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.

1 - 19 . (canceled) 
     
     
         20 . An assembly for inserting a glucose sensor into a subject, the assembly comprising:
 (1) an inserter assembly, comprising:
 a sharp support coupled with a sharp; 
 an insertion spring; 
 a retraction spring; and 
 a button subassembly configured to be depressed, the button subassembly comprising a plunger portion; 
   (2) an on body unit, comprising:
 an on body unit housing; 
 the glucose sensor, a portion of which is configured to be inserted under skin of the subject; and 
 sensor electronics disposed in the on body unit housing and coupled with the glucose sensor, 
   wherein, upon depression of the button subassembly, the insertion spring is configured to advance the sharp support and the on body unit from a proximal position within the inserter to a distal position,   wherein the sharp is configured to pierce the skin and position the portion of the glucose sensor under the skin of the subject,   wherein the retraction spring is configured to expand and retract the sharp support in a proximal direction after the on body unit has reached the distal position, and   wherein, after retraction of the sharp support, a distal end of the insertion spring is proximal to a proximal end of the retraction spring.   
     
     
         21 . The insertion assembly of  claim 20 , wherein, after the retraction of the sharp support, the distal end of the insertion spring is in a spaced relation with the proximal end of the retraction spring. 
     
     
         22 . The insertion assembly of  claim 20 , wherein the sensor electronics comprises one or more processors, memory, a power supply, and wireless communication circuitry configured to communicate data indicative of a glucose level according to a Bluetooth communication protocol. 
     
     
         23 . The insertion assembly of  claim 20 , wherein the inserter further comprises a distal end configured to be positioned on the skin of the subject. 
     
     
         24 . The insertion assembly of  claim 20 , wherein the on body unit is configured to remain on the skin after the sharp support has been retracted. 
     
     
         25 . The insertion assembly of  claim 25 , further comprising an adhesive portion configured to secure the on body unit to the skin of the subject. 
     
     
         26 . The insertion assembly of  claim 25 , wherein the adhesive portion comprises an aperture through which the sharp and the portion of the glucose sensor pass. 
     
     
         27 . The insertion assembly of  claim 20 , wherein the portion of the glucose sensor is housed within the sharp prior to the depression of the button subassembly. 
     
     
         28 . The insertion assembly of  claim 20 , wherein the button subassembly comprises a plurality of arms extending in a distal direction. 
     
     
         29 . The insertion assembly of  claim 28 , wherein the plurality of arms comprises two arms disposed on a circumference of a distal surface of the button subassembly and in a spaced relation with each other. 
     
     
         30 . The insertion assembly of  claim 29 , wherein each arm of the two arms further comprises a detent extending from a distal end of each arm. 
     
     
         31 . The insertion assembly of  claim 20 , wherein a longitudinal axis extends through a center of the insertion spring and a center of the retraction spring. 
     
     
         32 . The insertion assembly of  claim 31 , wherein at least a portion of the sharp is disposed along the longitudinal axis while the on body unit and the sharp support are in the proximal position. 
     
     
         33 . The insertion assembly of  claim 31 , wherein a part of the plunger portion is disposed along the longitudinal axis while the on body unit and the sharp support are in the proximal position. 
     
     
         34 . The insertion assembly of  claim 20 , wherein the at least a portion of the sharp is disposed in an interior of the retraction spring when the on body unit and the sharp support are in the proximal position. 
     
     
         35 . The insertion assembly of  claim 20 , wherein, after retraction of the sharp support, at least a portion of the sharp is disposed within an inner circumference of the retraction spring. 
     
     
         36 . The insertion assembly of  claim 20 , wherein the insertion spring comprises a first compression spring, and the retraction spring comprises a second compression spring. 
     
     
         37 . The insertion assembly of  claim 20 , wherein a proximal end of the insertion spring engages with a distal surface of the button subassembly. 
     
     
         38 . The insertion assembly of  claim 20 , wherein the button subassembly is slidably received within an opening on an upper portion of the inserter. 
     
     
         39 . The insertion assembly of  claim 20 , further comprising a removable cap configured to be removed from a distal end of the inserter. 
     
     
         40 . The insertion assembly of  claim 20 , wherein, before depression of the button subassembly, the distal end of the insertion spring is in a spaced relation with the proximal end of the retraction spring. 
     
     
         41 . The insertion assembly of  claim 20 , wherein at least a portion of plunger portion is configured to interface with the insertion spring. 
     
     
         42 . The insertion assembly of  claim 20 , wherein the plunger portion is configured to advance the sharp support and on body unit to the distal position after manual force is applied to the button subassembly.