Analyte Sensor Applicator Assembly to Prevent Premature Sharp Withdrawal

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Solution Overview

Problem

Existing in vivo analyte monitoring systems, particularly those using dermal sensors, are prone to malfunctions due to improper insertion caused by user error, lack of training, and poor coordination, leading to improperly inserted or damaged sensors that fail to accurately monitor analyte levels.

Innovation Solution

A user-assembleable sensor control device system is provided, comprising a sterile package with an applicator and sensor module, allowing for precise assembly and insertion of dermal sensors with improved insertion mechanisms, including increased firing velocity and delayed sharp retraction, to prevent premature withdrawal and ensure proper sensor placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If user-assembleable sensor control device with applicator is provided, then ease of operation is improved, but device complexity increases

Engineering Contradiction:

Improveease of operationVSAvoiddevice complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The sensor control device is divided into separate sterile components (applicator, sensor module, sharp module, container) that are assembled by the user. This segmentation allows each component to be optimized independently while maintaining overall ease of use through a simple assembly process involving inserting the applicator into the container.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system enables users to assemble and operate the sensor control device themselves without requiring professional training or intervention. The self-service nature is achieved through intuitive design and simplified assembly procedures that allow patients to independently prepare and use the device.

Inventive Principle:

Principle #25Self-service

2Ease of operation

If precision assembly and deployment by individual user is relied upon, then ease of operation is improved, but reliability deteriorates

Engineering Contradiction:

Improveease of operationVSAvoidreliability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The sterile components are pre-assembled and prepared in advance with precise configurations built into their designs. The applicator, sensor module, and sharp module are manufactured with predetermined alignment features and geometric constraints that guide proper assembly, eliminating the need for users to perform complex precision assembly while maintaining high reliability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The container serves as an intermediary structure that facilitates reliable assembly between the applicator and other components. The container provides a stable platform and geometric constraints that ensure proper positioning and alignment during the assembly process, reducing variability introduced by user manipulation.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Speed

If sharp insertion and retraction mechanisms are utilized, then insertion speed is improved, but reliability deteriorates due to premature withdrawal

Engineering Contradiction:

Improveinsertion speedVSAvoidreliability

Core Design Contradiction:

SpeedVSReliability

Solution Approach 1:

The sharp module is integrated with the applicator and sensor module in a combined assembly that ensures coordinated insertion and retention. The sharp, applicator, and sensor module function as a unified system where the sharp remains securely attached during insertion, preventing premature withdrawal while maintaining high insertion speed through the integrated design.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The insertion mechanism is designed to maintain equal potential energy states during the insertion process, ensuring that the sharp module remains firmly positioned throughout insertion. This equipotential design prevents premature withdrawal by eliminating energy gradients that could cause unstable positioning or early release of the sharp during the insertion sequence.

Inventive Principle:

Principle #12Equipotentiality

4Volume of moving object

If dermal sensors of smaller scale are used, then device miniaturization is improved, but manufacturing precision requirements increase

Engineering Contradiction:

Improvedevice miniaturizationVSAvoidmanufacturing precision

Core Design Contradiction:

Volume of moving objectVSManufacturing precision

Solution Approach 1:

The small-scale sensor module is nested within the applicator assembly, which itself is contained within the larger container structure. This nested arrangement allows the miniaturized sensor to be precisely positioned through the hierarchical structure of the assembly, where each level provides geometric constraints that guide the placement of smaller components, maintaining manufacturing precision despite reduced component size.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS12495993B2Systems, devices and methods for analyte sensor insertion

Publication Date: 2025.12.16 ABBOTT DIABETES CARE INC

AI summary

Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor, such as a dermal sensor, for sensing an analyte level in a bodily fluid of a subject. An applicator is positioned against a skin surface and a force is applied to the applicator causing at least a portion of a sharp and an in vivo analyte sensor to be positioned in the body of the subject. In particular, disclosed herein are embodiments of applicators designed to prevent premature sharp withdrawal and/or reduce the likelihood of improper sensor insertion. Also disclosed are embodiments of applicators including sharp modules having an angled sharp which can be configured to create an insertion path for a sensor.