Analyte Sensor Applicator Locking for Reliable Sharp Retraction
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Solution Overview
Problem
Existing analyte monitoring systems face issues with sensor insertion errors due to user error, improper insertion, and damage to surrounding tissue, leading to malfunctions and ineffective analyte level monitoring.
Innovation Solution
The applicator system includes a housing, sensor carrier, sheath, and cap with lock interfaces and sharp edges, designed to ensure proper sensor insertion and prevent premature sharp retraction, featuring a noise damper to reduce movement and trauma during the insertion process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If users perform sensor insertion manually with prior art systems, then the device can be simple and easy to manufacture, but user error and improper insertion occur frequently leading to sensor malfunction
Solution Approach 1:
The applicator system performs preliminary actions by pre-configuring the sensor carrier with the sensor in a ready-to-insert state, pre-loading the sharp into the sharp carrier, and pre-aligning all components within the housing before the user activates insertion. This preliminary preparation eliminates the need for users to perform complex assembly steps manually, reducing user error while maintaining manageable device complexity through automated pre-positioning mechanisms.
Solution Approach 2:
The applicator system introduces an intermediary device that mediates between the user and the sensor insertion process. The applicator housing, sensor carrier, and sharp carrier work together as intermediary components to guide the sensor into proper placement, provide mechanical advantage for insertion, and automatically retract the sharp. This intermediary mechanism improves reliability by removing direct user manipulation of the sensor and sharp, while the modular design keeps overall complexity manageable.
2Ease of operation
If sharp insertion mechanisms are designed to be easily retractable, then user operation is simplified, but premature withdrawal of the sharp occurs before proper sensor implantation
Solution Approach 1:
The sharp carrier is designed with dynamic characteristics that change during the insertion process. Initially, the sharp carrier is constrained within the housing to prevent premature retraction. Upon user activation, the system transitions to a state where the sharp can be inserted with force, and then automatically retracts after sensor deployment. This dynamic behavior—constrained during loading, forceful during insertion, and automatic during retraction—simplifies user operation while ensuring reliable completion of the insertion process.
Solution Approach 2:
The applicator system incorporates feedback mechanisms that respond to user activation. When the user presses the activation button or moves the slider, the system detects this input and triggers the sharp insertion sequence. After the sensor is implanted and the sharp has served its purpose, the system automatically initiates sharp retraction. This feedback-based control ensures the sharp remains in place long enough for proper sensor implantation while still allowing easy user operation to initiate and complete the process.
3Force
If sharps are designed for high insertion force, then sensor implantation is effective, but trauma to surrounding tissue increases
Solution Approach 1:
The insertion force is segmented into distinct phases: an initial low-force phase for needle penetration, a high-force phase for sensor deployment, and a final retraction phase. The applicator mechanism separates these force applications temporally and spatially, applying high force only when needed for sensor implantation while using lower forces during approach and retraction. This segmentation of force application reduces overall tissue trauma while maintaining effective sensor implantation when high force is required.
Solution Approach 2:
The applicator system prepares cushioning and protection measures beforehand to mitigate tissue trauma. The housing and internal components are designed to guide the sharp along a predetermined path that avoids critical structures. The sensor carrier and sharp carrier are pre-positioned to ensure the sensor is deployed at the correct depth and orientation, preventing excessive insertion depth that would cause trauma. These beforehand preparations reduce harmful effects while maintaining the necessary insertion force for effective sensor implantation.
Data Source
AI summary
Applicator including a housing; a sensor carrier coupled to the housing, and including a first lock interface; a sheath, slidably coupled to the housing, the sheath including a first lock arm having an attached distal end and a free proximal end, the free proximal end including a first lock arm interface disposed on an inner surface of the first lock arm and a first sharp edge disposed on an outer surface of the first lock arm; and a cap threadably coupled to the housing, the cap including an inner surface having a first plurality of crush ribs. The inner surface of the cap is configured to urge the first lock arm inwardly such that the first lock arm interface engages the first lock interface; and the first sharp edge is configured to engage the first plurality of crush ribs during a shock event.