Flared Prosthetic Cardiac Valve Structure for Transseptal Delivery
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Solution Overview
Problem
Existing prosthetic valves for treating diseased heart valves, such as the mitral valve, are too large to be delivered transeptally, require invasive transapical access, and have suboptimal strength-weight ratios, often causing obstruction and thrombosis.
Innovation Solution
A prosthetic valve device with a frame structure featuring a flared outflow end, unsupported inflow edge, and commissure attachment mechanisms, allowing for a gap between the outflow edge and frame circumference, which minimizes delivery size and maximizes functional space within the heart chamber.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If existing prosthetic valves are used to treat diseased heart valves, then valve replacement function is achieved, but the device size is too large to be delivered transeptally, requiring invasive transapical access
Solution Approach 1:
The prosthetic valve device is designed with a nested structure where the valve frame and components are contained within a delivery catheter. The valve can be collapsed into a compact form for delivery through the transeptal route, then expanded at the target site to provide full functionality. This nesting approach allows the valve to transition between small delivery size and large functional size, resolving the contradiction between deliverability and functional dimensions.
2Strength
If existing prosthetic valves are used, then valve replacement is achieved, but the strength-weight ratio is suboptimal, causing obstruction and thrombosis
Solution Approach 1:
The valve frame incorporates varying wall thicknesses and structural densities at different locations. The struts and arches have optimized thicknesses that provide maximum strength where needed while minimizing material usage in less critical areas. This local quality optimization improves the overall strength-weight ratio and reduces the valve's profile, thereby decreasing obstruction risks and thrombosis potential.
Solution Approach 2:
The valve device utilizes composite material construction, combining different materials with complementary properties. The frame may use materials with high strength-to-density ratios, while surface coatings provide thromboresistance. This composite approach simultaneously addresses strength requirements and harmful effects like thrombosis, resolving the contradiction between structural integrity and safety.
3Productivity
If existing prosthetic valves are used, then valve replacement function is provided, but the device takes up too much space within the valve chambers, resulting in obstruction of outflow
Solution Approach 1:
The valve frame is divided into multiple segmented struts and arches rather than a solid continuous structure. This segmentation creates open spaces between the structural elements, allowing blood to flow through multiple pathways. The segmented design reduces the effective volume occupied by the valve while maintaining structural strength, thereby improving blood flow capacity and reducing obstruction.
Solution Approach 2:
The valve frame employs a porous or lattice-like structural design that allows blood to pass through the framework. The spaces between struts and the porous nature of certain frame sections enable unrestricted blood flow while the structural elements provide necessary support. This approach minimizes the valve's effective volume and eliminates flow obstruction.
Data Source
AI summary
A device for treating a diseased native valve in a patient is provided, the device including a frame structure; a valve segment positioned radially within the frame structure, the valve segment comprising a plurality of leaflets, and a plurality of commissure attachment mechanisms coupling the leaflets to the frame structure, each commissure attachment mechanism extending radially inwards from an outflow end of the frame structure as to create a gap between an interior diameter of the outflow end and an outflow edge of the valve segment. Other embodiments and methods of use are also provided.