Sterilization Methods For Medical Devices

Abstract

Methods of sterilizing medical devices, including implantable medical devices like stents, chemically and with radiation are disclosed. Methods of preparing a sterile, packaged medical device, including a sterile, packaged implantable medical device or stent are disclosed.

1 . A method for preparing a sterilized packaged stent, the method comprising:
 exposing a stent comprising a polymer to radiation to sterilize the stent while the stent is in an uncrimped state; and   packaging the stent.   
     
     
         2 . The method of  claim 1 , wherein the stent is exposed to radiation prior to mounting the stent on a delivery device. 
     
     
         3 . The method of  claim 1 , further comprising coating the stent prior to exposing the stent to radiation. 
     
     
         4 . The method of  claim 1 , further comprising coating the stent, after exposing the stent to radiation, and mounting the coated stent onto a delivery device. 
     
     
         5 . The method of  claim 1 , further comprising performing one or more additional stent processing operations, wherein all of the one or more stent processing operations subsequent to the exposure of the stent to radiation are performed aseptically. 
     
     
         6 . The method of  claim 1 , wherein the sterilization is electron beam sterilization. 
     
     
         7 . A method of preparing a sterilized, packaged stent, the method comprising:
 exposing the stent to a fluid to a cleaning fluid in preparation for a coating operation;   exposing the stent to a sterilizing chemical at ambient temperature;   coating the stent; and   heating the stent after coating, wherein the stent comprises a polymer.   
     
     
         8 . The method of  claim 7 , wherein all processing operations subsequent to the exposure to the sterilizing chemical are executed aseptically. 
     
     
         9 . The method of  claim 7 , further comprising packaging the stent. 
     
     
         10 . The method of  claim 7 , further comprising exposing the stent to radiation of not more than 15 KGy after packaging the stent. 
     
     
         11 . The method of  claim 10 , wherein the radiation is electron beam sterilization. 
     
     
         12 . The method of  claim 7 , wherein all processing operations subsequent to exposing the stent to the cleaning fluid are performed aseptically. 
     
     
         13 . A method of preparing a sterilized, packaged stent, the method comprising:
 exposing the stent to a cleaning fluid in preparation for a coating operation;   coating the stent; and   heating the stent after coating;   mounting the stent onto a delivery device and attaching the mounted stent to a delivery system;   packaging the stent and delivery system; and   exposing the packaged stent and delivery system to radiation of not more than 15 KGy after packaging the stent;   wherein the stent comprises a polymer.