Storage package and a method for packaging

Abstract

A storage package ( 1 ) contains a medical device ( 7 ) having a coated surface ( 8 ) which exhibits a reduced friction when wetted with a wetting liquid and a supply of the wetting liquid ( 9 ). The package is adapted such that the coated surface of the medical device is maintained contact with the supply of wetting liquid during storage. A good shelf-life for the medical device is achieved and where the medical device is a urethral catheter the catheter is immediately “ready-for-use” after the package has been opened.

1 . A storage package ( 1 ) which contains a medical device ( 7 ) having a coated surface ( 8 ) which exhibits a reduced friction when wetted with a wetting liquid and a supply of the wetting liquid ( 9 ) characterized in that, during storage, the coated surface ( 8 ) of the medical device ( 7 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         2 . A storage package ( 1 ) as claimed in  claim 1 , wherein the storage package ( 1 ) comprises a container ( 3 ) within which the coated surface ( 8 ) and the wetting liquid ( 9 ) are contained.  
     
     
         3 . A storage package ( 1 ) as claimed in  claim 2 , wherein the container ( 3 ) defines a cavity ( 5 ) which houses the coated surface ( 8 ) and the wetting liquid ( 9 ) is contained in the cavity ( 5 ) in a volume sufficient for the coated surface ( 8 ) to remain constantly wetted thereby during storage.  
     
     
         4 . A storage package ( 1 ) as claimed in  claim 3 , wherein the cavity ( 5 ) is essentially filled with the wetting liquid.  
     
     
         5 . A storage package ( 1 ) as claimed in  claim 3  or  4 , wherein the cavity ( 5 ) encloses the whole of the medical device.  
     
     
         6 . A storage package ( 1 ) as claimed in any one of the claims  2 - 5 , wherein the container ( 3 ) is of a construction which is impermeable or substantially impermeable to the wetting liquid ( 9 ).  
     
     
         7 . A storage package ( 1 ) as claimed in any one of  claims 2  to  6 , wherein the container ( 3 ) is an inner container and that the package further comprises an outer container which encloses the inner container.  
     
     
         8 . A storage package ( 1 ) as claimed in any one of the precedings claims, wherein the surface coating ( 8 ) is provided on a substrate presented by a polyether block amide.  
     
     
         9 . A storage package ( 1 ), comprising a container ( 3 ) which defines a closed cavity ( 5 ), a medical device ( 7 ) positioned in the closed cavity ( 5 ) having a polyether block amide substrate surface ( 8 ) supporting a coating which exhibits a reduced friction when wetted with a wetting liquid, and a volume of the wetting liquid ( 9 ) in the closed cavity ( 5 ) sufficient for the coating to be maintained constantly wetted thereby during storage.  
     
     
         10 . A storage package ( 1 ) as claimed in any one of the preceding claims, wherein during storage, essentially the whole coated surface ( 8 ) of the medical device ( 7 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         11 . A storage package ( 1 ) as claimed in any one of the preceding claims, wherein during storage, essentially the whole of the medical device ( 7 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         12 . A storage package ( 1 ) as claimed in any one of the precedings claims, wherein the surface coating ( 8 ) is provided on a substrate of a material having a melting temperature exceeding 100 ° C., and preferably exceeding 130 ° C.  
     
     
         13 . A storage package ( 1 ) as claimed in  claim 12 , wherein the surface coating ( 8 ) is provided on a substrate of a material from the group polyurethanes, polyether block amides, silicon rubber, elastomeric alloys such as Santoprene® and polyolefin alloys based on polypropylene or SEBS (Styrene Ethylene Butadiene Styrene).  
     
     
         14 . A storage package ( 1 ) according to  claim 12  or  13 , wherein the medical device is steam-sterilised.  
     
     
         15 . A storage package ( 1 ) as claimed in any one of the precedings claims as dependent on  claim 2  or  claim 9 , wherein the container is formed of a material having a melting temperature exceeding 100 ° C., and preferably exceeding 130 ° C.  
     
     
         16 . A storage package ( 1 ) as claimed in  claim 15 , wherein the container is steam-sterilised.  
     
     
         17 . A storage package ( 1 ) as claimed in any one of the precedings claims as dependent on  claim 2  or  claim 9 , wherein the container is impermeable to the wetting liquid.  
     
     
         18 . A storage package ( 1 ) according to any one of the preceding claims, wherein the wetting liquid is steam-sterilised.  
     
     
         19 . A storage package ( 1 ) according to any one of the preceding claims, wherein the wetting liquid ( 9 ) contains an osmolality-increasing agent such as sodium chloride and/or a pharmaceutically active substance.  
     
     
         20 . A ready-to-use urinary catheter assembly comprising a container ( 3 ), said container containing a urinary catheter ( 7 ) having a hydrophilic surface layer ( 8 ) which exhibits a reduced friction when wetted with a wetting liquid and a supply of the wetting liquid ( 9 ) characterized in that, during storage, the whole of the coated surface ( 8 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         21 . A method for sterile packaging of a medical device ( 7 ) having a surface ( 8 ) which exhibits a reduced friction when wetted with a wetting liquid, comprising the following steps: 
 providing a container;    placing the medical device ( 7 ) in the container together with wetting liquid ( 9 ) in such a way that the surface ( 8 ) of the medical device ( 7 ) is maintained in contact with the wetting liquid during storage;    sterilising the medical device and the wetting liquid; and    sealing the container.    
     
     
         22 . The method as claimed in  claim 21 , wherein the medical device and the wetting liquid are sterilised at the same time.  
     
     
         23 . The method as claimed in  claim 21  or  22 , wherein steam-sterilisation is used for sterilising at least one of the medical device and the wetting liquid.  
     
     
         24 . The method as claimed in  claim 21  or  22 , wherein microwave-sterilisation is used for sterilising at least one of the medical device and the wetting liquid.  
     
     
         25 . The method as claimed in any one of the claims  21 - 24 , wherein the sterilisation of the wetting liquid is performed after the sealing of the container.  
     
     
         26 . The method as claimed in any one of the claims  21 - 25 , wherein the sterilisation of the medical device is performed after the sealing of the container.  
     
     
         27 . The method as claimed in any one of the claims  21 - 26 , wherein the volume of wetting liquid ( 9 ) placed in the container ( 3 ) is sufficient for the coated surface ( 8 ) to remain constantly wetted thereby during storage.  
     
     
         28 . The method as claimed in any one of the claims  21 - 27 , wherein the step of placing wetting liquid in the container comprises placing an amount of wetting liquid in the container such that during storage, essentially the whole coated surface ( 8 ) of the medical device ( 7 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         29 . The method as claimed in any one of the claims  21 - 28 , wherein the step of placing wetting liquid in the container comprises placing an amount of wetting liquid in the container such that during storage, essentially the whole the medical device ( 7 ) is constantly maintained in direct contact with said wetting liquid ( 9 ).  
     
     
         30 . The method as claimed in any one of the claims  21 - 29 , wherein the container ( 3 ) is an inner container, comprising the additional step of enclosing the inner container ( 3 ) in an additional outer container.  
     
     
         31 . The method as claimed in any one of the claims  21 - 30 , wherein the surface ( 8 ) which exhibits a reduced friction on the medical device ( 7 ) is provided as a surface coating on a substrate of a material having a melting temperature exceeding 100 ° C., and preferably exceeding 130 ° C.  
     
     
         32 . The method as claimed in  claim 31 , wherein the surface coating ( 8 ) is provided on a substrate of a material from the group polyurethanes, polyether block amides, silicon rubber, elastomeric alloys such as Santoprene® and polyolefin alloys based on polypropylene or SEBS (Styrene Ethylene Butadiene Styrene).  
     
     
         33 . The method as claimed in any one of the claims  21 - 32 , wherein a container being formed of a material being substantially impermeable to the wetting liquid is provided.  
     
     
         34 . The method as claimed in any one of the claims  21 - 33 , wherein a container being formed of a material having a melting temperature exceeding 100 ° C., and preferably exceeding 130 ° C., is provided.  
     
     
         35 . The method as claimed in any one of the claims  21 - 34 , comprising the further step of adding an osmolality-increasing agent, such as sodium chloride and/or a pharmaceutically active substance to the wetting liquid.  
     
     
         36 . The method as claimed in any one of the claims  21 - 35 , wherein the medical device is a urethral catheter and the catheter is immediately “ready-for-use” after the package has been opened.