Analyte Sensor Inserter Assembly to Prevent Premature Sharp Withdrawal
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Solution Overview
Problem
Existing in vivo analyte monitoring systems, particularly those using dermal sensors, are prone to malfunctions due to improper insertion caused by user error, lack of proper training, and complex procedures, leading to damaged sensors and inaccurate analyte level monitoring.
Innovation Solution
A user-assembleable sensor control device system with a sterile applicator and separate sensor module, featuring a sharp module that is coupled with the applicator through a specified assembly process, ensuring proper insertion and preventing premature retraction, and includes mechanisms to stabilize the sensor during insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dermal sensor is inserted using a sharp insertion mechanism, then the sensor can be implanted into the dermal layer, but the mechanism is susceptible to premature withdrawal before proper implantation
Solution Approach 1:
The sharp is pre-loaded into the applicator in a ready-to-use configuration, and the sensor is pre-positioned on the sharp. The user simply needs to activate the insertion mechanism by pressing against the skin, eliminating complex assembly steps during the actual insertion process.
Solution Approach 2:
The applicator serves as an intermediary device between the user and the sensor-sharp assembly. It provides a controlled insertion mechanism that delivers the sensor to the correct depth in the dermal layer and prevents premature withdrawal through its structural design.
2Reliability
If a sharp is used to create an insertion path in the dermal layer, then the sensor can be implanted, but surrounding tissue trauma may occur
Solution Approach 1:
The sharp is designed with specific local characteristics - a fine tip for precise penetration and an optimized geometry that minimizes tissue disruption along its path. The sensor itself is positioned to follow the exact trajectory created by the sharp, ensuring accurate placement with minimal collateral damage.
3Weight of moving object
If the sensor control device is made small for comfort and convenience, then it can be worn on the body, but proper assembly and deployment by the user becomes more difficult
Solution Approach 1:
The system is divided into distinct segments - the applicator, the sensor-sharp assembly, and the sensor control device - that can be separately prepared and then easily coupled together. This modular approach allows each component to be optimized independently while simplifying the final assembly process for the user.
Data Source
AI summary
Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor, such as a dermal sensor, for sensing an analyte level in a bodily fluid of a subject. An applicator is positioned against a skin surface and a force is applied to the applicator causing at least a portion of a sharp and an in vivo analyte sensor to be positioned in the body of the subject. In particular, disclosed herein are embodiments of applicators designed to prevent premature sharp withdrawal and/or reduce the likelihood of improper sensor insertion. Also disclosed are embodiments of applicators including sharp modules having an angled sharp which can be configured to create an insertion path for a sensor.