Method of fusing a component to a medical storage or transfer device and container assembly

Abstract

A method of fusing a component to a sterilized storage or delivery device formed of a cyclic olefin polymer which includes forming the storage or delivery device from a cyclic olefin polymer, forming a second member or component having at least a surface layer formed of the second polymer, wherein the Hansen relative energy distance Ra/Ro of the second polymer relative to the cyclic olefin polymer is equal to or less than 0.7, applying the second member to the storage or delivery device, and heating the assembly to the sterilization temperature, thereby causing the second polymer to chemically interact with the cyclic olefin polymer, fusing the second component to the storage or delivery device. The preferred embodiment of the invention is a medical container, such as a vial, wherein the vial is formed of a cyclic olefin polymer and the cap, closure or collar is formed of a second polymer heat fused to the vial or container.

1 . A method of fusing a second member to a sterilized or subsequently sterilized storage or delivery device formed of a cyclic olefin polymer, comprising the following steps: 
 forming said storage or delivery device from a cyclic olefin polymer;    forming a second member having a surface layer formed of a second polymer wherein the relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is equal to or less than 0.7;    applying said second member to said storage or delivery device wherein said surface layer contacts said storage device; and    heating said storage or delivery device to the sterilization temperature of said cyclic olefin polymer, thereby causing said second polymer to chemically interact with said cyclic olefin polymer, fusing said second member to said storage or delivery device.    
     
     
         2 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 1 , wherein said method includes selecting said second polymer from the group consisting essentially of butyl rubber, nitrile butadiene and isoprene elastomer.  
     
     
         3 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 1 , wherein said method includes forming said member from said second polymer.  
     
     
         4 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 1 , wherein said method includes forming in the form of a container from a cyclic polyolefin polymer having an open end, forming said second member in the form of a closure from said second polymer, applying said closure over said open end of said container, and heating said container and said closure to the sterilization temperature of said cyclic olefin polymer, thereby fusing said closure to said open end of said container and sealing said container.  
     
     
         5 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 4 , wherein said method includes forming said second member from said second polymer in the form of a cup-shaped cap having a tubular rim portion, disposing said cup-shaped cap over said container open end having a rim portion surrounding said open end and said container rim portion having a diameter generally equal to said tubular rim portion of said cap and heating said container and said cup-shaped cap to the sterilization temperature thereof, thereby fusing said tubular rim portion of said cap to said rim portion of said container.  
     
     
         6 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 1 , wherein said method includes forming said second member in the form of a label having an adhesive layer of said second polymer, applying said label to said storage or delivery device wherein said adhesive layer is contacting said storage or delivery device and heating said storage or delivery device and said label to said sterilization temperature, fusing said label to said storage or delivery device.  
     
     
         7 . The method of fusing a second member to a sterilizable storage or delivery device as defined in  claim 1 , wherein said method includes forming said second member of a second polymer wherein the relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is 0.3 to 0.5.  
     
     
         8 . A method of forming a sealed sterilized container, comprising the following steps: 
 forming a container having an open end and a closed end from a cyclic olefin polymer;    forming a closure configured to be received on said open end of said container from a second polymer, wherein the relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is equal to or less than 0.7;    applying said closure on said open end of said container in contact with said container; and    heating said container and said closure to the sterilization temperature of said cyclic olefin polymer and said second polymer, thereby causing said second polymer of said closure to chemically interact with said cyclic olefin polymer and fusing said closure to said container, sealing said container.    
     
     
         9 . The method of forming a sealed sterilized container as defined in  claim 8 , wherein said method includes forming said container from said cyclic olefin polymer having a rim portion surrounding said open end, forming a cup-shaped closure from said second polymer having a closed end portion and an integral tubular rim portion, disposing said cup-shaped closure over said rim portion of said container with said rim portion of said closure contacting said rim portion of said container and heating said container and said closure to the sterilization temperature thereof, fusing said rim portion of said closure to said rim portion of said container.  
     
     
         10 . The method of forming a sealed sterilized container as defined in  claim 8 , wherein said method includes forming said closure from said second polymer, wherein the relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is equal to or less than about 0.5.  
     
     
         11 . The method of forming a sealed sterilized container as defined in  claim 8 , wherein said method includes forming said closure from a polymer selected from the group consisting essentially of butyl rubber, nitrile butadiene and an isoprene elastomer.  
     
     
         12 . The method of forming a sealed sterilized container as defined in  claim 8 , wherein said method includes adding a medicament, drug or vaccine to said container prior to applying said closure on said open end of said container.  
     
     
         13 . The method of forming a sealed sterilized container as defined in  claim 8 , wherein said method includes heating said container and said closure to said sterilization temperature by autoclaving or via heating with no or little humidity.  
     
     
         14 . A sealed sterilized container and closure assembly, comprising: 
 a container having an open end and a closed end formed of a cyclic olefin polymer,    a closure received over said open end of said container and heat fused to said container open end, sealing said container, formed of a second polymer, wherein the relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is equal to or less than 0.7.    
     
     
         15 . The sealed sterilized container and closure assembly as defined in  claim 14 , wherein said second polymer of said closure is selected from the group consisting essentially of butyl rubber, nitrile butadiene and isoprene elastomer.  
     
     
         16 . The sealed sterilized container and closure assembly as defined in  claim 14 , wherein said relative energy distance Ra/Ro of said second polymer relative to said cyclic olefin polymer is equal to or less than 0.5.  
     
     
         17 . The sealed sterilized container and closure assembly as defined in  claim 14 , wherein said container includes an annular rim portion surrounding said open end having a generally cylindrical outer surface, said closure being cup-shaped having a closed end portion and a tubular rim portion having a diameter generally equal to the diameter of said container rim portion, and said closure rim portion heat fused to said container rim portion outer surface.  
     
     
         18 . The sealed sterilized container and closure assembly as defined in  claim 17 , wherein said closure closed end portion is heat sealed to said container open end.