Pre-loaded Sensor Introducer Assembly for Continuous Monitoring
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Solution Overview
Problem
Existing analyte monitoring systems require a separate deployment mechanism with a sharp needle inserter that is cumbersome and requires careful handling, and there is a need for a simpler and more accurate method to position and retain the sensor for continuous or semi-continuous monitoring.
Innovation Solution
A sensor introduction and retention mechanism that includes a pre-loaded insertion device with a trigger mechanism, which aligns with a base section on the patient's skin, allowing for easy and accurate placement of the sensor, and a retraction mechanism to securely position the sensor under the skin while removing the inserter, reducing the number of components and handling steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate deployment mechanism with sharp needle inserter is used, then the sensor can be inserted through the skin to establish fluid contact, but the device complexity increases and requires careful handling
Solution Approach 1:
The patent combines the sensor, introducer, and inserter into a single integrated assembly. The sensor is pre-attached to the introducer within the inserter housing, eliminating the need for separate deployment mechanisms and reducing the number of components the patient must handle while maintaining reliable sensor insertion through the skin.
Solution Approach 2:
The sensor is pre-positioned and pre-attached to the introducer before insertion. The entire assembly is prepared in advance with the sensor already in its insertion configuration, allowing for simple one-step deployment by the patient without requiring assembly or complex handling during the insertion process.
2Reliability
If a separate deployment mechanism is used, then the sensor can be inserted, but the ease of operation decreases due to multiple handling steps
Solution Approach 1:
The sensor, introducer, and inserter are merged into a single pre-assembled unit. The patient handles only one component rather than multiple separate parts, significantly reducing the number of handling steps while maintaining accurate sensor positioning through the pre-configured assembly geometry.
Solution Approach 2:
The inserter assembly is designed to be self-contained and self-explanatory, with the sensor pre-attached and pre-positioned. The patient can perform the insertion without requiring additional tools, instructions, or assembly steps, making the process simple and easy to operate.
3Reliability
If the inserter remains in contact with biological fluids, then sensor deployment is achieved, but safety concerns arise requiring special precautions
Solution Approach 1:
The inserter is designed as a disposable component that is discarded after a single use. The sharp needle and inserter mechanism are extracted from the system after sensor deployment, preventing any risk of contamination or damage to other skin areas. The patient does not need to handle or dispose of contaminated sharp instruments.
Solution Approach 2:
The inserter assembly is designed as a single-use disposable device. After the sensor is successfully deployed through the skin, the entire inserter is discarded, eliminating any safety concerns related to reusing contaminated instruments or requiring special handling precautions for subsequent use.
Data Source
AI summary
A method and apparatus for inserting at least a portion of a sensor into a patient is provided. Simple and easy to use mechanisms are provided that can position the sensor or any other device accurately with minimal complication. The method and apparatus can include an inserter device for use with the sensor. The method and apparatus can be for use in continuous or semi-continuous monitoring systems such as analyte monitoring systems.