Prosthetic Mitral Valve Anchors and Sealing Against Leakage
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Solution Overview
Problem
Existing prosthetic heart valves face challenges such as paravalvular leakage and difficulty in securing to intralumenal tissue without causing trauma, along with the risk of thrombosis.
Innovation Solution
A multi-portion prosthetic heart valve system with an inner and outer frame design, featuring atraumatic anchoring features and a sealing frame that can be delivered using a transseptal approach, allowing secure attachment to native heart valve tissue while minimizing trauma and reducing thrombosis risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional prosthetic heart valves are used to replace impaired native valves, then valve function is restored, but paravalvular leakage occurs and tissue trauma is caused
Solution Approach 1:
The prosthesis is divided into multiple functional components: an expandable frame for structural support, a sealing frame with sealing members for preventing paravalvular leakage, and anchoring members for securing to tissue. This segmentation allows each component to address specific problems independently while working together as a system.
Solution Approach 2:
The sealing frame acts as an intermediary element between the expandable frame and the native valve annulus. It includes sealing members that interface with the tissue to prevent leakage, while the anchoring members provide the connection to the expandable frame, thus mediating between structural support and sealing functions.
2Stability of the object's composition
If prostheses are secured to intralumenal tissue, then stability is improved, but tissue trauma increases
Solution Approach 1:
The anchoring members are designed with differentiated local properties: they have engagement portions that provide secure anchoring to the tissue, but also include rounded distal ends and flexible portions that minimize trauma. This local quality variation allows the same component to provide both stability and tissue protection.
Solution Approach 2:
The anchoring members can change their physical parameters depending on their state: they are flexible during delivery and deployment to minimize trauma, but provide rigid anchoring once engaged with the tissue. This parameter change allows the prosthesis to transition from a low-trauma delivery state to a high-stability anchored state.
3Object-affected harmful factors
If replacement valves are delivered through minimally invasive procedures, then patient trauma is reduced, but delivery system complexity increases
Solution Approach 1:
The prosthesis components are nested within each other during delivery: the sealing frame is positioned within the expandable frame, and both are contained within the delivery system. This nesting allows the complex multi-component prosthesis to be delivered through a single minimally invasive access point while maintaining structural integrity.
Solution Approach 2:
The delivery system is designed to be dynamic, allowing it to navigate the complex anatomy of the heart through flexible catheters and steerable components. The system transitions from a compressed delivery state to an expanded deployed state, with the ability to adapt to anatomical variations while maintaining minimally invasive access.
Data Source
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AI summary
A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.