Package of sensitive articles

Abstract

The invention is directed to the treating, e.g. sterilizing and packaging of medical devices and other articles, particularly such devices and articles which are reactive to oxygen or moisture containing atmospheres. The sterilized package has a container which includes at least one portion which is gas permeable and at least one portion which is gas impermeable and an interior in fluid communication with the gas permeable portion. The container may be sealed by applying an impermeable patch to the permeable portion thereof or by disposing the container in an enclosure formed of impermeable material and sealing the enclosure. After exposing the container to a sterilizing gas, the gas permeable portion may be removed or sealed off from the gas impermeable portion of the container in order to provide a package which is gas impermeable and can protect one or more articles within the interior of the container against environmental gases and moisture.

1 . A method for packaging a sterile article, comprising: 
 a. providing a container which has a wall defining at least in part an interior and which has at least one portion permeable to sterilizing gas;    b. placing an article into the interior of the container;    c. exposing at least one permeable portion of the container to an exterior environment which includes a sterilizing gas under conditions such that the sterilizing gas permeates through at least one permeable portion of the container into the interior of the container; and    d. removing sterilizing gas from the interior of the container after the articles therein are sterilized.    
   
   
       2 . The method of  claim 1  wherein the at least one permeable region of the container is sealed after the sterilizing gas is removed from the interior to prevent gas permeation while the article remains in the interior.  
   
   
       3 . A method as in  claim 1 , wherein the sterilizing gas is at least in part ethylene oxide.  
   
   
       4 . A method as in  claim 1 , wherein the sterilizing gas is removed from the interior of the container by applying a vacuum to the interior.  
   
   
       5 . A method as in  claim 1 , wherein the sterilized gas is removed from the interior of the container by purging the interior of the container with a non-active gas.  
   
   
       6 . A method as in  claim 1 , wherein sealing comprises partitioning the container to isolate the article within an impermeable portion of the container interior.  
   
   
       7 . A method as in  claim 6 , further comprising removing the gas permeable portion of the container.  
   
   
       8 . A method as in  claim 1 , wherein sealing comprises deploying the container into an impermeable enclosure.  
   
   
       9 . A method as in  claim 1 , wherein the container is sealed by applying a gas impermeable barrier over the gas permeable portion of the container.  
   
   
       10 . A method as in  claim 1 , wherein the article within the interior of the container is a medical device.  
   
   
       11 . A method as in  claim 10 , wherein the medical device is formed at least in part of a labile material which is degradable in an atmosphere containing oxygen and/or water vapor.  
   
   
       12 . A method as in  claim 10 , wherein the medical device is a stent coated with a therapeutic or diagnostic agent.  
   
   
       13 . A method as in  claim 12  wherein the interior of the container has less than about 150 ppm sterilizing gas or residuals.  
   
   
       14 . A method as in  claim 12  wherein the container interior has about 10 ppm to about 50 ppm sterilizing gas or residuals.  
   
   
       15 . A method as in  claim 1  wherein the sterilizing gas is selected from the group consisting of ethylene oxide, ethylene oxide and nitrogen, ethylene oxide and carbon dioxide, ethylene oxide with one or more chlorofluorocarbon diluents, Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide gas plasma, chlorine dioxide and mixtures thereof.  
   
   
       16 . A sterile packaging system for one or more sterile articles, comprising: 
 a. a container which has a wall, an interior defined at least in part by the container wall and configured to receive at least one article and at least one portion that is permeable to sterilizing gas and is in fluid communication with the interior, and    b. a patch of impermeable material on the permeable portions to prevent permeation of gas into the interior through the permeable portions.    
   
   
       17 . The sterile packaging system as in  claim 16  wherein the container interior is essentially free of sterilizing gas.  
   
   
       18 . The sterile packaging system as in  claim 16  wherein the container interior has less than about 150 ppm sterilizing gas or residuals.  
   
   
       19 . The sterile packaging system as in  claim 16  wherein the sterilizing gas is selected from the group consisting of ethylene oxide, ethylene oxide and nitrogen, ethylene oxide and carbon dioxide, ethylene oxide with one or more chlorofluorocarbon diluents, Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide gas plasma, chlorine dioxide and mixtures thereof.  
   
   
       20 . A system as in  claim 16 , wherein the at least one gas permeable portion is formed of material which is impermeable to liquid.  
   
   
       21 . A system as in  claim 16 , wherein the at least one gas permeable portion is at least in part formed of a spun olefin.  
   
   
       22 . A system as in  claim 16 , wherein the patch sealing the permeable portion is formed of a material which is moisture and gas impermeable and is non-transmissive for light and UV radiation.  
   
   
       23 . A system as in  claim 16 , wherein the sealing patch is part of a gas impermeable enclosure which receives the container.  
   
   
       24 . The system of  claim 23  wherein the impermeable enclosure is sealed about the container to isolate the container from an atmosphere containing oxygen and moisture.  
   
   
       25 . A system as in  claim 23 , wherein the enclosure is formed of a polymer film which is impermeable to oxygen and moisture.  
   
   
       26 . A system as in  claim 16 , wherein the container has a first portion which is impermeable to gas and a second portion which is permeable to gas, and wherein the first portion impermeable to gas contains the one or more articles and the second portion permeable to gas is sealed from the first portion by a partition line which can be selectively adhered to isolate the portion of the interior of the container within the gas impermeable portion from the inner portion of the gas permeable portion.  
   
   
       27 . A system as in  claim 16 , wherein the enclosure receiving the container is a pouch having a sealable open end and a receptacle portion formed from a non-gas permeable material and wherein the gas permeable portion lies between the receptacle portion and the open end and a partition line lies between the gas permeable portion and the receptacle portion.  
   
   
       28 . The system of  claim 16  wherein the container has oxygen absorbers or scavengers.  
   
   
       29 . The system of  claim 28  wherein oxygen absorbers or scavengers are provided in fluid communication with the interior of the container.  
   
   
       30 . The system of  claim 28  wherein the oxygen absorbers or scavengers are inside the permeable portion of the container.  
   
   
       31 . The system of  claim 28  wherein an oxygen absorber is incorporated into or coated on the permeable portion of the container.  
   
   
       32 . The system of  claim 28  wherein an oxygen absorber is incorporated into or coated on the impermeable portion of the container.  
   
   
       33 . The system of  claim 28  wherein the oxygen absorber is coated onto an interior surface of the container.  
   
   
       34 . The system of  claim 28  wherein the oxygen absorber is coated onto an exterior surface of the container.  
   
   
       35 . The system of  claim 28  wherein the oxygen absorber is selected from the group consisting of ethylene-cyclohexenylmethyl acrylate copolymer and ethylene-methylacrylate-cyclohexeneylmethyl acrylate terpolymer.  
   
   
       36 . The system of  claim 28  wherein the oxygen scavenger is selected from the group of materials consisting of ethylenically unsaturated polymers, ferrous oxide, titanium oxide, activated carbon with sodium ascorbate, diethylhydroxylamine, carbohydrazide, combinations of these materials.  
   
   
       37 . The system of  claim 28  wherein the oxygen absorbers or scavengers are packaged in a packet made from oxygen permeable material that has an oxygen permeability coefficient greater than 30 cm 3 /100 in 2 /day-atm.  
   
   
       38 . The system of  claim 28  wherein the oxygen absorbers or scavengers are packaged in a packet made from oxygen permeable material that has an oxygen Permeability Coefficient greater than 100 cm 3 /100 in 2 /day-atm.  
   
   
       39 . The system of  claim 28  wherein the oxygen absorbers or scavengers are packaged in a packet made from oxygen permeable material that has an oxygen permeability coefficient greater than about 300 cm 3 /100 in 2 /day-atm.  
   
   
       40 . The system of  claim 28  wherein the oxygen absorbers or scavengers are incorporated into a protective sheath that is disposed proximate to the sterilized medical device.  
   
   
       41 . A sterilized package, comprising: 
 a. a sealed container which has an interior defined at least in part by a wall, which has at least a portion permeable to sterilizing gas and which has at least one sterilized article within the interior; and    b. an atmosphere within the interior of the container which is substantially free of sterilizing gas.    
   
   
       42 . The sterilized package of  claim 41  wherein the container portion permeable to sterilizing gas is sealed to prevent penetration of non-sterilizing gas exterior to the container into the interior of the container.  
   
   
       43 . The sterilized package of  claim 41  wherein an oxygen scavenger is maintained in fluid communication with the interior of the container.  
   
   
       44 . The sterilized package of  claim 43  wherein the oxygen scavenger is in particulate form.  
   
   
       45 . The sterilized package of  claim 43  wherein the oxygen scavenger is incorporated within at least part of a wall defining the interior of the container.  
   
   
       46 . The sterilized package of  claim 41  wherein the container is sealed by disposing the container in a gas impermeable enclosure.  
   
   
       47 . The sterilized package of  claim 46  wherein the gas impermeable enclosure is formed at least in part of a polymer which is impermeable to vapor and moisture.  
   
   
       48 . The sterilized package of  claim 41  wherein the at least one article is a drug eluting stent.  
   
   
       49 . The sterilized package of  claim 48  wherein the stent is coated with a drug that is degraded by oxygen and/or water vapor.  
   
   
       50 . The sterilized package of  claim 48  wherein the stent is mounted on a balloon of a delivery catheter.  
   
   
       51 . The sterilized package of  claim 41  wherein the atmosphere within the container interior has less than about 150 ppm sterilizing gas or residuals.  
   
   
       52 . A method of packaging and treating an article, comprising: 
 a. providing a container which has an interior defined at least in part by a wall, which has a portion permeable to treating gas and which has a article to be treated disposed within the interior of the container;    b. surrounding the permeable portion of the container with a treating gas under conditions which facilitate permeation of the treating gas through the permeable portion of the container into the container interior to treat the article disposed therein; and    c. removing treating gas from the inner chamber after the article has been treated.    
   
   
       53 . The method of  claim 52  wherein treating gas is removed from the interior of the container by purging the interior with innocuous gas.  
   
   
       54 . The method of  claim 53  wherein the container interior is purged with innocuous gas until substantially free of treating gas.  
   
   
       55 . The method of  claim 53  wherein the container interior has less than about 150 ppm treating gas or residuals.  
   
   
       56 . The method of  claim 54  wherein the permeable portion is sealed after the container interior is purged with innocuous gas.  
   
   
       57 . The method of  claim 52  wherein the article is a medical device.  
   
   
       58 . The method of  claim 57  wherein the medical device is a delivery catheter with an inflatable balloon and a drug eluting stent mounted on the balloon.  
   
   
       59 . The method of packaging and sterilizing a medical device as in  claim 52  wherein the sterilizing gas is removed from the container interior until essentially free of sterilizing gas.  
   
   
       60 . The method of packaging and sterilizing a medical device as in  claim 52  wherein the sterilizing gas is removed from the container interior until the interior has less than about 150 ppm sterilizing gas or residuals.  
   
   
       61 . A method of packaging and sterilizing a medical device as in  claim 52  wherein the sterilizing gas is selected from the group consisting of ethylene oxide, ethylene oxide and nitrogen, ethylene oxide and carbon dioxide, ethylene oxide with one or more chlorofluorocarbon diluents, Oxyfume 2000 series of sterilant, ozone, hydrogen peroxide gas plasma, chlorine dioxide and mixtures thereof.  
   
   
       62 . A treated package, comprising: 
 a. a sealed container which has an interior defined at least in part by a wall, which has at least a portion permeable to treating gas and which has at least one treated article within the interior; and    b. an atmosphere within the interior of the container which is substantially free of treating gas.    
   
   
       63 . A method for packaging one or more treated articles, comprising: 
 a. providing a container which has a wall defining at least in part an interior and which has at least one portion permeable to treating gas;    b. placing one or more articles into the interior of the container;    c. exposing at least one permeable portion of the container to an exterior environment which includes a treating gas under conditions such that the treating gas permeates through at least one permeable portion of the container into the interior of the container; and    d. removing treating gas from the interior of the container after the articles therein are treated.    
   
   
       64 . A packaging system for one or more treated articles, comprising a container which has a wall, an interior defined at least in part by the container wall and configured to receive at least one article and a treating gas permeable means in fluid communication with the interior.  
   
   
       65 . The packaging system of  claim 64  wherein a patch of impermeable material covers at least part of the permeable means to prevent permeation of gas into the interior.  
   
   
       66 . A method for packaging one or more treated articles, comprising: 
 a. a step of providing a container which has a wall defining at least in part an interior and which has at least one portion permeable to treating gas;    b. a step of placing one or more articles into the interior of the container; and    c. a step of exposing at least one permeable portion of the container to an exterior environment which includes a treating gas under conditions such that the treating gas permeates through at least one permeable portion of the container into the interior of the container.    
   
   
       67 . The method of  claim 66  including the step of removing treating gas from the interior of the container after the articles therein are treated.