Heart Valve Prosthesis With Multiple Support Arms for Leakage and Migration
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Solution Overview
Problem
Existing prosthetic heart valves face challenges such as leakage between the implanted valve and surrounding tissue (paravalvular leakage) and movement/migration during the cardiac cycle, particularly in the mitral valve, due to anatomical complexities like the presence of chordae tendinae and high pressures in the left ventricle.
Innovation Solution
A heart valve prosthesis with a frame having multiple support arms, including a main support arm and supplemental arms of varying lengths, designed to engage native leaflets and annular tissue, preventing migration and leakage by distributing loads and securing the prosthesis in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthetic heart valve is implanted percutaneously, then minimally invasive delivery is achieved, but paravalvular leakage and valve migration occur due to insufficient engagement with native tissue
Solution Approach 1:
The support structure is divided into multiple discrete support arms extending from the valve frame, each capable of independent engagement with native tissue. This segmentation allows the valve to achieve secure anchoring through multiple distributed contact points while maintaining a compact deliverable form factor.
Solution Approach 2:
The support arms are designed with specific local characteristics including varying lengths, radial extensions, and engagement surface geometries optimized for interacting with specific native anatomical structures such as the annulus and leaflets. This local customization enables precise engagement at critical locations to prevent leakage and migration.
2Reliability
If the support arms are made longer to engage native tissue more effectively, then sealing and anti-migration improve, but the device complexity and risk of impingement on surrounding structures increase
Solution Approach 1:
The support arms are designed with asymmetric characteristics including varying lengths, different radial extension distances, and non-uniform angular distributions around the valve frame. This asymmetric configuration optimizes engagement with the asymmetric native mitral valve anatomy while avoiding impingement on surrounding structures such as the aortic valve.
Solution Approach 2:
The support arms incorporate dynamic characteristics allowing them to flex, bend, or adjust their engagement depth in response to cardiac cycle pressures and movements. This dynamic behavior enables reliable tissue engagement that adapts to physiological conditions without requiring excessive structural complexity.
Data Source
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AI summary
Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm (142) configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms (144) disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.