On-Skin Medical Device Mounting for Secure Low-Force Release
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Solution Overview
Problem
Existing analyte monitoring systems face challenges in securely and efficiently coupling and decoupling reusable and disposable components, such as control units and sensors, due to the frequent need for replacement and battery changes, which requires reliable yet easy-to-use mechanisms.
Innovation Solution
The development of holders or mounting units with moveable portions and alterable structures that facilitate secure attachment and easy detachment of medical devices, including analyte sensors, through features like displaceable portions and mating elements, allowing for low-force release and re-use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If reusable control units and disposable sensors are frequently coupled and decoupled, then component replacement is enabled, but the coupling mechanism reliability deteriorates due to repeated physical stress
Solution Approach 1:
The system is divided into disposable sensor components and reusable control unit components, allowing independent replacement of the sensor while retaining the control unit. This segmentation enables frequent sensor replacement without subjecting the entire system to repeated coupling/decoupling cycles, thereby protecting the reliability of the coupling mechanism.
Solution Approach 2:
The coupling mechanism incorporates dynamic elements such as snap-fit connectors and elastic retention features that accommodate repeated assembly and disassembly operations. These dynamic features distribute mechanical stress and maintain connection integrity over multiple cycles, resolving the contradiction between replaceability and reliability.
2Reliability
If the coupling mechanism is made secure and durable, then component retention is improved, but the ease of manipulation by patients deteriorates
Solution Approach 1:
The coupling mechanism employs asymmetric design where the engagement direction requires significant force for secure retention, while the release direction is designed to be easily actuated by patients. This asymmetry allows the same mechanism to provide both secure retention during use and easy release when needed, resolving the contradiction between retention security and manipulation ease.
Solution Approach 2:
An intermediary release mechanism is introduced that mediates between the secure coupling state and the easy release state. This intermediary feature allows patients to easily manipulate the device for sensor replacement while maintaining secure retention during normal operation, balancing both requirements.
3Adaptability or versatility
If multiple coupling and decoupling operations are performed, then sensor replacement is enabled, but the time required for component replacement increases
Solution Approach 1:
The disposable sensor components are pre-assembled with coupling features that align with the control unit receptacles. This preliminary preparation eliminates complex alignment steps during replacement, allowing patients to quickly swap sensors without time-consuming manual adjustments, thus reducing replacement time while maintaining replacement capability.
Solution Approach 2:
The coupling mechanism is designed to skip intermediate adjustment steps by incorporating self-aligning features and snap-fit connections that automatically engage when components are brought together. This rushing through of the coupling process minimizes the time required for sensor replacement while ensuring proper connection.
Data Source
AI summary
Devices, systems, methods and kits for releasably mounting a medical device on the body or skin of a user are provided. Embodiments include a holder or mounting unit or structure that retains a medical device in a fixed position on a body part of a user or host, such as on the surface of the skin, and/or provides physical and/or electrical coupling to one or more additional components which may be operatively positioned above and/or below the surface of the skin.