Surface modified devices and sterile packaging therefor

Abstract

A method for sterile packaging of a surface modified implantable device includes irradiating a surface of the device such that the hydrophobicity of the surface is decreased and, optionally, the device is simultaneously sterilized. The surface of the sterile, surface-modified implantable device is then covered in a polar solution to prevent hydrophobic recovery of the surface.

What is claimed is: 
     
         1 . A method of stabilizing a modified polymer surface of a medical implant to reduce reorganization of the surface, the method comprising:
 storing a modified polymer surface of a medical implant immersed in a polar solution, wherein the polymer surface has been modified to increase oxygen containing groups on the modified polymer surface and wherein the modified polymer surface is immersed in the polar solution within three hours of modification.   
     
     
         2 . The method of  claim 1 , wherein the polar solution comprises saline. 
     
     
         3 . The method of  claim 1 , wherein the polar solution comprises a water soluble polymer. 
     
     
         4 . The method of  claim 1 , wherein the polar solution comprises a bioactive molecule. 
     
     
         5 . The method of  claim 1 , further comprising subsequently sterilizing the modified polymer surface and the polar solution. 
     
     
         6 . The method of  claim 5 , wherein the sterilization is performed by low dose gamma radiation. 
     
     
         7 . A method for sterile packaging of a medical device with a modified silicone surface, comprising:
 sterilizing a medical device with a modified silicone surface;   aseptically packaging the medical device in a sterile polar solution and sterile packaging, the packaging containing the polar solution and the medical device.   
     
     
         8 . The method of  claim 7 , wherein the sterilizing of the medical device with the modified silicone surface is performed by exposure to a plasma. 
     
     
         9 . The method of  claim 7 , wherein the aseptically packaging of the medical device is performed within one hour of modification of the silicone surface. 
     
     
         10 . The method of  claim 7 , wherein the sterilization of the medical device reduces pyrogens on the medical device. 
     
     
         11 . The method of  claim 7 , wherein the polar solution comprises water. 
     
     
         12 . The method of  claim 7 , wherein the polar solution comprises saline. 
     
     
         13 . The method of  claim 7 , wherein the polar solution comprises at least one of: a bioactive molecule and a drug. 
     
     
         14 . A system comprising:
 a medical device comprising a sterilized hydrophilic silicone outer surface;   a polar solution, the medical device immersed in the polar solution; and   sterile packaging enclosing the polar solution and medical device.   
     
     
         15 . The system of  claim 14 , wherein the medical device is a catheter. 
     
     
         16 . The system of  claim 14 , wherein the system has been sterilized by low dose gamma radiation. 
     
     
         17 . The system of  claim 14 , wherein the system has not been sterilized by using gamma radiation. 
     
     
         18 . The system of  claim 14 , wherein the polar solution comprises phosphate buffered saline. 
     
     
         19 . The system of  claim 14 , wherein the hydrophilic silicone outer surface comprises oxygen substitutions produced by exposure to a plasma in the presence of oxygen. 
     
     
         20 . The system of  claim 14 , wherein the medical device remains immersed in the polar solution while in the packaging.