Method and System for Sterilizing an Analyte Sensor

Abstract

In one aspect, there is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal, and irradiating the packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.

1 . (canceled) 
     
     
         2 . A glucose sensor product comprising:
 a plastic package tray;   a glucose sensor assembly in the plastic package tray, the glucose sensor assembly comprising an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic; and   a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer;   wherein the product is manufactured by a process comprising the steps of:   placing the glucose sensor assembly into the plastic package tray having a sealing surface surrounding an opening;   covering the opening with the microbial barrier material such that the microbial barrier material overlies the sealing surface;   forming a seal between the sealing surface and the microbial barrier material, resulting in a sealed package tray containing the glucose sensor assembly; and   sterilizing the glucose sensor assembly inside the sealed package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while allowing the substances outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.   
     
     
         3 . The glucose sensor product of  claim 2 , wherein the microbial barrier material vents volatile substances that would otherwise degrade the glucose oxidase enzyme. 
     
     
         4 . The glucose sensor product of  claim 3 , wherein:
 the glucose sensor assembly comprises a sensor introducer for the electrochemical sensor, the sensor introducer formed at least in part from a plastic material; and   the microbial barrier material vents volatile substances outgassed from the plastic material.   
     
     
         5 . The glucose sensor product of  claim 2 , wherein the microbial barrier material is composed of high-density polyethylene. 
     
     
         6 . The glucose sensor product of  claim 2 , wherein the glucose sensor assembly is sterilized by applying radiation to the sealed package tray. 
     
     
         7 . A glucose sensor product comprising:
 a plastic package tray;   a glucose sensor assembly in the plastic package tray, the glucose sensor assembly comprising an electrochemical sensor with glucose oxidase enzyme; and   a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the glucose sensor assembly and/or the plastic package tray that would otherwise degrade the glucose oxidase enzyme.   
     
     
         8 . The glucose sensor product of  claim 7 , wherein the microbial barrier material maintains sterility of the glucose sensor assembly while volatile by-products outgassed from the glucose sensor assembly that would otherwise degrade the glucose oxidase enzyme. 
     
     
         9 . The glucose sensor product of  claim 7 , wherein the microbial barrier material maintains sterility of the glucose sensor assembly while volatile by-products outgassed from the plastic package tray that would otherwise degrade the glucose oxidase enzyme. 
     
     
         10 . The glucose sensor product of  claim 7 , wherein the microbial barrier material is composed of high-density polyethylene. 
     
     
         11 . The glucose sensor product of  claim 7 , wherein:
 the glucose sensor assembly is subjected to a sterilization process; and   the microbial barrier material maintains sterility of the glucose sensor assembly while venting volatile substances produced as by-products of the sterilization process.   
     
     
         12 . The glucose sensor product of  claim 11 , wherein the sterilization process applies radiation to the glucose sensor assembly.