Analyte Sensor Inserter Sheath 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, necessitating a need for cost-effective, convenient, and less painful analyte monitoring devices and systems that encourage frequent monitoring to improve glycemic control.

Innovation Solution

A medical device inserter apparatus with a sheath, device support, sharp support, and handle mechanism for inserting an analyte sensor into the skin, allowing for discreet and efficient placement of in vivo sensors with reduced pain and improved convenience.

Engineering Contradictions & Design Principles

VSEngineering 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

Engineering Contradiction:

Improveconvenience of glucose monitoringVSAvoidpain associated with testing

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces traditional mechanical lancet-based blood sampling with a microneedle array system that uses controlled insertion mechanics to access interstitial fluid, reducing pain through smaller needle diameter and controlled deployment

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The microneedle array is nested within a protective sheath that is itself nested within the applicator device. The microneedles are concealed within the sheath until deployment, allowing for precise control of insertion depth and timing, which reduces pain and improves convenience

Inventive Principle:

Principle #7Nested doll (Nesting)

2Productivity

If in vivo analyte monitoring devices are used, then frequent monitoring is encouraged, but device complexity and insertion difficulty increase

Engineering Contradiction:

Improvefrequency of glucose monitoringVSAvoidcomplexity of in vivo sensor system

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The system is segmented into separate components: a reusable applicator device and disposable sensor cartridges. This segmentation simplifies the insertion process for frequent use while containing the complexity within the disposable cartridge that can be pre-prepared and sterilized

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The microneedle array and sensor are pre-assembled and pre-sterilized in the cartridge before use. This preliminary preparation eliminates complex sterilization and assembly steps during the actual insertion process, making frequent monitoring more convenient

Inventive Principle:

Principle #10Preliminary action

3Manufacturing precision

If microneedle array with sheath is used, then insertion precision is improved, but device structure complexity increases

Engineering Contradiction:

Improveinsertion depth controlVSAvoidsheath and support structure complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The sheath is constructed as a thin, flexible structure that can be precisely formed to control microneedle insertion depth. The flexibility allows the sheath to conform to skin surface variations while maintaining precise geometric control over the insertion pathway, achieving precision without excessive structural complexity

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS12558122B2Medical device inserters and processes of inserting and using medical devices

Publication Date: 2026.02.24 ABBOTT DIABETES CARE INC

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.