Analyte Sensor Subassembly Sealing for Reliable Dermal Insertion
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing 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 poor coordination, leading to improperly inserted or damaged sensors that fail to accurately monitor analyte levels.
Innovation Solution
A method of assembling a sensor subassembly involving a sensor, mount, collar, sharp, and cap, using chemically-curable, heat-curable, or UV-curable adhesives, along with leak testing and sterilization, to create a sealed sensor subassembly, and assembling an on-body sensor puck assembly with a printed circuit board and adhesive curing, followed by constructing an applicator assembly with an inserter and sheath, ensuring precise and reliable sensor application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If dermal sensors are used for analyte monitoring, then patient comfort and convenience are improved, but insertion reliability deteriorates due to user error and improper insertion
Solution Approach 1:
The sensor system is divided into separate components: a sensor assembly with mounting features, a separate applicator device, and a sharp insertion element. This segmentation allows each component to be optimized independently while improving overall reliability through standardized interfaces and assembly procedures.
Solution Approach 2:
The applicator device serves as an intermediary between the user and the sensor, providing a controlled insertion mechanism that eliminates the need for users to directly manipulate the sharp sensor. The applicator includes guide features and positioning elements that ensure proper sensor orientation and insertion depth, thereby improving insertion reliability while maintaining patient comfort.
2Ease of operation
If manual sensor insertion by users is implemented, then ease of application is improved, but manufacturing precision deteriorates due to lack of proper training and coordination
Solution Approach 1:
The sensor assembly is pre-configured with mounting features, adhesive layers, and alignment elements during manufacturing. The applicator is pre-loaded with the sensor in a controlled environment, ensuring proper orientation and positioning before patient application. This preliminary preparation eliminates the need for users to perform precise manipulation, maintaining both ease of application and insertion precision.
Solution Approach 2:
The design incorporates specific geometric parameters such as sensor thickness (0.5mm to 2mm), sharp length (5mm to 15mm), and mounting feature dimensions that are optimized during manufacturing. These controlled parameters ensure consistent insertion depth and sensor positioning, achieving manufacturing precision while allowing simple user application.
3Object-affected harmful factors
If shorter sharps are used for dermal sensor insertion, then patient safety is improved, but insertion reliability deteriorates due to premature withdrawal before proper implantation
Solution Approach 1:
The applicator device incorporates a dynamic retention mechanism that holds the sharp in place during the insertion sequence. The mechanism includes spring-loaded or friction-based retention features that release the sharp only after proper insertion is achieved, preventing premature withdrawal. This dynamic control maintains patient safety through shorter sharps while ensuring reliable sensor implantation.
Solution Approach 2:
The insertion system includes feedback mechanisms such as tactile indicators, visual markers, or mechanical stops that provide real-time information to the user or control system about insertion depth and sensor placement. This feedback ensures the sharp remains engaged until proper implantation is confirmed, maintaining both patient safety and insertion reliability.
4Device complexity
If precision assembly of sensor control device and applicator by user is required, then device complexity is reduced, but reliability deteriorates due to user error and coordination issues
Solution Approach 1:
The sensor, applicator, and control device elements are merged into a pre-assembled unit or tightly integrated system. The sensor assembly includes integrated mounting features, electrical connections, and sealing elements that are factory-assembled with the applicator. This merging eliminates the need for users to perform precision assembly tasks, reducing assembly complexity while maintaining high reliability through controlled manufacturing processes.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method enhances the reliability and reproducibility of sensor insertion, reducing the likelihood of improper insertion, damage, and malfunctions, thereby improving the accuracy and consistency of analyte monitoring.
Implementation Method 1
exposing the adhesive to a UV light source to cure the adhesive
Implementation Method 2
heating a portion of the neck of the sensor to a predetermined temperature and bending the neck of the sensor
Data Source
AI summary
A method includes assembling a sensor subassembly that includes a sensor, a sensor mount, a collar, a sharp, and a sensor cap. The method includes loading a sensor in a sensor mount; dispensing adhesive into a mount channel of the sensor mount; clamping a collar to the sensor mount; and curing the adhesive to fix the collar to the sensor mount. The method can also include inserting a sharp into the sensor mount over the sensor an attaching a sensor cap to the sensor and sensor sharp to provide a sealed sensor subassembly. Methods of assembling an on-body sensor puck assembly and an applicator assembly, and a sensor including a tail, a flag, and a neck that interconnects the tail and the flag and methods of configuring a sensor are also disclosed.