External-Mounted TAVR Frame for Calcification-Resistant Hemodynamics
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Solution Overview
Problem
Existing transcatheter valve replacement (TAVR) prostheses suffer from calcification and degradation over time, leading to reduced hemodynamic performance and the need for repeated procedures, particularly in younger, lower-risk patients, with current designs focusing on delivery mechanisms rather than long-term durability and improved orifice area.
Innovation Solution
The valve construct is mounted to the exterior surface of the expandable frame, reducing inflammation and calcification by avoiding direct contact with native cardiac tissue, and featuring a design that allows leaflets to open beyond the frame's exterior surface, increasing the effective orifice area and improving hemodynamics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the valve construct is mounted to the interior surface of the frame, then the structural integration is improved, but the frame directly contacts native cardiac tissue causing inflammation and calcification
Solution Approach 1:
The patent inverts the conventional mounting arrangement by attaching the valve construct to the exterior surface of the frame rather than the interior surface. This inversion eliminates direct contact between the frame and native cardiac tissue, thereby reducing inflammation and calcification while maintaining structural integration through alternative attachment mechanisms on the exterior surface.
2Ease of operation
If the frame is designed with a compact structure for delivery, then the delivery through vascular is improved, but the effective orifice area is reduced
Solution Approach 1:
The frame is designed with dynamic expandability, transitioning from a compact compressed state for delivery through the vascular system to an expanded state at the deployment site. The frame can be compressed into a delivery catheter and then expanded to provide a larger effective orifice area, allowing both easy delivery and adequate valve function.
Solution Approach 2:
The valve construct is nested within the frame structure, with the frame providing a protective and supportive framework. The nested configuration allows the valve construct to be delivered through the frame's compressed state and then expanded to provide adequate orifice area, similar to nested dolls that can be compacted and then uncoiled.
3Reliability
If the valve prosthesis is designed for long-term durability, then the resistance to calcification is improved, but the hemodynamic performance may be compromised
Solution Approach 1:
The patent extracts the source of calcification by removing the frame's direct contact with native cardiac tissue. By mounting the valve construct to the exterior surface of the frame, the design eliminates the interface where calcification occurs, thereby improving long-term durability without compromising the hemodynamic performance of the valve construct itself.
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
This configuration enhances durability and reduces inflammation, calcification, and improves hemodynamic performance by maintaining a larger opening area and reducing pressure gradients, potentially eliminating the need for additional procedures.
Implementation Method 1
The frame may be self-expanding using a shape memory alloy
Data Source
AI summary
A replacement heart valve prosthesis for transcatheter repair of a native valve, the replacement heart valve comprises a valve construct mounted to the exterior surface of an expandable frame. The frame comprises an expandable region near the distal end of the frame, and a cusp region near the proximal region comprising a plurality of valve attachment features. The valve construct may be attached to the valve construct at least at the valve attachment features. The replacement heart valve prosthesis of present disclosure may be a more durable and long-lasting valve that has added benefits by placing valve tissue between the expandable frame and native cardiac tissue.