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 shell 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 mount aperture defined therein being aligned with the shell aperture; 
 
 a circuit board disposed within the electronics housing and including a plurality of electronics modules, wherein the circuit board includes a circuit board aperture aligned with the shell aperture and the mount aperture, wherein the plurality of electronic modules include: a data processing unit, a Bluetooth antenna, and a near field communication antenna; 
 the glucose sensor having a proximal portion and a distal portion, wherein the proximal portion is electrically coupled with the circuit board during factory assembly and, wherein the distal portion includes an enzyme and a glucose flux regulating membrane, extends from a bottom of the electronics housing and is configured to extend beneath a user's skin to sense a glucose level in a bodily fluid; 
 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 contact the user's skin at a target monitoring location; 
 a sharp carrier coupled to a sharp, the sharp extending through the shell aperture, the mount aperture, and the circuit board aperture and configured to penetrate the user's skin to position the distal portion of the glucose sensor into contact with the bodily fluid of the user; 
 an applicator cap having a distal end having a recessed portion extending proximally into an interior of the applicator cap with one or more vents defined in the recessed portion and a proximal end removably coupled during factory assembly to a distal end of the applicator housing and via a threading engagement, 
 wherein the applicator cap comprises a cap post located centrally on the recessed portion and extending proximally into the interior of the applicator cap, and configured to support the sensor control device within the applicator; 
 a sealing gasket configured to seal an interface between the applicator housing and the applicator cap when the proximal end of the applicator cap is coupled to the distal end of the applicator housing; 
 a gas permeable seal applied on the recessed portion of the applicator cap, 
 wherein, when the proximal end of the applicator cap is coupled to the distal end of the applicator housing, the applicator cap, the applicator housing, and the seal define a sterilization chamber with the sensor control device, the sheath, and the sharp disposed therein, and 
 wherein the gas permeable seal and the one or more vents are configured to allow permeation of ethylene oxide into the sterilization chamber. 
   
     
     
         2 . The assembly of  claim 1 , wherein the sensor control device further comprises a potting material filling one or more voids defined by the sensor control device. 
     
     
         3 . The assembly of  claim 2 , wherein the potting material comprises a urethane material. 
     
     
         4 . The assembly of  claim 2 , wherein the potting material comprises a silicone material. 
     
     
         5 . The assembly of  claim 2 , wherein the potting material comprises an acrylate adhesive material. 
     
     
         6 . The assembly of  claim 1 , further comprising a tamper evident seal configured to shear when the proximal end of the applicator cap is uncoupled from the distal end of the applicator housing. 
     
     
         7 . The assembly of  claim 1 , wherein the gas permeable seal includes a high-density polyethylene fiber. 
     
     
         8 . The assembly of  claim 1 , wherein the gas permeable seal protects the sterilization chamber against harmful elements. 
     
     
         9 . 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. 
     
     
         10 . The assembly of  claim 1 , wherein the first and second locations are spaced apart from a center of the electronics housing. 
     
     
         11 . The assembly of  claim 1 , wherein the distal portion of the applicator cap includes a plurality of integrally formed grip features. 
     
     
         12 . 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. 
     
     
         13 . The assembly of  claim 1 , wherein the sharp carrier and the sharp are configured to be automatically retracted after the sensor control device is secured on the user's skin. 
     
     
         14 . The assembly of  claim 1 , wherein the shell defines at least one of a chamfered or angled outer periphery. 
     
     
         15 . The assembly of  claim 1 , further comprising an adhesive to secure the shell to the mount. 
     
     
         16 . The assembly of  claim 15 , wherein the adhesive isolates an interior of the electronics housing from outside contamination. 
     
     
         17 . The assembly of  claim 1 , wherein the shell is secured to the mount via snap fit engagement. 
     
     
         18 . The assembly of  claim 1 , wherein the shell is secured to the mount via an interference fit. 
     
     
         19 . The assembly of  claim 1 , wherein the shell is secured to the mount via sonic welding. 
     
     
         20 . The assembly of  claim 1 , wherein the shell is secured to the mount via ultrasonic welding. 
     
     
         21 . The assembly of  claim 1 , wherein the shell is secured to the mount via mechanical fasteners. 
     
     
         22 . The assembly of  claim 1 , wherein the mount further comprises a plurality of module pockets to partially accommodate the plurality of electronics modules. 
     
     
         23 . The assembly of  claim 1 , further comprising a plurality of discrete grooves defined at an outer periphery of the mount. 
     
     
         24 . The assembly of  claim 23 , wherein the plurality of discrete grooves are symmetrically arranged on the underside of the mount and extend into a sidewall of the mount. 
     
     
         25 . The assembly of  claim 24 , wherein the plurality of discrete grooves do not interconnect on the underside of the mount. 
     
     
         26 . The assembly of  claim 1 , wherein the proximal portion of the glucose sensor is electrically coupled with the plurality of electronic modules on the circuit board.