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 . An assembly for delivery of a glucose sensor comprising:
 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, and 
 a mount mated to the shell and having an underside with a second aperture defined therein being 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; 
 an adhesive patch attached to the underside of the mount and configured to secure the sensor control device on the user's skin; and 
   an applicator comprising:
 an applicator housing; 
 a sheath coupled to the applicator housing and configured to engage the user's skin at a target monitoring location; 
 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; 
 an applicator cap having a distal end having one or more vents defined therein and a proximal end removably coupled to a distal end of the applicator housing; 
 a seal to occlude the one or more vents on the distal end of the applicator cap, 
 wherein the applicator cap, the applicator housing, and the seal define an interior space with the sensor control device, the sheath, the sharp carrier, and the sharp disposed therein, 
 wherein the interior space includes a sterilization chamber with the electronics housing, the circuit board, the adhesive patch, the sheath, and the sharp carrier exposed in the sterilization chamber, and 
 wherein the one or more vents are configured to allow injection of a sterilizing gas into the sterilization chamber. 
   
     
     
         2 . The assembly 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. 
     
     
         3 . The assembly of  claim 2 , wherein the seal is disposed on the recessed platform. 
     
     
         4 . The assembly of  claim 1 , wherein the one or more vents comprises two vents. 
     
     
         5 . The assembly of  claim 1 , wherein the seal is gas-permeable. 
     
     
         6 . The assembly of  claim 5 , wherein the seal includes a Tyvek material. 
     
     
         7 . The assembly of  claim 5 , wherein the seal protects the sterilization chamber against moisture and harmful elements. 
     
     
         8 . The assembly of  claim 1 , wherein the seal comprises two or more layers. 
     
     
         9 . The assembly of  claim 8 , wherein a first layer of the seal is gas-permeable and a second layer of the seal is vapor and moisture resistant material. 
     
     
         10 . The assembly of  claim 9 , wherein the second layer is configured to prevent ingress of contaminants into the sterilization chamber. 
     
     
         11 . The assembly of  claim 1 , wherein the sterilizing gas includes ethylene oxide. 
     
     
         12 . The assembly of  claim 1 , wherein the applicator further comprises a sealing gasket configured to seal an interface between the applicator housing and the applicator cap. 
     
     
         13 . The assembly of  claim 1 , wherein the applicator further comprises a spring biasing the sharp carrier to move towards a proximal end of the applicator housing. 
     
     
         14 . The assembly of  claim 1 , wherein the proximal end of the applicator cap is removably coupled to the distal end of the applicator housing during factory assembly. 
     
     
         15 . The assembly of  claim 1 , wherein the proximal end of the applicator cap is removably coupled to the distal end of the applicator housing via a threading engagement. 
     
     
         16 . The assembly of  claim 1 , wherein the first and second locations are spaced apart from a center of the electronics housing. 
     
     
         17 . The assembly of  claim 1 , wherein the distal portion of the applicator cap includes a plurality of integrally formed grip features. 
     
     
         18 . The assembly of  claim 1 , wherein the sheath is collapsible to allow the sensor control device to advance into engagement with the user's skin. 
     
     
         19 . The assembly of  claim 1 , wherein the sharp carrier and the sharp are configured to be automatically retracted after the applicator housing is advanced towards the target monitoring location. 
     
     
         20 . The assembly of  claim 1 , wherein the shell defines at least one of a chamfered or angled outer periphery. 
     
     
         21 . The assembly of  claim 1 , wherein the circuit board includes a third aperture aligned with the first aperture and the second aperture. 
     
     
         22 . The assembly of  claim 1 , further comprising an adhesive to secure the shell to the mount. 
     
     
         23 . The assembly of  claim 22 , wherein the adhesive isolates an interior of the electronics housing from outside contamination. 
     
     
         24 . The assembly of  claim 1 , wherein the shell is secured to the mount via snap fit engagement, an interference fit, sonic welding, ultrasonic welding, or mechanical fasteners. 
     
     
         25 . The assembly of  claim 1 , wherein the mount further comprises a plurality of module pockets to partially accommodate the plurality of electronics modules. 
     
     
         26 . The assembly of  claim 1 , further comprising a plurality of discrete grooves defined at an outer periphery of the mount. 
     
     
         27 . The assembly of  claim 26 , wherein the plurality of discrete grooves are on the underside of the mount and extend into a sidewall of the mount. 
     
     
         28 . The assembly of  claim 27 , wherein the plurality of discrete grooves do not interconnect on the underside of the mount. 
     
     
         29 . The assembly of  claim 26 , wherein the plurality of discrete grooves are symmetrically arranged on the underside of the mount.