Heart Valve Leaflet Support Apparatus for Mitral Regurgitation
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Solution Overview
Problem
Dysfunctional heart valves, particularly mitral valves, experience regurgitation due to prolapse of leaflets, which existing treatments fail to adequately address without resorting to leaflet resection or annulus plication, and there is a need for a solution that provides passive support to prevent or mitigate this issue.
Innovation Solution
An apparatus comprising an annular support member and leaflet support members that are securely attached to the heart valve annulus, extending across the free edges of the valve leaflets to prevent regurgitation, with a 3D shape matching the valve's saddle-like configuration to maintain support during the cardiac cycle without deformation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing treatments are used for mitral valve regurgitation, then surgical intervention can correct the valve dysfunction, but invasive procedures like leaflet resection or annulus plication are required which carry higher risks and longer recovery
Solution Approach 1:
A support member is introduced as an intermediary element between the annulus and the leaflet. This support member provides structural reinforcement to prevent leaflet prolapse during systole without requiring direct resection of the leaflet or plication of the annulus, thereby reducing surgical invasiveness while maintaining valve reliability
Solution Approach 2:
The support member is designed with a segmented structure including an annular portion attached to the annulus and a leaflet support portion extending toward the leaflet. This segmentation allows the device to address specific functional requirements (annular support and leaflet reinforcement) independently, avoiding the need for more invasive comprehensive surgical procedures
2Strength
If a rigid support structure is used to prevent leaflet prolapse, then structural support is provided, but the structure may deform under the dynamic pressure changes during the cardiac cycle
Solution Approach 1:
The support member is constructed from a shape memory alloy that can change its mechanical properties (rigidity, elasticity) in response to temperature or stress changes. This allows the support member to maintain structural strength during systole when high pressure is present while adapting to pressure changes during the cardiac cycle, preventing both deformation and failure
Solution Approach 2:
The support member utilizes composite material construction combining shape memory alloy with other biocompatible materials. This composite structure provides both the necessary structural strength to prevent prolapse and the flexibility to accommodate dynamic pressure changes without deformation, resolving the contradiction between strength and stability
Data Source
AI summary
An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The apparatus includes an annular support member and at least one posterior leaflet support member. The annular support member has an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between the end portions. The at least one posterior leaflet support member is securely connected to the annular support member and is dimensioned to extend across a portion of a free edge of a posterior valve leaflet. The posterior leaflet support member comprises an arcuate center portion integrally formed with and extending between first and second end portions. The arcuate center portion has a concave shape relative to the anterior end portion. At least one of the first and second end portions is securely attached to the posterior end portion.