Concentric Prosthetic Valve Frames for Secure Leaflet Coaptation
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to incomplete coaptation of valve leaflets and subsequent blood regurgitation, which increases stroke volume and weakens the ventricle.
Innovation Solution
A prosthetic valve implant with concentric frames, comprising an inner and outer frame, is percutaneously delivered and expanded at the native heart valve, securing tissue between the upstream support and flanges, with prosthetic leaflets connected via flexible sheets and connectors to ensure proper coaptation and prevent regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to prevent regurgitation, then coaptation of leaflets is improved, but device complexity increases due to concentric frames and connectors
Solution Approach 1:
The patent employs nested concentric frames where an inner frame is positioned within an outer frame. The inner frame provides structural support for the prosthetic leaflets while the outer frame offers additional stabilization and anchoring to the native valve annulus. This nested configuration ensures proper leaflet coaptation and prevents regurgitation without requiring overly complex single-structure designs.
Solution Approach 2:
The prosthetic valve is segmented into distinct functional components: the inner frame supporting the leaflets, the outer frame for annular stabilization, and flexible connectors joining the frames. This segmentation allows each component to be optimized for its specific function while working together as an integrated system to prevent regurgitation.
2Reliability
If the implant is made secure by sandwiching tissue between frames, then reliability of fixation is improved, but ease of operation during implantation deteriorates
Solution Approach 1:
The concentric frames are pre-configured with the inner frame nested within the outer frame before implantation. The flexible connectors are pre-attached to join the frames at predetermined locations. This preliminary assembly ensures that when the implant is deployed, the frames automatically assume their secure sandwiching configuration around the native valve tissue, reducing the complexity of the implantation procedure while maintaining reliable fixation.
3Reliability
If prosthetic leaflets are connected via flexible sheets and connectors, then coaptation quality is improved, but device complexity increases
Solution Approach 1:
The patent utilizes flexible sheet connectors to join the inner and outer frames and to attach the prosthetic leaflets. These thin film connectors provide the necessary flexibility to allow natural leaflet movement and coaptation while maintaining structural integrity. The flexible material accommodates physiological motions without compromising the connection between frames or the coaptation quality of the leaflets.
Data Source
AI summary
A unitary flexible sheet (612) is folded to define (i) a panel (608); (ii) a first tab (606a), having a first-tab outer layer and a first-tab inner layer, and protruding away from the panel; and (iii) a second tab (606b), having a second-tab outer layer and a second-tab inner layer, and protruding away from the panel. A commissural portion of a first prosthetic leaflet (58a), and a commissural portion of a second prosthetic leaflet (58b) are disposed between the first-tab inner layer and the second-tab inner layer. A first stitching (632) is stitched through the inner layer of each tab, and the commissural portion of each leaflet. A second stitching (634) is stitched through the outer and inner layers of each tab, and the commissural portion of each leaflet. The first-tab outer layer and the second-tab outer layer cover the first stitching. Other embodiments are also described.