Stent-Graft Perfusion Window for In Situ Fenestration

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Solution Overview

Problem

Current stent-grafts often poorly fit patient anatomy, leading to challenges in aligning fenestrations with side-branch vessels and potential occlusion of these vessels during implantation, requiring multiple surgical tools and imprecise placement.

Innovation Solution

A stent-graft design featuring a first portion that engages the vessel wall, a second portion with a smaller diameter that does not engage the wall, and a transition portion with perfusion windows for precise blood flow and visualization, allowing for in situ fenestration and precise alignment with side-branch vessels using contrast media and a fenestration device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stent-graft is implanted in a patient's abdominal aorta, then the aneurysm is treated, but blood flow to side-branch vessels (renal arteries) is occluded or blocked

Engineering Contradiction:
Improveaneurysm treatment effectivenessVSAvoidside-branch vessel occlusion
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The stent-graft is divided into multiple sections including a main body and separate side-branch components. The side-branch vessels are addressed as distinct segments that can be selectively opened or closed independently from the main aortic treatment, allowing the aneurysm to be treated while preserving side-branch perfusion through separate controllable mechanisms.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If fenestrations are manufactured a priori in stent-grafts, then side-branch vessel access is enabled, but the device fits poorly within patient anatomy due to pre-sized nature

Engineering Contradiction:
Improveside-branch vessel accessVSAvoidanatomic fit precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The stent-graft incorporates dynamic, adjustable fenestration mechanisms that can be opened or closed after implantation. This allows the device to adapt to the patient's specific anatomy post-implantation, combining the ease of pre-formed fenestrations with the precision of customized anatomic fitting through post-deployment adjustment capabilities.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If multiple guidewires and angiographic catheters are used for alignment, then fenestration alignment with side-branch vessels is achieved, but surgical complexity and equipment quantity increase

Engineering Contradiction:
Improvefenestration alignment precisionVSAvoidsurgical equipment quantity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The stent-graft integrates alignment and positioning functions directly into the device structure itself, combining what were previously separate tools (guidewires, catheters, and the stent-graft) into a single integrated system. This reduces the number of separate surgical tools needed while maintaining precise alignment capabilities through built-in positioning features.

Inventive Principle:
Principle #5Merging (Combining)

4Manufacturing precision

If stent-grafts are made with smaller diameter second portion, then device flexibility and placement precision are improved, but blood flow capacity is reduced

Engineering Contradiction:
Improveplacement precisionVSAvoidblood flow capacity
Core Design Contradiction:
Manufacturing precisionVSQuantity of substance

Solution Approach 1:

The stent-graft employs different diameters in different sections optimized for their specific functions: a smaller diameter in the precision placement zone for accurate positioning, and larger diameter sections in the main body and side-branches for adequate blood flow capacity. This local differentiation of dimensions allows both precise placement and sufficient flow capacity to coexist.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP2640311B1Stent-grafts and devices for in situ fenestration of a stent-graft at the site of a branch vessel
Publication Date: 2021.12.29 WL GORE & ASSOC INC
  • EP2640311B1 patent drawingFigure 1
  • EP2640311B1 patent drawingFigure 2
  • EP2640311B1 patent drawingFigure 3

AI summary

The present disclosure includes a stent-graft comprising a first portion that is configured to engage a vessel wall, a second portion that is configured not to engage the vessel wall, and a perfusion window that is configured to permit blood flow. The stent-graft may further comprise a transition portion between the first portion and the second portion, and the perfusion window may be formed in the first portion, the second portion, and/or the transition portion. In a variety of embodiments, one of the first and the second portion may have a smaller diameter than the other. Similarly, in a variety of embodiments, the transition portion may be frustoconically shaped.