Medical device inserters and processes of inserting and using medical devices
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. An inserter, comprising:
a housing;
a removable cap coupleable to the housing;
a sheath coupled to and partially contained within the housing, wherein a distal end of the sheath defines a distal surface for placement on a skin surface and an entire width of a proximal end of the sheath is fully contained within the housing;
an analyte sensor;
an on-body housing;
a sharp;
an on-body housing retention feature within the housing operative to releasably retain the on-body housing, the on-body housing coupled to the analyte sensor and including a sensor control unit;
a pusher coupled to and disposed within the housing and operative to translate the on-body housing and the sharp along a longitudinal axis of the inserter from a proximal position to a distal position in response to the housing being moved toward the distal surface relative to the sheath; and
a sharp retraction feature within the housing and operative to remove the sharp from the on-body housing when the pusher reaches the distal position.
2. The inserter of claim 1 , wherein the sheath recedes into the housing as the housing is moved toward the distal surface.
3. The inserter of claim 1 , wherein the sharp penetrates the skin surface in response to the housing being moved toward the distal surface.
4. The inserter of claim 1 , wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.