Leaflet Engagement Elements for Endovascular Valve Positioning
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Solution Overview
Problem
Current methods for endovascular heart valve replacement are invasive, risk high complications such as mispositioning, paravalvular leaks, and require life support during implantation, due to inadequate engagement and registration of replacement valves with native valves.
Innovation Solution
A percutaneous apparatus comprising an expandable anchor with a leaflet engagement element that actively foreshortens and locks in place, ensuring proper positioning and preventing migration, while allowing blood flow and preventing backflow, using a replacement valve integrated within the anchor.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current endovascular valve replacement devices are used, then percutaneous valve replacement can be achieved, but the devices become mispositioned with respect to the native valve
Solution Approach 1:
The delivery system includes a positioning mechanism that allows the anchor to be positioned relative to the native valve before final deployment. The system enables advancement of the anchor to a position proximal to the native valve, allowing verification of positioning before the valve is released, thereby preventing mispositioning that would block coronary ostia or impinge on the mitral apparatus
Solution Approach 2:
The system incorporates feedback mechanisms through fluoroscopic guidance and operator verification to ensure proper positioning of the anchor relative to the native valve. The ability to retract and reposition the anchor based on real-time imaging feedback ensures the device is correctly positioned before final deployment
2Ease of operation
If stent/valve devices crush the native valve leaflets against the heart wall, then valve replacement can be achieved, but positive registration is not provided
Solution Approach 1:
The device is divided into separate functional components: an anchor portion that engages the aortic wall and a valve portion that replaces the native valve. The anchor includes a positioning element that can be advanced independently to verify positioning before valve release, ensuring both device placement and positive registration are achieved through distinct operational steps
3Ease of operation
If stent/valve devices are used, then valve replacement can be performed, but the patient requires life support during implantation
Solution Approach 1:
The valve is designed to be deployable in a percutaneous fashion without requiring surgical exposure or life support. The anchor can be positioned and the valve deployed through catheter-based techniques, allowing the procedure to be completed without initiating life support systems, thereby reducing procedural complexity and patient risk
4Ease of manufacture
If stent comprises openings or gaps, then valve deployment is simplified, but paravalvular leaks increase
Solution Approach 1:
The device incorporates a sealing element or film that interfaces between the stent and the native valve to prevent paravalvular leaks. This flexible sealing component fills gaps and openings in the stent structure, maintaining seal integrity while allowing the stent to remain deployable through standard percutaneous techniques
Data Source
AI summary
The present invention relates to apparatus for methods for endovascularly replacing a patient's heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.