Leaflet Engagement Elements for Heart Valve Anchoring
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Solution Overview
Problem
Current methods for endovascular heart valve replacement are invasive, risk-prone, and suffer from issues like mispositioning, blockage of coronary ostia, and paravalvular leaks due to improper seating and migration of stent/valve devices, which complicate the procedure and prolong recovery.
Innovation Solution
An expandable anchor with a leaflet engagement element is used for percutaneous delivery and deployment, actively foreshortening to ensure proper positioning and locking, preventing distal migration, and incorporating a replacement valve that allows blood flow while preventing backflow, thus addressing the issues of mispositioning and leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current stent/valve devices are used for endovascular heart valve replacement, then the procedure can be performed percutaneously, but the devices become mispositioned and risk blocking coronary ostia
Solution Approach 1:
The delivery system includes a positioning mechanism that pre-establishes the correct position before valve deployment. The system allows the operator to advance the device to the target location and confirm positioning before releasing the valve, ensuring the valve is positioned distal to the coronary ostia before the procedure completes.
Solution Approach 2:
The system incorporates feedback mechanisms through imaging guidance (fluoroscopy, echocardiography, or other imaging modalities) that allow real-time monitoring of device position. The operator can adjust the delivery system based on feedback from imaging to ensure precise positioning before valve release.
2Device complexity
If stent/valve devices are deployed without proper leaflet engagement, then deployment is simplified, but the valve migrates and causes paravalvular leaks
Solution Approach 1:
The device is divided into separate functional components: a delivery system for positioning, a valve component for blood flow control, and an anchoring system for stability. The anchoring system includes leaflet engagement elements that can be activated independently to secure the valve to the native valve leaflets, preventing migration and paravalvular leaks.
Solution Approach 2:
The delivery system pre-positions the valve and anchoring components before activation. The anchoring system is designed to engage the native valve leaflets in a controlled manner, with the leaflet engagement elements positioned to make contact with the leaflet edges, ensuring stable attachment without complicating the overall deployment process.
3Manufacturing precision
If the valve is positioned too distally, then coronary ostia are blocked, but if positioned too proximally, then the mitral apparatus is impinged
Solution Approach 1:
The delivery system allows the operator to advance the device to the target location and confirm positioning before valve deployment. The system includes imaging guidance to verify the device is positioned distal to the coronary ostia but proximal to the mitral apparatus before the valve is released, preventing both coronary ostium blockage and mitral apparatus impingement.
Solution Approach 2:
Real-time imaging feedback (fluoroscopy, echocardiography, or other imaging modalities) allows the operator to monitor the device position relative to anatomical landmarks during deployment. The operator can adjust the delivery system based on feedback to ensure the valve is positioned in the correct location, avoiding both coronary ostium blockage and mitral apparatus impingement.
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.