Disposable CGM Mounting Assembly with Spring-Loaded Insertion
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Solution Overview
Problem
Current glucose monitoring systems for diabetes patients require complex setups, cause discomfort, and involve non-sterilized components, leading to increased production costs and pain during insertion and removal of sensors.
Innovation Solution
A fully disposable, one-piece continuous glucose monitoring system with a pre-assembled mounting assembly that includes a sterilized sensor probe and non-sterilized components, featuring a spring-loaded mechanism for automatic insertion and retraction, minimizing trauma and simplifying the process with a button-press operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a complex glucose monitoring system is used, then monitoring accuracy is improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The system is divided into two main segments: a reusable receiver unit that performs complex signal processing and glucose calculation, and a disposable sensor probe that performs only the sensing function. This segmentation allows the complex monitoring accuracy functions to be concentrated in the receiver while the disposable probe remains simple.
Solution Approach 2:
The sensor probe is designed as a disposable component that is discarded after a single use, eliminating the need for sterilization and complex maintenance procedures. This disposable approach simplifies the overall system operation while maintaining monitoring accuracy through the reusable receiver unit.
2Reliability
If sterilization is applied to all components, then reliability is improved, but manufacturing cost increases
Solution Approach 1:
The sensor probe is designed as a disposable component that is discarded after a single use, eliminating the need for sterilization and complex maintenance procedures. This disposable approach simplifies the overall system operation while maintaining monitoring accuracy through the reusable receiver unit.
Solution Approach 2:
The sensor probe is pre-packaged in a sterile barrier pouch that maintains sterility until use. This preliminary protective action ensures reliability without requiring sterilization of the entire assembly, reducing manufacturing costs.
3Ease of operation
If manual insertion procedure is used, then ease of operation is improved, but pain and trauma increase
Solution Approach 1:
The mounting assembly incorporates a spring-loaded mechanism that automatically performs the insertion action when the user activates it. The user simply applies the assembly to the skin and triggers the automatic insertion, eliminating the need for manual needle handling while minimizing trauma through controlled delivery.
4Ease of operation
If automatic mounting mechanism is used, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The spring-loaded insertion mechanism is integrated into the disposable mounting assembly rather than being a separate component. This merging of the automatic mechanism with the single-use probe keeps the complexity contained in a disposable unit that is discarded after use, simplifying the reusable portions of the system.
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 system provides continuous glucose monitoring with reduced pain and trauma, lower production costs, and simplified use by eliminating the need for patient intervention in sensor insertion and removal, while maintaining sterility and minimizing inflammatory reactions.
Implementation Method 1
featuring a spring-loaded mechanism for automatic insertion and retraction
Data Source
Figure 1
Figure 2A
Figure 2B~2C
AI summary
Embodiments of the present disclosure, inter alia, are directed to a one piece continuous glucose monitoring (CGM) device (device or sensor) and a fully disposable, one piece, mounting unit for mounting the CGM device, is provided. The device and the mounting unit, in some embodiments, are pre-assembled in the factory to a one piece, disposable, mounting assembly. The mounting assembly, can be comprised of sealed compartment that includes a portion of the sensor and a non-sealed compartment that includes another portion of the sensor. The mounting assembly can be fully automatic, at a button press the sensor is adhered to the skin, and the sensor probe is inserted into the subcutaneous tissue.