Expandable Heart Valve Prosthesis With Annular Skirt Sealing
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Solution Overview
Problem
Existing replacement heart valves face challenges such as paravalvular leakage, difficulty in securing to intralumenal tissue atraumatically, and increased risk of thrombosis, particularly when replacing existing valves.
Innovation Solution
A prosthesis with an expandable frame, annular skirt, and valve body that secures to intralumenal tissue using anchors, prevents axial fluid flow around the prosthesis, and includes intermediate components to enhance stability and reduce thrombosis risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If replacement heart valves are delivered through minimally invasive or percutaneous procedures, then patient trauma is reduced, but the ability to securely anchor the prosthesis to intralumenal tissue is compromised
Solution Approach 1:
The prosthesis is divided into distinct functional components: an expandable frame for structural support, an annular skirt for sealing, and multiple anchors for secure attachment. This segmentation allows each component to perform its specific function optimally while being delivered through a minimally invasive catheter-based delivery system.
Solution Approach 2:
The prosthesis components are nested within a delivery catheter during minimally invasive delivery. The expandable frame, annular skirt, and anchors are contained within the catheter lumen, allowing percutaneous delivery without open surgery. Upon deployment, the frame expands radially outward from the catheter, and the anchors deploy to engage the intralumenal tissue.
2Reliability
If the prosthesis is designed to block blood flow through the valve, then valve insufficiency is corrected, but paravalvular leakage occurs when blood flows around the exterior of the prosthesis
Solution Approach 1:
The annular skirt acts as an intermediary sealing element between the expandable frame and the intralumenal tissue. This fabric barrier prevents blood from flowing around the exterior of the prosthesis by creating a seal against the tissue, while still allowing the valve to block blood flow through its leaflets.
3Reliability
If anchors are used to secure the prosthesis to intralumenal tissue, then anchoring capability is improved, but the risk of thrombosis increases
Solution Approach 1:
The annular skirt is constructed from a flexible fabric material that creates a soft seal between the rigid expandable frame and the intralumenal tissue. This fabric barrier reduces thrombosis risk by preventing direct contact between the metallic frame and blood, while still allowing effective anchoring through the anchors that engage the tissue.
Data Source
AI summary
A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity 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 body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.