Expandable Prosthetic Heart Valve Outer Skirts for Paravalvular Sealing
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Solution Overview
Problem
Existing prosthetic heart valves face challenges in forming a complete seal against irregularly shaped native valves due to calcium nodules, leading to paravalvular leakage.
Innovation Solution
The development of prosthetic heart valves with outer skirts that can bulge or flex away from the frame when expanded, featuring pleats, layers, and spacers to adapt to the native valve anatomy, ensuring a full seal and minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the outer skirt is made rigid to maintain a stable structure, then the structural stability is improved, but the ability to conform to irregular native valve shapes deteriorates
Solution Approach 1:
The outer skirt is designed with dynamic properties, including pleats that can expand and contract, and materials that exhibit elastic deformation. This allows the skirt to transition from a compact crimped state during delivery to an expanded state where it conform s to the irregular native valve anatomy, resolving the contradiction between structural stability and adaptability
Solution Approach 2:
The outer skirt employs flexible materials and a pleated structure that enables it to bend and conform to the irregular surface of the native valve. The flexible nature of the skirt allows it to adapt to calcium nodules and other anatomical variations while maintaining sufficient structural integrity during the implantation process
2Reliability
If the outer skirt is expanded to increase radial contact area for sealing, then the sealing effectiveness is improved, but the delivery profile size increases
Solution Approach 1:
The outer skirt is designed as a dynamic structure that can be compressed to a small profile for delivery and then expanded at the implantation site to achieve full radial contact area. The pleats and elastic materials enable this transformation, allowing the skirt to provide effective sealing only when needed while maintaining a low delivery profile
Solution Approach 2:
The pleated structure of the outer skirt allows the material to be nested or folded back during delivery, creating a compact profile. Upon expansion at the target site, the pleats unfold to provide the full radial contact area necessary for sealing, effectively hiding the large final size within a compact delivery configuration
3Reliability
If the outer skirt uses complex multi-layer structures to improve sealing, then the sealing performance is improved, but the device complexity increases
Solution Approach 1:
The outer skirt is segmented into multiple pleats that can independently deform and conform to the native valve surface. This segmentation allows each pleat to adapt locally to irregularities such as calcium nodules, improving sealing performance without requiring a completely complex multi-layer construction. The pleats act as independent sealing elements that work together to achieve reliable sealing
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 outer skirts effectively reduce paravalvular leakage by conforming to irregular native valve shapes, providing a secure seal and maintaining a low profile during delivery and expansion.
Implementation Method 1
The outer skirt can include a material that is configured to stretch when a force is applied thereto and to return to an original shape of the outer skirt when the force is removed therefrom.
Data Source
AI summary
Sealing members for prosthetic heart valves are disclosed. As one example, a prosthetic valve can include a radially expandable frame, a valvular structure disposed within the frame, and a sealing member disposed around an outer surface of the frame. The sealing member can have an inflow end, an outflow end, and a frame attachment region positioned axially between the inflow and outflow ends. The sealing member can include a radially inner layer and a radially outer layer, wherein the sealing member is coupled to the frame at the frame attachment region.