US2014348703A1PendingUtilityA1

Method and System for Sterilizing an Analyte Sensor

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Assignee: ABBOTT DIABETES CARE INCPriority: Apr 10, 2008Filed: Aug 11, 2014Published: Nov 27, 2014
Est. expiryApr 10, 2028(~1.7 yrs left)· nominal 20-yr term from priority
Inventors:Christopher A. ThomasJasmin Y. Zhao
A61B 2560/0209A61B 2562/12B65B 5/04A61L 2/206A61M 5/003B65B 55/08B65D 65/38A61L 2/20A61L 2/087A61B 2562/125B65D 77/26A61B 50/39A61B 5/14865A61L 2/08A61B 2560/0252A61L 2202/14B65B 55/10B65B 7/16B65B 55/16A61B 90/70B65B 55/18A61B 5/14532A61L 2103/15
53
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of sterilization, comprising:
 packaging a glucose sensor assembly including a glucose sensor and a sensor introducer in a first tray;   packaging the first tray in a second tray that includes at least one glucose sensor assembly;   irradiating the second tray including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation; and   exposing a medical device assembly including sensor electronics to a chemical solution for a predetermined time period to sterilize the medical device assembly.   
     
     
         2 . The method of  claim 1 , wherein the chemical solution is a gaseous solution. 
     
     
         3 . The method of  claim 1 , further comprising sealing the first tray with a cover, wherein the first tray includes thermoformed plastic. 
     
     
         4 . The method of  claim 3 , wherein the cover includes aluminum. 
     
     
         5 . The method of  claim 3 , wherein the cover and the first tray form a seal with an adhesive material disposed therebetween. 
     
     
         6 . The method of  claim 1 , wherein the packaged glucose sensor assembly is irradiated at a surface dosage of between 25 kGy and 60 kGy. 
     
     
         7 . The method of  claim 1 , wherein the irradiation of the packaged glucose sensor assembly and the exposure of the medical device assembly to the chemical solution results in a 10 −6  sterility assurance level for both of the assemblies. 
     
     
         8 . The method of  claim 1 , wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least six months. 
     
     
         9 . The method of  claim 1 , wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least 18 months. 
     
     
         10 . The method of  claim 1 , wherein an enzyme layer comprises a mediator. 
     
     
         11 . The method of  claim 10 , wherein the enzyme layer comprises a redox polymer. 
     
     
         12 . The method of  claim 11 , wherein the redox polymer comprises an osmium-containing polymer. 
     
     
         13 . The method of  claim 1 , wherein a glucose diffusion limiting layer comprises a polymer. 
     
     
         14 . The method of  claim 1 , wherein the glucose sensor comprises a planar substrate on which at least one electrode is positioned. 
     
     
         15 . The method of  claim 2 , wherein the gaseous solution includes one of ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxide. 
     
     
         16 . The method of  claim 1 , wherein the packaged glucose sensor assembly is irradiated using at least one electron beam accelerator. 
     
     
         17 . The method of  claim 1 , wherein the medical device assembly is exposed to the chemical solution in an environment with a predetermined temperature. 
     
     
         18 . The method of  claim 17 , wherein the environment has a predetermined humidity. 
     
     
         19 . The method of  claim 18 , wherein a second predetermined time period is determined based on at least one of the predetermined temperature and the predetermined humidity of the environment, and wherein the chemical solution has a predetermined concentration. 
     
     
         20 . The method of  claim 1 , further comprising packaging the medical device assembly and the glucose sensor assembly in a kit. 
     
     
         21 . The method of  claim 1 , wherein the medical device assembly includes a sensor delivery unit. 
     
     
         22 . The method of  claim 1 , wherein the medical device assembly includes an adhesive for adhering the sensor electronics assembly to a skin surface. 
     
     
         23 . The method of  claim 1 , wherein the glucose sensor assembly includes a desiccant. 
     
     
         24 . A method of sterilization, comprising:
 packaging a glucose sensor assembly including a glucose sensor and a sensor introducer in a first tray;   packaging the first tray in a second tray that includes at least one glucose sensor assembly; and   irradiating the second tray including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation.   
     
     
         25 . The method of  claim 24 , wherein packaging the glucose sensor assembly in the first tray includes sealing the first tray including thermoformed plastic with a cover. 
     
     
         26 . The method of  claim 25 , wherein the cover includes foil. 
     
     
         27 . The method of  claim 25 , wherein the cover and the first tray form a seal with an adhesive material disposed therebetween. 
     
     
         28 . The method of  claim 24 , wherein irradiating the second tray includes irradiating at a surface dosage of between 25 kGy and 60 kGy. 
     
     
         29 . The method of  claim 24 , wherein irradiating the second tray including a predetermined number of glucose sensor assemblies results in a 10 −6  sterility assurance level. 
     
     
         30 . The method of  claim 24 , wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least six months. 
     
     
         31 . The method of  claim 24 , wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least 18 months. 
     
     
         32 . The method of  claim 24 , wherein an enzyme layer comprises a mediator. 
     
     
         33 . The method of  claim 32 , wherein the enzyme layer comprises a redox polymer. 
     
     
         34 . The method of  claim 33 , wherein the redox polymer comprises an osmium-containing polymer. 
     
     
         35 . The method of  claim 24 , wherein a glucose diffusion limiting layer comprises a polymer. 
     
     
         36 . The method of  claim 24 , wherein the packaged glucose sensor assembly is irradiated using an electron beam accelerator. 
     
     
         37 . The method of  claim 24 , wherein the glucose sensor assembly includes a desiccant. 
     
     
         38 . The method of  claim 24 , further comprising:
 assembling a medical device assembly including sensor electronics; and   packaging a sterilized glucose sensor assembly with the medical device assembly.   
     
     
         39 . The method of  claim 38 , wherein the medical device assembly includes a sensor delivery unit.

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