Custom Cannula Design via Tracheal Simulation

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Solution Overview

Problem

Tracheotomy cannulas often cause discomfort and complications due to mechanical stresses on the tracheal wall, leading to lesions, granulomas, and accidental decannulation, particularly in children with neuromuscular diseases, due to poor fit and anatomical mismatch.

Innovation Solution

A method for designing custom cannulas using 2D or 3D numerical representations of the patient's trachea, identifying anatomical landmarks, simulating cannula insertion, and iteratively adjusting cannula shape, dimensions, and material to minimize conflicts and ensure comfort and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a standard cannula is used for tracheotomy, then the procedure is simple and quick to perform, but the cannula causes mechanical stresses on the tracheal wall leading to discomfort, lesions, and complications

Engineering Contradiction:
Improveease of cannula insertionVSAvoidmechanical stress on tracheal wall
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The cannula shape is predetermined through 3D numerical simulation of tracheal anatomy and cannula insertion, allowing optimization of the cannula geometry before actual insertion to minimize mechanical stress on the tracheal wall

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The cannula design incorporates dynamic simulation of tracheal movements during breathing and patient position changes, allowing the cannula shape to adapt to tracheal deformation and reduce conflicts between the rigid cannula and flexible trachea

Inventive Principle:
Principle #15Dynamics

2Reliability

If a custom-fitted cannula is designed to match patient anatomy, then patient comfort and stability improve, but the design and manufacturing process becomes more complex

Engineering Contradiction:
Improvecannula stabilityVSAvoidcannula design complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

A 3D numerical representation (virtual copy) of the patient's trachea is created from medical imaging data, allowing the cannula design to be based on an accurate digital model rather than physical measurements or trial-and-error fitting

Inventive Principle:
Principle #26Copying

Solution Approach 2:

Physical trial-and-error cannula fitting is replaced with numerical simulation of cannula insertion and interaction with the trachea, allowing prediction and optimization of cannula performance before manufacturing

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

3Object-affected harmful factors

If the cannula shape is modified to reduce conflicts with the trachea, then patient comfort improves, but manufacturing precision requirements increase

Engineering Contradiction:
Improveconflicts with tracheaVSAvoidcannula shape precision
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The cannula design optimizes multiple geometric parameters (curvature, diameter, length, angulation) simultaneously based on the 3D numerical model of the patient's trachea, allowing customization without proportionally increasing manufacturing complexity

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3716106B1Method for designing and validating the shape and positioning of a cannula for a patient by simulating the insertion into the trachea
Publication Date: 2022.06.15 ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (APHP)
  • EP3716106B1 patent drawingFigure 1~2
  • EP3716106B1 patent drawingFigure 3
  • EP3716106B1 patent drawingFigure 4~5

AI summary

The present invention concerns a method for designing a cannula for a patient, wherein a processing unit is configured to implement following steps: a) generating a 2D or 3D numerical representation of the trachea of the patient in at least one position, b) identifying a set of anatomical landmarks, c) considering a 2D or 3D numerical representation of a cannula based at least on said landmarks, d) numerically simulating all or a part of an insertion and/or a final positioning of the cannula into the trachea, e) estimating at least one reciprocal conflict metric between the cannula and the trachea, f) changing the cannula when the estimated conflict metric do not meet predetermined conflict criterion, and iterating at least one of the preceding steps until a cannula is found for which said estimated conflict metric meets the predetermined conflict criterion.