Glucose Sensor Inserter Sleeve for Low-Pain Skin Placement
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Solution Overview
Problem
Individuals with diabetes often fail to monitor their glucose levels frequently due to convenience, testing discretion, pain, and cost, despite the importance of frequent monitoring for glycemic control.
Innovation Solution
A medical device inserter apparatus is developed to facilitate the insertion of analyte sensors, such as glucose sensors, into the skin with reduced pain and improved convenience, featuring a sheath, device support, sharp support, and a handle mechanism for easy and discreet monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional glucose testing methods are used, then glucose monitoring can be performed, but pain and inconvenience increase leading to reduced monitoring frequency
Solution Approach 1:
The patent introduces an intermediary device (analyte sensor with cannula) that continuously samples interstitial fluid beneath the skin, eliminating the need for repeated painful fingersticks. The sensor acts as a mediator between the patient's body and the glucose monitoring system, providing continuous data without direct repeated penetration of skin tissue.
Solution Approach 2:
The sensor is inserted into the subcutaneous tissue in advance and remains there to continuously sample interstitial fluid. This preliminary action of placing the sensor before monitoring begins allows for ongoing glucose measurement without repeated insertion pain, transforming a discrete painful procedure into a single initial insertion followed by continuous monitoring.
2Reliability
If frequent glucose monitoring is performed, then glycemic control improves, but pain and cost increase
Solution Approach 1:
The analyte sensor provides continuous glucose monitoring by continuously sampling interstitial fluid and transmitting data to a receiver. This continuous action replaces discrete repeated fingersticks, maintaining reliable glycemic control information while eliminating the cumulative pain and cost of frequent manual testing.
Solution Approach 2:
The continuous analyte sensor acts as an intermediary that continuously measures glucose in interstitial fluid, providing ongoing glycemic control data without requiring repeated patient participation in painful testing procedures. This mediator enables reliable monitoring while reducing harmful factors.
3Ease of operation
If manual insertion of analyte sensors is performed, then sensor placement is achieved, but insertion precision and patient comfort decrease
Solution Approach 1:
The patent replaces manual mechanical insertion with an automated insertion device that uses a motorized actuator to precisely control the movement of the sensor and cannula through the skin. This mechanical substitution provides controlled, precise insertion with consistent depth and angle, improving both ease of operation and insertion precision compared to manual methods.
Solution Approach 2:
The automated insertion device performs the insertion procedure itself without requiring manual manipulation by the user. The device self-actuates through a motorized mechanism to advance the sensor and cannula to the correct position, ensuring precise insertion while simplifying the user's role to merely initiating the process.
Data Source
AI summary
An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.


