Nonlinear Superelastic NiTi Endodontic File Manufacturing

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Solution Overview

Problem

Endodontic rotary instruments face challenges such as ledging, transportation, perforation, and instrument separation due to cyclic bending and torsional stresses during root canal procedures, with existing Shape Memory Alloy (SMA) files not adequately addressing these issues in terms of flexibility and resistance to fracture.

Innovation Solution

A method for manufacturing nonlinear superelastic files using a fixture to shape-set Nickel-Titanium (NiTi) files, which allows for expansion or collapse while maintaining geometry, and altering the austenite finish temperature to create a non-superelastic state for enhanced flexibility and fatigue resistance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If conventional crimping method is used to shape the file, then the file can be bent to desired radius, but the fluting may be damaged and the file weakened

Engineering Contradiction:
Improvefile bend radiusVSAvoidfile strength and fluting integrity
Core Design Contradiction:
ShapeVSReliability

Solution Approach 1:

The patent replaces the conventional mechanical crimping process with an electroforming process. Instead of mechanically crimping the file to achieve the desired bend radius, the file is electroformed directly into the target nonlinear shape, eliminating mechanical deformation that damages fluting and weakens the structure. This substitution of manufacturing methodology resolves the contradiction between achieving desired shape and maintaining structural integrity.

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

Solution Approach 2:

The patent applies preliminary action by pre-forming the nonlinear geometry through electroforming before the file is used. The desired bent shape is established during manufacturing rather than through post-manufacturing crimping, ensuring the fluting and structural integrity are maintained throughout the bending process without subsequent damage.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If Shape Memory Alloy files are used, then overall performance improves, but resistance to fracture from cyclic fatigue and torsional overload is insufficient

Engineering Contradiction:
Improveoverall instrument performanceVSAvoidresistance to fracture
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies parameter changes by modifying the material composition of the Shape Memory Alloy through controlled addition of elements like copper, aluminum, or iron. These compositional parameter changes tune the alloy's mechanical properties to achieve optimal balance between flexibility and fracture resistance, directly addressing the insufficient resistance to cyclic fatigue and torsional overload while maintaining overall performance.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials by creating multi-element Shape Memory Alloy systems (e.g., Ni-Ti-Cu, Ni-Ti-Al, Ni-Ti-Fe) rather than using binary Ni-Ti alloys. These composite alloy systems combine the beneficial properties of different elements to achieve superior mechanical strength and fracture resistance while retaining the shape memory characteristics needed for endodontic applications.

Inventive Principle:
Principle #40Composite materials

3Manufacturing precision

If conventional tapered file is used, then circular cross-section is produced, but ability to adapt to varying root canal geometries is limited

Engineering Contradiction:
Improvecircular cross-section geometryVSAvoidadaptability to root canal geometry
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The patent applies curvature principles by transitioning from straight, conventionally tapered files to files with controlled nonlinear curvatures and bends. The electroforming process enables precise creation of curved geometries that match the natural anatomy of root canals, allowing the instrument to adapt to varying canal shapes while maintaining manufacturing precision through controlled electrochemical deposition.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The patent implements dynamics by creating files with variable cross-sectional geometries along their length rather than uniform circular sections. The electroforming process allows different regions of the file to have optimized shapes - some sections may be more flexible, others more rigid - enabling the file to dynamically adapt to the complex three-dimensional geometry of root canals during clinical use.

Inventive Principle:
Principle #15Dynamics

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

The method results in endodontic instruments with improved flexibility, resistance to cyclic fatigue, and reduced likelihood of instrument separation, effectively navigating complex root canal geometries without damaging the fluting and maintaining structural integrity.

Implementation Method 1

heating the portion of the shaft to a temperature of at least about 300°C for a time period of at least about 5 minutes to shape-set the portion of the shaft

Methodology Applied
Scientific EffectHeat treatment: Heat Treatment

Implementation Method 2

providing a shape memory alloy file; heating the shape memory alloy file to a temperature from about 300° C to about 600° C for a period of time from about 5 minutes to about 120 minutes to alter the austenite finish temperature

Methodology Applied
Scientific EffectShape memory alloy phase transformation: Shape Memory Alloy

Data Source

PatentEP3345566B1Methods of manufacturing endodontic instruments
Publication Date: 2020.08.19 DENTSPLY SIRONA INC
  • EP3345566B1 patent drawingFigure 1A~2
  • EP3345566B1 patent drawingFigure 1B~1C
  • EP3345566B1 patent drawingFigure 3

AI summary

A method for manufacturing a nonlinear superelastic file comprising the steps providing a superelastic file having a shaft and a file axis; providing a fixture including a groove being defined by one or more displacement members, the file groove configured receiving the shaft; inserting at least a portion of the shaft into the fixture along the file groove the portion of the shaft including a first portion of the shaft; contacting the first portion of the shaft with a first displacement member of the one or more displacement members such that first portion of the shaft is displaced from the file axis thereby forming a first offset portion of shaft; heating the portion of the shaft while inserted in the fixture to a temperature of at least about 300°C for a time period of at least about 1 minute to shape-set the portion of the sh thereby forming a shape-set nonlinear file.