Shape-Conforming Prosthetic Valve Implant for Calcified Tissue
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Solution Overview
Problem
Mitral annular calcification leads to reduced flexibility and thickness of the mitral valve annulus, causing regurgitation and decreased cardiac output due to incomplete valve closure, which existing prosthetic valves struggle to address effectively.
Innovation Solution
A prosthetic valve with a frame and deformable shape-conforming element, such as a foam or metal mesh, is implanted via a catheter to conform to calcified native heart valves, enhancing anchoring and reducing paravalvular leakage by adapting to the abnormal geometry and topography.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid prosthetic valve is implanted at a calcified native valve, then the valve structure provides stable support, but the valve cannot conform to the abnormal geometry and topography of calcified tissue, resulting in paravalvular leakage
Solution Approach 1:
The prosthetic valve is divided into two functional components: a rigid frame providing structural stability and support, and a separate deformable shape-conforming element that adapts to the calcified tissue. This segmentation allows each component to optimize its specific function without compromising the other.
Solution Approach 2:
The prosthetic valve combines rigid and deformable materials in a composite structure. The frame is made of rigid material for stability, while the shape-conforming element uses deformable material (such as foam or sponge) to conform to the abnormal geometry of calcified tissue, creating a composite structure that achieves both stability and adaptability.
2Adaptability or versatility
If the prosthetic valve is made deformable to conform to calcified tissue, then anchoring is enhanced, but the valve structure loses rigidity and structural support
Solution Approach 1:
The valve is segmented into a rigid frame component that provides structural support and a separate deformable shape-conforming element that provides adaptability. This segmentation ensures that rigidity and deformability are not compromised in the same component but are distributed to different components with specialized functions.
Solution Approach 2:
The deformable shape-conforming element acts as an intermediary between the rigid frame and the calcified native valve. It transfers the conformability function to the tissue interface while the rigid frame maintains overall structural integrity, effectively mediating between the conflicting requirements of rigidity and adaptability.
3Ease of manufacture
If existing prosthetic valves are used at calcified native valves, then the valve can be implanted, but regurgitation occurs due to incomplete valve closure from inability to conform to abnormal geometry
Solution Approach 1:
The shape-conforming element changes its physical parameters (shape, volume, density) in response to the mechanical environment of the calcified valve. This parameter change allows the element to adapt to the abnormal geometry, ensuring complete valve closure and preventing regurgitation while maintaining ease of implantation.
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 prosthetic valve effectively anchors to calcified native valves, minimizing regurgitation and improving cardiac output by conforming to the native valve's shape, thereby reducing leakage and enhancing functional performance.
Implementation Method 1
Some portions of the shape-conforming element are deformed by being radially compressed toward a central longitudinal axis of the prosthetic valve so as to conform to radially-inwardly protruding calcified tissue
Data Source
AI summary
Apparatus is provided for use at a calcified native valve of a patient's heart, the apparatus including a prosthetic valve (22, 62, or 66) deliverable to the heart through a catheter. The prosthetic valve includes a frame (24) that includes: (i) a valve body (26) that circumscribes a central longitudinal axis of the prosthetic valve and defines a lumen along the axis; and (ii) arms (28) that are attached to and extend from respective circumferential sites of the valve body in an upstream direction. Each of the arms extends radially outward to a respective arm-tip (29) in an expanded state of the frame. Prosthetic leaflets (55) are disposed within the lumen and facilitate one-way fluid flow through the lumen following implantation of the prosthetic valve in the heart. A shape-conforming element (40) surrounds the valve body and conforms to calcified areas of cardiac tissue. Other embodiments are also described.