Vascular Prosthesis With Crimped Adapter for Branch Alignment
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Solution Overview
Problem
Existing endovascular repair devices face challenges in maximizing blood flow to vital organs and minimizing endoleaks during the repair of aortic aneurysms, particularly in regions with arterial branches, such as juxtarenal and short-neck abdominal aortic aneurysms, to avoid additional surgical intervention.
Innovation Solution
A vascular prosthesis with a luminal graft component and crimped adapter that includes concentric folds, allowing for flexible alignment and secure fixation of branch prostheses through fenestrations, enhancing alignment with arterial branches and reducing endoleaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size fenestration is used in the vascular prosthesis, then the structure is simple and manufacturing is easier, but the device cannot accommodate anatomical variations in branch vessel size and position, reducing adaptability
Solution Approach 1:
The crimped adapter incorporates concentric crimped folds that allow the adapter to dynamically change shape and size. These folds enable the adapter to expand and contract radially, allowing the opening to adapt to different branch prosthesis sizes and positions while maintaining a relatively simple base structure. The dynamic folding mechanism provides adaptability without requiring multiple different adapter sizes.
Solution Approach 2:
The crimped adapter changes its physical parameters (opening size and shape) through the folding mechanism. By crimping the adapter with concentric folds, the opening can be compressed to a smaller delivery profile and then expanded to various final configurations to match different anatomical variations in branch vessels.
2Reliability
If the opening in the crimped adapter has a fixed diameter smaller than the fenestration, then the adapter provides stable sealing, but the adapter cannot accommodate misalignment between the fenestration and branch prosthesis
Solution Approach 1:
The concentric crimped folds create a dynamic structure that can adjust the opening size and shape in response to alignment variations. When the branch prosthesis is positioned, the folds can flex and deform to accommodate slight misalignments while maintaining contact with the prosthesis, ensuring reliable sealing without requiring perfect initial alignment.
Solution Approach 2:
The crimped adapter functions as a flexible sealing structure that can deform to conform to the branch prosthesis. The thin-walled crimped construction allows the adapter to flex and adapt its shape to maintain sealing contact, providing reliable sealing even when there are variations in alignment between the fenestration and the branch prosthesis.
3Manufacturing precision
If the crimped adapter uses rigid structure, then manufacturing precision is easier to achieve, but the adapter cannot flex to accommodate positioning variations of the branch prosthesis
Solution Approach 1:
The crimped folds transform a relatively rigid structure into a dynamic, flexible component. The folding pattern allows the adapter to maintain precise dimensional control during manufacturing while enabling flexible deformation during implantation to accommodate positioning variations of the branch prosthesis.
Solution Approach 2:
The adapter uses a thin-walled crimped construction that provides flexibility. The crimped pattern creates a structure that is precise enough for manufacturing but flexible enough to deform and adapt to the actual positioning of the branch prosthesis during the procedure, bridging the gap between manufacturing precision and operational flexibility.
4Adaptability or versatility
If the crimped folds are made with large amplitude, then the adapter has greater flexibility to accommodate variations, but the adapter structure becomes more complex and harder to manufacture
Solution Approach 1:
The crimping process allows control of the fold amplitude as a manufacturing parameter. By optimizing the crimping parameters (force, depth, spacing), the adapter achieves sufficient flexibility for accommodating anatomical variations while keeping the fold amplitude within manufacturable limits. The concentration of folds in specific regions provides flexibility where needed without unnecessarily complicating the entire structure.
Data Source
AI summary
The vascular prosthesis includes a luminal graft component that defines at least one fenestration and a crimped adapter at the at least one fenestration. The crimped adapter includes a perimeter and an opening with a diameter smaller than the diameter of the fenestration, and includes a crimped portion of generally concentric folds about the opening. The opening can move relative to the perimeter region of the crimped adapter to accommodate positioning of a branch prosthesis extending through the crimped adaptor. The vascular prosthesis is implanted in a patient to thereby treat, for example, an arterial aneurysm that spans a region of an artery that includes at least one arterial branch.