Expandable Heart Valve Frames with Retention Members for Recapture
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Solution Overview
Problem
Existing prosthetic heart valves and their delivery apparatus lack precise control over placement relative to the native heart valve, and there is a need for improved ability to recapture the valve during implantation.
Innovation Solution
The prosthetic heart valves include a radially expandable frame with axially extending retention members that allow for controlled deployment and recapture, featuring a main body with interconnected struts forming cells and a valvular structure for blood flow regulation, along with a sealing member to prevent paravalvular leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a prosthetic heart valve is deployed using conventional delivery apparatus, then the valve can be implanted, but precise control over placement relative to the native heart valve is not achieved
Solution Approach 1:
The frame is divided into multiple expandable sections or cells that can be selectively deployed. This segmentation allows the valve to be positioned with precision relative to the native heart valve by controlling which sections expand first and how they are anchored during deployment.
Solution Approach 2:
The frame is pre-formed with specific geometric configurations and retention members positioned in advance. This preliminary structuring enables precise placement control during deployment, as the frame's geometry guides its interaction with the native valve anatomy before final expansion.
2Ease of operation
If conventional prosthetic heart valves are used, then implantation can be performed, but the ability to recapture the valve during implantation is insufficient
Solution Approach 1:
The frame incorporates dynamic retention members that can transition between engaged and disengaged states. These members allow the valve to be recaptured by retracting the delivery apparatus, providing operational flexibility while maintaining reliable anchoring when deployed.
Solution Approach 2:
Retention members act as intermediaries between the frame and the delivery apparatus. These members enable controlled engagement and disengagement, facilitating recapture capability while ensuring reliable attachment during the implantation process.
3Manufacturing precision
If a simple frame structure is used, then manufacturing is easier, but control over valve deployment location is limited
Solution Approach 1:
The frame is segmented into multiple cells or sections with varying degrees of freedom. This segmentation provides manufacturing precision for deployment location control while keeping each individual cell relatively simple in structure.
Solution Approach 2:
Different portions of the frame have different structural characteristics tailored to their specific functions. This local quality approach enables precise deployment location control in critical areas while maintaining simpler structures in less critical regions.
4Ease of operation
If retention members are added to the frame, then recapture capability is improved, but device complexity increases
Solution Approach 1:
The retention members are merged with the frame structure itself rather than being separate components. This integration provides recapture capability while minimizing the increase in overall device complexity, as the retention function is combined with the structural framework.
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
This design enables precise placement and recapture of prosthetic heart valves, reducing paravalvular leakage and enhancing the implantation process by allowing for adjustable positioning and secure attachment to the native heart valve.
Implementation Method 1
a radially expandable frame with axially extending retention members that allow for controlled deployment
Data Source
AI summary
A radially expandable frame includes a main body and a plurality of axially extending retention members extending axially from the stent. The frame can be deployed adjacent to a native annulus of a patient, with the retention members extending through the native annulus to retain the native leaflets in an open configuration. The retention members can also space the stent apart from the native valve in an upstream or downstream direction. The frame may be deployed as a docking station for a prosthetic heart valve or may have a valvular structure attached directly to the frame. Also disclosed herein are methods for deploying the radially expandable frame in a patient. The methods include methods for recapturing the frame into a delivery apparatus by the retention members.