Sensor Insertion Tool for Needle-Free Flexible Sensor Delivery

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Solution Overview

Problem

The insertion of flexible analyte sensors through the skin is often painful and uncomfortable due to the use of piercing mechanisms, discouraging long-term use and affecting user compliance with continuous blood analyte monitoring.

Innovation Solution

A sensor insertion tool (SIT) provides motive force for inserting flexible analyte sensors into the skin without needles, using a mechanism that includes a cocking member to load energy into springs or other means like chemical reactions, allowing the sensor to be driven through the skin via a channel guide assembly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If flexible sensors are used to improve comfort during long-term use, then user comfort is improved, but the ability to directly penetrate unbroken skin diminishes

Engineering Contradiction:
Improveuser comfortVSAvoidinability to penetrate skin
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent introduces a delivery device as an intermediary mechanism that enables flexible sensors to penetrate skin without requiring the sensor itself to be rigid or sharp. The delivery device contains the flexible sensor and provides the necessary force and guidance to push the soft sensor through the skin barrier, resolving the contradiction between sensor flexibility and skin penetration capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-generated harmful factors

If piercing mechanisms are used to enable sensor insertion through skin, then skin penetration capability is improved, but user discomfort and pain increase

Engineering Contradiction:
Improveskin penetration capabilityVSAvoiduser discomfort and pain
Core Design Contradiction:
Object-generated harmful factorsVSObject-affected harmful factors

Solution Approach 1:

The delivery device serves as a mediator that performs the skin penetration function without requiring traditional piercing mechanisms like needles. The device mechanically pushes the flexible sensor through the skin using controlled force, eliminating the need for sharp or traumatic insertion methods while maintaining effective skin penetration.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces traditional mechanical piercing systems (needles, sharp points) with a controlled mechanical pushing system. The delivery device uses a combination of mechanical force application and guidance structures to gently advance the flexible sensor through the skin, substituting harsh piercing mechanics with a more controlled and comfortable insertion process.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Object-generated harmful factors

If rigid hollow mechanisms like needles or cannulas are used for sensor insertion, then skin penetration is achieved, but device complexity and user reluctance increase

Engineering Contradiction:
Improveskin penetration capabilityVSAvoidinsertion mechanism complexity
Core Design Contradiction:
Object-generated harmful factorsVSDevice complexity

Solution Approach 1:

The patent extracts the skin penetration function from complex traditional piercing devices like needles and cannulas. The delivery device isolates and simplifies this function by using a straightforward mechanical pushing mechanism that advances the sensor through the skin without requiring the complexity of hollow structures or sharp geometric forms.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the key parameters of the insertion mechanism from rigid, sharp, hollow structures to a flexible, solid, controlled-force system. By altering the mechanical properties of the insertion approach (from piercing to pushing, from rigid to flexible), the device achieves skin penetration with reduced complexity and improved user acceptance.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method reduces user discomfort and increases compliance with continuous monitoring by enabling painless and efficient insertion of flexible sensors, improving user experience and medical outcomes.

Implementation Method 1

a sensor hammer positioned within the sensor insertion tool and configured to be struck by a release mechanism, causing the sensor hammer to strike the sensor subassembly with sufficient force to drive the sensor through a channel in the sensor assembly and into skin without the use of means for piercing the skin prior to insertion

Methodology Applied
Scientific EffectSpring: Spring

Data Source

PatentUS12446831B2System, method and apparatus for sensor insertion
Publication Date: 2025.10.21 KONAMITE LTD
  • US12446831B2 patent drawing
  • US12446831B2 patent drawing
  • US12446831B2 patent drawing

AI summary

Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.