Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

Abstract

A system includes a sensor applicator, a sensor control device arranged within the sensor applicator and including an electronics housing and a sensor extending from a bottom of the electronics housing, and a cap coupled to one of the sensor applicator and the sensor control device, wherein the cap is removable prior to deploying the sensor control device from the sensor applicator.

What is claimed is: 
     
         1 . A method of assembling a glucose sensor for delivery comprising:
 providing a sensor control device including:
 an electronics housing comprising a shell having an upper surface with a first aperture defined in the upper surface at a first location and a depression defined in the upper surface at a second location spaced apart from the first location, a mount mated to the shell and having an underside with a second aperture defined in the underside and aligned with the first aperture, a circuit board disposed within the electronics housing and including a plurality of electronics modules, a glucose sensor electrically coupled with the circuit board and configured to measure a glucose level, and an adhesive patch attached to the underside of the mount and configured to secure the electronics housing on a user's skin; 
   loading the sensor control device into an applicator housing;   coupling a proximal end of an applicator cap to a distal end of the applicator housing, wherein the applicator cap includes a distal end having one or more vents defined therein;   occluding the one or more vents on the distal end of the applicator cap with a seal,   wherein the applicator cap, the applicator housing, and the seal define an interior space with the sensor control device disposed therein,   wherein the interior space includes a sterilization chamber; and   injecting into the sterilization chamber a sterilizing gas.   
     
     
         2 . The method of  claim 1 , further comprising:
 injecting a sterilizing gas through the seal into the sterilization chamber via the one or more vents defined in the distal end of the applicator cap;   removing the sterilizing gas through the seal from the sterilization chamber via the one or more vents defined in the distal end of the applicator cap; and   aerating the sterilization chamber through the seal via the one or more vents defined in the distal end of the applicator cap.   
     
     
         3 . The method of  claim 2 , wherein aerating the sterilization chamber comprises circulating nitrogen gas or filtered air through the sterilization chamber using a series of vacuums. 
     
     
         4 . The method of  claim 1 , wherein the sterilizing gas includes ethylene oxide. 
     
     
         5 . The method of  claim 1 , wherein the one or more vents are occluded by the seal prior to injecting the sterilizing gas into the sterilization chamber. 
     
     
         6 . The method of  claim 1 , wherein the seal is gas-permeable to the sterilizing gas. 
     
     
         7 . The method of  claim 6 , wherein the seal includes a Tyvek material. 
     
     
         8 . The method of  claim 6 , wherein the seal protects the sterilization chamber against moisture and harmful elements. 
     
     
         9 . The method of  claim 1 , wherein the seal comprises two or more layers. 
     
     
         10 . The method of  claim 9 , wherein a first layer of the seal is gas-permeable and a second layer of the seal is vapor and moisture resistant material. 
     
     
         11 . The method of  claim 9 , wherein the second layer is configured to prevent ingress of contaminants into the sterilization chamber. 
     
     
         12 . The method of  claim 1 , wherein coupling the proximal end of the applicator cap to the distal end of the applicator housing comprises sealing an interface between the applicator housing and the applicator cap using a sealing gasket. 
     
     
         13 . The method of  claim 1 , wherein the distal end of the applicator cap includes a recessed platform, wherein the one or more vents are defined in the recessed platform. 
     
     
         14 . The method of  claim 1 , wherein coupling the proximal end of the applicator cap to the distal end of the applicator housing comprises removably coupling the proximal end of the applicator cap to the distal end of the applicator housing comprises. 
     
     
         15 . The method of  claim 10 , wherein removably coupling the proximal end of the applicator cap to the distal end of the applicator housing comprises rotating the applicator cap relative to the applicator housing to couple a plurality of threads on the proximal end of the applicator cap to a complimentary plurality of threads on the distal end of the applicator housing. 
     
     
         16 . The method of  claim 1 , wherein the one or more vents includes two vents. 
     
     
         17 . The method of  claim 1 , wherein the proximal end of the applicator cap is removably coupled to the distal end of the housing during factory assembly. 
     
     
         18 . The method of  claim 1 , wherein the first and second locations are spaced apart from a center of the electronics housing. 
     
     
         19 . The method of  claim 1 , wherein the distal portion of the applicator cap includes a plurality of integrally formed grip features. 
     
     
         20 . The method of  claim 1 , wherein the applicator further comprises a sheath coupled to the applicator housing and configured to engage the user's skin at a target monitoring location. 
     
     
         21 . The method of  claim 20 , wherein the sheath is collapsible to allow the sensor control device to advance into engagement with the user's skin. 
     
     
         22 . The method of  claim 1 , wherein the applicator further comprises a sharp carrier coupled to a sharp extending through the first aperture and the second aperture, the sharp configured to penetrate the user's skin to position the distal portion of the glucose sensor into contact with bodily fluid of the user. 
     
     
         23 . The method of  claim 22 , wherein the applicator further comprises a spring biasing the sharp carrier to move towards a proximal end of the applicator housing. 
     
     
         24 . The method of  claim 22 , wherein the sharp carrier and the sharp are configured to be automatically retracted after the housing is advanced towards the target monitoring location. 
     
     
         25 . The method of  claim 1 , wherein the circuit board includes a third aperture aligned with the first aperture and the second aperture. 
     
     
         26 . The method of  claim 1 , wherein the mount further comprises a plurality of module pockets to partially accommodate the plurality of electronics modules. 
     
     
         27 . The method of  claim 1 , further comprising a plurality of discrete grooves defined at an outer periphery of the mount. 
     
     
         28 . The method of  claim 27 , wherein the plurality of discrete grooves are on the underside of the mount and extend into a sidewall of the mount. 
     
     
         29 . The method of  claim 28 , wherein the plurality of discrete grooves do not interconnect on the underside of the mount. 
     
     
         30 . The method of  claim 27 , wherein the plurality of discrete grooves are symmetrically arranged on the underside of the mount.