Aortic Stent Frame With Dry Pericardial Valve for PVL Control
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Solution Overview
Problem
Existing aortic valve replacements face issues such as paravalvular leakage (PVL), malpositioning, calcium interference, and implant migration, particularly in high-risk or inoperable patients, and biological tissues used for prosthetic valves degrade and calcify, leading to device failure.
Innovation Solution
A stent with a stent frame formed by interconnected arms creating diamond-shaped cells, incorporating a dry bovine pericardium valve that can be rehydrated and secured with a skirt, and eyelets for fixation, designed for minimally invasive transcatheter implantation, with anti-calcification treatment to enhance durability and compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional surgical aortic valve replacement is performed, then valve replacement can be achieved with flexibility in implant type, but surgical risk increases particularly for elderly patients with comorbidities
Solution Approach 1:
The patent replaces traditional surgical mechanical valve implantation with a transcatheter-based delivery system that uses catheter inflation to deploy the valve prosthesis through the femoral artery, eliminating the need for open-heart surgery and significantly reducing surgical risk for elderly patients
Solution Approach 2:
The patent introduces a catheter as an intermediary delivery mechanism that carries the compressed valve prosthesis through the bloodstream to the aortic position, where it is deployed via balloon inflation, serving as a mediator between the implant and the target site without requiring direct surgical access
2Ease of operation
If stent sizing is incorrect or malpositioning occurs, then implantation is simplified, but paravalvular leakage increases
Solution Approach 1:
The patent incorporates preliminary positioning features including radiopaque markers that enable pre-deployment verification of correct stent position and sizing before final valve deployment, allowing correction of positioning errors before they cause paravalvular leakage
Solution Approach 2:
The patent uses radiopaque materials and markers that appear under fluoroscopic imaging to indicate stent position, sizing, and deployment status, enabling real-time visual feedback during implantation to prevent malpositioning and leakage
3Ease of operation
If calcium deposits interfere with implant expansion, then implantation proceeds, but valve function is compromised
Solution Approach 1:
The patent employs a balloon-expandable spherical or cylindrical deployment mechanism that applies uniform radial force around the entire stent circumference, ensuring complete expansion even in the presence of circumferential calcium deposits that might obstruct asymmetric expansion methods
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 stent reduces trauma and improves implant accuracy, preventing PVL and calcification, making it suitable for high-risk patients, ensuring stable and durable valve function.
Implementation Method 1
the dry bovine pericardium being configured to be rehydrated with a solution
Data Source
AI summary
The invention relates to a stent for placement at an aortic annulus that is expandable from an undeployed state to a deployed state comprising a stent frame having rows of cells with a proximal section and a distal section at a longitudinal axis of the stent, the stent frame being formed by a plurality of arms, the arms being connected to one another at connection points, and wherein the plurality of arms forms a plurality of diamond-shaped stent cells, in particular the rows of cells, formed of vertices at said connection points between the arms, a dry valve made out bovine pericardium arranged at least at the distal section of the stent with the dry bovine pericardium being configured to be rehydrated with a solution, a skirt surrounding the dry valve and comprising at least one of bovine pericardium and polyester, and one or more eyelets arranged at a distal end of some of the arms, with the eyelets being configured to fix the valve to the stent frame.