Other versions
WO2005073091A3 (fr
Inventor
John Yan
Original Assignee
Avantec Vascular Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Avantec Vascular Corporation filed Critical Avantec Vascular Corporation
Publication of WO2005073091A2 publication Critical patent/WO2005073091A2/fr
Publication of WO2005073091A3 publication Critical patent/WO2005073091A3/fr

Links

Classifications

    • 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

L'invention concerne le traitement, tel que la stérilisation, ainsi que le conditionnement de dispositifs médicaux et d'autres articles, en particulier de dispositifs et d'articles qui réagissent à des atmosphères contenant de l'oxygène ou de l'humidité. L'emballage stérilisé est constitué d'un réceptacle comportant au moins une partie qui est perméable aux gaz et au moins une partie qui est imperméable aux gaz, ainsi qu'une partie intérieure reliée par voie fluidique à la partie perméable aux gaz. Pour sceller ce réceptacle, il suffit d'appliquer une pièce imperméable sur la partie perméable du réceptacle ou à déposer le réceptacle dans une enceinte constituée d'un matériau imperméable et à sceller l'enceinte. Après que le réceptacle a été exposé à un gaz de stérilisation, la partie perméable aux gaz peut être retirée ou isolée de la partie imperméable aux gaz pour fournir un emballage imperméable aux gaz, permettant de protéger un ou plusieurs articles situés à l'intérieur du réceptacle contre des gaz ambiants et l'humidité ambiante.
PCT/US2005/002241 2004-01-20 2005-01-20 Emballage pour articles sensibles WO2005073091A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US53797204P 2004-01-20 2004-01-20
US60/537,972 2004-01-20
US54082804P 2004-01-29 2004-01-29
US60/540,828 2004-01-29
US11/038,377 2005-01-19
US11/038,377 US20050268573A1 (en) 2004-01-20 2005-01-19 Package of sensitive articles

Publications (2)

Publication Number Publication Date
WO2005073091A2 true WO2005073091A2 (fr) 2005-08-11
WO2005073091A3 WO2005073091A3 (fr) 2005-12-22

Family

ID=34831057

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/002241 WO2005073091A2 (fr) 2004-01-20 2005-01-20 Emballage pour articles sensibles

Country Status (2)

Country Link
US (1) US20050268573A1 (fr)
WO (1) WO2005073091A2 (fr)

Cited By (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007047028A1 (fr) * 2005-10-14 2007-04-26 Atrium Medical Corporation Emballage et sterilisation de dispositifs medicaux
WO2007049076A1 (fr) 2005-10-29 2007-05-03 Medicart International Limited Maintien de la desinfection d’un equipement medical
EP1864909A1 (fr) * 2006-06-06 2007-12-12 Aesculap AG & Co. KG Emballage en cyanoacrylate stérilisé
WO2008091409A1 (fr) * 2007-01-25 2008-07-31 Boston Scientific Limited Endoscope avec endoprothèse préchargée ou pré-chargeable
EP2108381A1 (fr) * 2008-02-07 2009-10-14 Amcor Flexible Healthcare, Inc. Poche à deux compartiments
WO2010000080A1 (fr) * 2008-07-04 2010-01-07 Arik Zucker Stent métallique pour le traitement de lésions dans des vaisseaux sanguins comportant une enveloppe
WO2011013640A1 (fr) 2009-07-31 2011-02-03 マニー株式会社 Sac d'emballage pour fournitures médicales, sac d'emballage contenant des fournitures médicales, et procédé d'emballage de fournitures médicales
EP2425863A1 (fr) * 2010-09-03 2012-03-07 Veriplast Flexible Emballage pour la stérilisation à la vapeur de produits
GB2485377A (en) * 2010-11-11 2012-05-16 Steripack Medical Ltd A peel-open sterilisable pouch
US8784473B2 (en) 2009-09-10 2014-07-22 Boston Scientific Scimed, Inc. Endoprosthesis with filament repositioning or retrieval member and guard structure
EP2651338A4 (fr) * 2010-12-16 2015-07-15 Edwards Lifesciences Corp Systèmes de pose et conditionnement de valvules cardiaques prothétiques
EP2944328A3 (fr) * 2014-04-24 2016-03-09 Schott AG Unité d'emballage pour un objet pharmaceutique, médical ou cosmétique et procédé de stérilisation d'un objet pharmaceutique, médical ou cosmétique pouvant être disposé dans une unité d'emballage
EP3085332A1 (fr) * 2015-04-23 2016-10-26 Sofradim Production Emballage pour une maille chirurgicale
WO2016191535A3 (fr) * 2015-05-27 2017-01-12 Becton, Dickinson And Company Procédé d'emballage permettant la restérilisation de dispositifs médicaux
US9682175B2 (en) 2004-09-28 2017-06-20 Atrium Medical Corporation Coating material and medical device system including same
US9801982B2 (en) 2004-09-28 2017-10-31 Atrium Medical Corporation Implantable barrier device
US9801913B2 (en) 2004-09-28 2017-10-31 Atrium Medical Corporation Barrier layer
US9827352B2 (en) 2004-09-28 2017-11-28 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US9867880B2 (en) 2012-06-13 2018-01-16 Atrium Medical Corporation Cured oil-hydrogel biomaterial compositions for controlled drug delivery
CN109089412A (zh) * 2016-05-23 2018-12-25 百多力股份公司 封装的吸收剂及其短暂激活
US10285964B2 (en) 2009-03-10 2019-05-14 Atrium Medical Corporation Fatty-acid based particles
WO2019099910A1 (fr) * 2017-11-17 2019-05-23 Merit Medical Systems, Inc. Systèmes et procédé de réduction de la dégradation d'éléments médicaux
US10322213B2 (en) 2010-07-16 2019-06-18 Atrium Medical Corporation Compositions and methods for altering the rate of hydrolysis of cured oil-based materials
US10350381B2 (en) 2011-08-29 2019-07-16 Coloplast A/S Closing of flow through catheter
WO2020033234A1 (fr) * 2018-08-09 2020-02-13 Medtronic Vascular, Inc. Techniques et emballages pour emballer des fournitures médicales
US10772995B2 (en) 2004-09-28 2020-09-15 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
WO2020232159A1 (fr) * 2019-05-15 2020-11-19 Medtronic Vascular, Inc. Poches stérilisables pour dispositifs médicaux
US10864304B2 (en) 2009-08-11 2020-12-15 Atrium Medical Corporation Anti-infective antimicrobial-containing biomaterials
US11083823B2 (en) 2005-09-28 2021-08-10 Atrium Medical Corporation Tissue-separating fatty acid adhesion barrier
US11324392B2 (en) 2012-09-26 2022-05-10 Cantel (Uk) Limited Vacuum storage system
US11833037B2 (en) 2007-12-14 2023-12-05 Edwards Lifesciences Corporation Leaflet attachment frame for prosthetic valve

Families Citing this family (92)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060272108A1 (en) * 2005-06-06 2006-12-07 Ruth Stern Method to apply a hair care preparation and kit for same
WO2007011707A2 (fr) 2005-07-15 2007-01-25 Micell Technologies, Inc. Enrobages polymeres renfermant de la poudre de medicament a morphologie commandee
WO2007011708A2 (fr) 2005-07-15 2007-01-25 Micell Technologies, Inc. Stent a revetement polymere renfermant de la rapamycine amorphe
US8394446B2 (en) 2005-07-25 2013-03-12 Abbott Cardiovascular Systems Inc. Methods of providing antioxidants to implantable medical devices
AU2006304590A1 (en) 2005-10-15 2007-04-26 Atrium Medical Corporation Hydrophobic cross-linked gels for bioabsorbable drug carrier coatings
US20070193454A1 (en) * 2006-02-17 2007-08-23 Western Precooling Systems Method and Apparatus for Killing Insects on Fresh Produce
ES2540059T3 (es) 2006-04-26 2015-07-08 Micell Technologies, Inc. Recubrimientos que contienen múltiples fármacos
DE102006027304A1 (de) * 2006-06-06 2007-12-13 Aesculap Ag & Co. Kg Sterilisierte Verpackung, Verfahren zu ihrer Herstellung sowie deren Verwendung in der Medizin
US8613698B2 (en) 2006-07-10 2013-12-24 Mcneil-Ppc, Inc. Resilient device
US10219884B2 (en) * 2006-07-10 2019-03-05 First Quality Hygienic, Inc. Resilient device
US10004584B2 (en) * 2006-07-10 2018-06-26 First Quality Hygienic, Inc. Resilient intravaginal device
US7717892B2 (en) * 2006-07-10 2010-05-18 Mcneil-Ppc, Inc. Method of treating urinary incontinence
JP5490533B2 (ja) 2006-07-10 2014-05-14 マクニール−ピーピーシー・インコーポレイテッド 弾性装置
US8747738B2 (en) * 2006-08-15 2014-06-10 Abbott Cardiovascular Systems Inc. Sterilization methods for medical devices
CA2667228C (fr) 2006-10-23 2015-07-14 Micell Technologies, Inc. Support pour charger electriquement un substrat au cours de l'enduction
US9492596B2 (en) 2006-11-06 2016-11-15 Atrium Medical Corporation Barrier layer with underlying medical device and one or more reinforcing support structures
EP2626091B1 (fr) 2006-11-06 2016-09-28 Atrium Medical Corporation Maille chirurgicale revêtue
EP2111184B1 (fr) 2007-01-08 2018-07-25 Micell Technologies, Inc. Stents comportant des couches biodégradables
US11426494B2 (en) 2007-01-08 2022-08-30 MT Acquisition Holdings LLC Stents having biodegradable layers
KR100794632B1 (ko) * 2007-01-19 2008-01-14 주식회사 에프에스코리아 멸균 포장용기 및 이를 이용한 포장방법
US9433516B2 (en) 2007-04-17 2016-09-06 Micell Technologies, Inc. Stents having controlled elution
AU2008256684B2 (en) * 2007-05-25 2012-06-14 Micell Technologies, Inc. Polymer films for medical device coating
US9216101B2 (en) * 2007-07-10 2015-12-22 Boston Scientific Scime, Inc. Dual taper stent protector
US20090018635A1 (en) * 2007-07-10 2009-01-15 Boston Scientific Scimed, Inc. Stent protector
US20090018633A1 (en) * 2007-07-10 2009-01-15 Boston Scientific Scimed, Inc. Protector for an insertable or implantable medical device
US20090071855A1 (en) * 2007-09-14 2009-03-19 Bahuguna Sumit Packaging for amorphous statins and compositions thereof
AU2009251504B2 (en) 2008-04-17 2013-09-05 Micell Technologies, Inc. Stents having bioabsorbable layers
CN107050490B (zh) 2008-05-05 2020-07-07 3M创新有限公司 灭菌过程验证装置和方法
AU2009270849B2 (en) 2008-07-17 2013-11-21 Micell Technologies, Inc. Drug delivery medical device
WO2011009096A1 (fr) 2009-07-16 2011-01-20 Micell Technologies, Inc. Dispositif médical distributeur de médicament
WO2010054095A1 (fr) * 2008-11-06 2010-05-14 3M Innovative Properties Company Dispositif et procédé de test de processus
EP2350307B1 (fr) 2008-11-06 2016-07-27 3M Innovative Properties Company Dispositif et procédés de mise à l'épreuve de procédé
US8006839B2 (en) * 2008-12-09 2011-08-30 Zimmer, Inc. Method and apparatus for packaging medical devices
US20100158751A1 (en) * 2008-12-24 2010-06-24 Steven Scott Friderich Single use sterilization container
US7942264B2 (en) * 2008-12-24 2011-05-17 Kimberly-Clark Worldwide, Inc. Sterilization container with peel top
US8241587B2 (en) * 2008-12-24 2012-08-14 Kimberly-Clark Worldwide, Inc. Collapsible sterilization container
US8623289B2 (en) 2008-12-24 2014-01-07 Kimberly-Clark Worldwide Inc. Single use sterilization container
US8834913B2 (en) 2008-12-26 2014-09-16 Battelle Memorial Institute Medical implants and methods of making medical implants
US8551454B2 (en) * 2009-03-13 2013-10-08 Luitpold Pharmaceuticals, Inc. Device for intranasal administration
JP2012522589A (ja) 2009-04-01 2012-09-27 ミシェル テクノロジーズ，インコーポレイテッド 被覆ステント
DE102009031447A1 (de) * 2009-07-01 2011-01-05 Manfred Sauer Gmbh Katheter-Set
US9649408B1 (en) 2009-11-05 2017-05-16 Lifecell Corporation Systems and methods for sterilization of bone or bone components
US20140193299A1 (en) * 2009-11-05 2014-07-10 Lifecell Corporation Systems and Methods for Sterilization
ES2640314T3 (es) 2010-01-22 2017-11-02 Allegiance Corporation Métodos para envasar y esterilizar artículos elastoméricos y artículos elastoméricos envasados producidos mediante los mismos
US11369498B2 (en) 2010-02-02 2022-06-28 MT Acquisition Holdings LLC Stent and stent delivery system with improved deliverability
US8795762B2 (en) 2010-03-26 2014-08-05 Battelle Memorial Institute System and method for enhanced electrostatic deposition and surface coatings
FR2958853B1 (fr) * 2010-04-20 2012-07-13 Sartorius Stedim Biotech Sa Emballage biopharmaceutique sterilisable.
US10232092B2 (en) 2010-04-22 2019-03-19 Micell Technologies, Inc. Stents and other devices having extracellular matrix coating
EP2593039B1 (fr) 2010-07-16 2022-11-30 Micell Technologies, Inc. Dispositif médical d'administration de médicament
WO2012016329A1 (fr) * 2010-08-06 2012-02-09 Valorisation-Recherche, Societe En Commandite Procédés de stérilisation au plasma à l'aide d'un matériau d'emballage
NZ607554A (en) 2010-08-30 2015-04-24 Sinusys Corp Devices for dilating a paranasal sinus opening and for treating sinusitis
NL1038265C2 (nl) * 2010-09-24 2012-03-27 Geerts Peter Reiniging en verpakking methode voor schone ruimte producten.
US9096368B2 (en) 2011-01-19 2015-08-04 Boston Scientific Scimed, Inc. Medical device packaging and methods for preparing and packaging medical devices
US9101305B2 (en) * 2011-03-09 2015-08-11 Medtronic Minimed, Inc. Glucose sensor product and related manufacturing and packaging methods
WO2012166819A1 (fr) 2011-05-31 2012-12-06 Micell Technologies, Inc. Système et procédé de formation de revêtement transférable à élution de médicament, libéré dans le temps
CA2841360A1 (fr) 2011-07-15 2013-01-24 Micell Technologies, Inc. Dispositif medical d'administration de medicament
US10188772B2 (en) 2011-10-18 2019-01-29 Micell Technologies, Inc. Drug delivery medical device
US20140262858A1 (en) 2011-10-21 2014-09-18 Ranbaxy Laboratories Limited Packaging for alitretinoin
DE202012001521U1 (de) * 2012-02-15 2012-02-28 Sartorius Stedim Biotech Gmbh Beutelförmige Umverpackung zur Aufnahme von gestapelten Produkten
CA2862297A1 (fr) 2012-02-29 2013-09-06 SinuSys Corporation Dispositifs et methodes pour dilater une ouverture de sinus paranasal et pour traiter la sinusite
US10780228B2 (en) 2012-05-07 2020-09-22 Medline Industries, Inc. Prefilled container systems
DK177651B1 (en) 2012-10-26 2014-02-03 Mbh Internat A S Method of preparing a ready-to-use urinary catheter and a catheter assembly for use in said method
AU2014248508B2 (en) 2013-03-12 2018-11-08 Micell Technologies, Inc. Bioabsorbable biomedical implants
CN107529427A (zh) * 2013-05-10 2018-01-02 竹斯柔公司 榨汁系统
AU2014265460B2 (en) 2013-05-15 2018-10-18 Micell Technologies, Inc. Bioabsorbable biomedical implants
WO2014187779A1 (fr) * 2013-05-24 2014-11-27 Bayer Pharma Aktiengesellschaft Procédé de stérilisation superficielle d'une seringue prête à l'emploi
US9687263B2 (en) 2013-05-30 2017-06-27 SinuSys Corporation Devices and methods for inserting a sinus dilator
US9364588B2 (en) 2014-02-04 2016-06-14 Abbott Cardiovascular Systems Inc. Drug delivery scaffold or stent with a novolimus and lactide based coating such that novolimus has a minimum amount of bonding to the coating
CN111214701A (zh) 2014-08-19 2020-06-02 加利福尼亚大学董事会 用于局部药物递送的植入物及其使用方法
FR3027288B1 (fr) * 2014-10-17 2022-11-04 Aptar Stelmi Sas Procede et dispositif de conditionnement de pieces en elastomere.
WO2016153744A1 (fr) * 2015-03-20 2016-09-29 Juicero, Inc. Cartouches de centrifugeuse
EP3413853B1 (fr) 2016-02-12 2022-11-09 C. R. Bard, Inc. Systèmes d'enveloppe pour kits de dispositifs médicaux
US10537707B2 (en) * 2016-02-12 2020-01-21 C. R. Bard, Inc. Wrap systems for medical device kits
US10543652B2 (en) 2016-03-03 2020-01-28 Fresh Press LLC Press
US20170349313A1 (en) * 2016-06-01 2017-12-07 Centurion Medical Products Corporation Methods for manufacturing non-glass prefilled syringes
JP6185631B2 (ja) * 2016-08-05 2017-08-23 ベクトン・ディキンソン・フランス・エス．エー．エス． 無菌包装体およびこの包装体を用いた殺菌方法
US10321967B2 (en) * 2016-09-27 2019-06-18 Medtronic Vascular, Inc. Pouches with multi-layer walls for improved durability and protection medical devices
JP6490113B2 (ja) * 2017-01-17 2019-03-27 小川産業株式会社 滅菌袋
WO2018142220A2 (fr) * 2017-02-03 2018-08-09 Bee Sight Limited Appareil médical et procédé de stérilisation d'appareil médical
WO2018206286A1 (fr) * 2017-05-09 2018-11-15 Straumann Holding Ag Procédé de fourniture d'un article dentaire
WO2019018290A1 (fr) 2017-07-17 2019-01-24 Admedus Corporation Système d'emballage stérilisé destiné à un cathéter
DE102017121537A1 (de) * 2017-09-18 2019-03-21 Rolf Lenhardt Beutel und Verfahren zur kontaminationsfreien Gefriertrocknung einer Substanz
JP2019058587A (ja) * 2017-09-28 2019-04-18 三井化学株式会社 医療材料又は医療機器用多重袋体及びその製造方法
WO2019090117A1 (fr) 2017-11-03 2019-05-09 The Regents Of The University Of California Procédés d'implantation d'un dispositif dans un cerveau
US11584558B2 (en) 2018-12-12 2023-02-21 Medtronic Vascular, Inc. Shrink-formed package
CN109878907A (zh) * 2019-03-01 2019-06-14 上海韧致医药科技有限公司 一种镁合金支架存储盒及方法
US11338119B2 (en) 2020-03-20 2022-05-24 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11173291B2 (en) 2020-03-20 2021-11-16 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11344526B2 (en) 2020-03-20 2022-05-31 The Regents Of The University Of California Implantable drug delivery devices for localized drug delivery
US11672880B2 (en) * 2020-04-20 2023-06-13 Honeywell Federal Manufacturing & Technologies, Llc Methods and devices for sterilizing medical equipment
DE102021106664A1 (de) 2021-03-18 2022-09-22 Plasmatreat Gmbh Verfahren und vorrichtung zum desinfizieren, insbesondere sterilisieren, verpackter güter
EP4260877A1 (fr) * 2022-04-11 2023-10-18 ELIS ITALIA S.p.A. Emballage de sterilisation et procede de sterilisation correspondant

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1569479A (en) * 1976-04-13 1980-06-18 Cordis Dow Corp Sterile artifical kidney dialyzer package
US4287995A (en) * 1978-11-30 1981-09-08 Mitsubishi Gas Chemical Company, Inc. Container sealing member with oxygen absorbent
US4644586A (en) * 1984-10-25 1987-02-17 Kimberly-Clark Corporation Combination sterilization and infectious waste disposal container
DE3717916A1 (de) * 1987-05-27 1988-12-08 Muenchner Medizin Mechanik Verfahren zum verpacken von sterilisiergut und sterilisierverpackung
EP0380319A1 (fr) * 1989-01-27 1990-08-01 Cmb Foodcan Plc Emballage
EP0513364A1 (fr) * 1990-11-07 1992-11-19 Otsuka Pharmaceutical Factory, Inc. Recipient a plusieurs chambres
EP0633013A1 (fr) * 1993-01-22 1995-01-11 Otsuka Pharmaceutical Factory, Inc. Recipient de stockage d'un medicament en poudre contenant du bicarbonate, et procede de stabilisation dudit medicament
WO1996029362A1 (fr) * 1995-03-21 1996-09-26 W.R. Grace & Co.-Conn. Procedes et compositions d'amelioration de l'amorçage de la desoxygenation
US6132781A (en) * 1998-04-03 2000-10-17 Pactiv Corporation Modified atmosphere package with accelerated reduction of oxygen level in meat compartment
WO2000071334A1 (fr) * 1999-05-20 2000-11-30 Pechiney Emballage Flexible Europe Structures de films contenant des compositions captant l'oxygene et leur procede d'application
US6447826B1 (en) * 1994-09-14 2002-09-10 Sealed Air (Nz) Limited Packaging for meat and foodstuff
WO2004039419A1 (fr) * 2002-10-29 2004-05-13 Millipore Corporation Sac de transfert sterile, autoclavable et dont l'integrite peut etre testee
EP1520795A1 (fr) * 2003-09-30 2005-04-06 CODMAN & SHURTLEFF, INC. Procédé et emballage pour la combinaison d'un médicament et d'un dispositif

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3004325A1 (de) * 1979-02-08 1980-08-14 Mitsubishi Gas Chemical Co Sauerstoffabsorptionsmittel enthaltender beutel und damit versehener behaelterverschluss
US4714595A (en) * 1984-12-27 1987-12-22 Baxter Travenol Laboratories, Inc. Tissue storage system
US5698250A (en) * 1996-04-03 1997-12-16 Tenneco Packaging Inc. Modifield atmosphere package for cut of raw meat
US5944709A (en) * 1996-05-13 1999-08-31 B. Braun Medical, Inc. Flexible, multiple-compartment drug container and method of making and using same
US5868244A (en) * 1997-12-01 1999-02-09 Ethicon, Inc. Microbial barrier vented package for sterile medical devices and method of packaging
US6477826B2 (en) * 2001-01-11 2002-11-12 Sara Lee Corporation Open end spun, cotton/rayon blended yarn
US20030204239A1 (en) * 2002-04-26 2003-10-30 Wenda Carlyle Endovascular stent with a preservative coating

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1569479A (en) * 1976-04-13 1980-06-18 Cordis Dow Corp Sterile artifical kidney dialyzer package
US4287995A (en) * 1978-11-30 1981-09-08 Mitsubishi Gas Chemical Company, Inc. Container sealing member with oxygen absorbent
US4644586A (en) * 1984-10-25 1987-02-17 Kimberly-Clark Corporation Combination sterilization and infectious waste disposal container
DE3717916A1 (de) * 1987-05-27 1988-12-08 Muenchner Medizin Mechanik Verfahren zum verpacken von sterilisiergut und sterilisierverpackung
EP0380319A1 (fr) * 1989-01-27 1990-08-01 Cmb Foodcan Plc Emballage
EP0513364A1 (fr) * 1990-11-07 1992-11-19 Otsuka Pharmaceutical Factory, Inc. Recipient a plusieurs chambres
EP0633013A1 (fr) * 1993-01-22 1995-01-11 Otsuka Pharmaceutical Factory, Inc. Recipient de stockage d'un medicament en poudre contenant du bicarbonate, et procede de stabilisation dudit medicament
US6447826B1 (en) * 1994-09-14 2002-09-10 Sealed Air (Nz) Limited Packaging for meat and foodstuff
WO1996029362A1 (fr) * 1995-03-21 1996-09-26 W.R. Grace & Co.-Conn. Procedes et compositions d'amelioration de l'amorçage de la desoxygenation
US6132781A (en) * 1998-04-03 2000-10-17 Pactiv Corporation Modified atmosphere package with accelerated reduction of oxygen level in meat compartment
WO2000071334A1 (fr) * 1999-05-20 2000-11-30 Pechiney Emballage Flexible Europe Structures de films contenant des compositions captant l'oxygene et leur procede d'application
WO2004039419A1 (fr) * 2002-10-29 2004-05-13 Millipore Corporation Sac de transfert sterile, autoclavable et dont l'integrite peut etre testee
EP1520795A1 (fr) * 2003-09-30 2005-04-06 CODMAN & SHURTLEFF, INC. Procédé et emballage pour la combinaison d'un médicament et d'un dispositif

Cited By (70)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9682175B2 (en) 2004-09-28 2017-06-20 Atrium Medical Corporation Coating material and medical device system including same
US10814043B2 (en) 2004-09-28 2020-10-27 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US9801913B2 (en) 2004-09-28 2017-10-31 Atrium Medical Corporation Barrier layer
US10869902B2 (en) 2004-09-28 2020-12-22 Atrium Medical Corporation Cured gel and method of making
US11793912B2 (en) 2004-09-28 2023-10-24 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US9801982B2 (en) 2004-09-28 2017-10-31 Atrium Medical Corporation Implantable barrier device
US10016465B2 (en) 2004-09-28 2018-07-10 Atrium Medical Corporation Cured gel and method of making
US10772995B2 (en) 2004-09-28 2020-09-15 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US10792312B2 (en) 2004-09-28 2020-10-06 Atrium Medical Corporation Barrier layer
US9827352B2 (en) 2004-09-28 2017-11-28 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US11083823B2 (en) 2005-09-28 2021-08-10 Atrium Medical Corporation Tissue-separating fatty acid adhesion barrier
WO2007047028A1 (fr) * 2005-10-14 2007-04-26 Atrium Medical Corporation Emballage et sterilisation de dispositifs medicaux
WO2007049076A1 (fr) 2005-10-29 2007-05-03 Medicart International Limited Maintien de la desinfection d’un equipement medical
US8747739B2 (en) 2005-10-29 2014-06-10 Medicart International Limited Maintaining disinfection of medical equipment
EP1864909A1 (fr) * 2006-06-06 2007-12-12 Aesculap AG & Co. KG Emballage en cyanoacrylate stérilisé
US9125761B2 (en) 2007-01-25 2015-09-08 Boston Scientific Scimed, Inc. Endoscope with preloaded or preloadable stent
WO2008091409A1 (fr) * 2007-01-25 2008-07-31 Boston Scientific Limited Endoscope avec endoprothèse préchargée ou pré-chargeable
US11850150B2 (en) 2007-12-14 2023-12-26 Edwards Lifesciences Corporation Leaflet attachment frame for prosthetic valve
US11833037B2 (en) 2007-12-14 2023-12-05 Edwards Lifesciences Corporation Leaflet attachment frame for prosthetic valve
US11925551B2 (en) 2007-12-14 2024-03-12 Edwards Lifesciences Corporation Leaflet attachment frame for prosthetic valve
US7631760B2 (en) 2008-02-07 2009-12-15 Amcor Flexibles Healthcare, Inc. Dual compartment pouch
EP2108381A1 (fr) * 2008-02-07 2009-10-14 Amcor Flexible Healthcare, Inc. Poche à deux compartiments
US8584852B2 (en) 2008-07-04 2013-11-19 Qvanteq Ag Metal stent for treating lesions in blood vessels, comprising a packaging
KR101630889B1 (ko) 2008-07-04 2016-06-15 크판테크 아게 패키징을 포함하는, 혈관의 병터를 치료하기 위한 금속 스텐트
EA020197B1 (ru) * 2008-07-04 2014-09-30 Квантек Аг Металлический стент для лечения повреждений в кровеносных сосудах, размещенный в упаковке
JP2011526163A (ja) * 2008-07-04 2011-10-06 クヴァンテック アーゲー 包装物を備える血管病変部治療用金属ステント
KR20110028646A (ko) * 2008-07-04 2011-03-21 크판테크 아게 패키징을 포함하는, 혈관의 병터를 치료하기 위한 금속 스텐트
CH699079A1 (de) * 2008-07-04 2010-01-15 Arik Zucker Anordnung, bestehend aus einem Stent und einer Verpackung.
WO2010000080A1 (fr) * 2008-07-04 2010-01-07 Arik Zucker Stent métallique pour le traitement de lésions dans des vaisseaux sanguins comportant une enveloppe
US11166929B2 (en) 2009-03-10 2021-11-09 Atrium Medical Corporation Fatty-acid based particles
US10285964B2 (en) 2009-03-10 2019-05-14 Atrium Medical Corporation Fatty-acid based particles
US10202215B2 (en) 2009-07-31 2019-02-12 Mani, Inc. Method for packaging medical supplies
EP2460506A4 (fr) * 2009-07-31 2013-10-02 Mani Inc Sac d'emballage pour fournitures médicales, sac d'emballage contenant des fournitures médicales, et procédé d'emballage de fournitures médicales
EP2460506A1 (fr) * 2009-07-31 2012-06-06 Mani, Inc. Sac d'emballage pour fournitures médicales, sac d'emballage contenant des fournitures médicales, et procédé d'emballage de fournitures médicales
WO2011013640A1 (fr) 2009-07-31 2011-02-03 マニー株式会社 Sac d'emballage pour fournitures médicales, sac d'emballage contenant des fournitures médicales, et procédé d'emballage de fournitures médicales
US10864304B2 (en) 2009-08-11 2020-12-15 Atrium Medical Corporation Anti-infective antimicrobial-containing biomaterials
US8784473B2 (en) 2009-09-10 2014-07-22 Boston Scientific Scimed, Inc. Endoprosthesis with filament repositioning or retrieval member and guard structure
US10322213B2 (en) 2010-07-16 2019-06-18 Atrium Medical Corporation Compositions and methods for altering the rate of hydrolysis of cured oil-based materials
US11097035B2 (en) 2010-07-16 2021-08-24 Atrium Medical Corporation Compositions and methods for altering the rate of hydrolysis of cured oil-based materials
EP2425863A1 (fr) * 2010-09-03 2012-03-07 Veriplast Flexible Emballage pour la stérilisation à la vapeur de produits
FR2964370A1 (fr) * 2010-09-03 2012-03-09 Veriplast Flexible Emballage pour la sterilisation a la vapeur de produits
GB2485377A (en) * 2010-11-11 2012-05-16 Steripack Medical Ltd A peel-open sterilisable pouch
US9498317B2 (en) 2010-12-16 2016-11-22 Edwards Lifesciences Corporation Prosthetic heart valve delivery systems and packaging
EP4275735A3 (fr) * 2010-12-16 2024-01-24 Edwards Lifesciences Corporation Systèmes de pose et conditionnement de valvules cardiaques prothétiques
EP2651338A4 (fr) * 2010-12-16 2015-07-15 Edwards Lifesciences Corp Systèmes de pose et conditionnement de valvules cardiaques prothétiques
US11027870B2 (en) 2010-12-16 2021-06-08 Edwards Lifesciences Corporation Prosthetic heart valve delivery systems and packaging
US10350381B2 (en) 2011-08-29 2019-07-16 Coloplast A/S Closing of flow through catheter
US10888617B2 (en) 2012-06-13 2021-01-12 Atrium Medical Corporation Cured oil-hydrogel biomaterial compositions for controlled drug delivery
US9867880B2 (en) 2012-06-13 2018-01-16 Atrium Medical Corporation Cured oil-hydrogel biomaterial compositions for controlled drug delivery
US11324392B2 (en) 2012-09-26 2022-05-10 Cantel (Uk) Limited Vacuum storage system
EP2944328A3 (fr) * 2014-04-24 2016-03-09 Schott AG Unité d'emballage pour un objet pharmaceutique, médical ou cosmétique et procédé de stérilisation d'un objet pharmaceutique, médical ou cosmétique pouvant être disposé dans une unité d'emballage
EP3085332A1 (fr) * 2015-04-23 2016-10-26 Sofradim Production Emballage pour une maille chirurgicale
US10959824B2 (en) 2015-04-23 2021-03-30 Sofradim Production Package for a surgical mesh
US10433944B2 (en) 2015-04-23 2019-10-08 Sofradim Production Package for a surgical mesh
AU2018260861B2 (en) * 2015-05-27 2020-06-11 Becton, Dickinson And Company Packaging method to enable re-sterilization of medical device
AU2016267149B2 (en) * 2015-05-27 2018-11-08 Becton, Dickinson And Company Packaging method to enable re-sterilization of medical device
US10293965B2 (en) 2015-05-27 2019-05-21 Becton, Dickinson And Company Packaging method to enable re-sterilization of medical device
WO2016191535A3 (fr) * 2015-05-27 2017-01-12 Becton, Dickinson And Company Procédé d'emballage permettant la restérilisation de dispositifs médicaux
CN107921154A (zh) * 2015-05-27 2018-04-17 贝克顿·迪金森公司 能使医疗装置再消毒的包装方法
US10710759B2 (en) 2015-05-27 2020-07-14 Becton, Dickinson And Company Packaging method to enable re-sterilization of medical device
CN109089412B (zh) * 2016-05-23 2021-02-02 百多力股份公司 封装的吸收剂及其短暂激活
CN109089412A (zh) * 2016-05-23 2018-12-25 百多力股份公司 封装的吸收剂及其短暂激活
US11160951B2 (en) 2017-11-17 2021-11-02 Merit Medical Systems, Inc. Systems and method for reducing medical component degradation
WO2019099910A1 (fr) * 2017-11-17 2019-05-23 Merit Medical Systems, Inc. Systèmes et procédé de réduction de la dégradation d'éléments médicaux
US11498742B2 (en) 2018-08-09 2022-11-15 Medtronic Vascular, Inc. Techniques and packages for packaging medical supplies
CN112672766B (zh) * 2018-08-09 2023-03-21 美敦力瓦斯科尔勒公司 用于包装医疗用品的技术和包装
WO2020033234A1 (fr) * 2018-08-09 2020-02-13 Medtronic Vascular, Inc. Techniques et emballages pour emballer des fournitures médicales
CN112672766A (zh) * 2018-08-09 2021-04-16 美敦力瓦斯科尔勒公司 用于包装医疗用品的技术和包装
US11691797B2 (en) 2019-05-15 2023-07-04 Medtronic Vascular, Inc. Sterilizable pouches for medical devices
WO2020232159A1 (fr) * 2019-05-15 2020-11-19 Medtronic Vascular, Inc. Poches stérilisables pour dispositifs médicaux

Also Published As

Publication number Publication date
US20050268573A1 (en) 2005-12-08
WO2005073091A3 (fr) 2005-12-22

Similar Documents

Publication Publication Date Title
US20050268573A1 (en) Package of sensitive articles
US20080023346A1 (en) Protected Stent Delivery System and Packaging
US5464580A (en) Process of sterilization
EP0218003B1 (fr) Article pour usage médical stérilisé par radiation et son emballage protecteur
US7762044B2 (en) Packaging for stent delivery systems
JP4610986B2 (ja) 薬剤・装置複合製品用パッケージおよび包装方法
JP4373910B2 (ja) 無菌の物体または消毒されるべき物体の輸送用包装容器
CN107074387B (zh) 自身灭菌包装及其制造和使用方法
JP2004513707A (ja) 滅菌製品または滅菌されるべき製品用の多目的パッケージ
KR20010021958A (ko) 배리어 재료
US20090236253A1 (en) Sterilized package, method for its production, and its use in medicine
WO2007099120A1 (fr) procede et appareil pour steriliser du materiau d'emballage
EP3782809B1 (fr) Film et emballage pour applications d'emballage décontaminable de gaz ou de vapeur et procédé de création d'un emballage décontaminé les utilisant
US20240131815A1 (en) Film and packaging for gas or vapor decontaminable packaging and methods decontaminating packages
JPH03168150A (ja) 放射線滅菌医療用具の製造方法
WO2021206673A1 (fr) Appareil médical et procédé de stérilisation d'appareil médical
WO2019215748A1 (fr) Système et procédé de stérilisation et d'emballage d'un dispositif médical
IE20030044U1 (en) Improved packaging for stent delivery systems
IES20030044A2 (en) Improved packaging for stent delivery systems

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: DE

WWW Wipo information: withdrawn in national office

Country of ref document: DE

122 Ep: pct application non-entry in european phase