Sensor assembly apparatus and methods for continuous glucose monitors

Abstract

In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (1) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (2) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (3) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. Numerous other aspects are provided.

1 . A sensor assembly for a continuous glucose monitoring system, comprising:
 a sensor unit, comprising:
 a sensor housing comprising a first opening and a second opening; 
 a conductive member extending through the first opening; 
 a sensor extending through the second opening; and 
 a sterilized region within the sensor housing, wherein the sensor is within the sterilized region and the conductive member is outside of the sterilized region; and 
   a sensor carrier, comprising:
 a sensor unit receiving area for receiving the sensor unit; and 
 an electronics receiving area for electrically connecting to the conductive member of the sensor unit. 
   
     
     
         2 . The sensor assembly of  claim 1 , wherein the sensor unit further comprises:
 an introducer comprising a handle and an insertion shaft,   wherein the insertion shaft extends through the second opening and is within the sterilized region.   
     
     
         3 . The sensor assembly of  claim 2 ,
 wherein the handle is sealed against a bottom of the sensor housing, and   wherein the sensor unit further comprises an insertion shaft cover sealed against a top of the sensor housing,   wherein the handle and the insertion shaft cover form a sealed region within the sensor housing, the sealed region comprising the sterilized region.   
     
     
         4 . The sensor assembly of  claim 1 , wherein the sensor housing further comprises:
 a top member, a bottom member, and a spacer pad disposed between the top member and the bottom member,   wherein the second opening extends from the bottom member through the spacer pad and to the top member, and   wherein the first opening extends from the bottom member to the spacer pad.   
     
     
         5 . The sensor assembly of  claim 4 ,
 wherein the sensor unit further comprises a cylindrical member extending through the second opening between the top member and the bottom member, and   wherein the sensor is received with in the cylindrical member.   
     
     
         6 . The sensor assembly of  claim 5 , wherein the sensor carrier comprises a third opening through which the cylindrical member passes when the sensor unit is positioned within the sensor unit receiving area. 
     
     
         7 . The sensor assembly of  claim 1 ,
 wherein the sensor carrier further comprises a top carrier member coupled to a bottom carrier member to define the electronics receiving area.   
     
     
         8 . The sensor assembly of  claim 1 , wherein the first opening is opposite the second opening in the sensor housing. 
     
     
         9 . An insertion device for a sensor assembly in a continuous glucose monitoring system, comprising:
 an insertion unit for receiving the sensor assembly therein,   wherein the sensor assembly comprises:
 a sensor unit, comprising:
 a sensor housing comprising a first opening and a second opening; 
 a conductive member extending through the first opening; 
 a sensor extending through the second opening; 
 an insertion shaft extending through the second opening; and 
 a sterilized region comprising the sensor and the insertion shaft, 
 wherein the conductive member is positioned outside of the sterilized region; and 
 
 a sensor carrier coupled to the sensor unit, the sensor carrier comprising a substrate in electrical contact with the conductive member; and 
   a removable cover configured to engage with the insertion unit,   wherein removal of the removable cover from the insertion unit exposes the sensor and the insertion shaft.   
     
     
         10 . The insertion device of  claim 9 , wherein the sensor unit further comprises an insertion shaft cover that covers the sensor and the insertion shaft and is sealed against the second opening. 
     
     
         11 . The insertion device of  claim 10 , wherein the removable cover comprises an interface unit configured to remove the insertion shaft cover so as to expose the sensor and the insertion shaft when the removable cover is removed from the insertion unit. 
     
     
         12 . The insertion device of  claim 11 , wherein the interface unit comprises one or more fingers that engage with guide channels on the insertion shaft cover. 
     
     
         13 . The insertion device of  claim 10 ,
 wherein the removable cover is a peelable cover, and   wherein the peelable cover is coupled to the insertion shaft cover via a strap member,   wherein, when the peelable cover is removed, the strap member detaches the insertion shaft cover to expose the sensor and the insertion shaft.   
     
     
         14 . The insertion device of  claim 9 ,
 wherein the insertion unit comprises external threads, and   wherein the removable cover comprises internal threads that engage with the external threads.   
     
     
         15 . A continuous glucose monitoring system, comprising:
 an insertion device comprising an insertion unit having a peelable cover formed thereon; and   a sensor assembly received within the insertion unit, the sensor assembly comprising:
 a sensor unit, comprising:
 a sensor housing comprising a first opening and a second opening; 
 a conductive member extending through the first opening; 
 a sensor extending through the second opening; 
 an insertion shaft extending through the second opening; 
 an insertion shaft cover covering the sensor and the insertion shaft, 
 wherein the insertion shaft cover is coupled to the peelable cover via a strap, and 
 wherein removal of the peelable cover removes the insertion shaft to expose the sensor and the insertion shaft; and 
 a sterilized region comprising the sensor and the insertion shaft; and 
 
 a sensor carrier coupled to the sensor unit, the sensor carrier comprising a substrate in electrical contact with the conductive member. 
   
     
     
         16 . The continuous glucose monitoring system of  claim 15 , wherein the conductive member makes electrical contact with the conductive member outside of the sterilized region. 
     
     
         17 . The continuous glucose monitoring system of  claim 15 , wherein the sensor unit further comprises:
 an introducer having a handle sealed against a bottom of the sensor housing at the second opening, and   an insertion shaft cover sealed against a top of the sensor housing at the second opening to seal the sterilized region.   
     
     
         18 . The continuous glucose monitoring system of  claim 17 , wherein the sensor and the insertion shaft are sterilized within the sterilized region. 
     
     
         19 . The continuous glucose monitoring system of  claim 15 , wherein the substrate is electrically non-conductive and has electrically conductive traces formed thereon for electrically connecting to the conductive member. 
     
     
         20 . The continuous glucose monitoring system of  claim 19 ,
 wherein the sensor carrier further comprises electronic circuitry electrically coupled to the substrate, and   wherein the electronic circuitry comprises one or more processors for determining a blood glucose level based on information received from the sensor.