Stent-Graft Curvature via Suture Tethers for Aortic Apposition

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Solution Overview

Problem

Thoracic aortic aneurysm treatment using stent-grafts often results in endoleaks due to a 'bird-beak' formation, which disrupts fluid dynamics and prevents optimal apposition of the stent-graft to the aortic wall, especially in the aortic arch.

Innovation Solution

An endovascular implant comprising a tubular graft and stent hoops with sinusoidal configuration, connected by sutures that allow the stent-graft to self-adjust and conform to the aortic vessel shape, reducing the gap between the stent-graft and the vessel wall by changing from a linear to a curvilinear configuration upon deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a standard stent-graft is used for TAA treatment, then the procedure is less invasive with reduced surgical morbidity and mortality, but endoleaks occur due to lack of apposition to the aortic wall along the inside curve

Engineering Contradiction:
Improveless invasive treatmentVSAvoidapposition to aortic wall
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The stent-graft incorporates a control arrangement that allows dynamic adjustment of the graft length along the longitudinal axis, enabling the device to transition from a straight configuration during delivery to a curved configuration in situ to match the aortic arch geometry and achieve proper apposition

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The expansion restriction arrangement modifies the physical parameters of the graft by restricting expansion at specific regions, creating predetermined curvature that changes the graft's geometric parameters to conform to the curved aortic lumen

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If the stent-graft is made straight for easy delivery, then catheter delivery is simplified, but the device cannot conform to the curved aortic arch and creates bird-beak formation

Engineering Contradiction:
Improvecatheter deliveryVSAvoidconformation to curved lumen
Core Design Contradiction:
Ease of manufactureVSShape

Solution Approach 1:

The stent-graft is pre-configured with a control arrangement during manufacturing that enables predetermined curvature formation, allowing the device to be delivered straight through the catheter and then automatically assume the required curved shape upon deployment in the aortic arch

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The control arrangement segments the graft structure into regions with different expansion characteristics, allowing differential expansion that creates the necessary curvature while maintaining overall device integrity during delivery

Inventive Principle:
Principle #1Segmentation

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 self-adjusting stent-graft effectively mitigates the 'bird-beak' issue, ensuring better apposition to the aortic wall and reducing endoleaks, thereby improving fluid dynamics and treatment efficacy.

Implementation Method 1

The at least one suture connects one apex of one stent hoop to two apices of another stent hoop to reduce the predetermined distance so that in a compressed or crimped configuration (as inside a catheter sheath prior to delivery in a vessel), the stent-graft extends generally linearly as with the typical stent-graft. Yet in a released configuration (unconstrained in a catheter sheath) in a body vessel, the stent-graft is self-adjusting in-situ so as to curve away from the longitudinal axis

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3583915B1Endoprosthesis with predetermined curvature formed by tethers
Publication Date: 2021.05.12 CARDINAL HEALTH SWITZERLAND 515 GMBH
  • EP3583915B1 patent drawingFigure 1A
  • EP3583915B1 patent drawingFigure 1B~1C
  • EP3583915B1 patent drawingFigure 2

AI summary

Described are various embodiments of an improved endoprosthesis that includes a generally tubular graft, a plurality of independent stent hoops connected to the graft and at least one suture. The at least one suture connects one apex of one stent hoop to two apices of another stent hoop to reduce a predetermined distance between distinct stent hoops so that in a released configuration in a body vessel, the stent-graft is curved away from the longitudinal axis to conform to the body vessel and reduce formation of a gap between one end of the stent-graft with an inner surface of the body vessel.