Reusable Analyte Sensor Applicator With Controlled Sharp Retraction
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Solution Overview
Problem
Existing analyte sensors face issues with user error, improper insertion, tissue trauma, and non-reusable applicators made from difficult-to-recycle materials, leading to inaccurate measurements and environmental waste.
Innovation Solution
A reusable applicator with a proximal and distal portion, featuring a housing, sensor carrier, sharp carrier, and actuator, allowing for multiple uses and recyclability, while minimizing tissue trauma through controlled insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-use applicator is used for sensor insertion, then sterility and reliability are improved, but device complexity and waste generation increase
Solution Approach 1:
The applicator is divided into two separate modules: a reusable main body and a disposable sterile insert. The reusable main body contains the actuator, housing, and electronic components, while the disposable insert contains the sensor and sharp needle assembly. This segmentation allows the sterile component to be discarded after single use while the expensive mechanical components are reused, reducing waste while maintaining sterility requirements.
Solution Approach 2:
The patent implements a system where the sterile insert is discarded after single use, while the reusable main body is recovered and reused for subsequent insertions. This approach eliminates the need to discard the entire applicator assembly, reducing material waste while ensuring that the critical sterile components are replaced with each use.
2Loss of substance
If a reusable applicator is used, then device complexity is reduced and sustainability improved, but sterility maintenance becomes more difficult
Solution Approach 1:
The applicator is divided into two separate modules: a reusable main body and a disposable sterile insert. The reusable main body contains the actuator, housing, and electronic components, while the disposable insert contains the sensor and sharp needle assembly. This segmentation allows the sterile component to be discarded after single use while the expensive mechanical components are reused, reducing waste while maintaining sterility requirements.
Solution Approach 2:
The sterile insert is pre-packaged in sterile condition and attached to the reusable main body immediately before use. This preliminary preparation ensures that sterility is maintained throughout storage and handling, and the sterile barrier is only broken at the moment of intended use, eliminating contamination risks associated with repeatedly sterilizing the entire device.
3Speed
If sharp insertion mechanisms are used, then insertion speed is improved, but tissue trauma increases leading to measurement errors
Solution Approach 1:
The sharp needle function is extracted as a separate, disposable component that is only in contact with the skin during the brief insertion moment. The reusable main body contains blunt, non-traumatic components that remain in contact with the patient throughout the monitoring period. This separation allows rapid insertion when needed while eliminating ongoing tissue trauma from sharp edges.
Solution Approach 2:
The patent incorporates cushioning elements and rounded edges in the reusable main body components that contact the patient after insertion. The design includes compliant materials and smooth surfaces that prevent tissue irritation during the extended wear period, compensating for the initial sharp insertion by providing gentle contact thereafter.
4Ease of operation
If user assembly is required, then ease of operation is improved, but user error increases leading to improper insertion
Solution Approach 1:
The sterile insert is pre-assembled with the sensor and sharp needle in the correct configuration before reaching the user. Alignment features, guide rails, and mechanical stops are built into the design to ensure that when the user attaches the insert to the main body, proper alignment is automatically achieved without requiring user skill or judgment.
Solution Approach 2:
The applicator incorporates self-aligning mechanical features such as keyed interfaces, guide pins, and snap-fit connections that automatically ensure correct orientation and positioning during assembly. The design makes improper assembly mechanically impossible, allowing users to assemble the device correctly through simple snap-together actions without requiring training or precision.
Data Source
AI summary
An assembly and method for delivery of an analyte sensor including a reusable applicator having a proximal portion and a distal portion are disclosed. The reusable applicator can include a housing, a sensor carrier configured to releasably receive the first analyte sensor, a sharp carrier configured to releasably receive a sharp module, and an actuator movable relative to the housing. The actuator can include three positions: a first position with the sensor carrier and the sharp carrier are at the proximal portion of the reusable applicator, a second position with the sensor carrier and the sharp carrier are at the distal portion of the reusable applicator for delivery of the first analyte sensor, and a third position with the sensor carrier at the distal portion of the reusable applicator and the sharp carrier at the proximal portion of the reusable applicator after delivery of the first analyte sensor from the reusable applicator, wherein the first position, the second position, and the third position are different, and wherein the actuator is configured to be returned from the third position to the first position for delivery of another analyte sensor.