Focused sterilization and sterilized subassemblies 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 an applicator for delivery of a glucose sensor comprising:
 assembling an applicator including:
 providing 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, a mount mated to the shell and having an underside with a mount aperture defined in the underside and 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, a 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, 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, during factory assembly, a proximal end of an applicator cap and a distal end of the applicator housing via a threading engagement, wherein the applicator cap includes a distal end of the applicator cap having a recessed portion extending proximally into an interior of the applicator cap with one or more vents defined in the recessed portion, wherein the applicator cap further includes a cap post located centrally on the recessed portion and extending proximally into the interior of the applicator cap; 
 applying a gas permeable seal on the recessed portion of the applicator cap, 
 wherein the cap post is configured to support the sensor control device within the assembled applicator, wherein the applicator cap, the applicator housing, and the seal define a sterilization chamber with the sensor control device disposed therein; and 
   sterilizing the sensor control device in the sterilization chamber by permeating ethylene oxide into the sterilization chamber via the gas permeable seal and the one or more vents.   
     
     
         2 . The method of  claim 1 , wherein permeating ethylene oxide into the sterilization chamber includes injecting the ethylene oxide through the gas permeable seal and the one or more vents. 
     
     
         3 . The method of  claim 2 , further comprising removing the ethylene oxide through the seal from the sterilization chamber via the one or more vents defined in the distal end of the applicator cap. 
     
     
         4 . The method of  claim 3 , further comprising aerating the sterilization chamber through the seal via the one or more vents defined in the distal end of the applicator cap. 
     
     
         5 . The method of  claim 4 , wherein aerating the sterilization chamber comprises circulating nitrogen gas or filtered air through the sterilization chamber using a series of vacuums. 
     
     
         6 . The method of  claim 1 , further comprising filling one or more voids defined by the sensor control device with a potting material. 
     
     
         7 . The method of  claim 6 , wherein the potting material comprises urethane material. 
     
     
         8 . The method of  claim 6 , wherein the potting material comprises silicone material. 
     
     
         9 . The method of  claim 6 , wherein the potting material comprises acrylate adhesive material. 
     
     
         10 . The method of  claim 1 , further comprising providing 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. 
     
     
         11 . The method of  claim 1 , wherein the one or more vents are covered by the seal prior to injecting the ethylene oxide into the sterilization chamber. 
     
     
         12 . The method of  claim 11 , wherein the seal includes a high-density polyethylene fiber. 
     
     
         13 . The method of  claim 11 , wherein the seal protects the sterilization chamber against moisture and harmful elements. 
     
     
         14 . 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. 
     
     
         15 . The method of  claim 1 , wherein the first and second locations are spaced apart from a center of the electronics housing. 
     
     
         16 . The method of  claim 1 , wherein the distal portion of the applicator cap includes a plurality of integrally formed grip features. 
     
     
         17 . The method of  claim 1 , wherein the applicator further comprises a sheath coupled to the applicator housing and configured to contact the user's skin at a target monitoring location. 
     
     
         18 . The method of  claim 17 , wherein the sheath is collapsible to allow the sensor control device to advance into engagement with the user's skin. 
     
     
         19 . The method of  claim 1 , wherein the distal portion of the sharp is further configured to extend through the shell aperture and configured to penetrate the user's skin to position the distal portion of the glucose sensor into contact with bodily fluid of the user. 
     
     
         20 . The method of  claim 19 , wherein the applicator further comprises a spring biasing the sharp carrier to move towards a proximal end of the applicator housing. 
     
     
         21 . The method of  claim 19 , 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. 
     
     
         22 . The method of  claim 1 , wherein the mount further comprises a plurality of module pockets to partially accommodate the plurality of electronics modules. 
     
     
         23 . The method of  claim 1 , further comprising a plurality of discrete grooves defined at an outer periphery of the mount. 
     
     
         24 . The method 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 method of  claim 24 , wherein the plurality of discrete grooves do not interconnect on the underside of the mount. 
     
     
         26 . The method of  claim 1 , wherein the proximal portion of the glucose sensor is electrically coupled with the plurality of electronic modules on the circuit board.