Subcutaneous sensor inserter and method

摘要

An inserter assembly for continuous glucose monitoring with medication delivery capability where the assembly has a deployment button containing a needle deployment mechanism having a sharp held in a pre-release position, a housing body in which the deployment button is movably received within a top end of the housing body, the housing body having a sensor deployment assembly containing a lumen and a sensor disposed within the lumen and extending out of the lumen to a circuit board that is part of the sensor deployment assembly, the sensor deployment assembly matingly connected to the sharp where the sharp extends beyond the sensor deployment assembly and contains the sensor not fixedly attached to the sharp, and a sensor housing releasably received within a lower end of the housing body, the sharp extending into a sensor deployment assembly recess within the sensor housing and directly above a sensor opening in a bottom of the sensor housing.

主权项

1. An inserter assembly for implanting a sensor subcutaneously into a patient, the assembly comprising:
a housing body having a first body end and a second body end; a deployment button at least partially disposed in and slidable within the housing body through the first body end, the deployment button being movable between a first position and a second locked position; a deployment mechanism slidably disposed within the deployment button and movable between a ready position, an insertion position, and a retracted position, the deployment mechanism having a needle; a sensor deployment assembly disposed within the housing body and removably mated with the deployment mechanism, the sensor deployment assembly having a lumen sealingly fixed to the sensor deployment assembly and extending concentric with a deployment axis through a needle bore to a lower lumen end, the lumen defining a lumen side opening in communication with a sensor bore extending transversely from the lumen, wherein the needle extends through the lumen when the deployment mechanism is in the ready position and in the insertion position; a sensor with an electrical contact portion, the sensor partially disposed within the needle and extending through the lumen side opening and sensor bore with the electrical contact portion extending transversely away from the deployment axis; and a sensor housing disposed at and removably retained by the second body end of the housing body, the sensor housing having a bottom surface and defining a sensor opening therethrough that is aligned with the deployment axis; wherein movement of the deployment button from the first position to the second locked position causes the sensor to be implanted subcutaneously into the patient along the deployment axis, the needle of the deployment mechanism to retract to the retracted position, the sensor deployment assembly to be fixed within the sensor housing, and the housing body, the deployment button and the deployment mechanism to release from the sensor housing.