Medical device inserters and processes of inserting and using medical devices

Abstract

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

1 - 25 . (canceled) 
     
     
         26 . An insertion assembly comprising:
 an inserter, comprising:
 a sharp hub coupled with a sharp, the sharp hub disposed in an interior of the inserter and configured to move from a proximal position to a distal position,
 wherein the sharp comprises a distal portion including a distal tip, a first set of distal edges, and a second set of distal edges, 
 wherein the first set of distal edges is proximal to the distal tip, and the second set of distal edges is proximal to the first set of distal edges and the distal tip, 
 wherein the first set of distal edges forms an included angle comprising a first acute angle, and 
 wherein the second set of distal edges forms a lead-in angle, wherein the lead-in angle comprises a second acute angle that is different from the first acute angle; and 
 
 a spring disposed in the interior of the inserter and configured to retract the sharp hub from the distal position towards a retracted position. 
   
     
     
         27 . The insertion assembly of  claim 26 , wherein the sharp further comprises a U-shaped cross-sectional area. 
     
     
         28 . The insertion assembly of  claim 27 , wherein the U-shaped cross-sectional area of the sharp comprises a flat bottom portion. 
     
     
         29 . The insertion assembly of  claim 26 , wherein the included angle is configured to facilitate piercing of skin by the distal tip. 
     
     
         30 . The insertion assembly of  claim 26 , wherein the lead-in angle is configured to strengthen the distal tip. 
     
     
         31 . The insertion assembly of  claim 26 , wherein the lead-in angle is between 20 degrees and 45 degrees. 
     
     
         32 . The insertion assembly of  claim 26 , wherein the lead-in angle is about 20 degrees. 
     
     
         33 . The insertion assembly of  claim 26 , wherein the lead-in angle is about 45 degrees. 
     
     
         34 . The insertion assembly of  claim 26 , wherein the second acute angle is less acute than the first acute angle. 
     
     
         35 . The insertion assembly of  claim 26 , wherein the distal portion of the sharp further comprises a pair of substantially parallel side walls. 
     
     
         36 . The insertion assembly of  claim 35 , wherein the second set of distal edges is disposed between the first set of distal edges and the pair of substantially parallel side walls. 
     
     
         37 . The insertion assembly of  claim 26 , wherein the distal portion of the sharp further comprises one or more rising edge portions. 
     
     
         38 . The insertion assembly of  claim 37 , wherein the one or more rising edge portions form a lead-out angle. 
     
     
         39 . The insertion assembly of  claim 38 , wherein the lead-out angle is configured to facilitate separation of tissue by the one or more rising edge portions. 
     
     
         40 . The insertion assembly of  claim 38 , wherein the lead-out angle is approximately 20 degrees. 
     
     
         41 . The insertion assembly of  claim 26 , wherein at least a portion of the sharp is formed through a die cutting process. 
     
     
         42 . The insertion assembly of  claim 26 , wherein at least a portion of the sharp is subjected to a grinding process. 
     
     
         43 . The insertion assembly of  claim 26 , wherein the inserter further comprises a button disposed on a top portion of the inserter, wherein the button is configured to be depressed, and wherein the button comprises a plunger portion. 
     
     
         44 . The insertion assembly of  claim 26 , further comprising:
 an on body unit, comprising:
 an on body unit housing; 
 an analyte sensor, wherein a portion of the analyte sensor is configured to be inserted under skin of a subject; and 
 sensor electronics disposed in the on body unit housing and coupled with the analyte sensor, 
 wherein the on body unit is disposed in the interior of the inserter while the sharp hub is in the proximal position. 
   
     
     
         45 . The insertion assembly of  claim 44 , wherein the sensor electronics comprises one or more processors, memory, a power supply, and wireless communication circuitry configured to communicate data indicative of an analyte level according to a Bluetooth communication protocol. 
     
     
         46 . The insertion assembly of  claim 26 , wherein after retraction of the sharp hub, at least a portion of the sharp is disposed within an inner circumference of the spring. 
     
     
         47 . The insertion assembly of  claim 44 , further comprising an adhesive portion configured to secure the on body unit to the skin of the subject. 
     
     
         48 . The insertion assembly of  claim 26 , further comprising a removable cap configured to be removed from a distal end of the inserter.