Replacement Heart Valve Flap Sealing for Paravalvular Leakage
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Solution Overview
Problem
Existing replacement heart valves face challenges in securing themselves to intralumenal tissue atraumatically and preventing paravalvular leakage, particularly in minimally invasive procedures.
Innovation Solution
A self-expanding or balloon-expandable frame with distal and proximal anchoring features, biasing arms, and a flap assembly that adjusts to create a barrier against fluid flow, allowing controlled deployment and secure attachment within the native heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If replacement valves are delivered through minimally invasive or percutaneous procedures, then patient trauma is reduced, but the ability to securely anchor the valve and prevent paravalvular leakage becomes more difficult
Solution Approach 1:
The prosthesis is divided into distinct functional segments: a self-expanding frame for structural support and anchoring, a separate valve assembly for flow control, and a flap assembly for sealing. This segmentation allows each component to be optimized independently for its specific function while being delivered through a minimally invasive percutaneous approach.
Solution Approach 2:
The prosthesis incorporates dynamic elements including a self-expanding frame that automatically assumes its functional configuration upon deployment, and a flap assembly that moves in response to pressure differentials to create sealing barriers. These dynamic features enable secure anchoring and leakage prevention without requiring complex manual deployment procedures.
2Reliability
If the prosthesis is designed to block blood flow, then valve function is achieved, but paravalvular leakage occurs when blood flows around the outside of the prosthesis
Solution Approach 1:
The flap assembly serves as an intermediary sealing element positioned between the blood flow and the prosthesis frame. When pressure differential occurs across the valve, the flap is pushed against the outer surface of the frame to create a sealing barrier, effectively blocking paravalvular leakage while maintaining normal valve function.
Solution Approach 2:
The flap assembly is pre-configured to move in response to pressure differentials in a direction that creates a sealing barrier before significant paravalvular leakage can occur. This preliminary sealing action prevents the harmful effect of leakage from developing.
3Ease of operation
If the frame is made expandable for controlled deployment, then minimally invasive delivery is enabled, but the complexity of securing the prosthesis relative to intralumenal tissue increases
Solution Approach 1:
The frame is designed as a self-expanding structure that automatically assumes its functional configuration upon release from the delivery system. This self-service mechanism eliminates the need for complex manual expansion procedures and simplifies the anchoring process, as the frame naturally engages with the intralumenal tissue upon expansion.
Solution Approach 2:
The flap assembly acts as an intermediary that simplifies the anchoring process by providing a sealing barrier that works in conjunction with the self-expanding frame. This intermediary element helps secure the prosthesis relative to the intralumenal tissue without requiring complex anchoring mechanisms.
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 solution provides effective sealing and secure anchoring within the native heart valve, reducing paravalvular leakage and enhancing the heart's blood-pumping efficiency.
Implementation Method 1
at least one biasing arm extending radially outward from the frame when the frame is in an expanded configuration. The at least one biasing arm can be configured to bias the flap assembly radially outward from the longitudinal axis of the frame
Implementation Method 2
fluid flow into the space can cause the flap assembly to move from a first configuration to a second configuration which can create a barrier to fluid flow exterior to the frame
Data Source
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AI summary
A valve prosthesis can be configured to be deployed within a native heart valve and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the native heart valve, a flap assembly positioned around an exterior of the expandable frame, a proximal end of the flap assembly being positioned at or proximate a proximal end of the expandable frame. In some embodiments, the flap assembly can extend outward from the frame and have an expanded configuration configured to create a barrier to fluid flow exterior to the frame when deployed within the native heart valve.