Flexible Retainer for Mitral Valve Conformability
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Solution Overview
Problem
Current prosthetic heart valve devices face challenges in effectively replacing the mitral valve due to its irregular, non-circular shape and lack of radial support, leading to issues like backflow and instability, especially when compared to aortic valve replacements, which are more symmetric and uniform.
Innovation Solution
The development of prosthetic heart valve devices with a flexible retainer that conforms to the mitral valve annulus while maintaining the structural integrity of the valve support, allowing for mechanical isolation from distorting forces and providing a snug fit to prevent leaks and ensure proper coaptation of prosthetic leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid, symmetric valve support is used for prosthetic heart valve replacement, then the structural integrity and stability of the valve is improved, but the ability to conform to the irregular, non-circular mitral valve annulus shape deteriorates
Solution Approach 1:
The valve support is divided into multiple segments or struts that can independently move relative to each other, allowing the overall structure to change from a symmetric rigid form to an asymmetric conformable shape that matches the mitral annulus while maintaining structural integrity through the segmented design
Solution Approach 2:
The valve support transitions from a static rigid structure to a dynamic structure capable of changing its configuration. The support elements can move and adjust their positions to conform to the irregular mitral annulus shape while maintaining sufficient structural strength to support the prosthetic valve
2Adaptability or versatility
If the valve support is made flexible to conform to the mitral annulus shape, then the adaptability to irregular anatomy is improved, but the stability and resistance to distorting forces deteriorates
Solution Approach 1:
The flexible valve support is segmented into multiple independent elements that can move relative to each other. This segmentation allows the structure to be flexible enough to conform to the mitral annulus while maintaining stability, as the segmented design provides multiple points of contact and support distribution
Solution Approach 2:
The valve support utilizes composite material construction combining flexible elements with reinforcement structures. This allows the support to exhibit both flexibility for conformability and sufficient rigidity for stability against distorting forces from heart muscle contraction
3Ease of manufacture
If a symmetric circular valve frame is used, then the manufacturing and assembly process is simplified, but the ability to prevent backflow and ensure proper leaflet coaptation in the irregular mitral valve anatomy deteriorates
Solution Approach 1:
The valve frame transitions from a fixed symmetric configuration to a dynamic asymmetric configuration that can adapt to the mitral annulus shape. This dynamic adjustment capability allows the frame to achieve proper leaflet coaptation and prevent backflow while maintaining reasonable manufacturing simplicity through standardized components
Solution Approach 2:
The valve support is designed to transition from a symmetric manufactured form to an asymmetric deployed form that matches the irregular mitral annulus. This asymmetric capability is achieved through movable struts that can be positioned to create the necessary asymmetric shape for proper leaflet coaptation and backflow prevention
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 solution enables a secure, long-term anchoring of the prosthetic valve with reduced risk and faster recovery, effectively addressing the anatomical challenges of the mitral valve by adapting to its unique shape and providing structural support to withstand dynamic heart conditions.
Implementation Method 1
the retainer can be deformed in a non-circular shape by engagement with the tissue
Data Source
AI summary
A prosthetic heart valve device (100) for percutaneous replacement of a native heart valve includes an expandable retainer (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to the valve support. The retainer forms a donut-shaped flange (190) having an arcuate outer surface (142) for engaging tissue and an inner lumen defining a passage for blood to flow through the valve support. The retainer can include a plurality of circumferentially positioned, resiliency deformable and flexible ribs (114) which are coupled at their downstream ends 116 to the valve support 120. The flexible ribs, in one embodiment, can have a general C-shape configuration with the tips (117) of the flexible ribs and an opening (119) of the C-shape configuration oriented toward a longitudinal axis (101) of the device.