Sensor Inserter Introducer with Compressible Skin Tenting
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Solution Overview
Problem
Current sensor inserter technologies cause trauma to the skin during sensor insertion and do not provide a safe and efficient method for inserting analyte sensors, such as glucose sensors, which are used for continuous monitoring of blood glucose levels in diabetes management.
Innovation Solution
A sensor inserter assembly with an introducer having a shaft portion with rolling members or a compressible member to tent and pierce the skin at a reduced depth, combined with a safety mechanism to prevent accidental actuation, allows for easy and minimally traumatic insertion of sensors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sensor inserter is used to insert analyte sensors through the skin, then sensor insertion is achieved, but skin trauma occurs during insertion
Solution Approach 1:
The patent introduces an introducer as an intermediary device between the sensor inserter and the skin. The introducer includes a shaft with a holding member that retains the sensor, a compressible member that tents the skin to reduce insertion depth, and a sharp that pierces the skin. This intermediary structure facilitates sensor insertion while minimizing skin trauma by controlling the insertion process and reducing the depth required.
Solution Approach 2:
The compressible member in the introducer changes the physical state of the skin by tenting it upward, effectively reducing the depth parameter required for sensor insertion. This parameter change allows the sensor to be inserted at a reduced depth, thereby minimizing skin trauma while maintaining insertion effectiveness.
2Ease of operation
If a sensor inserter is designed for easy operation, then insertion efficiency is improved, but accidental actuation risk increases
Solution Approach 1:
The patent incorporates a safety mechanism that applies preliminary anti-action to prevent accidental actuation. The safety member is configured to impede actuation of the sensor inserter unless intentionally activated. This preliminary protective measure counteracts unintended activation forces while allowing deliberate insertion operations to proceed efficiently.
3Reliability
If the introducer shaft penetrates deeper into the skin, then sensor placement is more secure, but skin trauma increases
Solution Approach 1:
The introducer serves as an intermediary that secures the sensor during insertion without requiring deep penetration. The holding member on the shaft retains the sensor, the compressible member tents the skin, and the sharp pierces only to the necessary depth. This intermediary approach ensures sensor placement security while minimizing skin trauma by controlling penetration depth.
Solution Approach 2:
The compressible member changes the skin's physical configuration by tenting it upward, which reduces the effective insertion depth parameter. This allows the sensor to be placed securely relative to the tented skin surface while the actual penetration depth into the underlying tissue is minimized, thereby reducing skin trauma.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution reduces skin trauma and facilitates the insertion of sensors with reduced pain and faster healing, while ensuring safe and controlled deployment of the sensor inserter.
Implementation Method 1
The introducer can further comprise a compressible member configured to tent the skin and puncture the skin to a reduced depth during insertion of a sensor
Implementation Method 2
The shaft portion can include a holding member configured to retain a sensor on the introducer
Data Source
AI summary
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.