Transcutaneous Sensor Applicator Sealing for Sterile Skin Insertion
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Solution Overview
Problem
Conventional methods for monitoring blood glucose levels in diabetes patients, such as finger pricking, are uncomfortable and infrequent, leading to delayed detection of hyperglycemic or hypoglycemic conditions, while continuous sensor systems lack convenient and secure application methods.
Innovation Solution
An applicator system with an insertion assembly, housing, actuation member, and sealing element for applying a transcutaneous analyte sensor to the skin, providing a sterile and vapor barrier, and including features like elastomeric membranes and tamper indicators for secure application and sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If finger pricking methods are used for blood glucose monitoring, then measurement can be obtained, but user comfort deteriorates and monitoring frequency decreases
Solution Approach 1:
The patent replaces the mechanical finger pricking system with a transcutaneous sensor system that measures glucose through the skin without penetration. The sensor assembly includes electrodes and a transmitter that wirelessly communicate glucose levels, eliminating the need for physical puncture and improving user comfort while maintaining measurement capability.
2Duration of action of stationary object
If transcutaneous sensor assembly is applied, then continuous monitoring is enabled, but secure and sterile application becomes challenging
Solution Approach 1:
The patent divides the application system into separate functional components: a sensor assembly for measurement, a distinct applicator device for delivery, and a separate transmitter for wireless communication. This segmentation allows each component to be optimized independently, with the applicator providing sterile delivery while the sensor ensures continuous monitoring duration.
Solution Approach 2:
The patent introduces an applicator device as an intermediary between the sterile sensor assembly and the user's skin. The applicator includes a housing with an aperture, sealing elements, and an insertion assembly that facilitates sterile placement of the sensor without direct handling of the sensor itself, thereby maintaining application sterility and security.
3Ease of manufacture
If conventional finger pricking is used, then simple application is maintained, but monitoring frequency is insufficient for timely condition detection
Solution Approach 1:
The patent implements a self-service system where the transcutaneous sensor assembly automatically measures and wirelessly transmits glucose levels without requiring user intervention for each measurement. The sensor continuously monitors glucose through the skin and the transmitter automatically communicates data, enabling high monitoring frequency while maintaining ease of initial application.
Data Source
AI summary
Applicators for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. An applicator includes an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host, a housing configured to house the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass, an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host, and a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.