Sinusoidal Prosthetic Valve Stents for Buckling-Resistant Deployment
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Solution Overview
Problem
Existing cardiac valve prostheses face challenges in deploying securely within enlarged right ventricular outflow tracts due to limited size availability, leading to issues like backfolding, buckling, and regurgitation, especially in patients with anatomical variations.
Innovation Solution
A prosthetic valve device with a tubular graft and sinusoidal patterned radially-expandable stents, featuring specific angular orientations and reinforced connections, designed to maintain structural integrity and prevent backfolding and buckling during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cardiac valve prostheses are used in enlarged right ventricular outflow tracts, then the device can be implanted, but backfolding and buckling occur during deployment
Solution Approach 1:
The stent is divided into multiple segments or sections along its length, with each segment capable of independent expansion control. This segmentation allows the proximal and distal portions to be deployed at different times or with different forces, preventing backfolding and buckling during the deployment process while maintaining overall structural integrity.
Solution Approach 2:
The stent incorporates dynamic characteristics through its sinusoidal pattern and radial expandability, allowing it to adapt its shape and rigidity during deployment. The structure transitions from a compressed delivery state to an expanded deployed state, with the ability to conform to anatomical variations while maintaining stability against backfolding and buckling forces.
2Adaptability or versatility
If standard-sized prosthetic valves are implanted in patients with anatomical variations, then implantation is possible, but regurgitation occurs
Solution Approach 1:
The stent features varying local properties along its length, with different radial strengths, expansion ratios, or structural densities at different segments. This allows the stent to adapt to local anatomical variations in the right ventricular outflow tract while maintaining adequate sealing performance at the valve annulus, preventing regurgitation despite anatomical diversity.
Solution Approach 2:
The stent design incorporates adjustable parameters such as radial expandability, sinusoidal amplitude, and segment length that can be modified to match different anatomical configurations. These parameter changes enable the same device to adapt to various anatomical variations while maintaining reliable sealing and preventing regurgitation.
3Ease of operation
If minimally invasive percutaneous replacement is performed, then patient recovery is improved, but device backfolding and buckling increase
Solution Approach 1:
The stent is pre-formed with a sinusoidal pattern and pre-loaded with radial expansion force before delivery. This preliminary preparation ensures that upon release from the delivery catheter, the stent expands in a controlled manner without backfolding or buckling, enabling minimally invasive percutaneous deployment while maintaining deployment stability.
Solution Approach 2:
The delivery catheter acts as an intermediary that maintains the stent in a compressed, stable configuration during navigation through the vascular system. The catheter provides support and control during insertion, then releases the stent at the target site, allowing minimally invasive deployment without backfolding or buckling.
4Adaptability or versatility
If venous valvular replacements with limited size range are used, then smaller devices can be implanted, but secure implantation in enlarged tracts is not achieved
Solution Approach 1:
The stent design provides universal applicability across a wide range of anatomical sizes and configurations. The sinusoidal patterned radially-expandable structure can be scaled to different diameters while maintaining its structural characteristics, allowing secure implantation in both smaller and enlarged right ventricular outflow tracts with a single device platform.
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 device ensures secure implantation in varied anatomies without regurgitation, buckling, or kinking, enhancing hemodynamic performance and reducing the need for specialized deployment techniques.
Implementation Method 1
sinusoidal patterned radially-expandable stents... Each of the inflow stent, the outflow stent, and each stent of the plurality of body stents is a sinusoidal patterned radially-expandable ring
Data Source
AI summary
A prosthesis includes a tubular graft, a prosthetic valve component, an inflow stent, an outflow stent, and a plurality of body stents disposed between the inflow and outflow stents. Each stent is a sinusoidal patterned radially-expandable ring having a first set of crowns and a second set of crowns, with the first set of crowns disposed closer to an inflow end of the tubular graft than the second set of crowns. The prosthesis is configured to be resistant to backfolding and/or buckling during deployment thereof.