Sensor inserter having introducer

Abstract

Methods, device and system for providing a sensor insertion assembly including an inserter housing, an introducer including a body portion having a proximal end and a distal end and a shaft portion comprising a channel and a distal end, the shaft portion extending downwardly from an edge of the body portion, the shaft portion including a holding member disposed along a length of the channel, the holding member configured to substantially releasably retain a sensor, an on-body electronics unit, wherein the introducer is configured for insertion of the sensor through an aperture in the on-body electronics unit prior to insertion through skin and a drive mechanism included in the inserter housing and operatively coupled to the introducer, wherein the drive mechanism drives the introducer and retained sensor through the skin are provided.

1 - 18 . (canceled) 
     
     
         19 . A sensor insertion assembly, comprising:
 an inserter housing;   a shuttle disposed in the inserter housing and coupled with an introducer sharp;   a glucose sensor;   a drive spring disposed in the inserter housing, wherein the drive spring, upon release, is configured to urge the shuttle, the introducer sharp, and the glucose sensor in a distal direction and to position at least a portion of the glucose sensor under skin and in contact with a bodily fluid;   an actuator button configured to be depressed in the distal direction and to release the drive spring; and   a removable safety clip configured to impede depression of the actuator button,
 wherein the removable safety clip comprises a first leg portion, a second leg portion, and a bridging portion connecting the first leg portion and the second leg portion, and 
 wherein the removable safety clip is configured to be disengaged from the sensor insertion assembly upon application of opposing and inward forces to the first leg portion and the second leg portion. 
   
     
     
         20 . The sensor insertion assembly of  claim 19 , wherein the actuator button resides in an opening at a top end of the inserter housing. 
     
     
         21 . The sensor insertion assembly of  claim 19 , further comprising a retraction spring disposed in the inserter housing. 
     
     
         22 . The sensor insertion assembly of  claim 21 , wherein the retraction spring, upon release, is configured to urge the shuttle and the introducer sharp in a proximal direction. 
     
     
         23 . The sensor insertion assembly of  claim 21 , wherein the drive spring and the retraction spring comprise compression springs. 
     
     
         24 . The sensor insertion assembly of  claim 19 , wherein the bridging portion is disposed on or near a proximal end of the removable safety clip. 
     
     
         25 . The sensor insertion assembly of  claim 19 , wherein the removable safety clip further comprises a first distal end and a second distal end. 
     
     
         26 . The sensor insertion assembly of  claim 25 , wherein the first distal end of the removable safety clip is configured to engage a first side portion of the actuator button, and wherein the second distal end of the removable safety clip is configured to engage a second side portion of the actuator button. 
     
     
         27 . The sensor insertion assembly of  claim 25 , wherein the application of the opposing and inward forces to the first leg portion and the second leg portion causes the first distal end and the second distal end to move further apart. 
     
     
         28 . The sensor insertion assembly of  claim 19 , wherein, after disengagement of the removable safety clip, the removable safety clip is further configured to be pulled away from the sensor insertion assembly. 
     
     
         29 . The sensor insertion assembly of  claim 19 , wherein the at least a portion of the glucose sensor is disposed in a channel of the introducer sharp while the drive spring is in a compressed state. 
     
     
         30 . The sensor insertion assembly of  claim 21 , wherein the drive spring and the retraction spring are each in a compressed state prior to the depression of the actuator button. 
     
     
         31 . The sensor insertion assembly of  claim 21 , wherein a proximal end of the drive spring is proximal to a proximal end of the retraction spring prior to the depression of the actuator button. 
     
     
         32 . The sensor insertion assembly of  claim 21 , wherein a distal end of the retraction spring is distal to a distal end of the drive spring prior to the depression of the actuator button. 
     
     
         33 . The sensor insertion assembly of  claim 21 , wherein a proximal end of the retraction spring is in contact with the shuttle prior to the depression of the actuator button. 
     
     
         34 . The sensor insertion assembly of  claim 19 , wherein a proximal end of the drive spring is in contact with the actuator button prior to the depression of the actuator button. 
     
     
         35 . The sensor insertion assembly of  claim 19 , wherein the introducer sharp is configured to pierce the skin as the drive spring urges the shuttle, the introducer sharp, and the glucose sensor in the distal direction. 
     
     
         36 . The sensor insertion assembly of  claim 19 , wherein the actuator button comprises a top surface, and wherein the removable safety clip is configured to engage a portion of the actuator button below the top surface. 
     
     
         37 . The sensor insertion assembly of  claim 19 , wherein the removable safety clip is further configured to impede movement of the actuator button in the distal direction. 
     
     
         38 . The sensor insertion assembly of  claim 19 , wherein the removable safety clip comprises a plastic material.