Analyte Sensor Connector Assembly for Sterile Skin Insertion
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Solution Overview
Problem
Existing in vivo analyte monitoring systems face challenges in ease of use, user convenience, and pain minimization during sensor insertion, as well as packaging and user interface issues.
Innovation Solution
The development of an applicator system that includes a sensor assembly, electronics assembly, and a sharp, designed for easy assembly and insertion of a sensor beneath the skin, with features like a guide sleeve and locking mechanisms to ensure sterility and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sharp is used to pierce the skin for sensor insertion, then the sensor can be inserted beneath the skin, but user pain and discomfort increase
Solution Approach 1:
The insertion device is divided into separate functional components: a sharp for piercing, a guide sleeve for sensor placement, and a retention mechanism. This segmentation allows the sharp to be withdrawn after initial piercing, leaving only the sensor beneath the skin, thereby reducing ongoing pain while maintaining insertion effectiveness
Solution Approach 2:
The sensor is pre-positioned within the guide sleeve before skin insertion. This preliminary positioning ensures the sensor is already in the correct location and orientation before the piercing action occurs, allowing for seamless transition from sharp removal to sensor operation, minimizing user discomfort
2Ease of manufacture
If the sensor assembly and electronics assembly are kept separate, then packaging and user interface issues are simplified, but assembly complexity increases
Solution Approach 1:
A connector assembly serves as an intermediary component between the sensor assembly and electronics assembly. This connector includes alignment features and engagement mechanisms that guide the two separate assemblies into proper configuration, reducing the perceived complexity for the user while enabling modular manufacturing and packaging
3Reliability
If locking mechanisms are added to ensure sterility and reliability, then sensor placement accuracy improves, but device complexity increases
Solution Approach 1:
The guide sleeve incorporates self-locking features that automatically engage when the sensor assembly is properly inserted. These features include friction-fit interfaces and snap-engagement elements that secure the sensor in place without requiring additional user actions or complex locking mechanisms, thereby maintaining reliability while minimizing added complexity
Data Source
AI summary
Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.


