Prosthetic Heart Valve Structure for Compact Delivery and Leakage Control
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Solution Overview
Problem
Conventional surgical implantation of prosthetic heart valves is risky and invasive, with high morbidity and mortality rates, particularly for frail patients, and existing minimally-invasive transcatheter valves face challenges in diameter profile and perivalvular leakage.
Innovation Solution
A prosthetic heart valve design featuring a radially collapsible and expandable frame with a valvular structure and sealing member, including leaflets with scalloped edges and a sealing member with uncovered openings to manage retrograde blood flow, reducing the crimped profile and minimizing abrasion, allowing for safer and more versatile implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a smaller crimped profile is used to reduce delivery catheter size, then the valve can be delivered to more patients, but the structural integrity and sealing capability may be compromised
Solution Approach 1:
The frame is divided into multiple struts that can be independently configured to provide structural support while maintaining a compact crimped profile. The struts are arranged in a pattern that allows the frame to collapse radially for delivery while maintaining sufficient strength when expanded.
Solution Approach 2:
The valve components are nested within each other during delivery, with the leaflets positioned within the frame structure and the sealing member integrated into the frame. This nesting allows the entire valve assembly to be compressed to a small profile for catheter delivery while maintaining all necessary functional components.
2Reliability
If a sealing member is added to prevent perivalvular leakage, then sealing capability is improved, but the device complexity and profile size increase
Solution Approach 1:
The sealing member is merged with the frame structure, where the sealing member is positioned between the frame and the surrounding tissue. This integration allows the sealing function to be added without requiring a completely separate complex assembly mechanism, as the sealing member is deployed simultaneously with the frame expansion.
Solution Approach 2:
The sealing member is positioned specifically at the interface between the frame and surrounding tissue where sealing is needed, rather than adding sealing components throughout the entire valve structure. This localized approach provides effective sealing while minimizing additional complexity and profile size.
3Reliability
If conventional surgical implantation is used to ensure proper valve placement, then implantation reliability is improved, but patient morbidity and mortality risk increase
Solution Approach 1:
The implantation method is replaced from open surgical mechanical procedures to a percutaneous catheter-based delivery system. The valve is delivered through a catheter and deployed using balloon expansion or self-expanding mechanisms, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart.
Solution Approach 2:
A delivery catheter is introduced as an intermediary device to transport the compressed valve to the implantation site and deploy it in place. This intermediary system allows the valve to be implanted through a peripheral vessel rather than requiring direct surgical access to the heart, significantly reducing patient trauma and risk.
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 design enables safer, less invasive implantation with reduced risk and a smaller crimped profile, accommodating a wider range of patient sizes and minimizing perivalvular leakage, thus improving patient outcomes and procedural safety.
Implementation Method 1
an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration
Data Source
AI summary
A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them, a valvular structure comprising a first leaflet including a first commissure tab and a second leaflet including a second commissure tab, and commissure attachment member. The commissure attachment member can be folded to define a central portion comprising a first surface and a second opposing surface, a first side portion extending from the first surface, and a second side portion extending from the first surface. The first and second commissure tabs can be disposed between and secured to the first and second side portions. The central portion and the first and second side portions of the commissure attachment member can be located inside of the frame.