Contoured Internal Limb for Endovascular Re-intervention
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Solution Overview
Problem
The complexity of re-intervening in endovascular aortic aneurysm repairs due to anatomical changes, size mismatches, and complications such as endoleak and stent graft migration poses challenges in accessing and re-lining existing stent grafts, especially with increased patient comorbidities and surgical risks.
Innovation Solution
A contoured internal limb is created from a tubular segment of graft material, tailored to fit specific anatomical features, allowing easy access for cannulation through existing stent graft legs or limbs, and designed to conform to fenestrations in bifurcated prostheses, ensuring secure sealing and minimizing interference with visceral arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard stent graft is implanted for endovascular aortic aneurysm repair, then the initial sealing and support are achieved, but anatomical changes and size mismatches occur over time leading to endoleak and migration
Solution Approach 1:
The internal limb is designed with a contoured, non-circular cross-section that can dynamically adapt to the anatomical geometry of the aorta and visceral arteries. The contoured shape allows the device to conform to changing anatomical conditions over time, maintaining sealing stability despite anatomical changes and preventing endoleak and migration.
Solution Approach 2:
The internal limb features a contoured cross-section with varying dimensions at different locations along its length. The proximal portion has different dimensions than the middle and distal portions, allowing each section to be optimized for local anatomical conditions. This local quality variation enables better adaptation to the complex geometry of the aorta and branch vessels, improving overall sealing reliability.
2Reliability
If re-intervention is performed to address endoleak or migration, then the complications can be treated, but the procedure complexity increases due to involvement of visceral arteries and existing stent graft structure
Solution Approach 1:
The internal limb is divided into distinct segments: a proximal portion, a middle portion, and a distal portion, each with specific contoured dimensions. This segmentation allows the device to be selectively deployed in different anatomical zones and facilitates targeted re-intervention if complications occur, reducing the complexity of subsequent procedures by limiting the scope of required adjustments.
Solution Approach 2:
The contoured internal limb acts as an intermediary device that can be deployed within the existing stent graft structure to address endoleak or migration. Its specialized geometry allows it to interface with both the existing prosthesis and the native anatomy, providing a bridge solution that simplifies re-intervention compared to complete explant and replacement.
3Reliability
If the internal limb is made to conform to fenestrations and anatomical features, then sealing and stability are improved, but the manufacturing complexity increases
Solution Approach 1:
The internal limb is pre-formed with a contoured cross-section during the manufacturing process, rather than requiring post-implantation shaping. The proximal, middle, and distal portions are predetermined with specific dimensional variations to match expected anatomical geometries. This preliminary action simplifies the overall process by incorporating the contouring into manufacturing, reducing the need for complex custom shaping after implantation.
4Adaptability or versatility
If the stent graft design accommodates visceral artery involvement, then anatomical versatility is improved, but the device length and complexity increase
Solution Approach 1:
The internal limb utilizes variations in its cross-sectional parameters along its length, with the proximal portion having different dimensions than the middle and distal portions. These parameter changes allow the device to accommodate different anatomical configurations and visceral artery involvement patterns without requiring proportional increases in overall device length, maintaining compactness while improving adaptability.
Data Source
AI summary
A method of making a contoured internal limb including providing a flattened tubular segment of graft material, and a prosthesis including the contoured internal limb. The tubular segment includes a left lateral edge, a right lateral edge, a first length extending from the left lateral edge to the right lateral edge, and a second length extending from a proximal end to a distal end of the tubular segment. The method also includes contouring a proximal portion, a middle portion, and a distal portion of the contoured internal limb from the tubular segment. The method also includes closing a right lateral edge of the proximal portion and a right lateral edge of a first section of the middle portion. The method further includes removing the proximal, middle and distal portions of the contoured internal limb from the tubular segment and maintaining a second section of the middle portion as circumferentially continuous.