Analyte Sensor Inserter With Segmented Sharp for Low-Pain Placement
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Solution Overview
Problem
Existing inserter assemblies for implantable analyte sensors are cumbersome, painful, and difficult to use, necessitating a simpler and more reliable method for inserting medical devices like glucose sensors with minimal discomfort.
Innovation Solution
A sensor assembly with a mount and insertion sharp, featuring a sensor body with distinct sections and a switch mechanism for activating the circuit upon contact with the skin, along with an inserter apparatus for easy and controlled insertion of medical devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional inserter assembly is used to insert an analyte sensor, then the sensor can be inserted into the skin, but the insertion process becomes cumbersome and painful
Solution Approach 1:
The sensor is divided into multiple sections including a distal section, intermediate section, and proximal section. The insertion sharp is separately configured to engage only the distal section during insertion. This segmentation allows the sharp to be minimal and less invasive while still achieving proper sensor deployment under the skin.
Solution Approach 2:
The insertion sharp acts as an intermediary tool that temporarily engages the distal section of the sensor to guide it through the skin. After insertion, the sharp is removed, leaving the sensor properly positioned. This intermediary approach minimizes the invasive nature of the insertion process.
2Reliability
If a complex inserter assembly is used to ensure reliable sensor insertion, then insertion reliability improves, but device complexity increases
Solution Approach 1:
The essential insertion function is extracted into a simple, separate insertion sharp that engages only the distal section of the sensor. The complex mounting and retention mechanisms are separated from the insertion process itself, allowing the insertion step to be simple and reliable without requiring a complex integrated assembly.
Solution Approach 2:
The distal section of the sensor is pre-configured with engagement features that interface with the insertion sharp before insertion occurs. This preliminary configuration ensures that when the sharp is applied, the sensor is automatically guided into the correct insertion path and depth, improving reliability without adding complexity to the inserter itself.
3Ease of operation
If the sensor is designed with multiple sections and gaps for flexibility, then comfort and wearability improve, but manufacturing precision requirements increase
Solution Approach 1:
The sensor has different structural qualities in different sections: the distal section is designed for rigid engagement with the insertion sharp, the intermediate section provides flexibility with gaps, and the proximal section accommodates the mounting structure. This local differentiation allows each section to be optimized for its specific function while maintaining overall manufacturability.
Solution Approach 2:
The sensor is segmented into distinct sections with gaps between them, allowing independent optimization of each section. The gaps provide necessary flexibility for comfort during wear while the segmented structure can be manufactured using standard techniques without requiring ultra-precise continuous fabrication.
4Object-affected harmful factors
If a simple insertion method is used to reduce pain, then user comfort improves, but secure anchoring of the sensor may be compromised
Solution Approach 1:
The distal section of the sensor is pre-configured with engagement features that interface with the insertion sharp. This preliminary configuration ensures that even with a simple insertion motion, the sensor is securely guided into the correct position and achieves proper anchoring through its mounting structure that adheres to the skin surface.
Solution Approach 2:
The sensor is divided into sections where the distal section handles insertion engagement and the proximal section with the mount handles secure anchoring to the skin. This segmentation allows the insertion process to be simple and minimally invasive while the mounting structure independently provides secure anchoring after insertion.
Data Source
AI summary
An apparatus for insertion of a medical device in the skin of a subject is provided.